๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2025-08-22

Study of Cabozantinib in Combination With Nivolumab and Ipilimumab in Patients With Previously Untreated Advanced or Metastatic Renal Cell Carcinoma (NCT03937219)

A Randomized, Double-Blind, Controlled Phase 3 Study of Cabozantinib in Combination With Nivolumab and Ipilimumab Versus Nivolumab and Ipilimumab in Subjects With Previously Untreated Advanced or Metastatic Renal Cell Carcinoma of Intermediate or Poor Risk

๐Ÿ”ต Active, Not Recruiting Phase3 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: Exelixis

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

This is a multicenter, randomized, double-blinded, controlled Phase 3 trial of cabozantinib in combination with nivolumab and ipilimumab versus nivolumab and ipilimumab in combination with matched placebo. Approximately 840 eligible subjects with intermediate- or poor-risk advanced or metastatic RCC by IMDC criteria will be randomized in a 1:1 ratio at approximately 180 sites.

Who can join: Review the eligibility criteria below.

Location: Exelixis Clinical Site #116 โ€” La Jolla, California

Age range: 18 Years

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

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

๐Ÿ“ All Participating Trial Locations (159 Sites)

Showing the first 25 of 159 sites.

  • Exelixis Clinical Site #116 โ€” La Jolla, California
  • Exelixis Clinical Site #166 โ€” Orange, California
  • Exelixis Clinical Site #29 โ€” Boca Raton, Florida
  • Exelixis Clinical Site #44 โ€” Miami, Florida
  • Exelixis Clinical Site #3 โ€” Atlanta, Georgia
  • Exelixis Clinical Site #95 โ€” Chicago, Illinois
  • Exelixis Clinical Site #69 โ€” Scarborough, Maine
  • Exelixis Clinical Site #58A โ€” Baltimore, Maryland
  • Exelixis Clinical Site #7B โ€” Boston, Massachusetts
  • Exelixis Clinical Site #7A โ€” Boston, Massachusetts
  • Exelixis Clinical Site #7C โ€” Boston, Massachusetts
  • Exelixis Clinical Site #6 โ€” Burlington, Massachusetts
  • Exelixis Clinical Site #15 โ€” Detroit, Michigan
  • Exelixis Clinical Site #24 โ€” Kansas City, Missouri
  • Exelixis Clinical Site #4 โ€” St Louis, Missouri
  • Exelixis Clinical Site #2 โ€” Omaha, Nebraska
  • Exelixis Clinical Site #159 โ€” New York, New York
  • Exelixis Clinical Site #8 โ€” New York, New York
  • Exelixis Clinical Site #19 โ€” Syracuse, New York
  • Exelixis Clinical Site #101 โ€” Charlotte, North Carolina
  • Exelixis Clinical Site #107 โ€” Portland, Oregon
  • Exelixis Clinical Site #12 โ€” Pittsburgh, Pennsylvania
  • Exelixis Clinical Site #102 โ€” Charleston, South Carolina
  • Exelixis Clinical Site #5 โ€” Myrtle Beach, South Carolina
  • Exelixis Clinical Site #10 โ€” Nashville, Tennessee

๐Ÿ’ฐ 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 ยง 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.

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  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.
๐Ÿ›๏ธ View Official NIH Record โ†—