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OncoMatch/Clinical Trials/NCT06053658

Phase 2 Study of Combination Tivozanib and Nivolumab in Advanced Non-Clear Cell Renal Cell Carcinoma

Is NCT06053658 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Tivozanib and Nivolumab for renal cell carcinoma.

Phase 2RecruitingM.D. Anderson Cancer CenterNCT06053658Data as of May 2026

Treatment: Tivozanib · NivolumabTo learn if giving tivozanib in combination with nivolumab can help to control advanced nccRCC.

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Extracted eligibility criteria

Cancer type

Renal Cell Carcinoma

Disease stage

Metastatic disease required

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

Max 1 prior line

Cannot have received: VEGFR inhibitor (tivozanib)

Prior tivozanib therapy

Cannot have received: anti-PD-1 therapy (nivolumab)

Prior nivolumab therapy

Lab requirements

Blood counts

absolute neutrophil count ≥1,000/mcL; platelets ≥100,000/mcL

Kidney function

creatinine ≤1.5 × institutional ULN; eGFR ≥30 ml/min

Liver function

total bilirubin ≤ institutional upper limit of normal (ULN); AST ≤3 × institutional ULN; ALT ≤3 × institutional ULN

Cardiac function

NYHA Functional Classification class 2B or better

Patients must have adequate organ and marrow function as defined below: 1. absolute neutrophil count ≥1,000/mcL 2. platelets ≥100,000/mcL 3. total bilirubin ≤ institutional upper limit of normal (ULN) 4. AST ≤3 × institutional ULN 5. (ALT) ≤3 × institutional ULN 6. creatinine ≤1.5 × institutional ULN 7. eGFR ≥30 ml/min ...patients should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better.

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • Beth Israel Deaconess Medical Center · Boston, Massachusetts
  • Dana-Farber Cancer Institute · Boston, Massachusetts
  • University of Michigan · Ann Arbor, Michigan
  • UT Southwestern Medical Center · Dallas, Texas
  • M D Anderson Cancer Center · Houston, Texas

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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