## Protocol Section
### Identification Module
**NCT ID:** NCT06416930

**Brief Title:** Study of Cadonilimab Combined With Chemotherapy in Recurrent / Refractory Pleural Mesothelioma

**Official Title:** Study of Cadonilimab Combined With Chemotherapy in Recurrent / Refractory Pleural Mesothelioma

#### Organization Study ID Info
**ID:** AK104-IIT-039
#### Organization
**Class:** OTHER
**Full Name:** Cancer Institute and Hospital, Chinese Academy of Medical Sciences
### Status Module
#### Completion Date
**Date:** 2029-06-20

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-16

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-12

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2027-06-20

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06-20

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-16
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-12
**Study First Submit QC Date:** 2024-05-12
### Sponsor Collaborators Module

#### Collaborators

**Class:** UNKNOWN

**Name:** Akesobio

#### Lead Sponsor

**Class:** OTHER

**Name:** Cancer Institute and Hospital, Chinese Academy of Medical Sciences

#### Responsible Party

**Investigator Affiliation:** Cancer Institute and Hospital, Chinese Academy of Medical Sciences

**Investigator Full Name:** Jie Wang

**Investigator Title:** Chief physician

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** This is a multicenter, single-arm, phase II clinical study to evaluate the safety and efficacy of Cadonilimab combined with gemcitabine, or vinorelbine, or pemetrexed in the treatment of patients with recurrent / refractory pleural mesothelioma.

### Conditions Module

**Conditions:**

- Pleural Mesothelioma

**Keywords:**

- Cadonilimab

- pleural mesothelioma

- Bispecific Antibody

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 59

**Type:** ESTIMATED

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** All subjects in the group will be treated with Cadonilimab plus gemcitabine / vinorelbine / pemetrexed once every three weeks.

**Intervention Names:**

- Drug: Cadonilimab Combined with chemotherapy

**Label:** Cadonilimab combined with chemotherapy

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Cadonilimab combined with chemotherapy

**Description:** Cadonilimab (15mg/kg, intravenous drip, D1) + gemcitabine (1250mg/m2, intravenous drip, D1/D8) or vinorelbine (30mg, oral, tiw, D1/D3/D5) or pemetrexed (500mg/m2, intravenous drip, D1), every 3 weeks.

**Name:** Cadonilimab Combined with chemotherapy

**Other Names:**

- AK104

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** defined as the percentage of participants who achieve a best overall response of complete response or partial response assessed according to mRECIST v1.1 for assessment of response in malignant pleural mesothelioma.

**Measure:** Objective Response Rate (ORR)

**Time Frame:** 2 year

#### Secondary Outcomes

**Description:** defined as the percentage of participants who achieve a best overall response of complete response, partial response, or stable disease assessed according to mRECIST v1.1 for assessment of response in malignant pleural mesothelioma.

**Measure:** Disease Control Rate (DCR)

**Time Frame:** 2 year

**Description:** defined as the time between the date of first dose of study drug and the date of first documented tumor progression per mRECIST v1.1, or death due to any cause, whichever occurs first.

**Measure:** Progression Free Survival (PFS)

**Time Frame:** 2 year

**Description:** defined as the interval from the date of first documentation of objective response (complete response or partial response, according to the mRECIST v1.1) to the date of first documented tumor progression, or death due to any cause, whichever occurs first.

**Measure:** Duration of Response (DoR)

**Time Frame:** 2 year

**Description:** defined as the interval from the date of first documentation of objective response (complete response or partial response, according to the mRECIST v1.1) to the date of first documented tumor progression, or death due to any cause, whichever occurs first.

**Measure:** Overall Survival (OS)

**Time Frame:** 2 year

**Description:** Incidence and severity of adverse events (AE) and clinically significant abnormal laboratory results

**Measure:** Adverse Events (AEs)

**Time Frame:** 2 year

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

1. Histologically confirmed advanced or metastatic pleural mesothelioma;
2. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
3. Participants must have previously failed to receive platinum-containing chemotherapy with or without bevacizumab, and have received at most two-line systemic therapy.
4. Measurable disease as per mRECIST v1.1 for assessment of response in malignant pleural mesothelioma.
5. Adequate haematological, renal and liver function.

Exclusion Criteria:

1. Primary mesothelioma of peritoneum, pericardium and testes
2. Active, untreated central nervous system (CNS) metastasis.
3. Use of Chinese herbal medicine or immunomodulatory agents with anti-tumor indications within 14 days prior to the first dose of study treatment.
4. Known active autoimmune diseases.
5. Presence of other uncontrolled serious medical conditions.

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** zlhuxi@163.com

**Name:** Jie Wang

**Phone:** 13910704669

**Role:** CONTACT

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000000236

- Term: Adenoma

- ID: D000009375

- Term: Neoplasms, Glandular and Epithelial

- ID: D000009370

- Term: Neoplasms by Histologic Type

- ID: D000009369

- Term: Neoplasms

- ID: D000018301

- Term: Neoplasms, Mesothelial

- ID: D000008175

- Term: Lung Neoplasms

- ID: D000012142

- Term: Respiratory Tract Neoplasms

- ID: D000013899

- Term: Thoracic Neoplasms

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000010997

- Term: Pleural Neoplasms

- ID: D000008171

- Term: Lung Diseases

- ID: D000012140

- Term: Respiratory Tract Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC08

- Name: Respiratory Tract (Lung and Bronchial) Diseases

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M14850

- Name: Recurrence

- Relevance: LOW

- As Found: Unknown

- ID: M11634

- Name: Mesothelioma

- Relevance: HIGH

- As Found: Mesothelioma

- ID: M2537

- Name: Mesothelioma, Malignant

- Relevance: HIGH

- As Found: Mesothelioma

- ID: M3591

- Name: Adenoma

- Relevance: LOW

- As Found: Unknown

- 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: M20445

- Name: Neoplasms, Mesothelial

- Relevance: LOW

- As Found: Unknown

- ID: M11172

- Name: Lung Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M14979

- Name: Respiratory Tract Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M16658

- Name: Thoracic Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M13887

- Name: Pleural Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M11168

- Name: Lung Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14977

- Name: Respiratory Tract Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T3584

- Name: Malignant Mesothelioma

- Relevance: HIGH

- As Found: Mesothelioma

### Condition Browse Module - Meshes

- ID: D000008654

- Term: Mesothelioma

- ID: D000086002

- Term: Mesothelioma, Malignant

### Intervention Browse Module - Browse Branches

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: ANeo

- Name: Antineoplastic Agents

### Intervention Browse Module - Browse Leaves

- ID: M4225

- Name: Antibodies

- Relevance: LOW

- As Found: Unknown

- ID: M2985

- Name: Gemcitabine

- Relevance: LOW

- As Found: Unknown

- ID: M1710

- Name: Vinorelbine

- Relevance: LOW

- As Found: Unknown

- ID: M264

- Name: Pemetrexed

- Relevance: LOW

- As Found: Unknown

- ID: M20194

- Name: Antibodies, Bispecific

- Relevance: LOW

- As Found: Unknown

- ID: M10184

- Name: Immunoglobulins

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
