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

Phase 2

Not yet recruiting

• Conditions: Pleural Mesothelioma
• Interventions: Drug: Cadonilimab Combined with chemotherapy

• Registration Number: NCT06416930
• Lead Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-05
• Study First Submitted: 2024-05-12
• Study First Submitted QC: 2024-05-12
• Last Update Submitted: 2024-05-12
• Study First Posted: 2024-05-16
• Last Update Posted: 2024-05-16
• Study Start: 2024-06-20
• Primary Completion: 2027-06-20
• Study Completion: 2029-06-20

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 59

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cadonilimab combined with chemotherapy	Cadonilimab Combined with chemotherapy	All subjects in the group will be treated with Cadonilimab plus gemcitabine / vinorelbine / pemetrexed once every three weeks.

Primary Outcome Measures

Name	Time	Method
Objective Response Rate (ORR)	2 year	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.

Secondary Outcome Measures

Name	Time	Method
Disease Control Rate (DCR)	2 year	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.
Progression Free Survival (PFS)	2 year	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.
Duration of Response (DoR)	2 year	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.
Overall Survival (OS)	2 year	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.
Adverse Events (AEs)	2 year	Incidence and severity of adverse events (AE) and clinically significant abnormal laboratory results