NCT04456699

Efficacy and Safety of Olaparib (MK-7339) With or Without Bevacizumab Compared to Bevacizumab With a Fluoropyrimidine in Unresectable or Metastatic Colorectal Cancer (CRC) (MK-7339-003/LYNK-003)

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 a Fluoropyrimidine in Participants With Unresectable or Metastatic Colorectal Cancer Who Have Not Progressed Following First-line Induction (LYNK-003)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 335 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an efficacy and safety study of olaparib alone or in combination with bevacizumab being compared to bevacizumab with a fluoropyrimidine in participants with unresectable or metastatic colorectal cancer who have not progressed following first-line induction. The primary hypotheses are: Olaparib + Bevacizumab is superior to a fluoropyrimidine + Bevacizumab with respect to progression-free survival (PFS) using Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1) as assessed by blinded independent central review (BICR); Olaparib is superior to a fluoropyrimidine + Bevacizumab with respect to PFS using RECIST 1.1 as assessed by BICR. As of amendment 5 study enrollment is being discontinued and study participants randomized to one of the two experimental arms (olaparib plus bevacizumab or olaparib monotherapy) must discontinue study intervention. Participants who are still on study treatment will no longer have tumor response assessments by BICR.

Conditions

• Metastatic Colorectal Cancer

Interventions

Type	Name	Description
DRUG	Olaparib	300 mg BID, oral until progressive disease or end of study
DRUG	5-FU	2400 mg/m\^2 over 46 to 48 hours Q2W IV infusion until disease progression or end of study; bolus 5-FU (400mg/m2) can be added prior to infusional 5-FU, per local standards and at the investigator's discretion
DRUG	Bevacizumab	5 mg/kg or 7.5 mg/kg Q2W or Q3W IV infusion until progressive disease or end of study
DRUG	Capecitabine	1000 mg/m\^2 oral capsule BID for 14 days, then 7 days off, Q3W) until progressive disease or end of study
DRUG	Leucovorin/ levoleucovorin	400 mg/m\^2 (leucovorin) or 200 mg/m\^2 (levoleucovorin) may be added to Bevacizumab + 5-FU per investigator's discretion Q2W IV infusion until progressive disease or end of study

Timeline

• Start date: 2020-08-19
• Primary completion: 2023-03-27
• Completion: 2023-11-06
• First posted: 2020-07-02
• Last updated: 2024-10-29
• Results posted: 2024-04-02

Locations

129 sites across 18 countries: United States, Australia, Belgium, Canada, Chile, Colombia, France, Germany, Hungary, Japan, Latvia, Lithuania, Russia, South Africa, South Korea, Spain, Turkey (Türkiye), Ukraine

Regulatory

• FDA-regulated drug study