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NCT04008030 · ClinicalTrials.gov registry record · Phase 3

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)

A Phase 3 study of Metastatic Colorectal Cancer, sponsored by Bristol-Myers Squibb.

Active
Registry status
Phase 3
Development phase
839
Enrollment target
20
Study locations

NCT04008030: Active Phase 3 study of Metastatic Colorectal Cancer, sponsored by Bristol-Myers Squibb.

NCT04008030 is a Phase 3 study of Metastatic Colorectal Cancer that is active but no longer recruiting, run by Bristol-Myers Squibb. The registered enrollment target is 839 participants, above the 167-participant average among 45 other Metastatic Colorectal Cancer trials with a reported enrollment target (402% higher). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04008030, a Phase 3 study of Metastatic Colorectal Cancer, is active but no longer recruiting, sponsored by Bristol-Myers Squibb.

ACTIVE NOT RECRUITING
Registry status
Phase 3
Development phase
839 participants
Enrollment target
20
Study locations

Study Summary

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.

Primary Outcome

BICR-assessed Progression-free survival (PFS) is defined as the time from the randomization date to the date of first objectively documented disease progression per RECIST 1.1 (i.e, radiologic) or death due to any cause, whichever occurs first.

Conditions Studied

Metastatic Colorectal Cancer

Interventions

  • DRUG Fluorouracil
  • DRUG Leucovorin
  • DRUG Oxaliplatin
  • DRUG Irinotecan
  • BIOLOGICAL Ipilimumab

Study Locations (20)

Other

  • Local Institution - 0084 - Buenos Aires
  • Local Institution - 0100 - CABA
  • Local Institution - 0072 - CABA
  • Local Institution - 0064 - Graz

California

  • Local Institution - 0059 - Los Angeles
  • Local Institution - 0130 - Sacramento

Victoria

  • Local Institution - 0041 - Clayton
  • Local Institution - 0017 - Heidelberg

Colorado

  • Local Institution - 0103 - Denver

Illinois

  • Local Institution - 0119 - Arlington Heights

New York

  • Local Institution - 0060 - New York

Oregon

  • Local Institution - 0105 - Portland

Pennsylvania

  • Local Institution - 0121 - Pittsburgh

Trial Details

FieldValue
Enrollment Target 839 participants
Start Date 2019-08-05
Est. Completion 2026-06-10
Phase Phase 3
Bristol-Myers Squibb

1,025 total trials

What the registry record for NCT04008030 still lists

NCT04008030 is an interventional study that assigns participants to a tested intervention. The registered 839 participants enrollment target is mid-sized for trials with a published cap, above the 167-participant average among 45 other Metastatic Colorectal Cancer trials with a reported enrollment target (402% higher).

The record links to 1 condition, with Metastatic Colorectal Cancer appearing as the primary indexed condition, and to 5 interventions - of which Fluorouracil is the first listed.

NCT04008030 names 20 study sites across 15 states, led by Other, California, Victoria.

Frequently Asked Questions

What is clinical trial NCT04008030 about?

NCT04008030 is a clinical study titled "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)". 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 Instabilit...

What is the current status of trial NCT04008030?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 839 participants. The study started on 2019-08-05. Estimated completion is 2026-06-10.

What conditions does trial NCT04008030 study?

This clinical trial studies the following conditions: Metastatic Colorectal Cancer.

What interventions are being tested in trial NCT04008030?

The interventions under investigation include: Fluorouracil (DRUG), Leucovorin (DRUG), Oxaliplatin (DRUG), Irinotecan (DRUG), Ipilimumab (BIOLOGICAL).

Who is sponsoring clinical trial NCT04008030?

This trial is sponsored by Bristol-Myers Squibb, which has 1,025 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04008030 being conducted?

This trial has 20 study locations across California, Colorado, Illinois, New York, Oregon. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Metastatic Colorectal Cancer

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT04008030's enrollment target sits among peer trials

839 1st of 45 higher than 45 of 45 other Metastatic Colorectal Cancer trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Metastatic Colorectal Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT04008030, the US trial registry maintained by the National Library of Medicine. NCT04008030 (mid enrollment · wide site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.