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ACTIVE NOT RECRUITING Phase 3

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

NCT03937219 · View on ClinicalTrials.gov ↗

Study Summary

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.

Conditions Studied

Interventions

  • BIOLOGICAL Nivolumab
  • DRUG Cabozantinib
  • BIOLOGICAL Ipilimumab
  • DRUG Cabozantinib-matched placebo

Study Locations (20)

Massachusetts

  • Exelixis Clinical Site #7B — Boston
  • Exelixis Clinical Site #7A — Boston
  • Exelixis Clinical Site #7C — Boston
  • Exelixis Clinical Site #6 — Burlington

New York

  • Exelixis Clinical Site #159 — New York
  • Exelixis Clinical Site #8 — New York
  • Exelixis Clinical Site #19 — Syracuse

California

  • Exelixis Clinical Site #116 — La Jolla
  • Exelixis Clinical Site #166 — Orange

Florida

  • Exelixis Clinical Site #29 — Boca Raton
  • Exelixis Clinical Site #44 — Miami

Missouri

  • Exelixis Clinical Site #24 — Kansas City
  • Exelixis Clinical Site #4 — St Louis

Georgia

  • Exelixis Clinical Site #3 — Atlanta

Illinois

  • Exelixis Clinical Site #95 — Chicago

Maine

  • Exelixis Clinical Site #69 — Scarborough

Trial Details

FieldValue
Enrollment Target 855 participants
Start Date 2019-06-25
Est. Completion 2027-01-31
Phase Phase 3

Sponsor

Exelixis

54 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03937219

The ClinicalTrials.gov registry entry for NCT03937219 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 855 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Exelixis, which has 54 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Renal Cell Carcinoma appearing as the primary indexed condition, and to 4 interventions — of which Nivolumab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03937219 reports 20 study locations spanning 12 distinct geographic areas — top geographies include Massachusetts, New York, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT03937219 about?

NCT03937219 is a clinical study titled "Study of Cabozantinib in Combination With Nivolumab and Ipilimumab in Patients With Previously Untreated Advanced or Metastatic Renal Cell Carcinoma". 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...

What is the current status of trial NCT03937219?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 855 participants. The study started on 2019-06-25. Estimated completion is 2027-01-31.

What conditions does trial NCT03937219 study?

This clinical trial studies the following conditions: Renal Cell Carcinoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03937219?

The interventions under investigation include: Nivolumab (BIOLOGICAL), Cabozantinib (DRUG), Ipilimumab (BIOLOGICAL), Cabozantinib-matched placebo (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03937219?

This trial is sponsored by Exelixis, which has 54 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT03937219 being conducted?

This trial has 20 study locations across California, Florida, Georgia, Illinois, Maine. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial