Ipilimumab N01 Plus Sintilimab and Lenvatinib as First-line Therapy for Locally Advanced or Metastatic TFE3-Rearranged Renal Cell Carcinoma: A Prospective, Multicenter, Single-Arm, Phase II Clinical Trial

Starting soon · Phase 2

Conditions studied: Renal Cell Carcinoma (Kidney Cancer), Immunotherapy, Molecular Targeted Therapy

In brief

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.

Key facts

Study ID: NCT07715565
Run by: West China Hospital
People needed: 66
Starts: 2026-08-01
Expected to finish: 2029-12-01
Last updated by the study team: 2026-07-20

Who can join

Age: 14 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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).
Eastern Cooperative Oncology Group (ECOG) performance status ≤2.
Life expectancy ≥3 months.
Signed informed consent and ability to comply with study visits and procedures.
Willingness to provide tumor tissue and blood specimens for correlative studies.
Adequate organ and bone marrow function within 14 days prior to enrollment:
Hematology: ANC ≥1.5×10⁹/L, platelets ≥100×10⁹/L, hemoglobin ≥90 g/L. Hepatic: TBIL ≤1.5×ULN, ALT/AST ≤2.5×ULN, albumin ≥20 g/L. Renal: serum creatinine ≤1.5×ULN or creatinine clearance ≥50 mL/min.

You may not qualify if…

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).
Known or suspected active autoimmune disease (e.g., interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, thyroiditis), except type 1 diabetes, hypothyroidism requiring hormone replacement only, or skin conditions not requiring systemic treatment. Known allogeneic organ transplant (except corneal) or allogeneic hematopoietic stem cell transplant.
Known hypersensitivity to ipilimumab N01, sintilimab, or lenvatinib.
Uncontrolled severe comorbidities including:
Active or poorly controlled severe infection. HIV infection. Active hepatitis B (HBsAg-positive and HBV DNA >1×10³ IU/mL) or active hepatitis C (HCV antibody-positive and HCV RNA >15 IU/mL).
Active pulmonary tuberculosis. New York Heart Association Class III-IV congestive heart failure, symptomatic arrhythmia, uncontrolled atrial fibrillation, or left ventricular ejection fraction below the lower limit of normal.
Uncontrolled arterial hypertension (systolic ≥160 mmHg or diastolic ≥100 mmHg). Arterial thrombosis, embolism, or ischemia within 6 months (e.g., myocardial infarction, unstable angina, cerebrovascular accident, transient ischemic attack).
Uncontrolled adrenal insufficiency. Severe, non-healing wounds or ulcers; gastrointestinal disorders impairing absorption; active uncontrolled bleeding or high bleeding risk (e.g., esophageal/gastric varices requiring intervention); or unstable anticoagulation with clinically significant bleeding.
Any other acute or chronic medical or psychiatric condition, or laboratory abnormality, that in the opinion of the investigator increases the risk associated with study participation, may interfere with interpretation of study results, or makes the patient unsuitable for the study.
Pregnant or lactating women.

Where it is running

West China Hospital, Chengdu, Sichuan 610000 — Chengdu, China

Full record on ClinicalTrials.gov

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