## Protocol Section
### Identification Module
**NCT ID:** NCT04495179

**Acronym:** AARDVARC

**Brief Title:** A Study of AZD4635 With Durvalumab and With Cabazitaxel and Durvalumab in Patients With mCRPC.

**Official Title:** A Phase II, Open-label, Study to Assess the Efficacy, Safety, and Tolerability of AZD4635 in Combination With Durvalumab and in Combination With Cabazitaxel and Durvalumab in Patients Who Have Progressive Metastatic Castrate-Resistant Prostate Cancer (AARDVARC)

#### Organization Study ID Info
**ID:** D8731C00002
#### Organization
**Class:** INDUSTRY
**Full Name:** AstraZeneca
#### Secondary ID Infos
**ID:** 2020-000209-10
**Type:** EUDRACT_NUMBER
### Status Module
#### Completion Date
**Date:** 2022-08-08

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-08-09

**Type:** ACTUAL

**Last Update Submit Date:** 2023-07-21

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2021-11-01

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2023-08-09

**Type:** ACTUAL

**Results First Submit Date:** 2022-10-27

**Results First Submit QC Date:** 2023-07-21

#### Start Date
**Date:** 2020-08-04

**Type:** ACTUAL

**Status Verified Date:** 2023-07

#### Study First Post Date
**Date:** 2020-07-31
**Type:** ACTUAL
**Study First Submit Date:** 2020-07-23
**Study First Submit QC Date:** 2020-07-30
### Sponsor Collaborators Module

#### Collaborators

**Class:** INDUSTRY

**Name:** Parexel

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** AstraZeneca

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** True

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** This is a Phase II, international, open-label, two-arm, non-randomised study of AZD4635 in participants with metastatic castration-resistant prostate cancer (mCRPC).

**Detailed Description:** This is a Phase II, international, open-label, two-arm, non-randomised study of AZD4635 in participants with mCRPC. Participants in each arm will be stratified by the presence of measurable soft tissue metastasis (per Response Evaluation Criteria in Solid Tumours \[RECIST v1.1\]) or bone-only metastasis (per Prostate Cancer Working Group 3 \[PCWG3 criteria\]). There will be no formal comparisons between treatment arms.

AZD4635 plus durvalumab (Arm A) will consist of 80 participants with mCRPC previously treated with one or more approved new hormonal agent(s) (NHAs) and one or more taxanes or participants who are taxane ineligible.

AZD4635 plus durvalumab plus cabazitaxel (Arm B) will consist of 80 participants mCRPC previously treated with docetaxel and one prior NHA.

As of November 2020, the Sponsor stopped enrolment in Arm A following decisions at the program level, not related to any safety issues. Ongoing participants in Arm A may continue treatment as planned.

### Conditions Module

**Conditions:**

- Progressive Metastatic Castrate-Resistant Prostate Cancer

**Keywords:**

- Prostate Cancer

### Design Module

#### Design Info

**Allocation:** NON_RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 30

**Type:** ACTUAL

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** AZD4635 plus durvalumab (Arm A) will consist of participants with mCRPC previously treated with one or more approved NHAs (eg, abiraterone acetate, enzalutamide, apalutamide and/or darolutamide), and one or more taxanes, or participants who are taxane ineligible.

**Intervention Names:**

- Drug: AZD4635

- Drug: Durvalumab

**Label:** Arm A: AZD4635 + durvalumab

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** AZD4635 plus durvalumab plus cabazitaxel (Arm B) will consist of participants with mCRPC previously treated with docetaxel and one prior NHA (either abiraterone acetate or enzalutamide but not both (prior apalutamide is not allowed in Arm B).

**Intervention Names:**

- Drug: AZD4635

- Drug: Durvalumab

- Drug: Cabazitaxel

**Label:** Arm B: AZD4635 + durvalumab + cabazitaxel

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Arm A: AZD4635 + durvalumab

- Arm B: AZD4635 + durvalumab + cabazitaxel

**Description:** Subjects will receive AZD4635 orally daily

**Name:** AZD4635

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Arm A: AZD4635 + durvalumab

- Arm B: AZD4635 + durvalumab + cabazitaxel

**Description:** Subjects will receive intravenous durvalumab every 4 weeks for Arm A and every 3 weeks for Arm B.

**Name:** Durvalumab

**Type:** DRUG

#### Intervention 3

**Arm Group Labels:**

- Arm B: AZD4635 + durvalumab + cabazitaxel

**Description:** Subjects will receive intravenous cabazitaxel every 3 weeks

**Name:** Cabazitaxel

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** rPFS was defined as the time from first dose to radiographic progression, assessed by the Investigator per RECIST 1.1 (soft tissue) and PCWG3 (Prostate Cancer Working Group 3) criteria \[bone\] or death from any cause, whichever occurred first.

**Measure:** Radiographic Progression Free Survival (rPFS) in Each Arm Separately to Determine the Efficacy of AZD4635 Plus Durvalumab and of AZD4635 Plus Durvalumab Plus Cabazitaxel in Patients With Metastatic Castrate-resistant Prostate Cancer (mCRPC)

**Time Frame:** From first dose to first documented progression or death from any cause (whichever comes first) (approximately 1 year)

#### Secondary Outcomes

**Description:** rPFS was defined as the time from first dose to radiographic progression, assessed by the Investigator per RECIST 1.1 (soft tissue) and PCWG3 criteria (bone) or death from any cause, whichever occurred first.

**Measure:** rPFS by Adenosine (ADO) Signalling Gene Expression in High and Low Subgroups to Determine the Efficacy of AZD4635 Plus Durvalumab Plus Cabazitaxel in Participants With mCRPC

**Time Frame:** From first dose to first documented progression or death from any cause (whichever comes first), up to two years

**Description:** OS was defined as the time from first dose until death due to any cause regardless of whether the participant withdrew from study treatment or received another anti-cancer therapy.

**Measure:** Overall Survival (OS) in Each Arm Separately to Determine the Efficacy of AZD4635 Plus Durvalumab and of AZD4635 Plus Durvalumab Plus Cabazitaxel in Participants With mCRPC

**Time Frame:** Arm A and B: Every 90 days from the last dose of study drug up to 2 years

**Description:** Confirmed ORR was defined as the proportion of participants with a confirmed complete response (CR) or partial response (PR) using overall radiographic response assessed by RECIST v1.1 and PCWG-3 criteria (bone), and was based on a subset of all treated participants with measurable disease at baseline per the site Investigator.

**Measure:** Number of Participants With Objective Response in Subjects With MCRPC Who Received AZD4635 Plus Durvalumab Plus Cabazitaxel

**Time Frame:** From first dose to first documented progression or death from any cause (whichever comes first), up to two years

**Description:** Confirmed PSA50 response is defined as the proportion of participants who achieved a ≥50% decrease in PSA from baseline to the lowest post-baseline PSA, confirmed by a consecutive PSA at least 3 weeks later and was based on PSA evaluable participants (dosed participants with an abnormal baseline PSA \[≥1 ng/mL\]).

**Measure:** Number of Participants With Prostate-specifin Antigen (PSA50) Response in Subjects With MCRPC Who Received AZD4635 Plus Durvalumab Plus Cabazitaxel

**Time Frame:** Arm A: Screening, Day 1 of each cycle up to 11 months (Each cycle was 28 days in length); Arm B: Screening, Day 1 of each cycle up to 11 months (Cycle 1 to Cycle 10 = 21 days, Cycle 11 onwards = 28 days)

**Description:** "Worst pain" and "Average pain" are 'single question' scores from the BPI short form and may take any value from 0 to 10 (worst outcome). "Interference Pain" is the total score of 7 sub-scores, where each value may take any value from 0 to 10 (worst outcome). The range of the "Interference Score" can be from 0 to 70.

**Measure:** Change From Baseline in Worst Pain in the Daily Activities Scales of the Brief Pain Inventory - Short Form (BPI-SF)

**Time Frame:** Arm A: Screening, Day 1 of each cycle up to 9 months (Each cycle was 28 days in length); Arm B: Screening, Day 1 of each cycle up to 9 months (Each cycle was 21 days in length)

**Description:** "Worst pain" and "Average pain" are 'single question' scores from the BPI short form and may take any value from 0 to 10 (worst outcome). "Interference Pain" is the total score of 7 sub-scores, where each value may take any value from 0 to 10 (worst outcome). The range of the "Interference Score" can be from 0 to 70.

**Measure:** Change From Baseline in Average Pain in the Daily Activities Scales of the Brief Pain Inventory - Short Form (BPI-SF)

**Time Frame:** Arm A: Screening, Day 1 of each cycle up to 9 months (Each cycle was 28 days in length); Arm B: Screening, Day 1 of each cycle up to 9 months (Each cycle was 21 days in length)

**Description:** "Worst pain" and "Average pain" are 'single question' scores from the BPI short form and may take any value from 0 to 10 (worst outcome). "Interference Pain" is the total score of 7 sub-scores, where each value may take any value from 0 to 10 (worst outcome). The range of the "Interference Score" can be from 0 to 70.

