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A Prospective, Single-arm, Multicenter, Phase II Clinical Study of Iparomlimab and Tuvoraleimab Injection in Combination With Bevacizumab, Albumin-bound Paclitaxel, and Carboplatin as First- or Second-line Treatment for Patients With Advanced Acral and Mucosal Melanoma
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, albumin-bound paclitaxel, and carboplatin as first- or second-line treatment in patients with acral and mucosal melanoma.
Details
| Lead sponsor | Fudan University |
|---|---|
| Phase | Phase 2 |
| Status | NOT_YET_RECRUITING |
| Enrolment | 48 |
| Start date | 2026-02 |
| Completion | 2028-12 |
Conditions
- Acral Melanoma
- Mucosal Melanoma
Interventions
- Iparomlimab and Tuvoraleimab injection+Bev+nab-PC
Primary outcomes
- Objective response rate (ORR) — up to 2 years
Defined as the percentage of participants in the analysis population who experienced a Complete Response or a Partial Response and was assessed using RECIST 1.1 based on investigator evaluation.
Countries
China