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NCT04675333 Clinical Trial

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

Head and Neck Cancer Clinical Trial

Official 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)

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04675333
Other study ID # AT148004
Secondary ID KEYNOTE-B88MK-34
Status Recruiting
Phase Phase 2
First received
Last updated
Start date May 10, 2021
Est. completion date December 31, 2025

Study information
Verified date February 2024
Source ALX Oncology Inc.
Contact Harry Liu, MD, MPH, MBA
Phone +1 650.502.4697
Email info@alxoncology.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 168
Est. completion date December 31, 2025
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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-SIRPa agent. - Prior treatment with anti-PD-1 or PD-L1.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• evorpacept
IV Q3W
• pembrolizumab
IV Q3W
• Cisplatin/Carboplatin; 5FU
IV Q3W

Locations
Country Name City State
Australia Ashford Cancer Centre Adelaide South Australia
Belgium Cliniques Universitaires Saint-Luc Bruxelles
Spain Hospital Universitari Dexeus Barcelona
Spain Hospital Universitario La Paz Madrid
United States University of Maryland Medical System Baltimore Maryland
United States Rush University Medical Center Chicago Illinois
United States Hoag Hospital Irvine California
United States University of California San Diego La Jolla California
United States University of Louisville Louisville Kentucky
United States Sylvester Comprehensive Cancer Center Miami Florida
United States Vanderbilt - Ingram Cancer Center Nashville Tennessee

Sponsors (2)
Lead Sponsor Collaborator
ALX Oncology Inc. Merck Sharp & Dohme LLC

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary Objective response rate per RECIST 1.1 Last randomized patient reaching at least 24 weeks of follow-up
Primary 12-month overall survival rate Last randomized patient reaching 12 months of follow-up
Secondary Duration of response Up to 36 months
Secondary Progression-free survival Up to 36 months
Secondary Overall survival Up to 36 months
Secondary Adverse events Up to 36 months
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