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

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 Arm
    anti PD-1/CTLA-4 (Iparomlimab/Tuvonralimab) injection and Bevacizumab

Primary Outcome Measure

Objective Response Rate, ORR [ Time Frame: 105 weeks ]

Central Contacts

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