Clinical Trial 21078

Cancer Type: Head & Neck
Study Type: Treatment
NCT#: NCT04675333

Phase: Phase II
Principal Investigator: Chung, Christine

Call 813-745-6100
or 1-800-679-0775 Learn More

Overview

Study Title

A Phase 2 Study of ALX148 in Combination with Pembrolizumab and chemotherapy in Patients with Advanced Head and Neck Squamous Cell Carcinoma (ASPEN-04)

Summary

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

Objective

Primary Objective * To assess the effect of ALX148 plus pembrolizumab + chemotherapy on overall response rate (ORR) in patients with metastatic or unresectable, recurrent HNSCC who have not yet been treated for their advanced disease. Secondary Objectives * To assess secondary measures of efficacy for ALX148 administered in combination with pembrolizumab + chemotherapy and for pembrolizumab + chemotherapy alone. * To assess the safety and tolerability of ALX148 administered in combination with pembrolizumab + chemotherapy and for pembrolizumab + chemotherapy alone.

Treatments

Therapies

Immunotherapy; Therapy (NOS)

Medications

5-fluorouracil (); ALX148 (); Paraplatin (carboplatin); Pembrolizumab (Keytruda); carboplatin (); cisplatin ()

Inclusion Criteria

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.

Other criteria may apply

Exclusion Criteria

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