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

Study results available
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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

Durvalumab

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

FOLFOX

Participants will receive IV infusion of FOLFOX (5-FU, oxaliplatin, and folinic acid) as stated in arm description.

DRUG

Bevacizumab

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04068610 on ClinicalTrials.gov