This is a prospective, single-arm, multicenter, phase II clinical trial designed to evaluate the efficacy and safety of iparomlimab and tuvoraleimab, in combination with bevacizumab, albumin-bound paclitaxel, and carboplatin as first- or second-line treatment in patients with acral and mucosal melanoma.
Subjects (or their legal representatives/guardians) must sign the informed consent form, indicating that they understand the purpose of this study, are aware of the necessary procedures involved, and are willing to participate.
Aged ≥18 years and ≤75 years, regardless of gender.
Histologically or pathologically confirmed mucosal or acral melanoma.
Braf, Nras, and Ckit gene mutation status is unrestricted.
History or presence of other malignancies within the past 5 years, except for cured localized tumors (e.g., basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the cervix, etc.).
Participation in treatment with an investigational drug or use of an investigational device within 4 weeks prior to the first dose of study treatment.
Palliative local therapy for non-target lesions within 2 weeks prior to the first dose; Non-specific immunomodulatory therapy (e.g., interleukins, interferons, thymosin, etc., excluding IL-11 used for treating thrombocytopenia) within 2 weeks prior to the first dose; Treatment with Chinese herbal medicine or Chinese patent medicine with anti-tumor indications within 1 week prior to the first dose.
Patients who have previously received iparomlimab and tuvoraleimab or other dual immunotherapy, bevacizumab, albumin-bound paclitaxel, or carboplatin.
Single group
Iparomlimab and Tuvoraleimab injection+Bev+nab-PC
DrugIparomlimab and Tuvoraleimab injection: 5mg/kg, D1,Q3W; Bevacizumab: 7.5 mg/kg, D1, Q3W; Albumin-bound paclitaxel: 125mg/m2, D1,8, Q3W; Carboplatin: AUC=2, D1,8, Q3W.
Objective response rate (ORR)
Defined as the percentage of participants in the analysis population who experienced a Complete Response or a Partial Response and was assessed using RECIST 1.1 based on investigator evaluation.
Disease control rate (DCR)
Defined as the percentage of participants in the analysis population who achieved Complete Response, Partial Response, or Stable Disease, as assessed by the investigator according to RECIST 1.1 criteria.
Duration of Response (DoR)
Defined as the time from the first documented confirmed response (CR or PR) to the first documented disease progression (per RECIST 1.1) or death from any cause, whichever occurs first.
Time to Response (TTR)
Defined as the time from the first administration of the investigational drug to the first occurrence of Complete Response (CR) or Partial Response (PR).
Progression-Free Survival (PFS)
Defined as the time from the initiation of treatment until the first documented disease progression (per RECIST 1.1) or death from any cause, whichever occurs first.
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This trial is not recruiting at the moment. You can still explore other options:
