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

NCT ID: NCT04675294

Last Updated: 2025-08-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

189 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-02

Study Completion Date

2026-06-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Head and Neck Cancer Head and Neck Squamous Cell Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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evorpacept (ALX148) + pembrolizumab

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

Group Type EXPERIMENTAL

evorpacept

Intervention Type DRUG

IV Q3W

pembrolizumab

Intervention Type DRUG

IV Q3W

pembrolizumab

pembrolizumab 200 mg IV given every 3 weeks.

Group Type ACTIVE_COMPARATOR

pembrolizumab

Intervention Type DRUG

IV Q3W

Interventions

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evorpacept

IV Q3W

Intervention Type DRUG

pembrolizumab

IV Q3W

Intervention Type DRUG

Other Intervention Names

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ALX148 KEYTRUDA®

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role collaborator

ALX Oncology Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hoag Hospital

Irvine, California, United States

Site Status

University of California San Diego

La Jolla, California, United States

Site Status

H. Lee Moffitt Cancer Center

Tampa, Florida, United States

Site Status

Northwest Georgia Oncology Centers

Marietta, Georgia, United States

Site Status

Rush University Medical Center

Chicago, Illinois, United States

Site Status

Blessing Cancer Center

Quincy, Illinois, United States

Site Status

University of Maryland Medical System

Baltimore, Maryland, United States

Site Status

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Rutgers Cancer Institute of New Jersey

Newark, New Jersey, United States

Site Status

Memorial Sloan-Kettering Cancer Center

Long Island City, New York, United States

Site Status

The Ohio State University

Columbus, Ohio, United States

Site Status

Oregon Health & Science University

Portland, Oregon, United States

Site Status

Vanderbilt - Ingram Cancer Center

Nashville, Tennessee, United States

Site Status

Houston Methodist Cancer Center

Houston, Texas, United States

Site Status

St. Vincent's

Sydney, New South Wales, Australia

Site Status

Royal Brisbane and Womens Hospital

Brisbane, Queensland, Australia

Site Status

Peter MacCallum Cancer Centre

Melbourne, Victoria, Australia

Site Status

Sir Charles Gairdner Hospital

Perth, Western Australia, Australia

Site Status

Ashford Cancer Centre Research

Windsor Gardens, , Australia

Site Status

Cliniques Universitaires Saint-Luc

Brussels, , Belgium

Site Status

AZ Groeninge

Kortrijk, , Belgium

Site Status

UZ Leuven

Leuven, , Belgium

Site Status

Hamilton Health Sciences - Juravinski Cancer Centre

Hamilton, Ontario, Canada

Site Status

LHSC - Victoria Hospital

London, Ontario, Canada

Site Status

Ottawa Hospital Cancer Centre

Ottawa, Ontario, Canada

Site Status

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Site Status

VUMC Goederenontvangst

Amsterdam, , Netherlands

Site Status

Universitair Medisch Centrum Groningen

Groningen, , Netherlands

Site Status

National University Cancer Institute

Singapore, , Singapore

Site Status

National Cancer Centre Singapore

Singapore, , Singapore

Site Status

Chungbuk National University Hospital

Cheongju-si, , South Korea

Site Status

Yeungnam University Medical Center

Daegu, , South Korea

Site Status

Chungnam National University Hospital

Daejeon, , South Korea

Site Status

CHA University of Bundang

Gyeonggi-do, , South Korea

Site Status

Gachon University - Gil Medical Center

Incheon, , South Korea

Site Status

Seoul National University Bundang Hospital

Seongnam, , South Korea

Site Status

Korea University Medical Center (KUMC) - Korea University Anam Hospital

Seoul, , South Korea

Site Status

Seoul National University Hospital

Seoul, , South Korea

Site Status

The Catholic University of Korea - Eunpyeong St. Mary's Hospital

Seoul, , South Korea

Site Status

Samsung Medical Center

Seoul, , South Korea

Site Status

SNU Boramae Medical Center

Seoul, , South Korea

Site Status

Severance Hospital Yonsei University

Seoul, , South Korea

Site Status

Catholic University of Korea, St. Vincent's Hospital Suwon

Suwon, , South Korea

Site Status

Yonsei University - Wonju Severance Christian Hospital

Wŏnju, , South Korea

Site Status

Hospital Universitari Dexeus

Barcelona, Barcelona, Spain

Site Status

Institud Catala d´Oncologia

Barcelona, , Spain

Site Status

Hospital Universitario La Paz

Madrid, , Spain

Site Status

HM Sanchinarro

Madrid, , Spain

Site Status

Hospital Severo Ochoa

Madrid, , Spain

Site Status

Hospital Regional Universitario de Malaga

Málaga, , Spain

Site Status

Hospital Universitario de Navarra

Pamplona, , Spain

Site Status

Royal Marsden NHS Foundation Trust

London, , United Kingdom

Site Status

Royal Marsden NHS Foundation Trust

Sutton, , United Kingdom

Site Status

Countries

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United States Australia Belgium Canada Netherlands Singapore South Korea Spain United Kingdom

Other Identifiers

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KEYNOTE-B87

Identifier Type: OTHER

Identifier Source: secondary_id

MK-3475-B87

Identifier Type: OTHER

Identifier Source: secondary_id

2020-004093-21

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

2023-508340-22-00

Identifier Type: CTIS

Identifier Source: secondary_id

AT148003

Identifier Type: -

Identifier Source: org_study_id

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