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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 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.
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.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 839 participants |
| Start Date | 2019-08-05 |
| Est. Completion | 2026-06-10 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04008030
The ClinicalTrials.gov registry entry for NCT04008030 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 839 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 167-participant average among 45 other Metastatic Colorectal Cancer trials with a reported enrollment target (402% higher). The listed sponsor is Bristol-Myers Squibb, which has 1,025 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 15 distinct geographic areas - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.