**Measure:** Change From Baseline in Pain Interference in the Daily Activities Scales of the Brief Pain Inventory - Short Form (BPI-SF)

**Time Frame:** Arm A: Screening, Day 1 of each cycle up to 9 months (Each cycle was 28 days in length); Arm B: Screening, Day 1 of each cycle up to 9 months (Each cycle was 21 days in length)

**Description:** Pain progression was assessed using BPI-SF.

**Measure:** Number of Participants Who Progressed Based on BPI-SF Item 3

**Time Frame:** Arm A: Screening, Day 1 of each cycle up to 12 months (Each cycle was 28 days in length); Arm B: Screening, Day 1 of each cycle up to 12 months (Cycle 1 to Cycle 10 = 21 days, Cycle 11 onwards = 28 days)

**Description:** The Functional Assessment of Cancer Therapy-Prostate (FACT-P) will be used to measure health related quality of life (HRQL) in men with prostate cancer. It consists of 4 subscales (physical, emotional, functional and social/family well-being) plus a 12-item prostate-specific module, the PCS subscale, which highlights concerns specific to participants with prostate cancer. FAPSI-6 is defined as a symptom score made up of 6 items from within the FACT-P (pain \[n = 3\], fatigue \[n = 1\], weight loss \[n = 1\], and concerns about the condition getting worse \[n = 1\]). Each question in the FACT-P questionnaires has a choice of 5 responses, "Not at all", "A little bit", "Somewhat", "Quite a bit" and "Very much". The scores range from 0 ("Not at all") to 4 ("Very much") for positively phrased questions. Negatively phrased questions have a reverse scoring, from 0 ("Very much") to 4 ("Not at all"). This results in a consistent approach, where higher scores indicate a better quality of life.

**Measure:** Change From Baseline in the FACT Advanced Prostate Symptom Indext-6 (FAPSI-6), as Derived From 6 Items, the FAPSI-8 From 8 Items Within the FACT-P and the Prostate Cancer Symptoms (PCS), From the 12 Items in the Prostrate-specific Module of the FACT-P

**Time Frame:** Arm A: Screening, Day 1 of each cycle up to 9 months (Each cycle was 28 days in length); Arm B: Screening, Day 1 of each cycle up to 9 months (Each cycle was 21 days in length)

**Description:** Investigate the PK of AZD4635 when given in combination with durvalumab, and when given in combination with durvalumab plus cabazitaxel.

**Measure:** Maximum Observed Plasma Concentration (Cmax)

**Time Frame:** Arm A:Cycle 1 to 3, and Cycle 4 onwards, and 90-day follow-up (FU) visit up to 14 months [Each cycle was 28 days in length];Arm B: Cycle 1 to 7 and Cycle 11 onwards, and 90-day FU up to 14 months (Cycle 1 to Cycle 10 = 21 days, Cycle 11 onwards = 28 days)

**Description:** Investigated the PK of AZD4635 when given in combination with durvalumab, and when given in combination with durvalumab plus cabazitaxel.

**Measure:** Terminal Half-life (t1/2λz)

**Time Frame:** Arm A:Cycle 1 to 3, and Cycle 4 onwards, and 90-day follow-up (FU) visit up to 14 months [Each cycle was 28 days in length];Arm B: Cycle 1 to 7 and Cycle 11 onwards, and 90-day FU up to 14 months (Cycle 1 to Cycle 10 = 21 days, Cycle 11 onwards = 28 days)

**Description:** Investigated the PK of AZD4635 when given in combination with durvalumab, and when given in combination with durvalumab plus cabazitaxel.

**Measure:** Area Under the Plasma Concentration Time Curve From Zero to the Time of the Last Measurable Concentration (AUClast)

**Time Frame:** Arm A:Cycle 1 to 3, and Cycle 4 onwards, and 90-day follow-up (FU) visit up to 14 months [Each cycle was 28 days in length];Arm B: Cycle 1 to 7 and Cycle 11 onwards, and 90-day FU up to 14 months (Cycle 1 to Cycle 10 = 21 days, Cycle 11 onwards = 28 days)

**Description:** Investigated the PK of AZD4635 when given in combination with durvalumab, and when given in combination with durvalumab plus cabazitaxel.

**Measure:** Area Under the Plasma Concentration Time Curve From Zero to 24 Hours [AUC(0-24)]

**Time Frame:** Arm A:Cycle 1 to 3, and Cycle 4 onwards, and 90-day follow-up (FU) visit up to 14 months [Each cycle was 28 days in length];Arm B: Cycle 1 to 7 and Cycle 11 onwards, and 90-day FU up to 14 months (Cycle 1 to Cycle 10 = 21 days, Cycle 11 onwards = 28 days)

**Description:** Investigated the PK of AZD4635 when given in combination with durvalumab, and when given in combination with durvalumab plus cabazitaxel.

**Measure:** Area Under the Plasma Concentration Time Curve From Zero Extrapolated to Infinity (AUCinf)

**Time Frame:** Arm A:Cycle 1 to 3, and Cycle 4 onwards, and 90-day follow-up (FU) visit up to 14 months [Each cycle was 28 days in length];Arm B: Cycle 1 to 7 and Cycle 11 onwards, and 90-day FU up to 14 months (Cycle 1 to Cycle 10 = 21 days, Cycle 11 onwards = 28 days)

**Description:** Investigated the PK of AZD4635 when given in combination with durvalumab, and when given in combination with durvalumab plus cabazitaxel.

**Measure:** Apparent Volume of Distribution During the Terminal Phase (Vz/F)

**Time Frame:** Arm A:Cycle 1 to 3, and Cycle 4 onwards, and 90-day follow-up (FU) visit up to 14 months [Each cycle was 28 days in length];Arm B: Cycle 1 to 7 and Cycle 11 onwards, and 90-day FU up to 14 months (Cycle 1 to Cycle 10 = 21 days, Cycle 11 onwards = 28 days)

**Description:** Safety and tolerability of each treatment regimen were assessed in participants with mCRPC.

**Measure:** Number of Subjects With Serious and Non-serious Adverse Events

**Time Frame:** Arm A: From Screening up to 14 months (Each cycle was 28 days in length); Arm B: From Screening up to 14 months (Cycle 1 to Cycle 10 was 21 days in length, and Cycle 11 onwards was 28 days in length)

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

1. Histologically confirmed adenocarcinoma of the prostate.
2. Known castrate-resistant disease.
3. Evidence of disease progression ≤6 months.
4. Body weight \>30 kg at screening.
5. Willingness to adhere to the study treatment-specific contraception requirements.
6. Adequate bone marrow reserve and organ function.
7. Adequate organ function for Arm A as demonstrated by all of the following laboratory values:

   * Alanine aminotransferase (ALT) ≤2.5 × upper limit of normal (ULN) if no demonstrable liver metastases or ≤5 × ULN in the presence of liver metastases.
   * Aspartate aminotransferase (AST) ≤2.5 × ULN if no demonstrable liver metastases or ≤5 × ULN in the presence of liver metastases
   * Total bilirubin (TBL) ≤1.5 × ULN
   * TBL ≤2.0 × ULN in the case of known Gilbert syndrome with normal direct bilirubin
8. Participants in Arm A must have received the following prior therapy:

   * Maximum of 3 lines of therapy in the mCRPC setting
   * Prior therapy with one or more NHAs (eg, abiraterone acetate, enzalutamide, apalutamide, darolutamide) in either hormone-sensitive or hormone-refractory settings
   * Prior therapy with one or more lines of taxanes (eg, docetaxel and/or cabazitaxel)
   * Alternatively, must be taxane-ineligible
   * Prior therapy can be in either the hormone-sensitive or the hormone-refractory setting
9. Adequate organ function for Arm B as demonstrated by all of the following laboratory values:

   * AST and/or ALT ≤1.5 × ULN
   * TBL ≤ ULN
   * TBL ≤2.0 × ULN in the case of known Gilbert syndrome with normal direct bilirubin
10. Participants in Arm B must have received the following prior therapy:

    * Prior docetaxel (taxane) in either hormone-sensitive or hormone-refractory settings
    * Received no prior cytotoxic chemotherapy other than docetaxel for prostate cancer except for estramustine and except adjuvant/neo-adjuvant treatment completed \>3 years ago.
    * Prior therapy with only one NHAs (eg, abiraterone acetate or enzalutamide; prior apalutamide is not permitted) for treatment of mCRPC in either hormone-sensitive or hormone-refractory settings.
    * Be suitable to receive concomitant Granulocyte-colony stimulating factor during all cycles of cabazitaxel.
    * Participants who meet inclusion criteria for Arm B will be allocated preferentially to that arm until recruitment to that arm is completed.

