Pleural Mesothelioma
Conditions
Keywords
Cadonilimab, pleural mesothelioma, Bispecific Antibody
Brief 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.
Interventions
DRUGCadonilimab Combined with chemotherapy
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.
Sponsors
Akesobio
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate (ORR) | 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
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) | 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. |
| Adverse Events (AEs) | 2 year | Incidence and severity of adverse events (AE) and clinically significant abnormal laboratory results |
| Disease Control Rate (DCR) | 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. |
| Progression Free Survival (PFS) | 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. |
| Duration of Response (DoR) | 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. |
Contacts
Primary ContactJie Wang
Outcome results
None listed