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Trial Title:
Study of Cadonilimab Combined With Chemotherapy in Recurrent / Refractory Pleural Mesothelioma
NCT ID:
NCT06416930
Condition:
Pleural Mesothelioma
Conditions: Official terms:
Mesothelioma
Mesothelioma, Malignant
Conditions: Keywords:
Cadonilimab
pleural mesothelioma
Bispecific Antibody
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Cadonilimab Combined with chemotherapy
Description:
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.
Arm group label:
Cadonilimab combined with chemotherapy
Other name:
AK104
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
June 20, 2024
Completion date:
June 20, 2029
Lead sponsor:
Agency:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Agency class:
Other
Collaborator:
Agency:
Akesobio
Agency class:
Other
Source:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06416930