Exclusion Criteria:

1. Active brain metastases or leptomeningeal metastases.
2. There must be no requirement for immunosuppressive doses of systemic corticosteroids for at least 2 weeks prior to study enrollment.
3. History of pneumonitis requiring corticosteroids, second malignancy that is progressing and/or received active treatment ≤3 years before the first dose of study intervention, and hypersensitivity to polysorbate-80 if allocated to cabazitaxel.
4. As judged by the Investigator, any evidence of severe or uncontrolled systemic diseases.
5. Creatinine clearance \<40 mL/min (calculated by Cockcroft-Gault equation).
6. Prior exposure to immune-mediated therapy including.
7. Ongoing treatment with warfarin (Coumadin).
8. Major surgery (excluding placement of vascular access) within 4 weeks of the first dose of study intervention.

**Gender Based:** True

**Maximum Age:** 150 Years

**Minimum Age:** 18 Years

**Sex:** MALE

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Sacramento

**Country:** United States

**Facility:** Research Site

**State:** California

**Zip:** 95817

**Location 2:**

**City:** Tampa

**Country:** United States

**Facility:** Research Site

**State:** Florida

**Zip:** 33612

**Location 3:**

**City:** Atlanta

**Country:** United States

**Facility:** Research Site

**State:** Georgia

**Zip:** 30318

**Location 4:**

**City:** Saint Louis

**Country:** United States

**Facility:** Research Site

**State:** Missouri

**Zip:** 63110

**Location 5:**

**City:** Winston-Salem

**Country:** United States

**Facility:** Research Site

**State:** North Carolina

**Zip:** 27157

**Location 6:**

**City:** Brasschaat

**Country:** Belgium

**Facility:** Research Site

**Zip:** 2930

**Location 7:**

**City:** Gent

**Country:** Belgium

**Facility:** Research Site

**Zip:** 9000

**Location 8:**

**City:** Bordeaux

**Country:** France

**Facility:** Research Site

**Zip:** 33076

**Location 9:**

**City:** Villejuif

**Country:** France

**Facility:** Research Site

**Zip:** 94805

**Location 10:**

**City:** Goyang-si

**Country:** Korea, Republic of

**Facility:** Research Site

**Zip:** 10408

**Location 11:**

**City:** Seoul

**Country:** Korea, Republic of

**Facility:** Research Site

**Zip:** 06351

**Location 12:**

**City:** Seoul

**Country:** Korea, Republic of

**Facility:** Research Site

**Zip:** 06591

**Location 13:**

**City:** Barcelona

**Country:** Spain

**Facility:** Research Site

**Zip:** 08041

**Location 14:**

**City:** Barcelona

**Country:** Spain

**Facility:** Research Site

**Zip:** 8035

**Location 15:**

**City:** Hospitalet deLlobregat

**Country:** Spain

**Facility:** Research Site

**Zip:** 08907

**Location 16:**

**City:** Madrid

**Country:** Spain

**Facility:** Research Site

**Zip:** 28034

#### Overall Officials

**Official 1:**

**Affiliation:** Dana-Farber Cancer Institute

**Name:** Christopher J Sweeney, MBBS

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**Access Criteria:** When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

**Description:** Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

**Info Types:**

- STUDY_PROTOCOL

- SAP

**IPD Sharing:** YES

**Time Frame:** AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

**URL:** https://astrazenecagroup-dt.pharmacm.com/DT/Home

### References Module

#### See Also Links

**Label:** Related Info

**URL:** https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&amp;parentIdentifier=D8731C00002&amp;attachmentIdentifier=094a199c-bf37-4374-90e2-5f80530bdae1&amp;fileName=D8731C00002_Protocol.pdf&amp;versionIdentifier=

**Label:** Related Info

**URL:** https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&amp;parentIdentifier=D8731C00002&amp;attachmentIdentifier=d3ddec19-8569-41e1-9a0d-d7950c823cc6&amp;fileName=D8731C00002_SAP.pdf&amp;versionIdentifier=

**Label:** Related Info

**URL:** https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&amp;parentIdentifier=D8731C00002&amp;attachmentIdentifier=8497cc3d-bcf9-447f-9d24-a712c91a5027&amp;fileName=D8731C00002_CSR_Synopsis.pdf&amp;versionIdentifier=

## Document Section

### Large Document Module

#### Large Docs

- Date: 2020-11-24

- Filename: Prot_000.pdf

- Has ICF: False

- Has Protocol: True

- Has SAP: False

- Label: Study Protocol

- Size: 6777319

- Type Abbrev: Prot

- Upload Date: 2022-10-28T07:57

- Date: 2022-04-20

- Filename: SAP_001.pdf

- Has ICF: False

- Has Protocol: False

- Has SAP: True

- Label: Statistical Analysis Plan

- Size: 14003768

- Type Abbrev: SAP

- Upload Date: 2022-10-28T07:57

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000005834

- Term: Genital Neoplasms, Male

- ID: D000014565

- Term: Urogenital Neoplasms

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000009369

- Term: Neoplasms

- ID: D000005832

- Term: Genital Diseases, Male

- ID: D000091662

- Term: Genital Diseases

- ID: D000091642

- Term: Urogenital Diseases

- ID: D000011469

- Term: Prostatic Diseases

- ID: D000052801

- Term: Male Urogenital Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M14335

- Name: Prostatic Neoplasms

- Relevance: HIGH

- As Found: Prostate Cancer

- ID: M8946

- Name: Genital Neoplasms, Male

- Relevance: LOW

- As Found: Unknown

- ID: M17315

- Name: Urogenital Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M2876

- Name: Genital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8944

- Name: Genital Diseases, Male

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14333

- Name: Prostatic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27095

- Name: Male Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000011471

- Term: Prostatic Neoplasms

### Intervention Browse Module - Ancestors

- ID: D000074322

- Term: Antineoplastic Agents, Immunological

- ID: D000000970

- Term: Antineoplastic Agents

### Intervention Browse Module - Browse Branches

- Abbrev: ANeo

- Name: Antineoplastic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M1668

- Name: Docetaxel

- Relevance: LOW

- As Found: Unknown

- ID: M272500

- Name: Durvalumab

- Relevance: HIGH

- As Found: Non-Small Cell

- ID: M451

- Name: Abiraterone Acetate

- Relevance: LOW

- As Found: Unknown

- ID: M147959

- Name: Taxane

- Relevance: LOW

- As Found: Unknown

- ID: M1346

- Name: Antineoplastic Agents, Immunological

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: C000613593

- Term: Durvalumab

### Misc Info Module

#### Removed Countries

- Country: Denmark

- Country: Germany

- Country: Italy

- Country: Netherlands

- Country: United Kingdom

#### Submission Tracking

##### First MCP Info

###### Post Date

- Date: 2022-11-23

- Type: ACTUAL

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

#### Event Groups

**Group ID:** EG000

**Title:** Arm A: AZD4635 + Durvalumab

**Deaths Num Affected:** 2

**Deaths Num At Risk:** 2

**Description:** Participants received AZD4635 Dose A orally daily, and durvalumab Dose B intravenously every 4 weeks.

**ID:** EG000

**Other Num Affected:** 2

**Other Num at Risk:** 2

**Serious Number Affected:** 2

**Serious Number At Risk:** 2

**Title:** Arm A: AZD4635 + Durvalumab

**Group ID:** EG001

**Title:** Arm B: AZD4635 + Durvalumab + Cabazitaxel

**Deaths Num Affected:** 7

**Deaths Num At Risk:** 28

**Description:** Participants received AZD4635 Dose A orally daily, durvalumab Dose B intravenously (IV) every 3 weeks (Q3W), and cabazitaxel Dose C IV Q3W

