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This is a prospective, single-arm, multicenter, phase II clinical trial designed to evaluate the efficacy and safety of iparomlimab and tuvoraleimab in combination with bevacizumab and chemotherapy as first-line treatment for advanced mesothelioma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Iparomlimab and Tuvoraleimab injection+Bevacizumab+Pemetrexed+Cisplatin | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Iparomlimab and Tuvoraleimab injection+Bevacizumab+Pemetrexed+Cisplatin | Drug | Iparomlimab and Tuvoraleimab: 5 mg/kg each, on Day 1, intravenous injection, every 3 weeks (Q3W); Bevacizumab: 7.5 mg/kg, on Day 1, intravenous infusion, Q3W; Pemetrexed: 500 mg/m², on Day 1, intravenous infusion, Q3W; Platinum-based agent: either Cisplatin 75 mg/m² on Day 1, intravenous infusion, Q3W, or Carboplatin AUC = 5 on Day 1, intravenous infusion, Q3W; the specific agent is at the investigator's discretion. |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) | Defined as the percentage of subjects achieving complete response (CR) or partial response (PR). | up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Disease control rate (DCR) | Defined as the percentage of participants in the analysis population who achieved Complete Response, Partial Response, or Stable Disease. | up to 2 years |
| Duration of Response (DoR) |
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Inclusion Criteria:
Coagulation function: international normalized ratio (INR) ≤ 1.5 × ULN, and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| xin Liu | Contact | 021-64175590-88503 | jeanettexin@hotmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan university cancer hospital | Shanghai | China |
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Defined as the time from the first tumor assessment showing response (complete response [CR] or partial response [PR]) to disease progression or death, whichever occurs first, in patients who achieve CR or PR.
| up to 2 years |
| Progression-Free Survival (PFS) | Defined as the time from enrollment to the date of first documented tumor progression (as assessed per mRECIST 1.1 and RECIST v1.1 criteria, regardless of whether treatment is continued) or death from any cause, whichever occurs first. | up to 2 years |
| Overall Survival (OS) | Defined as the time from the initiation of treatment until death from any cause. | up to 2 years |
| Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 | Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 | up to 2 years |
| ID | Term |
|---|---|
| D008654 | Mesothelioma |
| ID | Term |
|---|---|
| D000236 | Adenoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D018301 | Neoplasms, Mesothelial |
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