A Study of Nivolumab, Nivolumab Plus Ipilimumab, or Investigator's Choice Chemotherapy for the Treatment of Participants With Deficient Mismatch Repair (dMMR)/Microsatellite Instability High (MSI-H) Metastatic Colorectal Cancer (mCRC) (NCT04008030)
A Phase 3 Randomized Clinical Trial of Nivolumab Alone, Nivolumab in Combination With Ipilimumab, or Investigator's Choice Chemotherapy in Participants With Microsatellite Instability High (MSI-H) or Mismatch Repair Deficient (dMMR) Metastatic Colorectal Cancer
🩺 Plain-English Summary (8th-Grade Level)
The main purpose of this study is to compare the clinical benefit, as measured by Progression-Free Survival (PFS), Objective Response Rate (ORR), and Overall Survival (OS), achieved by nivolumab in combination with ipilimumab or by nivolumab monotherapy in participants with Microsatellite Instability High (MSI-H) or Mismatch Repair Deficient (dMMR) metastatic colorectal cancer (mCRC). This study will also compare nivolumab plus ipilimumab combination vs chemotherapy for treatment of MSI-H/dMMR mCRC participants.
Who can join: Review the eligibility criteria below.
Location: Local Institution - 0059 — Los Angeles, California
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (157 Sites)
Showing the first 25 of 157 sites.
- Local Institution - 0059 — Los Angeles, California
- Local Institution - 0130 — Sacramento, California
- Local Institution - 0103 — Denver, Colorado
- Local Institution - 0119 — Arlington Heights, Illinois
- Local Institution - 0060 — New York, New York
- Local Institution - 0105 — Portland, Oregon
- Local Institution - 0121 — Pittsburgh, Pennsylvania
- Local Institution - 0106 — Dallas, Texas
- Local Institution - 0104 — Roanoke, Virginia
- Local Institution - 0073 — Ciudad Autonoma Beunos Aires, Buenos Aires
- Local Institution - 0074 — Viedma, Río Negro Province
- Local Institution - 0084 — Buenos Aires,
- Local Institution - 0100 — CABA,
- Local Institution - 0072 — CABA,
- Local Institution - 0019 — Westmead, New South Wales
- Local Institution - 0053 — Woolloongabba, Queensland
- Local Institution - 0018 — Elizabeth Vale, South Australia
- Local Institution - 0041 — Clayton, Victoria
- Local Institution - 0017 — Heidelberg, Victoria
- Local Institution - 0064 — Graz,
- Local Institution - 0068 — Linz,
- Local Institution - 0120 — Salzburg,
- Local Institution - 0065 — Vienna,
- Local Institution - 0067 — Wiener Neustadt,
- Local Institution - 0045 — Bonheiden, Antwerpen
💰 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 § 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.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.