drugset / Trial / NCT04068610

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

NCT04068610

Phase 1/2 Active not recruiting 61 enrolled MedImmune LLC
RandomizedParallel-groupOpen-labelTreatment

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).

Timeline

Start
2019-09-13
Primary completion
2022-10-10
Completion
2026-11-24

Drugs

EvaluationDrugModalityDoseRoute
Subject Durvalumab Monoclonal antibody 1500 mg Intravenous
Subject Oleclumab Monoclonal antibody 3000 mg Intravenous
Background Bevacizumab Monoclonal antibody 5 mg/kg Intravenous
Background Leucovorin Small molecule 400 mg/m2 Intravenous
Background Oxaliplatin Small molecule 85 mg/m2 Intravenous
Background fluorouracil Small molecule 2400 mg/m2 Intravenous

Indications