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.
Both male and female patients aged 18 to 75 years (inclusive).
Histopathologically confirmed advanced mesothelioma.
No prior systemic therapy.
At least one measurable lesion according to mRECIST 1.1 and RECIST 1.1 criteria.
Prior systemic anti-tumor therapy, except for patients who relapsed more than six months after completion of adjuvant chemotherapy.
Known history of hypersensitivity to macromolecular protein preparations, or contraindication or allergy to any component of iparomlimab and tuvoraleimab, bevacizumab, pemetrexed, or platinum-based agents.
Major surgery (excluding diagnostic laparoscopy; local surgical treatment of isolated lesions is acceptable) within 28 days before the first dose.
History of allogeneic tissue/solid organ transplantation.
Single group
Iparomlimab and Tuvoraleimab injection+Bevacizumab+Pemetrexed+Cisplatin
DrugIparomlimab 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.
Objective response rate (ORR)
Defined as the percentage of subjects achieving complete response (CR) or partial response (PR).
Disease control rate (DCR)
Defined as the percentage of participants in the analysis population who achieved Complete Response, Partial Response, or Stable Disease.
Duration of Response (DoR)
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.
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.
Overall Survival (OS)
Defined as the time from the initiation of treatment until death from any cause.
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