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
- Sponsor
- Hebei Medical University Fourth Hospital
- Study ID
- NCT07004335
- Phase
- PHASE4
- Status
- Not Yet Recruiting
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Conditions
- Advanced Melanoma
- Bevacizumab
- CTLA-4
- Iparomlimab
- PD-(L)1
- Tuvonralimab
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Iparomlimab and Tuvonralimab Injection plus Bevacizumab — DRUGThe 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).
Study Details
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.
Key Dates
- First listed
- Jun 4, 2025
- Start date
- Jul 1, 2025
- Status verified
- May 2025
- Primary completion
- Dec 31, 2028
- Completion
- Jan 31, 2029
Study Design
- Enrollment
- 40 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Experimental Armanti PD-1/CTLA-4 (Iparomlimab/Tuvonralimab) injection and Bevacizumab
Primary Outcome Measure
Objective Response Rate, ORR [ Time Frame: 105 weeks ]
Central Contacts
- Zhiyu Wang, MD008631186095810
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