Efficacy and Safety of Iparomlimab and Tuvonralimab Injection in Combination With Bevacizumab After Progression on Anti-PD-(L)1 Therapy in Advanced Melanoma: A Prospective, Single-Arm, Exploratory Clinical Study
NCT07004335 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40
Last updated 2025-06-04
Summary
Several studies have shown that the combination of Iparomlimab, Tuvonralimab, and Bevacizumab exhibits potent anti-tumor activity and favorable safety in various solid tumors, including liver cancer. However, the efficacy and safety of this regimen in melanoma patients with acquired resistance to immunotherapy remain unexplored and require further validation.
This study aims to evaluate the efficacy and safety of the Iparomlimab, Tuvonralimab, and Bevacizumab combination in patients with immune-resistant melanoma. Furthermore, it will analyze and compare treatment responses among different melanoma subtypes to identify optimal treatment strategies for clinical practice.
Conditions
- PD-(L)1
- CTLA-4
- Advanced Melanoma
- Iparomlimab
- Tuvonralimab
- Bevacizumab
Interventions
- DRUG
-
Iparomlimab and Tuvonralimab Injection plus Bevacizumab
The experimental group will receive intravenous infusion of anti PD-1/CTLA-4 (Iparomlimab/Tuvonralimab) Injection (5 mg/kg) and Bevacizumab (dose 7.5mg/kg) once every 3 weeks up to 35 cycles (105 weeks).
Sponsors & Collaborators
-
Qilu Pharmaceutical Co., Ltd.
collaborator INDUSTRY -
Hebei Medical University Fourth Hospital
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-07-01
- Primary Completion
- 2028-12-31
- Completion
- 2029-01-31
Countries
- China
Study Locations
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