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.
Age ≥18 years;
Histologically-confirmed unresectable Stage III or IV melanoma, unsuitable for local therapy;
Confirmed PD according to iRECIST within 12 weeks after receiving the last dose of anti-PD-(L)1 monotherapy or in combination with other treatments (including anti-CTLA-4) for at least two doses. (Up to 25% of participants may have received both anti-CTLA-4 and anti-PD-(L)1 treatment);
Participants with BRAF/CKIT/NRAS gene mutations must have progressed after targeted therapy;
Any active autoimmune disease or a history of autoimmune disease requiring treatment (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, colitis, hepatitis, pituitary炎, vasculitis, nephritis, hyperthyroidism; participants with vitiligo; childhood asthma that has completely resolved without any intervention in adulthood can be included; participants with asthma requiring bronchodilators for medical intervention cannot be included);
Received more than 10 mg of prednisolone or other immunosuppressive therapy within seven days prior to study treatment;
Severe allergic reaction to other monoclonal antibodies;
Uncontrolled cardiac clinical symptoms or disease, such as: heart failure of NYHA class 2 or above; unstable angina; myocardial infarction within the past year; clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention; QTc >450 ms (males); QTc >470 ms (females);
Single group
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).
Objective Response Rate, ORR
ORR includes complete response (CR) and partial response (PR) cases. According to RECIST V1.1, the first appearance of PR or CR requires additional imaging to confirm the lesion
Overall Survival Time, OS
Overall survival (OS) is the time between the participant's first infusion injection and death from any cause.
Progression-free Survival, PFS
Progression-free survival (PFS) is defined as the time between a participant's first treatment and the first radiographic evaluation of disease progression or death from any cause, whichever comes first.
Duration of Overall Response, DOR
It was defined as the time from the first documentation of an objective response (CR or PR) to the first documentation of objective disease progression (according to RECIST v1.1 criteria) or death from any cause, whichever occurred first.
Adverse Event, AE
The rates and severity of AEs
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Hebei Medical University Fourth Hospital
Lead sponsor
Qilu Pharmaceutical Co., Ltd.
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
