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Colon: Metastatic PDL 1+ second or later lines

A Phase 3 Study of MK-4280A (Coformulated Favezelimab [MK-4280] Plus Pembrolizumab [MK-3475]) Versus Standard of Care in Previously Treated Metastatic PD-L1 Positive Colorectal Cancer

Title
Merck MK4280A-007 (Metastatic PDL1+ CRC)
Study Title

A Phase 3 Study of MK-4280A (Coformulated Favezelimab [MK-4280] Plus Pembrolizumab [MK-3475]) Versus Standard of Care in Previously Treated Metastatic PD-L1 Positive Colorectal Cancer

Site Link
Malignancy
Colon, Colorectal
Stage
Disease Setting
metastatic
Line Of Therapy
second or later
Investigational Agent
favezelimab/pembrolizumab
Drug Class
Anti-Lag3 + PDL1 inhibitor
PI
Bradley Somer, MD
Sponsor
Merck Sharp & Dohme Corp.
Phase
Status
Key Eligibility Criteria
Key Eligibility Criteria Details
  • Metastatic, unresectable colorectal adenocarcinoma, PDL1+
  • Has measurable disease per RECIST 1.1 
  • Has been previously treated for the disease and radiographically progressed on or after or could not tolerate standard treatment.
  • Submits an archival (≤ 5 years) or newly obtained tumor tissue sample or newly obtained tumor tissue sample that has not been previously irradiated.
  • ECOG 0-1
  • Life Expectancy >= 3 months
  • Ability to swallow oral medications
  • Has adequate organ function.
  • MMR proficient
  • Does not have active central nervous system (CNS) metastases and/or carcinomatous meningitis or leptomeningeal disease.
  • Has not received prior therapy with an anti-programmed cell death 1 (PD-1), anti-programmed death ligand 1 (PD-L1), or anti-programmed cell death ligand 2 (PD-L2), anti-lymphocyte activation gene 3 (LAG-3) antibody, with a tyrosine kinase inhibitor (TKI; eg, lenvatinib) other than rapidly accelerated fibrosarcoma (RAF) inhibitors (binimetinib is permitted if combined with a RAF inhibitor), or with an agent directed to another stimulatory or coinhibitory T-cell receptor (eg, cytotoxic T-lymphocyte-associated protein 4, OX-40, cluster of differentiation [CD] 137).
  • Has not previously received regorafenib or TAS-102.
  • Has not received prior radiotherapy within 2 weeks of start of study intervention.
Objective

Primary Objective: Overall Survival

Assessment Frequency
_
Assessment Frequency 2
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Assessment Frequency Link
Path
PDL1+
Dosing Frequency
Control Agents
Study Protocol
Randomized
Yes
X