Vanderbilt Clinical Trials

Evorpacept (ALX148) in Combination with Pembrolizumab and Chemotherapy in Patients with Advanced Head and Neck Squamous Cell Carcinoma (ASPEN-04)

Purpose

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

Conditions

Head and Neck Cancer
Head and Neck Squamous Cell Carcinoma

Eligibility

Eligible Ages: Over 18 Years
Eligible Genders: All
Accepts 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.

Study Design

Phase: Phase 2
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Masking: None (Open Label)

Arm Groups

Arm	Description	Assigned Intervention
Experimental evorpacept (ALX148) + pembrolizumab + Chemotherapy	evorpacept (ALX148) 45 mg/kg IV, pembrolizumab 200 mg IV, and chemotherapy given every 3 weeks.	Drug: evorpacept IV Q3W Other names: ALX148 Drug: pembrolizumab IV Q3W Other names: KEYTRUDA® Drug: Cisplatin/Carboplatin; 5FU IV Q3W Other names: Platinol/Paraplatin; Adrucil
Active Comparator pembrolizumab + Chemotherapy	pembrolizumab 200 mg IV and chemotherapy given every 3 weeks.	Drug: evorpacept IV Q3W Other names: ALX148 Drug: pembrolizumab IV Q3W Other names: KEYTRUDA® Drug: Cisplatin/Carboplatin; 5FU IV Q3W Other names: Platinol/Paraplatin; Adrucil

More Details

Status: Active, not recruiting
Sponsor: ALX Oncology Inc.

Study Contact

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.