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

NCT06416930 | Not Yet Recruiting Phase 2

• 1 other identifier: AK104-IIT-039
• Study Type: interventional
• Target: 59
• Locations: 0 countries
• Sites: N/A

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

Keywords

Cadonilimab; pleural mesothelioma; Bispecific Antibody

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR)

  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.

  2 year

Secondary Outcomes (5)

• Disease Control Rate (DCR)

  2 year

• Progression Free Survival (PFS)

  2 year

• Duration of Response (DoR)

  2 year

• Overall Survival (OS)

  2 year

• Adverse Events (AEs)

  2 year

Study Arms (1)

Cadonilimab combined with chemotherapy

EXPERIMENTAL

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

Drug: Cadonilimab Combined with chemotherapy

Interventions

Cadonilimab Combined with chemotherapy 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.

Also known as: AK104

Cadonilimab combined with chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead
• Akesobio: collaborator

MeSH Terms

Conditions

Mesothelioma, Malignant

Interventions

Drug Therapy

Condition Hierarchy (Ancestors)

Mesothelioma; Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Mesothelial; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Pleural Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

Jie Wang

CONTACT

13910704669; zlhuxi@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: May 12, 2024
• First Posted: May 16, 2024
• Study Start: June 20, 2024
• Primary Completion (Estimated): June 20, 2027
• Study Completion (Estimated): June 20, 2029
• Last Updated: May 16, 2024

Record last verified: 2024-05