NCT04068610

COLUMBIA-1: Novel Oncology Therapies in Combination With Chemotherapy and Bevacizumab as First- Line Therapy in MSS-CRC

A Phase Ib/II, Open-label, Multicenter Study of Novel Oncology Therapies in Combination With Chemotherapy and Bevacizumab as First-line Therapy in Metastatic Microsatellite-stable Colorectal Cancer (COLUMBIA-1)

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: MedImmune LLC · Industry
• Sex: All
• Age: 18 Years – 101 Years
• Healthy volunteers: Not accepted

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).

Detailed description

COLUMBIA-1 is a Phase 1b/2, open-label, multicenter, randomized, multidrug platform study to evaluate the safety and efficacy of standard of care (FOLFOX plus bevacizumab) in combination with novel oncology therapies in patients with first-line metastatic MSS-CRC. The study is designed to concurrently evaluate potential novel combinations with clinical promise using a 2-part approach. Part 1 is a Phase 1b study of safety, and Part 2 is a Phase 2 study of efficacy and safety.

Conditions

• Metastatic Microsatellite-stable Colorectal Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-09-13
• Primary completion: 2022-10-10
• Completion: 2026-11-24
• First posted: 2019-08-28
• Last updated: 2026-03-02
• Results posted: 2023-11-15

Locations

21 sites across 5 countries: United States, Australia, Canada, France, Spain

Regulatory

• FDA-regulated drug study