**ID:** EG001

**Other Num Affected:** 28

**Other Num at Risk:** 28

**Serious Number Affected:** 19

**Serious Number At Risk:** 28

**Title:** Arm B: AZD4635 + Durvalumab + Cabazitaxel

**Frequency Threshold:** 5

#### Other Events

**Term:** Urinary tract infection

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA v24.1

**Term:** Anaemia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** MedDRA v24.1

**Term:** Neutropenia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** MedDRA v24.1

**Term:** Thrombocytopenia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** MedDRA v24.1

**Term:** Decreased appetite

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA v24.1

**Term:** Hyperglycaemia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA v24.1

**Term:** Hyperkalaemia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA v24.1

**Term:** Hyperuricaemia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA v24.1

**Term:** Hypocalcaemia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA v24.1

**Term:** Hypokalaemia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA v24.1

**Term:** Hypophosphataemia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA v24.1

**Term:** Depression

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** MedDRA v24.1

**Term:** Insomnia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** MedDRA v24.1

**Term:** Dizziness

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA v24.1

**Term:** Dysgeusia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA v24.1

**Term:** Headache

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA v24.1

**Term:** Neuropathy peripheral

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA v24.1

**Term:** Peripheral sensory neuropathy

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA v24.1

**Term:** Hypertension

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA v24.1

**Term:** Hypotension

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA v24.1

**Term:** Dyspnoea

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA v24.1

**Term:** Abdominal pain

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA v24.1

**Term:** Constipation

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA v24.1

**Term:** Diarrhoea

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA v24.1

**Term:** Dry mouth

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA v24.1

**Term:** Dyspepsia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA v24.1

**Term:** Gastrooesophageal reflux disease

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA v24.1

**Term:** Nausea

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA v24.1

**Term:** Oral pain

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA v24.1

**Term:** Vomiting

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA v24.1

**Term:** Dry skin

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA v24.1

**Term:** Pruritus

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA v24.1

**Term:** Arthralgia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA v24.1

**Term:** Back pain

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA v24.1

**Term:** Flank pain

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA v24.1

**Term:** Muscle spasms

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA v24.1

**Term:** Muscular weakness

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA v24.1

**Term:** Myalgia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA v24.1

**Term:** Pain in extremity

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA v24.1

**Term:** Haematuria

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA v24.1

**Term:** Urinary retention

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA v24.1

**Term:** Reproductive system and breast disorders

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Reproductive system and breast disorders

**Source Vocabulary:** MedDRA v24.1

**Term:** Asthenia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA v24.1

**Term:** Chills

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA v24.1

**Term:** Fatigue

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA v24.1

**Term:** Non-cardiac chest pain

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA v24.1

**Term:** Oedema peripheral

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA v24.1

**Term:** Pain

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA v24.1

**Term:** Pyrexia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA v24.1

**Term:** Alanine aminotransferase increased

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA v24.1

**Term:** Amylase increased

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA v24.1

**Term:** Aspartate aminotransferase increased

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA v24.1

**Term:** Blood alkaline phosphatase increased

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA v24.1

**Term:** Blood lactate dehydrogenase increased

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA v24.1

**Term:** Lipase increased

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA v24.1

**Term:** Neutrophil count decreased

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA v24.1

**Term:** Weight decreased

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA v24.1

**Term:** White blood cell count decreased

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA v24.1

**Term:** Fall

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA v24.1

#### Serious Events

**Term:** Abscess neck

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA v24.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 2

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 28

**Term:** Diverticulitis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA v24.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 2

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 28

**Term:** Ureteritis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA v24.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 2

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 28

**Term:** Urinary tract infection

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA v24.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 2

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 28

**Term:** Anaemia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** MedDRA v24.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 2

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 28

**Term:** Febrile Neutropenia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** MedDRA v24.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 2

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 28

**Term:** Decreased Appetite

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA v24.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 2

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 28

**Term:** Hypotension

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA v24.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 2

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 28

**Term:** Dyspnoea

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA v24.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 2

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 28

**Term:** Haemoptysis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA v24.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 2

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 28

**Term:** Colitis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA v24.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 2

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 28

**Term:** Diarrhoea

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA v24.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 2

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 28

**Term:** Dysphagia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA v24.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 2

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 28

**Term:** Nausea

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA v24.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 2

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 28

**Term:** Rectal Haemorrhage

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA v24.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 2

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 28

**Term:** Vomiting

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA v24.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 2

**Group ID:** EG001

**Num Affected:** 3

**Num At Risk:** 28

**Term:** Cholecystitis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

**Source Vocabulary:** MedDRA v24.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 2

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 28

**Term:** Cholecystitis Acute

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

**Source Vocabulary:** MedDRA v24.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 2

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 28

**Term:** Arthralgia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA v24.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 2

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 28

**Term:** Myositis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA v24.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 2

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 28

**Term:** Cystitis Haemorrhagic

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA v24.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 2

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 28

**Term:** Haematuria

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA v24.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 2

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 28

**Term:** Hydronephrosis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA v24.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 2

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 28

**Term:** Urinary Retention

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA v24.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 2

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 28

**Term:** Malaise

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA v24.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 2

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 28

**Term:** Pyrexia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA v24.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 2

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 28

**Term:** Neutrophil Count Decreased

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA v24.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 2

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 28

**Term:** Acute Post Hemorrhagic Anemia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** MedDRA v24.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 2

**Group ID:** EG001

**Num At Risk:** 28

**Time Frame:** All-Cause Mortality: Up to 2 years; Serious and/or other adverse events: From Screening up to 14 months (Each cycle was 28 days in length) for Arm A and from Screening up to 14 months (Cycle 1 to Cycle 10 was 21 days in length, and Cycle 11 onwards was 28 days in length) for Arm B.

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 2

**Group ID:** BG001

**Value:** 28

**Group ID:** BG002

**Value:** 30

**Units:** Participants

### Group

**ID:** BG000

**Title:** Arm A: AZD4635 + Durvalumab

**Description:** Participants received AZD4635 Dose A orally daily, and durvalumab Dose B intravenously every 4 weeks.

### Group

**ID:** BG001

**Title:** Arm B: AZD4635 + Durvalumab + Cabazitaxel

**Description:** Participants received AZD4635 Dose A orally daily, durvalumab Dose B intravenously (IV) every 3 weeks (Q3W), and cabazitaxel Dose C IV Q3W

### Group

**ID:** BG002

**Title:** Total

**Description:** Total of all reporting groups

### Measure

#### Measurement

**Group ID:** BG001

**Spread:** 8.18

**Value:** 68.0

#### Measurement

**Group ID:** BG002

**Spread:** 8.18

**Value:** 68.0

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 0

**Group ID:** BG001

**Value:** 28

**Group ID:** BG002

**Value:** 28

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 28

#### Measurement

**Group ID:** BG002

**Value:** 28

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 0

**Group ID:** BG001

**Value:** 28

**Group ID:** BG002

**Value:** 28

**Class Title:** Male

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 4

#### Measurement

**Group ID:** BG002

**Value:** 4

**Category Title:** Hispanic or Latino

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 21

#### Measurement

**Group ID:** BG002

**Value:** 21

**Category Title:** Not Hispanic or Latino

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 3

#### Measurement

**Group ID:** BG002

**Value:** 3

**Category Title:** Unknown or Not Reported

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 0

**Group ID:** BG001

**Value:** 28

**Group ID:** BG002

**Value:** 28

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** American Indian or Alaska Native

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 5

#### Measurement

**Group ID:** BG002

**Value:** 5

**Category Title:** Asian

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** Native Hawaiian or Other Pacific Islander

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** Black or African American

