Clinical Trials

Inclusion Criteria:

• Written informed consent and HIPAA authorization for release of personal health information prior to study enrollment.

• Women and men of any racial and smoking status, age 18-85 years at the time of consent.

• Histological or cytological confirmation of RCC.

• Evaluable metastatic disease according to RECIST 1.1 criteria within 28 days prior to registration.

• Karnofsky Performance Status (KPS) ≥ 60 within 28 days prior to registration.

• Archived or fresh FFPE tumor specimen of at least 25 mm2.

• Demonstrate adequate organ function: leukocytes >1,000/mm3; an absolute neutrophil count ≥1,000/mL; platelets ≥70,000/mL; hemoglobin ≥8 g/dL; total bilirubin within normal laboratory limits (≤1.5 times the upper limit of normality [≤2.0 in patients with known Gilbert’s syndrome] OR direct bilirubin ≤1 times the upper limit of normality; AST(SGOT)/ALT(SGPT) ≤2.5 times the upper limit of normality; serum creatinine ≤1.5 times the upper limit of normal or calculated creatinine clearance > 30mL/minutes.

Exclusion Criteria:

• Active infection requiring systemic therapy.

• Known HIV-positive with detectable viral load.

• Pregnant or breastfeeding.

• Known additional invasive malignancy that is active and/or progressive requiring treatment; exceptions include locally curable cancers, or other cancer for which the subject has been disease-free for at least three years or prostate cancer on surveillance.

• Subjects who have not recovered from toxicities from prior systemic anti-cancer treatment or local therapies (a residual toxicity likely to be chronic but controlled and manageable is allowed, e.g. endocrine syndromes from prior interleukin-2).

• Subjects who have undergone major surgery < 4 weeks or minor surgery < 2 weeks prior to registration. Wounds must be healed prior to study entry and subjects must have recovered from all toxicities from surgery. NOTE: Placement of a vascular access device not considered major or minor surgery in this regard.

• Prior radiation therapy is allowed as long as irradiated area was not the sole source of measurable disease and radiotherapy was completed ≥2 weeks prior to registration, and subject has recovered from toxicity.

• Renal failure requiring hemo- or peritoneal dialysis.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 4/23/2025. Questions regarding updates should be directed to the study team contact.