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

Pleural Mesothelioma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06416930
• Other study ID #: AK104-IIT-039
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: June 20, 2024
• Est. completion date: June 20, 2029

Study information

• Verified date: May 2024
• Source: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Contact: Jie Wang
• Phone: 13910704669
• Email: zlhuxi[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 59
• Est. completion date: June 20, 2029
• Est. primary completion date: June 20, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Mesothelioma
• Mesothelioma, Malignant
• Pleural Mesothelioma

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences	Akesobio

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Disease Control Rate (DCR)	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.	2 year
Secondary	Progression Free Survival (PFS)	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.	2 year
Secondary	Duration of Response (DoR)	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.	2 year
Secondary	Overall Survival (OS)	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.	2 year
Secondary	Adverse Events (AEs)	Incidence and severity of adverse events (AE) and clinically significant abnormal laboratory results	2 year