A Study of Coformulated Favezelimab/Pembrolizumab (MK-4280A) Versus Standard of Care in Subjects With Previously Treated Metastatic PD-L1 Positive Colorectal Cancer (MK-4280A-007)
- Conditions
- Colorectal Cancer
- Registration Number
- NCT05064059
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- 505
Inclusion Criteria:<br><br> - Has a histologically confirmed colorectal adenocarcinoma that is metastatic and<br> unresectable.<br><br> - Has measurable disease per RECIST 1.1 as assessed by the local site investigator.<br><br> - Has been previously treated for the disease and radiographically progressed on or<br> after or could not tolerate standard treatment.<br><br> - Submits an archival (= 5 years) or newly obtained tumor tissue sample or newly<br> obtained tumor tissue sample that has not been previously irradiated.<br><br> - Has an Eastern Cooperative Oncology Group Performance Score (ECOG PS) of 0 to 1<br> within 10 days prior to first dose of study intervention.<br><br> - Has a life expectancy of at least 3 months, based on the investigator assessment.<br><br> - Has the ability to swallow and retain oral medication and not have any clinically<br> significant gastrointestinal abnormalities that might alter absorption.<br><br> - Has adequate organ function.<br><br>Exclusion Criteria:<br><br> - Has previously been found to have deficient mismatch repair/microsatellite<br> instability-high (dMMR/MSI-H) tumor status.<br><br> - Has known active central nervous system (CNS) metastases and/or carcinomatous<br> meningitis or leptomeningeal disease.<br><br> - Has a history of acute or chronic pancreatitis.<br><br> - Has neuromuscular disorders associated with an elevated creatine kinase (eg,<br> inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis, spinal<br> muscular atrophy).<br><br> - Has clinically significant cardiovascular disease within 12 months from first dose<br> of study intervention, including New York Heart Association Class III or IV<br> congestive heart failure, unstable angina, myocardial infarction, cerebral vascular<br> accident, or cardiac arrhythmia associated with hemodynamic instability.<br><br> - Has urine protein greater than or equal to 1g/24h.<br><br> - A woman of childbearing potential who has a positive urine/serum pregnancy test<br> within 24/72 hours prior to the first dose of study intervention.<br><br> - Has received prior therapy with an anti-programmed cell death 1 (PD-1),<br> anti-programmed death ligand 1 (PD-L1), or anti-programmed cell death ligand 2<br> (PD-L2), anti-lymphocyte activation gene 3 (LAG-3) antibody, with a tyrosine kinase<br> inhibitor (TKI; eg, lenvatinib) other than rapidly accelerated fibrosarcoma (RAF)<br> inhibitors (binimetinib is permitted if combined with a RAF inhibitor), or with an<br> agent directed to another stimulatory or coinhibitory T-cell receptor (eg, cytotoxic<br> T-lymphocyte-associated protein 4, OX-40, cluster of differentiation [CD] 137).<br><br> - Has previously received regorafenib or TAS-102.<br><br> - Has received prior systemic anticancer therapy including investigational agents<br> within 28 days before randomization.<br><br> - Has received prior radiotherapy within 2 weeks of start of study intervention.<br> Participants must have recovered from all radiation-related toxicities, not require<br> corticosteroids, and not have had radiation pneumonitis. A 1-week washout is<br> permitted for palliative radiation (=2 weeks of radiotherapy) to non-CNS disease.<br><br> - Has received a live or live-attenuated vaccine within 30 days before the first dose<br> of study intervention.<br><br> - Has a known additional malignancy that is progressing or has required active<br> treatment within the past 3 years.<br><br> - Has severe hypersensitivity (=Grade 3) to pembrolizumab and/or any of its<br> excipients.<br><br> - Has an active autoimmune disease that has required systemic treatment in past 2<br> years.<br><br> - Has a history of (noninfectious) pneumonitis/interstitial lung disease that required<br> steroids or has current pneumonitis/interstitial lung disease.<br><br> - Has an active infection requiring systemic therapy (eg, tuberculosis, known viral or<br> bacterial infections, etc.).<br><br> - Has a known history of human immunodeficiency virus (HIV) infection.<br><br> - Has known history of Hepatitis B or known active Hepatitis C virus infection.<br><br> - Has a history or current evidence of any condition, therapy, or laboratory<br> abnormality that might confound the results of the study, interfere with the<br> participant's participation for the full duration of the study, or is not in the<br> best interest of the participant to participate, in the opinion of the treating<br> investigator.<br><br> - Has had an allogenic tissue/solid organ transplant.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall Survival (OS)
- Secondary Outcome Measures
Name Time Method