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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04675294
Recruitment Status : Recruiting
First Posted : December 19, 2020
Last Update Posted : November 11, 2021
Sponsor:
Collaborator:
Merck Sharp & Dohme LLC
Information provided by (Responsible Party):
ALX Oncology Inc.

Study Description
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Brief Summary:
A Phase 2 Study of Evorpacept (ALX148) in Combination With Pembrolizumab in Patients With Advanced Head and Neck Squamous Cell Carcinoma.

Condition or disease Intervention/treatment Phase
Head and Neck Cancer Head and Neck Squamous Cell Carcinoma Drug: Evorpacept Drug: Pembrolizumab Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 183 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Study of Evorpacept (ALX148) in Combination With Pembrolizumab in Patients With Advanced Head and Neck Squamous Cell Carcinoma (ASPEN-03)
Actual Study Start Date : April 2, 2021
Estimated Primary Completion Date : October 2023
Estimated Study Completion Date : October 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: ALX148

Drug: Pembrolizumab
IV Q3W
Other Name: Keytruda
Active Comparator: Pembrolizumab
Pembrolizumab 200 mg IV given every 3 weeks.
 Drug: Pembrolizumab
IV Q3W
Other Name: Keytruda


Outcome Measures
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Primary Outcome Measures :
  1. Objective response rate per RECIST 1.1 [ Time Frame: Last randomized patient reaching at least 24 weeks of follow-up ]
  2. 12-month overall survival rate [ Time Frame: Last randomized patient reaching 12 months of follow-up ]

Secondary Outcome Measures :
  1. Duration of response [ Time Frame: Up to 36 months ]
  2. Progression-free survival [ Time Frame: Up to 36 months ]
  3. Overall survival [ Time Frame: Up to 36 months ]
  4. Adverse events [ Time Frame: Up to 36 months ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04675294


Contacts
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Contact: Tim Welliver, MD, PhD 650-466-7125 info@alxoncology.com

Locations
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United States, California
Hoag Hospital Recruiting
Irvine, California, United States, 92618
University of California San Diego Recruiting
La Jolla, California, United States, 92037
United States, Illinois
Rush University Medical Center Recruiting
Chicago, Illinois, United States, 60612
United States, Maryland
University of Maryland Medical System Recruiting
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
United States, Tennessee
Vanderbilt - Ingram Cancer Center Recruiting
Nashville, Tennessee, United States, 37232
Australia, South Australia
Ashford Cancer Center Recruiting
Adelaide, South Australia, Australia, 5037
Belgium
Cliniques Universitaires Saint-Luc Recruiting
Bruxelles, Belgium
Canada, Ontario
Princess Margaret Cancer Centre Recruiting
Toronto, Ontario, Canada
Spain
Hospital Universitari Dexeus Recruiting
Barcelona, Spain, 08028
Hospital Universitario La Paz Recruiting
Madrid, Spain
Sponsors and Collaborators
ALX Oncology Inc.
Merck Sharp & Dohme LLC
More Information
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Responsible Party: ALX Oncology Inc.
ClinicalTrials.gov Identifier: NCT04675294    
Other Study ID Numbers: AT148003
KEYNOTE-B87 ( Other Identifier: Merck & Co )
First Posted: December 19, 2020    Key Record Dates
Last Update Posted: November 11, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by ALX Oncology Inc.:
ALX148
CD47
SIRPα
 HNSCC
Pembrolizumab
Evorpacept
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
 Head and Neck Neoplasms
Neoplasms by Site
Pembrolizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action