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Study of Cadonilimab Combined With Bevacizumab and Standard Chemotherapy as First Line Therapy in Unresectable Pleural Mesothelioma

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ClinicalTrials.gov Identifier: NCT05930665
Recruitment Status : Recruiting
First Posted : July 5, 2023
Last Update Posted : February 21, 2024
Sponsor:
Information provided by (Responsible Party):
Wenfeng Fang, Sun Yat-sen University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Pleural Mesothelioma Drug: Cadonilimab+Bevacizumab+Pemetrexed+Carboplatin Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 38 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : November 1, 2023
Estimated Primary Completion Date : July 2025
Estimated Study Completion Date : July 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mesothelioma

Arms and Interventions
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Arm Intervention/treatment
Experimental: Cadonilimab+Bevacizumab+Pemetrexed+Carboplatin
Cadonilimab+Bevacizumab+Pemetrexed+Carboplatin for 4 to 6 cycles, followed by Maintenance with Cadonilimab and Bevacizumab
 Drug: Cadonilimab+Bevacizumab+Pemetrexed+Carboplatin
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
Other Name: AK104


Outcome Measures
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Primary Outcome Measures :
  1. Objective Response Rate (ORR) [ Time Frame: Up to 36 months ]
    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 :
  1. Progression Free Survival (PFS) [ Time Frame: Up to 36 months ]
    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. Disease Control Rate (DCR) [ Time Frame: Up to 36 months ]
    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.

  3. Duration of Response (DoR) [ Time Frame: Up to 36 months ]
    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.

  4. Overall Survival (OS) [ Time Frame: Up to 36 months ]
    defined as the time between the date of first dose of study drug and the date of death due to any cause.

  5. Adverse Events (AEs) [ Time Frame: Up to 36 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  1. Histologically confirmed pleural malignant mesothelioma not eligible for curative surgery
  2. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
  3. No previous systemic anti-tumor treatment for advanced/metastatic disease
  4. Measurable disease as per mRECIST v1.1 for assessment of response in malignant pleural mesothelioma.
  5. Adequate haematological, renal and liver function.

Key Exclusion Criteria:

  1. Primitive peritoneal, pericardial and tunica vaginalis testis mesothelioma.
  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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05930665


Contacts
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Contact: Wenfeng Fang, MD +86-15322302066 fangwf@sysucc.org.cn

Locations
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China, Guangdong
Sun Yat-sen University Cancer Center Recruiting
Guangzhou, Guangdong, China
Contact: Wenfeng Fang, MD    +86-15322302066    fangwf@sysucc.org.cn   
Sponsors and Collaborators
Sun Yat-sen University
More Information
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Responsible Party: Wenfeng Fang, chief physician, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT05930665    
Other Study ID Numbers: AK104-IIT-028
First Posted: July 5, 2023    Key Record Dates
Last Update Posted: February 21, 2024
Last Verified: February 2024

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Wenfeng Fang, Sun Yat-sen University:
bispecific antibody
Additional relevant MeSH terms:
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Mesothelioma
Mesothelioma, Malignant
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
 Bevacizumab
Carboplatin
Pemetrexed
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors