COLUMBIA-1: Novel Oncology Therapies in Combination With Chemotherapy and Bevacizumab as First- Line Therapy in MSS-CRC
NCT04068610 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 61
Last updated 2026-05-15
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).
Conditions
- Metastatic Microsatellite-stable Colorectal Cancer
Interventions
- DRUG
-
Participants will receive IV infusion of durvalumab as stated in arm description.
- DRUG
-
Oleclumab
Participants will receive IV infusion of oleclumab as stated in arm description.
- DRUG
-
Participants will receive IV infusion of FOLFOX (5-FU, oxaliplatin, and folinic acid) as stated in arm description.
- DRUG
-
Participants will receive IV infusion of bevacizumab as stated in arm description.
Sponsors & Collaborators
-
MedImmune LLC
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 101 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-09-13
- Primary Completion
- 2022-10-10
- Completion
- 2026-11-24
- FDA Drug
- Yes
Countries
- United States
- Australia
- Canada
- France
- Spain
Study Locations
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