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 19

#### Measurement

**Group ID:** BG002

**Value:** 19

**Category Title:** White

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** More than one race

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 1

#### Measurement

**Group ID:** BG002

**Value:** 1

**Category Title:** Unknown or Not Reported

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 0

**Group ID:** BG001

**Value:** 25

**Group ID:** BG002

**Value:** 25

**Class Title:** 

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Population Description:** The data for Arm A was not calculated because of only two participants in this arm due to which there will be a patient identification risk.
**Title:** Age, Continuous
**Unit of Measure:** years
### Measure 2
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** The data for Arm A was not calculated because of only two participants in this arm due to which there will be a patient identification risk.
**Title:** Sex/Gender, Customized
**Unit of Measure:** Participants
### Measure 3
**Description:** The data for Arm A was not calculated because of only two participants in this arm due to which there will be a patient identification risk.
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** The number analyzed in the row differs from the overall value as efficacy for low number of participants were not presented.
**Title:** Ethnicity (NIH/OMB)
**Unit of Measure:** Participants
### Measure 4
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** The data for Arm A was not calculated because of only two participants in this arm due to which there will be a patient identification risk.
**Title:** Race (NIH/OMB)
**Unit of Measure:** Participants
**Population Description:** Safety analysis set consisted of all patients who received at least one dose of study treatment. The data for Arm A was not calculated because of only two participants in this arm due to which there will be a patient identification risk.
## Results Section - More Information Module
### Certain Agreement
**Other Details:** This document contains trade secrets and confidential commercial information, disclosure of which is prohibited without providing advance notice to AstraZeneca and opportunity to object.
**Restriction Type:** OTHER
**Restrictive Agreement:** True
### Point of Contact
**Email:** information.center@astrazeneca.com
**Organization:** AstraZeneca Clinical Study Information Center
**Phone:** 1-877-240-94 79
**Title:** Global Clinical Head
## Results Section - Outcome Measures Module
### Outcome Measure 1
### Outcome Measure 2
### Outcome Measure 3
### Outcome Measure 4
### Outcome Measure 5
### Outcome Measure 6
### Outcome Measure 7
### Outcome Measure 8
### Outcome Measure 9
### Outcome Measure 10
### Outcome Measure 11
### Outcome Measure 12
### Outcome Measure 13
### Outcome Measure 14
### Outcome Measure 15
### Outcome Measure 16
### Outcome Measure 17
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** An upper limit for the 95%CI was not calculated because there were not enough events at later times to get a reliable upper CI.
- **Group ID:** OG001
- **Lower Limit:** 4.2
- **Spread:** 
- **Upper Limit:** NA
- **Value:** 5.8
**Title:** 
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 14
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 13
**Title:** 
#### Outcome Measure 3
**Class:**
##### Category
**Measurements:**
- **Comment:** This value was not calculated since less than 50% patients died during the study.
- **Group ID:** OG001
- **Lower Limit:** 7.9
- **Spread:** 
- **Upper Limit:** NA
- **Value:** NA
**Title:** 
#### Outcome Measure 4
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0.88
- **Spread:** 
- **Upper Limit:** 23.50
- **Value:** 2
**Title:** 
#### Outcome Measure 5
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0.06
- **Spread:** 
- **Upper Limit:** 0.37
- **Value:** 5
**Title:** 
#### Outcome Measure 6
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 2.44
- **Upper Limit:** 
- **Value:** 3.4
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 0
- **Group ID:** OG001
- **Value:** 14
**Units:** Participants
**Class:**
**Denomination:**
- **Group ID:** OG000
- **Value:** 0
- **Group ID:** OG001
- **Value:** 0
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 2.94
- **Upper Limit:** 
- **Value:** -1.6
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 0
- **Group ID:** OG001
- **Value:** 11
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 4.40
- **Upper Limit:** 
- **Value:** -0.3
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 0
- **Group ID:** OG001
- **Value:** 13
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 2.88
- **Upper Limit:** 
- **Value:** -1.6
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 0
- **Group ID:** OG001
- **Value:** 9
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 3.58
- **Upper Limit:** 
- **Value:** -2.1
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 0
- **Group ID:** OG001
- **Value:** 7
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 3.00
- **Upper Limit:** 
- **Value:** -1.9
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 0
- **Group ID:** OG001
- **Value:** 8
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1.85
- **Upper Limit:** 
- **Value:** 1.0
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 0
- **Group ID:** OG001
- **Value:** 8
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 2.66
- **Upper Limit:** 
- **Value:** -1.7
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 0
- **Group ID:** OG001
- **Value:** 6
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 2.17
- **Upper Limit:** 
- **Value:** -0.2
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 0
- **Group ID:** OG001
- **Value:** 5
**Units:** Participants
#### Outcome Measure 7
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 2.09
- **Upper Limit:** 
- **Value:** 2.3
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 0
- **Group ID:** OG001
- **Value:** 14
**Units:** Participants
**Class:**
**Denomination:**
- **Group ID:** OG000
- **Value:** 0
- **Group ID:** OG001
- **Value:** 0
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1.19
- **Upper Limit:** 
- **Value:** -1.3
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 0
- **Group ID:** OG001
- **Value:** 11
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 3.15
- **Upper Limit:** 
- **Value:** 0.6
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 0
- **Group ID:** OG001
- **Value:** 13
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1.27
- **Upper Limit:** 
- **Value:** -0.9
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 0
- **Group ID:** OG001
- **Value:** 9
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 2.15
- **Upper Limit:** 
- **Value:** -1.6
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 0
- **Group ID:** OG001
- **Value:** 7
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1.51
- **Upper Limit:** 
- **Value:** -1.4
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 0
- **Group ID:** OG001
- **Value:** 8
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1.41
- **Upper Limit:** 
- **Value:** 0.0
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 0
- **Group ID:** OG001
- **Value:** 8
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1.47
- **Upper Limit:** 
- **Value:** -0.8
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 0
- **Group ID:** OG001
- **Value:** 6
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.84
- **Upper Limit:** 
- **Value:** -1.2
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 0
- **Group ID:** OG001
- **Value:** 5
**Units:** Participants
#### Outcome Measure 8
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 8.47
- **Upper Limit:** 
- **Value:** 8.0
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 0
- **Group ID:** OG001
- **Value:** 14
**Units:** Participants
**Class:**
**Denomination:**
- **Group ID:** OG000
- **Value:** 0
- **Group ID:** OG001
- **Value:** 0
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 13.90
- **Upper Limit:** 
- **Value:** 2.5
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 0
- **Group ID:** OG001
- **Value:** 11
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 18.96
- **Upper Limit:** 
- **Value:** 12.3
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 0
- **Group ID:** OG001
- **Value:** 13
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 12.73
- **Upper Limit:** 
- **Value:** 4.9
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 0
- **Group ID:** OG001
- **Value:** 9
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 5.19
- **Upper Limit:** 
- **Value:** 1.3
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 0
- **Group ID:** OG001
- **Value:** 7
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 8.40
- **Upper Limit:** 
- **Value:** 2.0
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 0
- **Group ID:** OG001
- **Value:** 8
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 9.93
- **Upper Limit:** 
- **Value:** 8.1
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 0
- **Group ID:** OG001
- **Value:** 8
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 13.98
- **Upper Limit:** 
- **Value:** 7.2
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 0
- **Group ID:** OG001
- **Value:** 6
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 15.16
- **Upper Limit:** 
- **Value:** 5.4
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 0
- **Group ID:** OG001
- **Value:** 5
**Units:** Participants
#### Outcome Measure 9
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
**Title:** 
#### Outcome Measure 10
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 2.88
- **Upper Limit:** 
- **Value:** 16.6
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 0
- **Group ID:** OG001
- **Value:** 10
**Units:** Participants
**Class:**
**Denomination:**
- **Group ID:** OG000
- **Value:** 0
- **Group ID:** OG001
- **Value:** 0
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1.68
- **Upper Limit:** 
- **Value:** 1.9
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 0
- **Group ID:** OG001
- **Value:** 7
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 5.52
- **Upper Limit:** 
- **Value:** -0.7
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 0
- **Group ID:** OG001
- **Value:** 9
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 3.34
- **Upper Limit:** 
- **Value:** -0.1
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 0
- **Group ID:** OG001
- **Value:** 7
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 3.36
- **Upper Limit:** 
- **Value:** 0.6
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 0
- **Group ID:** OG001
- **Value:** 5
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1.38
- **Upper Limit:** 
- **Value:** 1.5
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 0
- **Group ID:** OG001
- **Value:** 6
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 3.92
- **Upper Limit:** 
- **Value:** 0.0
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 0
- **Group ID:** OG001
- **Value:** 7
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 4.15
- **Upper Limit:** 
- **Value:** -1.8
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 0
- **Group ID:** OG001
- **Value:** 5
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 4.55
- **Upper Limit:** 
- **Value:** -3.0
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 0
- **Group ID:** OG001
- **Value:** 4
**Units:** Participants
#### Outcome Measure 11
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 231.1
- **Upper Limit:** 
- **Value:** 483.0
**Title:** 
#### Outcome Measure 12
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 4.82
- **Upper Limit:** 
- **Value:** 8.87
**Title:** 
#### Outcome Measure 13
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1056
- **Upper Limit:** 
- **Value:** 2787
**Title:** 
#### Outcome Measure 14
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1084
- **Upper Limit:** 
- **Value:** 2874
**Title:** 
#### Outcome Measure 15
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1272
- **Upper Limit:** 
- **Value:** 3311
**Title:** 
#### Outcome Measure 16
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 254.4
- **Upper Limit:** 
- **Value:** 334.6
**Title:** 
#### Outcome Measure 17
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 28
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 28
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 23
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 20
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 28
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 24
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 20
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 9
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 9
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 19
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 17
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 10
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 19
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 12
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 4
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 5
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 4
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 15
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 4
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 5
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 7
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 4
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 8
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** rPFS was defined as the time from first dose to radiographic progression, assessed by the Investigator per RECIST 1.1 (soft tissue) and PCWG3 (Prostate Cancer Working Group 3) criteria \[bone\] or death from any cause, whichever occurred first.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** MEDIAN
**Population Description:** Evaluable for efficacy set consisted of dosed patients with a baseline tumour assessment. The data for Arm A was not calculated because of only two participants in this arm due to which there will be a patient identification risk.
**Reporting Status:** POSTED
**Time Frame:** From first dose to first documented progression or death from any cause (whichever comes first) (approximately 1 year)
**Title:** Radiographic Progression Free Survival (rPFS) in Each Arm Separately to Determine the Efficacy of AZD4635 Plus Durvalumab and of AZD4635 Plus Durvalumab Plus Cabazitaxel in Patients With Metastatic Castrate-resistant Prostate Cancer (mCRPC)
**Type:** PRIMARY
**Unit of Measure:** months
##### Group
**Description:** Participants received AZD4635 Dose A orally daily, and durvalumab Dose B intravenously every 4 weeks.
**ID:** OG000
**Title:** Arm A: AZD4635 + Durvalumab
##### Group
**Description:** Participants received AZD4635 Dose A orally daily, durvalumab Dose B intravenously (IV) every 3 weeks (Q3W), and cabazitaxel Dose C IV Q3W
**ID:** OG001
**Title:** Arm B: AZD4635 + Durvalumab + Cabazitaxel
#### Outcome Measure 2
**Description:** rPFS was defined as the time from first dose to radiographic progression, assessed by the Investigator per RECIST 1.1 (soft tissue) and PCWG3 criteria (bone) or death from any cause, whichever occurred first.
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** Evaluable for efficacy set consisted of dosed patients with a baseline tumour assessment. The data for Arm A was not calculated because of only two participants in this arm due to which there will be a patient identification risk. The analysis of rPFS by ADO was not done.
**Reporting Status:** POSTED
**Time Frame:** From first dose to first documented progression or death from any cause (whichever comes first), up to two years
**Title:** rPFS by Adenosine (ADO) Signalling Gene Expression in High and Low Subgroups to Determine the Efficacy of AZD4635 Plus Durvalumab Plus Cabazitaxel in Participants With mCRPC
**Type:** SECONDARY
**Unit of Measure:** Participants
##### Group
**Description:** Participants received AZD4635 Dose A orally daily, and durvalumab Dose B intravenously every 4 weeks.
**ID:** OG000
**Title:** Arm A: AZD4635 + Durvalumab
##### Group
**Description:** Participants received AZD4635 Dose A orally daily, durvalumab Dose B intravenously (IV) every 3 weeks (Q3W), and cabazitaxel Dose C IV Q3W
**ID:** OG001
**Title:** Arm B: AZD4635 + Durvalumab + Cabazitaxel
#### Outcome Measure 3
**Description:** OS was defined as the time from first dose until death due to any cause regardless of whether the participant withdrew from study treatment or received another anti-cancer therapy.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** MEDIAN
**Population Description:** Evaluable for efficacy set consisted of dosed patients with a baseline tumour assessment. The data for Arm A was not calculated because of only two participants in this arm due to which there will be a patient identification risk.
**Reporting Status:** POSTED
**Time Frame:** Arm A and B: Every 90 days from the last dose of study drug up to 2 years
**Title:** Overall Survival (OS) in Each Arm Separately to Determine the Efficacy of AZD4635 Plus Durvalumab and of AZD4635 Plus Durvalumab Plus Cabazitaxel in Participants With mCRPC
**Type:** SECONDARY
**Unit of Measure:** months
##### Group
**Description:** Participants received AZD4635 Dose A orally daily, and durvalumab Dose B intravenously every 4 weeks.
**ID:** OG000
**Title:** Arm A: AZD4635 + Durvalumab
##### Group
**Description:** Participants received AZD4635 Dose A orally daily, durvalumab Dose B intravenously (IV) every 3 weeks (Q3W), and cabazitaxel Dose C IV Q3W
**ID:** OG001
**Title:** Arm B: AZD4635 + Durvalumab + Cabazitaxel
#### Outcome Measure 4
**Description:** Confirmed ORR was defined as the proportion of participants with a confirmed complete response (CR) or partial response (PR) using overall radiographic response assessed by RECIST v1.1 and PCWG-3 criteria (bone), and was based on a subset of all treated participants with measurable disease at baseline per the site Investigator.
**Parameter Type:** NUMBER
**Population Description:** Evaluable for efficacy set consisted of dosed patients with a baseline tumour assessment. The data for Arm A was not calculated because of only two participants in this arm due to which there will be a patient identification risk.
**Reporting Status:** POSTED
**Time Frame:** From first dose to first documented progression or death from any cause (whichever comes first), up to two years
**Title:** Number of Participants With Objective Response in Subjects With MCRPC Who Received AZD4635 Plus Durvalumab Plus Cabazitaxel
**Type:** SECONDARY
**Unit of Measure:** Participants
##### Group
**Description:** Participants received AZD4635 Dose A orally daily, and durvalumab Dose B intravenously every 4 weeks.
**ID:** OG000
**Title:** Arm A: AZD4635 + Durvalumab
##### Group
**Description:** Participants received AZD4635 Dose A orally daily, durvalumab Dose B intravenously (IV) every 3 weeks (Q3W), and cabazitaxel Dose C IV Q3W
**ID:** OG001
**Title:** Arm B: AZD4635 + Durvalumab + Cabazitaxel
#### Outcome Measure 5
**Description:** Confirmed PSA50 response is defined as the proportion of participants who achieved a ≥50% decrease in PSA from baseline to the lowest post-baseline PSA, confirmed by a consecutive PSA at least 3 weeks later and was based on PSA evaluable participants (dosed participants with an abnormal baseline PSA \[≥1 ng/mL\]).
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** PSA evaluable analysis set consisted of dosed participants with an abnormal baseline PSA (=1ng/mL). The data for Arm A was not calculated because of only two participants in this arm due to which there will be a patient identification risk.
**Reporting Status:** POSTED
**Time Frame:** Arm A: Screening, Day 1 of each cycle up to 11 months (Each cycle was 28 days in length); Arm B: Screening, Day 1 of each cycle up to 11 months (Cycle 1 to Cycle 10 = 21 days, Cycle 11 onwards = 28 days)
**Title:** Number of Participants With Prostate-specifin Antigen (PSA50) Response in Subjects With MCRPC Who Received AZD4635 Plus Durvalumab Plus Cabazitaxel
**Type:** SECONDARY
**Unit of Measure:** Participants
##### Group
**Description:** Participants received AZD4635 Dose A orally daily, and durvalumab Dose B intravenously every 4 weeks.
**ID:** OG000
**Title:** Arm A: AZD4635 + Durvalumab
##### Group
**Description:** Participants received AZD4635 Dose A orally daily, durvalumab Dose B intravenously (IV) every 3 weeks (Q3W), and cabazitaxel Dose C IV Q3W
**ID:** OG001
**Title:** Arm B: AZD4635 + Durvalumab + Cabazitaxel
#### Outcome Measure 6
**Description:** "Worst pain" and "Average pain" are 'single question' scores from the BPI short form and may take any value from 0 to 10 (worst outcome). "Interference Pain" is the total score of 7 sub-scores, where each value may take any value from 0 to 10 (worst outcome). The range of the "Interference Score" can be from 0 to 70.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** Full analysis set consisted of all participants who received at least one (non-zero) dose of study treatment. The data for Arm A was not calculated because of only two participants in this arm due to which there will be a patient identification risk. Only safety data have been provided.

