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NCT Number: NCT05930665

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Location status: Recruiting

Location contact

Wenfeng Fang, MD

CONTACT

[email protected]

+86-15322302066

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cadonilimab+Bevacizumab+Pemetrexed+Carboplatin

Drug

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 names: AK104

Primary outcomes

  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 outcomes

  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

Study contacts

Contact information is provided by the study sponsor or research team.

Wenfeng Fang, MD

CONTACT

[email protected]

+86-15322302066

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Jul 5, 2023
Registry last updated
Feb 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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