πŸ›οΈ Verified NIH Record β€’ Updated 2026-05-20

Study of Nivolumab and Axitinib in Patients With Advanced Renal Cell Carcinoma (NCT03172754)

Phase I/II Study of Nivolumab and Axitinib in Patients With Advanced Renal Cell Carcinoma

πŸ”΅ Active, Not Recruiting Phase1 / Phase2 πŸ’Š Investigational Drug / Biologic Sponsor: Fox Chase Cancer Center

🩺 Plain-English Summary (8th-Grade Level)

This is a Phase I/II, open-label, multi-center study of axitinib in combination with nivolumab in patients with previously treated and untreated advanced RCC. This clinical study will be composed of a dose finding phase (Phase I) and two parallel dose expansion phases (Phase II). The dose finding phase will assess the safety of the combination and establish a recommended phase II dose (RP2D, the highest tested dose that is declared safe and tolerable by the Investigators and the Sponsor Investigator) in patients with advanced RCC who have received prior systemic therapy for metastatic disease. Phase II will evaluate the efficacy of the combination at the RP2D in two parallel expansion cohorts in both previously treated and treatment naΓ―ve patients.

Who can join: Review the eligibility criteria below.

Location: Johns Hopkins β€” Baltimore, Maryland

Age range: 18 Years

πŸ§ͺ Interventions in This Study

πŸ“‹ "Do I Qualify?" β€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria β†—

πŸ“ All Participating Trial Locations (4 Sites)

  • Johns Hopkins β€” Baltimore, Maryland
  • US Oncology and Hematology β€” Albany, New York
  • Cornell β€” New York, New York
  • Fox Chase Cancer Center β€” Philadelphia, Pennsylvania

πŸ“ž Contact the Study Coordinator

Phone: (855) 694-6725

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

πŸ’° Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA Β§ 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

πŸ’‘ How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
πŸ›οΈ View Official NIH Record β†—