None of the 14 participants at Baseline answered the questionnaire at Cycle 1 Day 1. Therefore, related statistics were not derived for this timepoint.
**Reporting Status:** POSTED
**Time Frame:** Arm A: Screening, Day 1 of each cycle up to 9 months (Each cycle was 28 days in length); Arm B: Screening, Day 1 of each cycle up to 9 months (Each cycle was 21 days in length)
**Title:** Change From Baseline in Worst Pain in the Daily Activities Scales of the Brief Pain Inventory - Short Form (BPI-SF)
**Type:** SECONDARY
**Unit of Measure:** Score on a Scale
##### Group
**Description:** Participants received AZD4635 Dose A orally daily, and durvalumab Dose B intravenously every 4 weeks.
**ID:** OG000
**Title:** Arm A: AZD4635 + Durvalumab
##### Group
**Description:** Participants received AZD4635 Dose A orally daily, durvalumab Dose B intravenously (IV) every 3 weeks (Q3W), and cabazitaxel Dose C IV Q3W
**ID:** OG001
**Title:** Arm B: AZD4635 + Durvalumab + Cabazitaxel
#### Outcome Measure 7
**Description:** "Worst pain" and "Average pain" are 'single question' scores from the BPI short form and may take any value from 0 to 10 (worst outcome). "Interference Pain" is the total score of 7 sub-scores, where each value may take any value from 0 to 10 (worst outcome). The range of the "Interference Score" can be from 0 to 70.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** Full analysis set consisted of all participants who received at least one (non-zero) dose of study treatment. The data for Arm A was not calculated because of only two participants in this arm due to which there will be a patient identification risk. Only safety data have been provided.

