Study of Cadonilimab Combined With Chemotherapy in Recurrent / Refractory Pleural Mesothelioma

NCT ID: NCT06416930

Last Updated: 2024-05-16

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 59 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-20
• Study Completion Date: 2029-06-20

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

Pleural Mesothelioma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cadonilimab combined with chemotherapy

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

Group Type: EXPERIMENTAL

Cadonilimab Combined with chemotherapy

Intervention Type: DRUG

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.

Interventions

Cadonilimab Combined with chemotherapy

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.

Intervention Type: DRUG

Other Intervention Names

AK104

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 Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Akesobio

INDUSTRY

Sponsor Role: collaborator

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Jie Wang

Chief physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Jie Wang

Role: CONTACT

zlhuxi@163.com

13910704669

Other Identifiers

AK104-IIT-039

Identifier Type: -

Identifier Source: org_study_id