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)

  • STATUS
    Not Recruiting
  • End date
    Jan 22, 2027
  • participants needed
    525
  • sponsor
    Merck Sharp & Dohme LLC
Updated on 8 August 2022
fluorouracil
oxaliplatin
bevacizumab
folfox regimen
chemotherapy regimen
systemic chemotherapy
adenocarcinoma
solid tumour
colorectal adenocarcinoma

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.

Details
Condition Metastatic Colorectal Cancer
Treatment Capecitabine, bevacizumab, 5-FU, olaparib, Leucovorin/ levoleucovorin
Clinical Study IdentifierNCT04456699
SponsorMerck Sharp & Dohme LLC
Last Modified on8 August 2022

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