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

ALX Oncology

Status and phase: Active, not recruiting; Phase 2

Conditions: Head and Neck Cancer; Head and Neck Squamous Cell Carcinoma

Treatments: Drug: evorpacept; Drug: pembrolizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT04675294

AT148003

KEYNOTE-B87 (Other Identifier)

MK-3475-B87 (Other Identifier)

2020-004093-21 (EudraCT Number)

Details and patient eligibility

About

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

Full description

This is a open-label, randomized phase 2 multi-center study of the anti-tumor efficacy of evorpacept (ALX148) + pembrolizumab and of pembrolizumab alone in patients with metastatic or unresectable, recurrent HNSCC that is PD-L1 positive (CPS ≥1 by an FDA-approved test) and who have not yet been treated for their advanced disease. The study comprises an initial safety lead-in cohort followed by a randomized portion.

Enrollment: 189 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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189 participants in 2 patient groups

evorpacept (ALX148) + pembrolizumab

Experimental group

Description:

evorpacept (ALX148) 45 mg/kg IV and pembrolizumab 200 mg IV given every 3 weeks.

Treatment:

Drug: pembrolizumab

Drug: evorpacept

pembrolizumab

Active Comparator group

Description:

pembrolizumab 200 mg IV given every 3 weeks.

Treatment:

Drug: pembrolizumab