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

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ClinicalTrials.gov Identifier: NCT04675294
Recruitment Status : Recruiting
First Posted : December 19, 2020
Last Update Posted : August 20, 2021
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
ALX Oncology Inc.

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) who have not yet been treated for their advanced disease. The study comprises an initial safety lead-in cohort followed by a randomized portion.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 111 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


Arm Intervention/treatment
Experimental: Evorpacept (ALX148) + Pembrolizumab
Evorpacept (ALX148) 45 mg/kg IV and pembrolizumab 200mg IV given every 3 weeks.
Drug: Evorpacept
IV Q3W
Other Name: ALX148

Drug: Pembrolizumab
IV Q3W
Other Name: Keytruda

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




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


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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:

  • 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 & Liver Function.
  • Adequate 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.

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
Contact: Chaitali Nangia, MD         
United States, Illinois
Rush University Medical Center Recruiting
Chicago, Illinois, United States, 60612
Contact: Michael Jelinek, MD         
United States, Maryland
University of Maryland Medical System Recruiting
Baltimore, Maryland, United States, 21201
Contact: Ranee Mehra, MD         
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Jong Chul Park, MD         
United States, Tennessee
Vanderbilt - Ingram Cancer Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Michael Gibson, MD, PhD         
Australia, South Australia
Ashford Cancer Center Recruiting
Adelaide, South Australia, Australia, 5037
Contact: Dainik Patel, MBBS, FRACP         
Spain
Hospital Universitari Dexeus Recruiting
Barcelona, Spain, 08028
Contact: Andres Aguilar, MD         
Sponsors and Collaborators
ALX Oncology Inc.
Merck Sharp & Dohme Corp.
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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: August 20, 2021
Last Verified: August 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