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

Official Title

A Phase 1b/2, Open-label, Multicentre Study of Novel Oncology Therapies in Combination With Chemotherapy and Bevacizumab as First-line Therapy in Metastatic Microsatellite-stable Colorectal Cancer (COLUMBIA-1)

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).

Trial Description

Primary Outcome:

  • Part 1 of the study: Number of participants with Dose Limiting Toxicities (DLTs) as a measure of safety.
  • Part 2 of the study: Objective Response (OR) rate as a measure of antitumour activity of FOLFOX plus bevacizumab plus novel oncology therapy combinations versus FOLFOX plus bevacizumab.
Secondary Outcome:
  • Incidence of Adverse Events as a measure of safety during the treatment period
  • Incidence of clinically significant vital sign values as a measure of safety during the treatment period
  • Incidence of clinically significant laboratory values as a measure of safety during the treatment period
  • Duration of Response (DoR) as a measure of efficacy of FOLFOX plus bevacizumab plus novel oncology therapy combinations versus FOLFOX plus bevacizumab
  • Disease Control Rate (DCR) as a measure of efficacy of FOLFOX plus bevacizumab plus novel oncology therapy combinations versus FOLFOX plus bevacizumab
  • Progression-Free Survival (PFS) as a measure of efficacy of FOLFOX plus bevacizumab plus novel oncology therapy combinations versus FOLFOX plus bevacizumab
  • Progression-Free Survival 12 month landmark rate (PFS-12) as a measure of efficacy of FOLFOX plus bevacizumab plus novel oncology therapy combinations versus FOLFOX plus bevacizumab
  • Overall Survival (OS) as a measure of efficacy of FOLFOX plus bevacizumab plus novel oncology therapy combinations versus FOLFOX plus bevacizumab
  • Serum concentration levels of novel agents in combination with FOLFOX + bevacuzimab
  • Number of subjects with detectable anti-drug antibody (ADA) to novel agents in combination with FOLFOX + bevacuzimab
COLUMBIA-1 is a Phase 1b/2, open-label, multicentre, 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.

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society