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NCT03414983 · ClinicalTrials.gov registry record · Phase 2
An Investigational Immunotherapy Study of Nivolumab With Standard of Care Therapy vs Standard of Care Therapy for First-Line Treatment of Colorectal Cancer That Has Spread
A Phase 2 study, sponsored by Bristol-Myers Squibb.
- Completed
- Registry status
- Phase 2
- Development phase
- 196
- Enrollment target
NCT03414983: Completed Phase 2 study, sponsored by Bristol-Myers Squibb.
NCT03414983 is a Phase 2 study that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 196 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (47% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03414983, a Phase 2 study, has completed, sponsored by Bristol-Myers Squibb.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 196 participants
- Enrollment target
Study Summary
This purpose of this study is to evaluate nivolumab (BMS-936558) in combination with standard of care (SOC) chemotherapy with bevacizumab for the treatment of first-line metastatic colorectal cancer (mCRC).
Primary Outcome
Progression Free Survival (PFS) is defined as the time from randomization to the date of the first documented progression, as determined by BICR (per RECIST 1.1), or death due to any cause, whichever occurs first. Baseline tumor assessment is defined as tumor scans prior to or on randomization date. Participants who did not have documented progression per BICR and who did not die or participants who started any subsequent anti-cancer therapy without a prior reported progression per BICR will be
Interventions
- DRUG Bevacizumab
- DRUG Fluorouracil
- DRUG Leucovorin
- DRUG Oxaliplatin
- BIOLOGICAL Nivolumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 196 participants |
| Start Date | 2018-02-20 |
| Est. Completion | 2022-12-28 |
| Phase | Phase 2 |
What the finished NCT03414983 record still lists
NCT03414983 is an interventional study that assigns participants to a tested intervention. The registered 196 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (47% higher).
The record links to 0 conditions, and to 5 interventions - of which Bevacizumab is the first listed.
NCT03414983 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03414983 about?
NCT03414983 is a clinical study titled "An Investigational Immunotherapy Study of Nivolumab With Standard of Care Therapy vs Standard of Care Therapy for First-Line Treatment of Colorectal Cancer That Has Spread". This purpose of this study is to evaluate nivolumab (BMS-936558) in combination with standard of care (SOC) chemotherapy with bevacizumab for the treatment of first-line metastatic colorectal cancer (mCRC).
What is the current status of trial NCT03414983?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 196 participants. The study started on 2018-02-20. Estimated completion is 2022-12-28.
What interventions are being tested in trial NCT03414983?
The interventions under investigation include: Bevacizumab (DRUG), Fluorouracil (DRUG), Leucovorin (DRUG), Oxaliplatin (DRUG), Nivolumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT03414983?
This trial is sponsored by Bristol-Myers Squibb, which has 1,025 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03414983's enrollment target sits among peer trials
196 349th of 2000 higher than 1,651 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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