This phase II, multicenter, single-arm, open-label study evaluates first-line ipilimumab N01 plus sintilimab and lenvatinib in patients with locally advanced or metastatic TFE3-rearranged renal cell carcinoma (TFE3-rRCC), a rare subtype lacking established first-line systemic therapy. Eligible patients (age ≥14 years, ECOG ≤2, measurable disease per RECIST v1.1, no prior systemic therapy) will receive ipilimumab N01 1 mg/kg Q6W for 4 cycles, sintilimab 200 mg Q3W for up to 35 cycles, and lenvatinib 12 mg or 8 mg QD continuously. The primary endpoint is objective response rate (ORR) per RECIST v1.1. Secondary endpoints include disease control rate, duration of response, progression-free survival, overall survival, safety per NCI CTCAE v5.0, and quality of life. Exploratory biomarker analyses will assess potential predictors of treatment response.
Age ≥14 years, any gender.
Histologically confirmed locally advanced or metastatic TFE3-rearranged renal cell carcinoma (TFE3-rRCC) by FISH and/or next-generation sequencing.
Stage IV disease per the 2017 8th edition TNM staging system.
No prior systemic therapy with immune checkpoint inhibitors (PD-1/PD-L1 inhibitors) or targeted agents (TKI, mTORi); prior targeted therapy ≤1 month is allowed after an adequate washout (5.5 half-lives).
Active central nervous system metastases.
History of other malignancies within 3 years (different primary site or histology), except well-controlled basal cell carcinoma, squamous cell carcinoma, or cervical carcinoma in situ.
Major surgery or severe trauma within 4 weeks prior to enrollment.
Systemic corticosteroids (>10 mg/day prednisone equivalent) or other immunosuppressive agents within 14 days before first dose (topical, ophthalmic, intra-articular, intranasal, inhaled, or physiologic replacement steroids are permitted).
Single group
Ipilimumab Injection
DrugA human monoclonal antibody targeting CTLA-4.
Sintilimab injection
DrugRecombinant human-derived immunoglobulin G (IgG4)-type anti-programmed cell death receptor-1 (PD-1) monoclonal antibody, by binding to PD-1 and blocking PD-1 binding to PD-L1 and PD-L2, disarms the immunosuppressive effect, activates T-cell function, and enhances T-cell immunosurveillance and killing ability against tumors to generate tumor immune response.
Lenvatinib
DrugA multi-target tyrosine kinase inhibitor (VEGFR1-3, FGFR1-4, PDGFRα, KIT, RET).
Objective Response Rate (ORR)
Objective response rate is the proportion of participates with complete response (CR) or partial response (PR), based on RECIST1.1.
Adverse Events (AEs)
Adverse events are the incidence of treatment-emergent adverse events as assessed by CTCAE v5.0, including type and severity.
Overall Survival (OS)
Overall survival is the time from starting treatment to still being alive.
Progression-Free Survival (PFS)
Progression-free survival is assessed by investigators based on RECIST1.1, including disease progression or death from any cause.
Disease Control Rate (DCR)
Disease control rate is the proportion of participates with complete response (CR), partial response (PR) or stable disease (SD), based on RECIST1.1.
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