## Protocol Section
### Identification Module
**NCT ID:** NCT05285579

**Acronym:** ANGIOCOR

**Brief Title:** Biomarkers of Angiogenesis for Response to Therapeutic Combination in Advanced or Metastatic Kidney Cancer

**Official Title:** Predictive Role of Circulating Biomarkers Involved in Angiogenesis in Metastatic Kidney Cancer in the Era of New Therapeutic Associations: Immunotherapies, Anti-angiogenic

#### Organization Study ID Info
**ID:** APHP211213
#### Organization
**Class:** OTHER
**Full Name:** Assistance Publique - Hôpitaux de Paris
#### Secondary ID Infos
**Domain:** Agence nationale de sécurité du médicament et des produits de santé
**ID:** IDRCB2021-A02030-41
**Type:** REGISTRY
### Status Module
#### Completion Date
**Date:** 2025-08

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-04-19

**Type:** ACTUAL

**Last Update Submit Date:** 2023-04-14

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2025-08

**Type:** ESTIMATED

#### Start Date
**Date:** 2022-05-05

**Type:** ACTUAL

**Status Verified Date:** 2023-04

#### Study First Post Date
**Date:** 2022-03-17
**Type:** ACTUAL
**Study First Submit Date:** 2022-03-09
**Study First Submit QC Date:** 2022-03-09
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER_GOV

**Name:** Institut National de la Santé Et de la Recherche Médicale, France

**Class:** UNKNOWN

**Name:** FONCER contre le cancer

#### Lead Sponsor

**Class:** OTHER

**Name:** Assistance Publique - Hôpitaux de Paris

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** This is a multicenter, exploratory, prospective study to identify angiogenesis and immune-related biomarkers predictive of progression free survival in patients with metastatic or advanced renal cell carcinoma treated by a combination of immunotherapy and antiangiogenic.

**Detailed Description:** Recently, the management of renal cell carcinoma has undergone major changes with the emergence of combined therapies associating tyrosine kinase inhibitors (TKI) and immune checkpoint inhibitors (ICI) as first line treatments. However, there are no criteria to guide the choice between the different combinations validated and or between ICI combinations. Angiogenesis and immunity are intimately linked and some markers related have could be interesting to predict the efficacy of these combinations. Angiogenesis and immunity are highly related. This link may lead to new biomarkers to be explored to predict the response to TKI + ICI therapy combinations. On this basis, the investigators propose to conduct an open-label exploratory, multicenter prospective trial to study the association between angiogenesis and immune markers and the effect of combined TKI+ICI treatments.

### Conditions Module

**Conditions:**

- Renal Cell Carcinoma

- Renal Cancer

- Renal Cancer Metastatic

**Keywords:**

- renal cell carcinoma

- blood biomarkers

- predictive factor

- tyrosine kinase inhibitor

- immune checkpoint inhibitor

### Design Module

#### Bio Spec

**Description:** Plasma + tumour tissue

**Retention:** SAMPLES_WITHOUT_DNA

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 100

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Therapeutic combination tyrosine kinase inhibitor (TKI) + immune checkpoint inhibitors (ICI)

**Intervention Names:**

- Biological: Blood collection

- Other: Tumour samples

**Label:** TKI+ICI

#### Arm Group 2

**Description:** Therapeutic combination with different immune checkpoint inhibitors (ICI)

**Intervention Names:**

- Biological: Blood collection

- Other: Tumour samples

**Label:** ICI+ICI

### Interventions

#### Intervention 1

**Arm Group Labels:**

- ICI+ICI

- TKI+ICI

**Description:** Systematic extra blood sampling at inclusion, 6 weeks after inclusion and in case of progression of the cancer

**Name:** Blood collection

**Type:** BIOLOGICAL

#### Intervention 2

**Arm Group Labels:**

- ICI+ICI

- TKI+ICI

**Description:** reuse of tumour tissue collect in usual patient care

**Name:** Tumour samples

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** Time from inclusion to progression documented by imaging and based on RECIST 1.1 and iRECIST criteria or patient death. The iRECIST criteria use the same methods of monitoring tumor lesions as the RECIST 1.1 criteria but a confirmation 4-6 weeks after suspicion of progression is required to confirm or rule out progression because patients undergoing immunotherapy may present pseudo-progressions.

**Measure:** Progression-free survival

**Time Frame:** 24 months

#### Secondary Outcomes

**Description:** Observation of a partial or complete response according to RECIST 1.1 criteria during the follow-up

**Measure:** Objective response rate

**Time Frame:** 24 months

**Description:** Time between the observation of an objective response (partial or complete according to RECIST 1.1 criteria) and the progression

**Measure:** Response duration

**Time Frame:** 24 months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Histologically proven advanced or metastatic renal carcinoma
* treated in first line with an ICI-ICI or ITK-ICI combination (following current recommendations at inclusion)

Exclusion Criteria:

* Previous systemic treatment for renal cell carcinoma
* Other cancer developed in the last 5 years except local forms apparently healed as basal cell cancer.
* Contraindication for ICI-ICI or TKI-ICI combinations recommended on 1st line
* Refusal to participate in the study
* No affiliation to a social security regime (beneficiary or entitled)
* Vulnerable patients as defined by french law (Public Heath Code sections L1121 -5 to L1121-8) :
* Major patient subjected to legal protection (guardianship, curatorship, protection of justice)
* Pregnant or breastfeeding woman

**Minimum Age:** 18 Years

**Sampling Method:** PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** Patients with a metastatic or advanced renal cell carcinoma who will benefit of an ICI-TKI or ICI-ICI combination as a first-line treatment (according to the current guidelines at the time of inclusion).

