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

March 21, 2024 updated by: ALX Oncology Inc.

A Phase 2 Study of ALX148 in Combination With Pembrolizumab in Patients With Advanced Head and Neck Squamous Cell Carcinoma (ASPEN-03)

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

183

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
    • New South Wales
      • Sydney, New South Wales, Australia, 2146
        • Recruiting
        • St. Vincent's
    • Queensland
      • Brisbane, Queensland, Australia, 4029
        • Recruiting
        • Royal Brisbane and Womens Hospital
    • Victoria
      • Melbourne, Victoria, Australia, 3051
        • Recruiting
        • Peter Maccallum Cancer Centre
    • Western Australia
      • Perth, Western Australia, Australia, 6009
        • Recruiting
        • Sir Charles Gairdner Hospital
  • Belgium
      • Brussels, Belgium, 1200
        • Recruiting
        • Cliniques Universitaires Saint-Luc
      • Kortrijk, Belgium, 8500
        • Recruiting
        • AZ Groeninge
      • Leuven, Belgium, B - 3000
        • Recruiting
        • UZ Leuven
  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L9G2X1
        • Recruiting
        • Hamilton Health Sciences - Juravinski Cancer Centre
      • London, Ontario, Canada, N6A5W9
        • Recruiting
        • LHSC - Victoria Hospital
      • Ottawa, Ontario, Canada, K1H 8L6
        • Recruiting
        • Ottawa Hospital Cancer Centre
      • Toronto, Ontario, Canada
        • Recruiting
        • Princess Margaret Cancer Centre
  • Korea, Republic of
      • Cheongju, Korea, Republic of, 28644
        • Recruiting
        • Chungbuk National University Hospital
      • Daegu, Korea, Republic of, 42415
        • Recruiting
        • Yeungnam University Medical Center
      • Daejeon, Korea, Republic of, 35015
        • Recruiting
        • Chungnam National University Hospital
      • Gyeonggi-do, Korea, Republic of, 13496
        • Recruiting
        • CHA University of Bundang
      • Incheon, Korea, Republic of, 21565
        • Recruiting
        • Gachon University - Gil Medical Center
      • Seongnam, Korea, Republic of, 13620
        • Recruiting
        • Seoul National University Bundang Hospital
      • Seoul, Korea, Republic of, 03080
        • Recruiting
        • Seoul National University Hospital
      • Seoul, Korea, Republic of, 06351
        • Recruiting
        • Samsung Medical Center
      • Seoul, Korea, Republic of, 03312
        • Recruiting
        • The Catholic University of Korea - Eunpyeong St. Mary's Hospital
      • Seoul, Korea, Republic of, 07061
        • Recruiting
        • SNU Boramae Medical Center
      • Seoul, Korea, Republic of, 3722
        • Recruiting
        • Severance Hospital Yonsei University
      • Seoul, Korea, Republic of, 02841
        • Recruiting
        • Korea University Medical Center (KUMC) - Korea University Anam Hospital
      • Suwon, Korea, Republic of, 16247
        • Recruiting
        • Catholic University of Korea, St. Vincent's Hospital Suwon
      • Wŏnju, Korea, Republic of, 26426
        • Recruiting
        • Yonsei University - Wonju Severance Christian Hospital
  • Netherlands
      • Amsterdam, Netherlands, 1081
        • Recruiting
        • VUMC Goederenontvangst
      • Groningen, Netherlands, 9713
        • Recruiting
        • Universitair Medisch Centrum Groningen
  • Singapore
      • Singapore, Singapore, 169610
        • Recruiting
        • National Cancer Centre Singapore
      • Singapore, Singapore, 119074
        • Recruiting
        • National University Cancer Institute
  • Spain
      • Barcelona, Spain, 08028
        • Recruiting
        • Hospital Universitari Dexeus
      • Barcelona, Spain, 08908
        • Recruiting
        • Institud Catala d´Oncologia
      • Madrid, Spain, 28046
        • Recruiting
        • Hospital Universitario La Paz
      • Madrid, Spain, 28050
        • Recruiting
        • HM Sanchinarro
      • Madrid, Spain, 28911
        • Recruiting
        • Hospital Severo Ochoa
      • Málaga, Spain, 29010
        • Recruiting
        • Hospital Regional Universitario de Málaga
      • Pamplona, Spain, 31008
        • Recruiting
        • Hospital Universitario de Navarra
  • United Kingdom
      • London, United Kingdom, SW3 6JJ
        • Recruiting
        • Royal Marsden NHS Foundation Trust
      • Sutton, United Kingdom, SM2 5PT
        • Recruiting
        • Royal Marsden NHS Foundation Trust
  • United States
    • California
      • Irvine, California, United States, 92618
        • Recruiting
        • Hoag Hospital
      • La Jolla, California, United States, 92037
        • Recruiting
        • University of California San Diego
    • Florida
      • Tampa, Florida, United States, 33612
        • Recruiting
        • H. Lee Moffitt Cancer Center
    • Georgia
      • Marietta, Georgia, United States, 30060
        • Recruiting
        • Northwest Georgia Oncology Centers
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Recruiting
        • Rush University Medical Center
      • Quincy, Illinois, United States, 62301
        • Recruiting
        • Blessing Cancer Center
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Recruiting
        • University of Maryland
      • Baltimore, Maryland, United States, 21201
        • Recruiting
        • University of Maryland Medical System
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Massachusetts General Hospital
    • New Jersey
      • Newark, New Jersey, United States, 07103
        • Recruiting
        • Rutgers Cancer Institute of New Jersey
    • New York
      • Long Island City, New York, United States, 11101
        • Recruiting
        • Memorial Sloan-Kettering Cancer Center
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • The Ohio State University
    • Oregon
      • Portland, Oregon, United States, 97239
        • Recruiting
        • Oregon Health & Science University
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Recruiting
        • Vanderbilt - Ingram Cancer Center
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • Houston Methodist Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: evorpacept (ALX148) + pembrolizumab
evorpacept (ALX148) 45 mg/kg IV and pembrolizumab 200 mg IV given every 3 weeks.
Drug: evorpacept
IV Q3W
Other Names:
  • ALX148
Drug: pembrolizumab
IV Q3W
Other Names:
  • KEYTRUDA®
Active Comparator: pembrolizumab
pembrolizumab 200 mg IV given every 3 weeks.
Drug: pembrolizumab
IV Q3W
Other Names:
  • KEYTRUDA®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Objective response rate per RECIST 1.1
Time Frame: Last randomized patient reaching at least 24 weeks of follow-up
Last randomized patient reaching at least 24 weeks of follow-up
12-month overall survival rate
Time Frame: Last randomized patient reaching 12 months of follow-up
Last randomized patient reaching 12 months of follow-up

Secondary Outcome Measures

Outcome Measure
Time Frame
Duration of response
Time Frame: Up to 36 months
Up to 36 months
Progression-free survival
Time Frame: Up to 36 months
Up to 36 months
Overall survival
Time Frame: Up to 36 months
Up to 36 months
Adverse events
Time Frame: Up to 36 months
Up to 36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ALX Oncology Inc.

Collaborators

Merck Sharp & Dohme LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 2, 2021

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

December 15, 2020

First Submitted That Met QC Criteria

December 15, 2020

First Posted (Actual)

December 19, 2020

Study Record Updates

Last Update Posted (Actual)

March 22, 2024

Last Update Submitted That Met QC Criteria

March 21, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AT148003
  • KEYNOTE-B87 (Other Identifier: Merck Sharp & Dohme LLC)
  • MK-3475-B87 (Other Identifier: Merck Sharp & Dohme LLC)
  • 2020-004093-21 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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