Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
Conditions
Keywords
ALX148, CD47, SIRPα, HNSCC, pembrolizumab, evorpacept
Brief summary
A Phase 2 Study of evorpacept (ALX148) in Combination With pembrolizumab and Chemotherapy in Patients With Advanced Head and Neck Squamous Cell Carcinoma.
Detailed description
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.
Interventions
Sponsors
Merck Sharp & Dohme LLC
ALX Oncology Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Previously untreated metastatic or unresectable, recurrent head and neck squamous cell carcinoma. * Adequate bone marrow function. * Adequate renal and liver function. * Adequate ECOG performance status.
Exclusion criteria
* Patients with known symptomatic CNS metastases or leptomeningeal disease requiring steroids. * History of (non-infectious) pneumonitis that required steroids or current pneumonitis. * Prior treatment with any anti-CD47 or anti-SIRPα agent. * Prior treatment with anti-PD-1 or PD-L1.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate per RECIST 1.1 | Last randomized patient reaching at least 24 weeks of follow-up |
Secondary
| Measure | Time frame |
|---|---|
| Duration of response | Up to 36 months |
| Progression-free survival | Up to 36 months |
| Overall survival | Up to 36 months |
| Adverse events | Up to 36 months |
Countries
Australia, Belgium, Netherlands, Singapore, South Korea, Spain, United Kingdom, United States
Outcome results
None listed