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** natacha.nohile@aphp.fr

**Name:** Natacha Nohilé

**Phone:** 33156095982

**Role:** CONTACT

**Contact 2:**

**Email:** laetitia.mauge@aphp.fr

**Name:** Laetitia MAUGE, PharmD, PhD

**Phone:** 33156093905

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Paris

**Contacts:**

***Contact 1:***

- **Name:** Marie AUVRAY-KUNITZ, MD

- **Role:** CONTACT

***Contact 2:***

- **Name:** Marie AUVRAY-KUNITZ, MD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** France

**Facility:** Hôpital européen Georges-Pompidou AP-HP

**Status:** RECRUITING

**Zip:** 75015

**Location 2:**

**City:** Paris

**Contacts:**

***Contact 1:***

- **Name:** Olivier HUILLARD, MD

- **Role:** CONTACT

***Contact 2:***

- **Name:** Olivier HUILLARD, MD, PhD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** France

**Facility:** Hôpital Cochin - AP-HP

**Status:** RECRUITING

#### Overall Officials

**Official 1:**

**Affiliation:** Assitance Puplique - Hôpitaux de Paris

**Name:** Laetitia MAUGE, PharmD, PhD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**Access Criteria:** Data sharing must be accepted by the sponsor and the PI based on a scientific project and scientific involvement of the PI team. Collaboration will be fostered. Data sharing must respect the agreements made with funders. Teams wishing obtain IPD must meet the sponsor and IP team to present scientific (and commercial) purpose, IPD needed, format of data transmission, and timeframe. Technical feasibility and financial support will be discussed before mandatory contractual agreement. Processing of shared data must comply with European General Data Protection Regulation (GDPR).

**Description:** Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared

**Info Types:**

- STUDY_PROTOCOL

- ICF

**IPD Sharing:** YES

**Time Frame:** Two years after the last publication

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000002277

- Term: Carcinoma

- ID: D000009375

- Term: Neoplasms, Glandular and Epithelial

- ID: D000009370

- Term: Neoplasms by Histologic Type

- ID: D000009369

- Term: Neoplasms

- ID: D000000230

- Term: Adenocarcinoma

- ID: D000014571

- Term: Urologic Neoplasms

- ID: D000014565

- Term: Urogenital Neoplasms

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000052776

- Term: Female Urogenital Diseases

- ID: D000005261

- Term: Female Urogenital Diseases and Pregnancy Complications

- ID: D000091642

- Term: Urogenital Diseases

- ID: D000007674

- Term: Kidney Diseases

- ID: D000014570

- Term: Urologic Diseases

- ID: D000052801

- Term: Male Urogenital Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: All

- Name: All Conditions

- Abbrev: BXS

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

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M5534

- Name: Carcinoma

- Relevance: LOW

- As Found: Unknown

- ID: M5548

- Name: Carcinoma, Renal Cell

- Relevance: HIGH

- As Found: Renal Cancer

- ID: M10703

- Name: Kidney Neoplasms

- Relevance: HIGH

- As Found: Renal Cancer

- ID: M12320

- Name: Neoplasms, Glandular and Epithelial

- Relevance: LOW

- As Found: Unknown

- ID: M12315

- Name: Neoplasms by Histologic Type

- Relevance: LOW

- As Found: Unknown

- ID: M3585

- Name: Adenocarcinoma

- Relevance: LOW

- As Found: Unknown

- ID: M17320

- Name: Urologic Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M17315

- Name: Urogenital Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27093

- Name: Female Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14127

- Name: Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M8399

- Name: Female Urogenital Diseases and Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M10698

- Name: Kidney Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M17319

- Name: Urologic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27095

- Name: Male Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T4906

- Name: Renal Cell Carcinoma

- Relevance: HIGH

- As Found: Renal Cell Carcinoma

- ID: T1341

- Name: Clear Cell Renal Cell Carcinoma

- Relevance: HIGH

- As Found: Renal Cell Carcinoma

### Condition Browse Module - Meshes

- ID: D000002292

- Term: Carcinoma, Renal Cell

- ID: D000007680

- Term: Kidney Neoplasms

### Intervention Browse Module - Browse Branches

- Abbrev: ANeo

- Name: Antineoplastic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: AA

- Name: Amino Acids

### Intervention Browse Module - Browse Leaves

- ID: M22318

- Name: Angiogenesis Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M2853

- Name: Immunomodulating Agents

- Relevance: LOW

- As Found: Unknown

- ID: M2342

- Name: Immune Checkpoint Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M2889

- Name: Tyrosine Kinase Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: T22

- Name: Tyrosine

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
