NCT07004335

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

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Hebei Medical University Fourth Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a single-center, prospective, single-arm, exploratory clinical trial. Following the signing of informed consent, all participants will undergo screening according to the inclusion and exclusion criteria.It is anticipated that a total of 40 patients will be enrolled. Participants will receive a combination of Iparomlimab/Tuvonralimab injection and Bevacizumab every 3 weeks. Follow-up visits will be scheduled every 6 weeks. The final assessment of the study endpoints will take place at Week 105, while the last evaluation of other adverse events will be conducted at Week 109.

Conditions

• PD-(L)1
• CTLA-4
• Advanced Melanoma
• Iparomlimab
• Tuvonralimab
• Bevacizumab

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2025-07-01
• Primary completion: 2028-12-31
• Completion: 2029-01-31
• First posted: 2025-06-04
• Last updated: 2025-06-04

Locations

1 site across 1 country: China