Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03377361 · ClinicalTrials.gov registry record · Phase 1
An Investigational Immuno-therapy Study Of Nivolumab In Combination With Trametinib With Or Without Ipilimumab In Participants With Previously Treated Cancer of the Colon or Rectum That Has Spread
A Phase 1 study, sponsored by Bristol-Myers Squibb.
- Completed
- Registry status
- Phase 1
- Development phase
- 325
- Enrollment target
NCT03377361: Completed Phase 1 study, sponsored by Bristol-Myers Squibb.
NCT03377361 is a Phase 1 study that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 325 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (442% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03377361, a Phase 1 study, has completed, sponsored by Bristol-Myers Squibb.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 325 participants
- Enrollment target
Study Summary
The purpose of this study is to investigate treatment with nivolumab in combination with trametinib with or without ipilimumab in participants with previously treated cancer of the colon or rectum that has spread.
Primary Outcome
Dose Limiting Toxicities are defined as adverse events have to be at least possibly related to study treatment, and not to disease progression, be clinically relevant and a clinically relevant shift from baseline.
Interventions
- DRUG Regorafenib
- BIOLOGICAL Nivolumab
- DRUG Trametinib
- BIOLOGICAL Ipilimumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 325 participants |
| Start Date | 2018-01-31 |
| Est. Completion | 2024-11-04 |
| Phase | Phase 1 |
What the finished NCT03377361 record still lists
NCT03377361 is an interventional study that assigns participants to a tested intervention. The registered 325 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (442% higher).
The record links to 0 conditions, and to 4 interventions - of which Regorafenib is the first listed.
NCT03377361 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03377361 about?
NCT03377361 is a clinical study titled "An Investigational Immuno-therapy Study Of Nivolumab In Combination With Trametinib With Or Without Ipilimumab In Participants With Previously Treated Cancer of the Colon or Rectum That Has Spread". The purpose of this study is to investigate treatment with nivolumab in combination with trametinib with or without ipilimumab in participants with previously treated cancer of the colon or rectum that has spread.
What is the current status of trial NCT03377361?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 325 participants. The study started on 2018-01-31. Estimated completion is 2024-11-04.
What interventions are being tested in trial NCT03377361?
The interventions under investigation include: Regorafenib (DRUG), Nivolumab (BIOLOGICAL), Trametinib (DRUG), Ipilimumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT03377361?
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 NCT03377361's enrollment target sits among peer trials
325 111th of 2000 higher than 1,890 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02543983 · 325 participants · Phase 2
Neurobiology of Suicide
- NCT03016819 · 325 participants · Phase 3
Phase III Trial of Anlotinib, Catequentinib in Advanced Alveolar Soft Part Sarcoma, Leiomyosarcoma, Synovial Sarcoma (APROMISS)
- NCT03288207 · 325 participants · NA
Tailoring Mobile Health Technology to Reduce Obesity and Improve Cardiovascular Health in Resource-Limited Neighborhood Environments
- NCT04986657 · 325 participants · NA
Whole Genome Sequencing (ChromoSeq) as an Adjunct to Conventional Genomic Profiling in AML and MDS
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI