Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06416930

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

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

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Other names: AK104

Primary outcomes

  1. Objective Response Rate (ORR)

    Time frame: 2 year

    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. Disease Control Rate (DCR)

    Time frame: 2 year

    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. Progression Free Survival (PFS)

    Time frame: 2 year

    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.

  3. Duration of Response (DoR)

    Time frame: 2 year

    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: 2 year

    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.

  5. Adverse Events (AEs)

    Time frame: 2 year

    Incidence and severity of adverse events (AE) and clinically significant abnormal laboratory results

Study contacts

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

Jie Wang

CONTACT

[email protected]

13910704669

Sponsors and collaborators

Lead sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Other

Collaborators

  • Akesobio

Registry information

Important dates

Study start
2024
Primary completion
2027
Study completion
2029
First posted
May 16, 2024
Registry last updated
May 16, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.