Back to resultsStudy of Cadonilimab Combined With Bevacizumab and Standard Chemotherapy as First Line Therapy in Unresectable Pleural Mesothelioma
Primary Purpose
Pleural Mesothelioma
Status
Not yet recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Cadonilimab+Bevacizumab+Pemetrexed+Carboplatin
Sponsored by
About this trial
This is an interventional treatment trial for Pleural Mesothelioma focused on measuring bispecific antibody
Eligibility Criteria
Key Inclusion Criteria: Histologically confirmed pleural malignant mesothelioma not eligible for curative surgery Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. No previous systemic anti-tumor treatment for advanced/metastatic disease Measurable disease as per mRECIST v1.1 for assessment of response in malignant pleural mesothelioma. Adequate haematological, renal and liver function. Key Exclusion Criteria: Primitive peritoneal, pericardial and tunica vaginalis testis mesothelioma. 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.
Sites / Locations
- Sun Yat-sen University Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Cadonilimab+Bevacizumab+Pemetrexed+Carboplatin
Arm Description
Cadonilimab+Bevacizumab+Pemetrexed+Carboplatin for 4 to 6 cycles, followed by Maintenance with Cadonilimab and Bevacizumab
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
Overall Survival (OS)
defined as the time between the date of first dose of study drug and the date of death due to any cause.
Adverse Events (AEs)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05930665
Brief Title
Study of Cadonilimab Combined With Bevacizumab and Standard Chemotherapy as First Line Therapy in Unresectable Pleural Mesothelioma
Official Title
A Phase II, Prospective, Single Arm Trial of Cadonilimab in Combination With Bevacizumab and Standard Chemotherapy as First Line Therapy in Unresectable Pleural Mesothelioma
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 2023 (Anticipated)
Primary Completion Date
July 2025 (Anticipated)
Study Completion Date
July 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Cadonilimab, a tetravalent bispecific antibody targeting PD-1 and CTLA-4, is designed to retain the efficacy benefit of combination of PD-1 and CTLA-4 and improve on the safety profile of the combination therapy. The aim of this study is to evaluate the efficacy and safety of cadonilimab in combination with bevacizumab and standard chemotherapy as first Line therapy in unresectable pleural mesothelioma.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pleural Mesothelioma
Keywords
bispecific antibody
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
38 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cadonilimab+Bevacizumab+Pemetrexed+Carboplatin
Arm Type
Experimental
Arm Description
Cadonilimab+Bevacizumab+Pemetrexed+Carboplatin for 4 to 6 cycles, followed by Maintenance with Cadonilimab and Bevacizumab
Intervention Type
Drug
Intervention Name(s)
Cadonilimab+Bevacizumab+Pemetrexed+Carboplatin
Other Intervention Name(s)
AK104
Intervention Description
Cadonilimab 10mg/kg intravenous (IV) every 3 weeks + Bevacizumab 7.5mg/kg IV every 3 weeks + Pemetrexed 500 mg/m² IV every 3 weeks + Carboplatin AUC 5 IV every 3 weeks for 4 to 6 cycles, followed by maintenance with Cadonilimab 10mg/kg IV every 3 weeks + Bevacizumab 7.5mg/kg IV every 3 weeks
Primary Outcome Measure Information:
Title
Objective Response Rate (ORR)
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.
Time Frame
Up to 36 months
Secondary Outcome Measure Information:
Title
Progression Free Survival (PFS)
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.
Time Frame
Up to 36 months
Title
Disease Control Rate (DCR)
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.
Time Frame
Up to 36 months
Title
Duration of Response (DoR)
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.
Time Frame
Up to 36 months
Title
Overall Survival (OS)
Description
defined as the time between the date of first dose of study drug and the date of death due to any cause.
Time Frame
Up to 36 months
Title
Adverse Events (AEs)
Time Frame
Up to 36 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria:
Histologically confirmed pleural malignant mesothelioma not eligible for curative surgery
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
No previous systemic anti-tumor treatment for advanced/metastatic disease
Measurable disease as per mRECIST v1.1 for assessment of response in malignant pleural mesothelioma.
Adequate haematological, renal and liver function.
Key Exclusion Criteria:
Primitive peritoneal, pericardial and tunica vaginalis testis mesothelioma.
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wenfeng Fang, MD
Phone
+86-15322302066
Email
fangwf@sysucc.org.cn
Facility Information:
Facility Name
Sun Yat-sen University Cancer Center
City
Guangzhou
State/Province
Guangdong
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wenfeng Fang, MD
Phone
+86-15322302066
Email
fangwf@sysucc.org.cn
12. IPD Sharing Statement
Learn more about this trial
Study of Cadonilimab Combined With Bevacizumab and Standard Chemotherapy as First Line Therapy in Unresectable Pleural Mesothelioma
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