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NCT04068610 · ClinicalTrials.gov registry record · Phase 1
COLUMBIA-1: Novel Oncology Therapies in Combination With Chemotherapy and Bevacizumab as First- Line Therapy in MSS-CRC
A Phase 1 study of Metastatic Microsatellite-stable Colorectal Cancer, sponsored by MedImmune.
- Active
- Registry status
- Phase 1
- Development phase
- 61
- Enrollment target
- 20
- Study locations
NCT04068610: Active Phase 1 study of Metastatic Microsatellite-stable Colorectal Cancer, sponsored by MedImmune.
NCT04068610 is a Phase 1 study of Metastatic Microsatellite-stable Colorectal Cancer that is active but no longer recruiting, run by MedImmune. The registered enrollment target is 61 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04068610, a Phase 1 study of Metastatic Microsatellite-stable Colorectal Cancer, is active but no longer recruiting, sponsored by MedImmune.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 61 participants
- Enrollment target
- 20
- Study locations
Study Summary
COLUMBIA-1 is a Phase 1b/2 platform study to evaluate the safety and efficacy of standard of care (FOLFOX plus bevacizumab) alone and in combination with novel oncology therapies in first-line metastatic microsatellite-stable colorectal cancer (MSS-CRC).
Primary Outcome
An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The TEAEs are defined as events present at
Conditions Studied
Interventions
- DRUG Bevacizumab
- DRUG Durvalumab
- DRUG FOLFOX
- DRUG Oleclumab
Study Locations (20)
Other
- Research Site - Clayton
- Research Site - Heidelberg
- Research Site - Melbourne
- Research Site - Nantes
- Research Site - Villejuif
- Research Site - Barcelona
- Research Site - Barcelona
- Research Site - Madrid
California
- Research Site - Los Angeles
- Research Site - Sacramento
Tennessee
- Research Site - Chattanooga
- Research Site - Nashville
Michigan
- Research Site - Ann Arbor
Nevada
- Research Site - Las Vegas
New York
- Research Site - New York
Ohio
- Research Site - Canton
Rhode Island
- Research Site - Providence
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 61 participants |
| Start Date | 2019-09-13 |
| Est. Completion | 2026-11-24 |
| Phase | Phase 1 |
What the registry record for NCT04068610 still lists
NCT04068610 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 61 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 1 condition, with Metastatic Microsatellite-stable Colorectal Cancer appearing as the primary indexed condition, and to 4 interventions - of which Bevacizumab is the first listed.
NCT04068610 names 20 study sites across 11 states, led by Other, California, Tennessee.
Frequently Asked Questions
What is clinical trial NCT04068610 about?
NCT04068610 is a clinical study titled "COLUMBIA-1: Novel Oncology Therapies in Combination With Chemotherapy and Bevacizumab as First- Line Therapy in MSS-CRC". COLUMBIA-1 is a Phase 1b/2 platform study to evaluate the safety and efficacy of standard of care (FOLFOX plus bevacizumab) alone and in combination with novel oncology therapies in first-line metastatic microsatellite-stable colorectal cancer (MSS-CRC).
What is the current status of trial NCT04068610?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 61 participants. The study started on 2019-09-13. Estimated completion is 2026-11-24.
What conditions does trial NCT04068610 study?
This clinical trial studies the following conditions: Metastatic Microsatellite-stable Colorectal Cancer.
What interventions are being tested in trial NCT04068610?
The interventions under investigation include: Bevacizumab (DRUG), Durvalumab (DRUG), FOLFOX (DRUG), Oleclumab (DRUG).
Who is sponsoring clinical trial NCT04068610?
This trial is sponsored by MedImmune, which has 210 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04068610 being conducted?
This trial has 20 study locations across California, Michigan, Nevada, New York, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04068610's enrollment target sits among peer trials
61 828th of 2000 higher than 1,170 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
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