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

March 21, 2024 updated by: ALX Oncology Inc.

A Phase 2 Study of ALX148 in Combination With Pembrolizumab and Chemotherapy in Patients With Advanced Head and Neck Squamous Cell Carcinoma (ASPEN-04)

A Phase 2 Study of evorpacept (ALX148) in Combination With pembrolizumab and Chemotherapy 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 + 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.

Study Type

Interventional

Enrollment (Estimated)

168

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 Contact Backup

Study Locations

  • Australia
    • South Australia
      • Adelaide, South Australia, Australia, 5037
        • Recruiting
        • Ashford Cancer Centre
  • Belgium
      • Bruxelles, Belgium
        • Recruiting
        • Cliniques Universitaires Saint-Luc
  • Spain
      • Barcelona, Spain, 08028
        • Recruiting
        • Hospital Universitari Dexeus
      • Madrid, Spain
        • Recruiting
        • Hospital Universitario La Paz
  • United States
    • California
      • Irvine, California, United States, 92618
        • Recruiting
        • Hoag Hospital
      • La Jolla, California, United States, 92037
        • Recruiting
        • University of California San Diego
    • Florida
      • Miami, Florida, United States, 33136
        • Recruiting
        • Sylvester Comprehensive Cancer Center
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Recruiting
        • Rush University Medical Center
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Recruiting
        • University of Louisville
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Recruiting
        • University of Maryland Medical System
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Recruiting
        • Vanderbilt - Ingram 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:

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

May 10, 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 17, 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

  • AT148004
  • KEYNOTE-B88 (Other Identifier: Merck Sharp & Dohme LLC)
  • MK-3475-B88 (Other Identifier: Merck Sharp & Dohme LLC)
  • 2020-004662-19 (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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