Efficacy and Safety of Olaparib, Olaparib + Bevacizumab Compared to Bevacizumab + 5-Fluorouracil (FU)

Official Title

A Phase 3 Randomized, Open-label Study to Evaluate the Efficacy and Safety of Olaparib Alone or in Combination With Bevacizumab Compared to Bevacizumab With 5-FU in Participants With Unresectable or Metastatic Colorectal Cancer Who Have Not Progressed Following First-line Induction of FOLFOX With Bevacizumab (LYNK-003)

Summary:

This is an efficacy and safety study of olaparib alone or in combination with bevacizumab being compared to bevacizumab with Fluorouracil (5-FU) in participants with unresectable or metastatic colorectal cancer (CRC) who have not progressed following first-line induction of FOLFOX with bevacizumab. Hypothesis 1 - Olaparib + Bevacizumab is superior to 5-FU + Bevacizumab with respect to progression-free survival (PFS) using Response Evaluation Criteria In Solid Tumours version 1.1 (RECIST 1.1) as assessed by blinded independent central review (BICR) in the treatment of CRC. Hypothesis 2 - Olaparib is superior to 5-FU + Bevacizumab with respect to PFS using RECIST 1.1 as assessed by BICR) in the treatment of CRC.

Trial Description

Primary Outcome:

• Progression-free Survival (PFS) Using Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)

• Overall Survival (OS)
• Objective Response Rate (ORR) per RECIST 1.1 as Assessed by BICR
• Duration of Response (DOR) Per RECIST 1.1 as Assessed by BICR
• Number of Participants with One or More Adverse Events (AE)
• Number of Participants Discontinuing Study Intervention Due to an AE

View this trial on ClinicalTrials.gov