COLORECTAL: Metastatic: 1st Line Maintenance: 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 5-FU in Participants With Unresectable or Metastatic Colorectal Cancer Who Have Not Progressed Following First-line Induction of FOLFOX With Bevacizumab (LYNK-003)

Title
Merck MK7339-003 (LYNK-003, Colorectal)
Study 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)

Site Link
Malignancy
Colon, Rectal, Colorectal
Stage
Disease Setting
Metastatic/Palliative
Line Of Therapy
Maintenance (after 1st Line)
Investigational Agent
Olaparib + Bevacizumab
Drug Class
PARP inhibitor
PI
Axel Grothey, MD
Sponsor
Merck Sharp & Dohme Corp
Phase
Status
Key Eligibility Criteria
Key Eligibility Criteria Details
  • Metastatic or unresectable colorectal adenocarcinoma
  • Has not progressed after first-line induction of at least 6 cycles of FOLFOX with bevacizumab
    • May have received prior adjuvant/neoadjuvant chemo for CRC as long as it was completed at least 6 months prior to initiation of metastatic FOLFOX-bev
  • Has experienced unacceptable toxicity to oxaliplatin that required the discontinuation of oxaliplatin (such as neurotoxicity)
  • Must be randomized within a minimum of 2 weeks and a maximum of 6 weeks after their last dose of FOLFOX+bev
  • ECOG PS 0-1
  • No known CNS disease
  • No known HIV/HBV/HCV
  • No clinically significant bleeding within 28 days
  • No uncontrolled hypertension, nephrotic syndrome, GI perforation
  • No prior tx with olaparib or other PARP inhibitor
Objective
  • Primary
    • PFS
  • Secondary
    • OS
    • ORR
    • DoR
    • Safety
Assessment Frequency
_
Assessment Frequency 2
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Assessment Frequency Link
Path
Adenocarcinoma
Dosing Frequency
Control Agents
5-FU
Study Protocol
Randomized
Yes
X