None of the 14 participants at Baseline answered the questionnaire at Cycle 1 Day 1 and, therefore, related statistics were not derived for this timepoint.
**Reporting Status:** POSTED
**Time Frame:** Arm A: Screening, Day 1 of each cycle up to 9 months (Each cycle was 28 days in length); Arm B: Screening, Day 1 of each cycle up to 9 months (Each cycle was 21 days in length)
**Title:** Change From Baseline in Average Pain in the Daily Activities Scales of the Brief Pain Inventory - Short Form (BPI-SF)
**Type:** SECONDARY
**Unit of Measure:** Score on a Scale
##### Group
**Description:** Participants received AZD4635 Dose A orally daily, and durvalumab Dose B intravenously every 4 weeks.
**ID:** OG000
**Title:** Arm A: AZD4635 + Durvalumab
##### Group
**Description:** Participants received AZD4635 Dose A orally daily, durvalumab Dose B intravenously (IV) every 3 weeks (Q3W), and cabazitaxel Dose C IV Q3W
**ID:** OG001
**Title:** Arm B: AZD4635 + Durvalumab + Cabazitaxel
#### Outcome Measure 8
**Description:** "Worst pain" and "Average pain" are 'single question' scores from the BPI short form and may take any value from 0 to 10 (worst outcome). "Interference Pain" is the total score of 7 sub-scores, where each value may take any value from 0 to 10 (worst outcome). The range of the "Interference Score" can be from 0 to 70.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** Full analysis set consisted of all participants who received at least one (non-zero) dose of study treatment. The data for Arm A was not calculated because of only two participants in this arm due to which there will be a patient identification risk. Only safety data have been provided.

None of the 14 participants at Baseline answered the questionnaire at Cycle 1 Day 1 and, therefore, related statistics were not derived for this timepoint.
**Reporting Status:** POSTED
**Time Frame:** Arm A: Screening, Day 1 of each cycle up to 9 months (Each cycle was 28 days in length); Arm B: Screening, Day 1 of each cycle up to 9 months (Each cycle was 21 days in length)
**Title:** Change From Baseline in Pain Interference in the Daily Activities Scales of the Brief Pain Inventory - Short Form (BPI-SF)
**Type:** SECONDARY
**Unit of Measure:** Score on a Scale
##### Group
**Description:** Participants received AZD4635 Dose A orally daily, and durvalumab Dose B intravenously every 4 weeks.
**ID:** OG000
**Title:** Arm A: AZD4635 + Durvalumab
##### Group
**Description:** Participants received AZD4635 Dose A orally daily, durvalumab Dose B intravenously (IV) every 3 weeks (Q3W), and cabazitaxel Dose C IV Q3W
**ID:** OG001
**Title:** Arm B: AZD4635 + Durvalumab + Cabazitaxel
#### Outcome Measure 9
**Description:** Pain progression was assessed using BPI-SF.
**Parameter Type:** NUMBER
**Population Description:** Full analysis set consisted of all participants who received at least one (non-zero) dose of study treatment. The data for Arm A was not calculated because of only two participants in this arm due to which there will be a patient identification risk.
**Reporting Status:** POSTED
**Time Frame:** Arm A: Screening, Day 1 of each cycle up to 12 months (Each cycle was 28 days in length); Arm B: Screening, Day 1 of each cycle up to 12 months (Cycle 1 to Cycle 10 = 21 days, Cycle 11 onwards = 28 days)
**Title:** Number of Participants Who Progressed Based on BPI-SF Item 3
**Type:** SECONDARY
**Unit of Measure:** Participants
##### Group
**Description:** Participants received AZD4635 Dose A orally daily, and durvalumab Dose B intravenously every 4 weeks.
**ID:** OG000
**Title:** Arm A: AZD4635 + Durvalumab
##### Group
**Description:** Participants received AZD4635 Dose A orally daily, durvalumab Dose B intravenously (IV) every 3 weeks (Q3W), and cabazitaxel Dose C IV Q3W
**ID:** OG001
**Title:** Arm B: AZD4635 + Durvalumab + Cabazitaxel
#### Outcome Measure 10
**Description:** The Functional Assessment of Cancer Therapy-Prostate (FACT-P) will be used to measure health related quality of life (HRQL) in men with prostate cancer. It consists of 4 subscales (physical, emotional, functional and social/family well-being) plus a 12-item prostate-specific module, the PCS subscale, which highlights concerns specific to participants with prostate cancer. FAPSI-6 is defined as a symptom score made up of 6 items from within the FACT-P (pain \[n = 3\], fatigue \[n = 1\], weight loss \[n = 1\], and concerns about the condition getting worse \[n = 1\]). Each question in the FACT-P questionnaires has a choice of 5 responses, "Not at all", "A little bit", "Somewhat", "Quite a bit" and "Very much". The scores range from 0 ("Not at all") to 4 ("Very much") for positively phrased questions. Negatively phrased questions have a reverse scoring, from 0 ("Very much") to 4 ("Not at all"). This results in a consistent approach, where higher scores indicate a better quality of life.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** Full analysis set consisted of all participants who received at least one (non-zero) dose of study treatment. The data for Arm A was not calculated because of only two participants in this arm due to which there will be a patient identification risk.

