Evorpacept (ALX148) in Combination With Pembrolizumab in Patients With Advanced Head and Neck Squamous Cell Carcinoma (ASPEN-03)

Trial number:
NCT04675294
Trial phase:
2
Study type:
Immunotherapy, Targeted therapy
Overall status:
Recruiting

Study start date

April, 2021

Scientific title

A Phase 2 Study of Evorpacept (ALX148) in Combination With Pembrolizumab in Patients With Advanced Head and Neck Squamous Cell Carcinoma (ASPEN-03)

Summary

A Phase 2 Study of Evorpacept (ALX148) in Combination With Pembrolizumab in Patients With Advanced Head and Neck Squamous Cell Carcinoma.

Patients with metastatic or unresectable, recurrent head and neck squamous cell carcinoma (HNSCC) that is PD-L1 positive (CPS > 1) and who have not received prior systemic therapy for their advanced disease.Adequate bone marrow function. Adequate renal and liver function. Adequate ECOG performance status.

Patients with known symptomatic CNS metastases or leptomeningeal disease requiring steroids.History of (non-infectious) pneumonitis that required steroids or has current pneumonitis. Prior treatment with any anti-CD47 or anti-SIRPα agent. Prior treatment with anti-PD-1 or PD-L1.

Study design

Primary purpose: Treatment, Allocation: Randomized, Intervention model: Parallel Assignment, Masking: None (Open Label),

Conditions

Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma

Other study ID numbers

AT148003; KEYNOTE-B87

Choose trial site (13)

National Cancer Centre Singapore
National Cancer Centre Singapore Recruiting