A Phase 2 Study of evorpacept (ALX148) in Combination With pembrolizumab and Chemotherapy in Patients With Advanced Head and Neck Squamous Cell Carcinoma.
This is a open-label, randomized phase 2 multi-center study of the anti-tumor efficacy of evorpacept (ALX148) + pembrolizumab + 5FU + platinum and of pembrolizumab + 5FU + platinum in patients with metastatic or unresectable, recurrent HNSCC who have not yet been treated for their advanced disease. The study comprises of an initial safety lead-in followed by a randomized portion.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
172
Objective response rate per RECIST 1.1
Time frame: Last randomized patient reaching at least 24 weeks of follow-up
Duration of response
Time frame: Up to 36 months
Progression-free survival
Time frame: Up to 36 months
Overall survival
Time frame: Up to 36 months
Adverse events
Time frame: Up to 36 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Hoag Hospital
Irvine, California, United States
University of California San Diego
La Jolla, California, United States
Cedar Sinai Medical Center
Los Angeles, California, United States
University of Miami, Sylvester Comprehensive Cancer Center
Miami, Florida, United States
Moffitt Cancer Center
Tampa, Florida, United States
Rush University Medical Center
Chicago, Illinois, United States
University of Louisville
Louisville, Kentucky, United States
University of Maryland Medical System
Baltimore, Maryland, United States
Memorial Sloan Kettering
New York, New York, United States
The Ohio State University
Columbus, Ohio, United States
...and 34 more locations