None of the 10 participants at Baseline answered the questionnaire at Cycle 1 Day 1. Therefore, related statistics were not derived for this timepoint.
**Reporting Status:** POSTED
**Time Frame:** Arm A: Screening, Day 1 of each cycle up to 9 months (Each cycle was 28 days in length); Arm B: Screening, Day 1 of each cycle up to 9 months (Each cycle was 21 days in length)
**Title:** Change From Baseline in the FACT Advanced Prostate Symptom Indext-6 (FAPSI-6), as Derived From 6 Items, the FAPSI-8 From 8 Items Within the FACT-P and the Prostate Cancer Symptoms (PCS), From the 12 Items in the Prostrate-specific Module of the FACT-P
**Type:** SECONDARY
**Unit of Measure:** Score on a Scale
##### Group
**Description:** Participants received AZD4635 Dose A orally daily, and durvalumab Dose B intravenously every 4 weeks.
**ID:** OG000
**Title:** Arm A: AZD4635 + Durvalumab
##### Group
**Description:** Participants received AZD4635 Dose A orally daily, durvalumab Dose B intravenously (IV) every 3 weeks (Q3W), and cabazitaxel Dose C IV Q3W
**ID:** OG001
**Title:** Arm B: AZD4635 + Durvalumab + Cabazitaxel
#### Outcome Measure 11
**Description:** Investigate the PK of AZD4635 when given in combination with durvalumab, and when given in combination with durvalumab plus cabazitaxel.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** The pharmacokinetics (PK) analysis set consisted of dosed participants for whom an adequate PK profile was obtained. The data for Arm A was not calculated because of only two participants in this arm due to which there will be a patient identification risk.
**Reporting Status:** POSTED
**Time Frame:** Arm A:Cycle 1 to 3, and Cycle 4 onwards, and 90-day follow-up (FU) visit up to 14 months [Each cycle was 28 days in length];Arm B: Cycle 1 to 7 and Cycle 11 onwards, and 90-day FU up to 14 months (Cycle 1 to Cycle 10 = 21 days, Cycle 11 onwards = 28 days)
**Title:** Maximum Observed Plasma Concentration (Cmax)
**Type:** SECONDARY
**Unit of Measure:** nanogram/millilitre (ng/mL)
##### Group
**Description:** Participants received AZD4635 Dose A orally daily, and durvalumab Dose B intravenously every 4 weeks.
**ID:** OG000
**Title:** Arm A: AZD4635 + Durvalumab
##### Group
**Description:** Participants received AZD4635 Dose A orally daily, durvalumab Dose B intravenously (IV) every 3 weeks (Q3W), and cabazitaxel Dose C IV Q3W
**ID:** OG001
**Title:** Arm B: AZD4635 + Durvalumab + Cabazitaxel
#### Outcome Measure 12
**Description:** Investigated the PK of AZD4635 when given in combination with durvalumab, and when given in combination with durvalumab plus cabazitaxel.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** The PK analysis set consisted of dosed participants for whom an adequate PK profile was obtained. The data for Arm A was not calculated because of only two participants in this arm due to which there will be a patient identification risk.
**Reporting Status:** POSTED
**Time Frame:** Arm A:Cycle 1 to 3, and Cycle 4 onwards, and 90-day follow-up (FU) visit up to 14 months [Each cycle was 28 days in length];Arm B: Cycle 1 to 7 and Cycle 11 onwards, and 90-day FU up to 14 months (Cycle 1 to Cycle 10 = 21 days, Cycle 11 onwards = 28 days)
**Title:** Terminal Half-life (t1/2λz)
**Type:** SECONDARY
**Unit of Measure:** hour (h)
##### Group
**Description:** Participants received AZD4635 Dose A orally daily, and durvalumab Dose B intravenously every 4 weeks.
**ID:** OG000
**Title:** Arm A: AZD4635 + Durvalumab
##### Group
**Description:** Participants received AZD4635 Dose A orally daily, durvalumab Dose B intravenously (IV) every 3 weeks (Q3W), and cabazitaxel Dose C IV Q3W
**ID:** OG001
**Title:** Arm B: AZD4635 + Durvalumab + Cabazitaxel
#### Outcome Measure 13
**Description:** Investigated the PK of AZD4635 when given in combination with durvalumab, and when given in combination with durvalumab plus cabazitaxel.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** The PK analysis set consisted of dosed participants for whom an adequate PK profile was obtained. The data for Arm A was not calculated because of only two participants in this arm due to which there will be a patient identification risk.
**Reporting Status:** POSTED
**Time Frame:** Arm A:Cycle 1 to 3, and Cycle 4 onwards, and 90-day follow-up (FU) visit up to 14 months [Each cycle was 28 days in length];Arm B: Cycle 1 to 7 and Cycle 11 onwards, and 90-day FU up to 14 months (Cycle 1 to Cycle 10 = 21 days, Cycle 11 onwards = 28 days)
**Title:** Area Under the Plasma Concentration Time Curve From Zero to the Time of the Last Measurable Concentration (AUClast)
**Type:** SECONDARY
**Unit of Measure:** hour (h)*nanogram/millilitre (ng/mL)
##### Group
**Description:** Participants received AZD4635 Dose A orally daily, and durvalumab Dose B intravenously every 4 weeks.
**ID:** OG000
**Title:** Arm A: AZD4635 + Durvalumab
##### Group
**Description:** Participants received AZD4635 Dose A orally daily, durvalumab Dose B intravenously (IV) every 3 weeks (Q3W), and cabazitaxel Dose C IV Q3W
**ID:** OG001
**Title:** Arm B: AZD4635 + Durvalumab + Cabazitaxel
#### Outcome Measure 14
**Description:** Investigated the PK of AZD4635 when given in combination with durvalumab, and when given in combination with durvalumab plus cabazitaxel.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** The PK analysis set consisted of dosed participants for whom an adequate PK profile was obtained. The data for Arm A was not calculated because of only two participants in this arm due to which there will be a patient identification risk.
**Reporting Status:** POSTED
**Time Frame:** Arm A:Cycle 1 to 3, and Cycle 4 onwards, and 90-day follow-up (FU) visit up to 14 months [Each cycle was 28 days in length];Arm B: Cycle 1 to 7 and Cycle 11 onwards, and 90-day FU up to 14 months (Cycle 1 to Cycle 10 = 21 days, Cycle 11 onwards = 28 days)
**Title:** Area Under the Plasma Concentration Time Curve From Zero to 24 Hours [AUC(0-24)]
**Type:** SECONDARY
**Unit of Measure:** hour (h)*nanogram/millilitre (ng/mL)
##### Group
**Description:** Participants received AZD4635 Dose A orally daily, and durvalumab Dose B intravenously every 4 weeks.
**ID:** OG000
**Title:** Arm A: AZD4635 + Durvalumab
##### Group
**Description:** Participants received AZD4635 Dose A orally daily, durvalumab Dose B intravenously (IV) every 3 weeks (Q3W), and cabazitaxel Dose C IV Q3W
**ID:** OG001
**Title:** Arm B: AZD4635 + Durvalumab + Cabazitaxel
#### Outcome Measure 15
**Description:** Investigated the PK of AZD4635 when given in combination with durvalumab, and when given in combination with durvalumab plus cabazitaxel.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** The PK analysis set consisted of dosed participants for whom an adequate PK profile was obtained. The data for Arm A was not calculated because of only two participants in this arm due to which there will be a patient identification risk.
**Reporting Status:** POSTED
**Time Frame:** Arm A:Cycle 1 to 3, and Cycle 4 onwards, and 90-day follow-up (FU) visit up to 14 months [Each cycle was 28 days in length];Arm B: Cycle 1 to 7 and Cycle 11 onwards, and 90-day FU up to 14 months (Cycle 1 to Cycle 10 = 21 days, Cycle 11 onwards = 28 days)
**Title:** Area Under the Plasma Concentration Time Curve From Zero Extrapolated to Infinity (AUCinf)
**Type:** SECONDARY
**Unit of Measure:** hour (h)*nanogram/millilitre (ng/mL)
##### Group
**Description:** Participants received AZD4635 Dose A orally daily, and durvalumab Dose B intravenously every 4 weeks.
**ID:** OG000
**Title:** Arm A: AZD4635 + Durvalumab
##### Group
**Description:** Participants received AZD4635 Dose A orally daily, durvalumab Dose B intravenously (IV) every 3 weeks (Q3W), and cabazitaxel Dose C IV Q3W
**ID:** OG001
**Title:** Arm B: AZD4635 + Durvalumab + Cabazitaxel
#### Outcome Measure 16
**Description:** Investigated the PK of AZD4635 when given in combination with durvalumab, and when given in combination with durvalumab plus cabazitaxel.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** The PK analysis set consisted of dosed participants for whom an adequate PK profile was obtained. The data for Arm A was not calculated because of only two participants in this arm due to which there will be a patient identification risk.
**Reporting Status:** POSTED
**Time Frame:** Arm A:Cycle 1 to 3, and Cycle 4 onwards, and 90-day follow-up (FU) visit up to 14 months [Each cycle was 28 days in length];Arm B: Cycle 1 to 7 and Cycle 11 onwards, and 90-day FU up to 14 months (Cycle 1 to Cycle 10 = 21 days, Cycle 11 onwards = 28 days)
**Title:** Apparent Volume of Distribution During the Terminal Phase (Vz/F)
**Type:** SECONDARY
**Unit of Measure:** Litre
##### Group
**Description:** Participants received AZD4635 Dose A orally daily, and durvalumab Dose B intravenously every 4 weeks.
**ID:** OG000
**Title:** Arm A: AZD4635 + Durvalumab
##### Group
**Description:** Participants received AZD4635 Dose A orally daily, durvalumab Dose B intravenously (IV) every 3 weeks (Q3W), and cabazitaxel Dose C IV Q3W
**ID:** OG001
**Title:** Arm B: AZD4635 + Durvalumab + Cabazitaxel
#### Outcome Measure 17
**Description:** Safety and tolerability of each treatment regimen were assessed in participants with mCRPC.
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** The safety analysis set consisted of all participants who received at least 1 dose of study drug. The data for Arm A was not calculated because of only two participants in this arm due to which there will be a patient identification risk.
**Reporting Status:** POSTED
**Time Frame:** Arm A: From Screening up to 14 months (Each cycle was 28 days in length); Arm B: From Screening up to 14 months (Cycle 1 to Cycle 10 was 21 days in length, and Cycle 11 onwards was 28 days in length)
**Title:** Number of Subjects With Serious and Non-serious Adverse Events
**Type:** SECONDARY
**Unit of Measure:** Participants
##### Group
**Description:** Participants received AZD4635 Dose A orally daily, and durvalumab Dose B intravenously every 4 weeks.
**ID:** OG000
**Title:** Arm A: AZD4635 + Durvalumab
##### Group
**Description:** Participants received AZD4635 Dose A orally daily, durvalumab Dose B intravenously (IV) every 3 weeks (Q3W), and cabazitaxel Dose C IV Q3W
**ID:** OG001
**Title:** Arm B: AZD4635 + Durvalumab + Cabazitaxel
### Participant Flow Module
#### Group
**Description:** Participants received AZD4635 Dose A orally daily, and durvalumab Dose B intravenously every 4 weeks.
**ID:** FG000
**Title:** Arm A: AZD4635 + Durvalumab
#### Group
**Description:** Participants received AZD4635 Dose A orally daily, durvalumab Dose B intravenously (IV) every 3 weeks (Q3W), and cabazitaxel Dose C IV Q3W
**ID:** FG001
**Title:** Arm B: AZD4635 + Durvalumab + Cabazitaxel
#### Period
**Title:** Overall Study
##### Withdraw
**Type:** Lost to Follow-up
###### Reason
**Group ID:** FG000
**Number of Subjects:** 0
###### Reason
**Group ID:** FG001
**Number of Subjects:** 1
##### Withdraw
**Type:** Withdrawal by Subject
###### Reason
**Group ID:** FG000
**Number of Subjects:** 2
###### Reason
**Group ID:** FG001
**Number of Subjects:** 4
##### Withdraw
**Type:** Study terminated by sponsor
###### Reason
**Group ID:** FG000
**Number of Subjects:** 0
###### Reason
**Group ID:** FG001
**Number of Subjects:** 18
##### Withdraw
**Type:** Death
###### Reason
**Group ID:** FG000
**Number of Subjects:** 0
###### Reason
**Group ID:** FG001
**Number of Subjects:** 4
##### Withdraw
**Type:** Adverse Event
###### Reason
**Group ID:** FG000
**Number of Subjects:** 0
###### Reason
**Group ID:** FG001
**Number of Subjects:** 1
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 2
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 28
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 0
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 2
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 28
**Pre-Assignment Details:** Participants who met the inclusion and none of the exclusion criteria were enrolled to the study. All study assessments were performed as per the schedule of assessment.
**Recruitment Details:** Participants were enrolled in this study from 04-August-2020 to 08-August-2022.
**Has Results:** True