We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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: NCT04675333
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
A Phase 2 Study of Evorpacept (ALX148) in Combination With Pembrolizumab and Chemotherapy 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 Drug: Cisplatin/Carboplatin; 5FU Phase 2

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 168 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 and Chemotherapy in Patients With Advanced Head and Neck Squamous Cell Carcinoma (ASPEN-04)
Actual Study Start Date : May 10, 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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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: Evorpacept
IV Q3W
Other Name: ALX148

Drug: Pembrolizumab
IV Q3W
Other Name: Keytruda

Drug: Cisplatin/Carboplatin; 5FU
IV Q3W
Other Name: Platinol/Paraplatin; Adrucil
Active Comparator: Pembrolizumab + Chemotherapy
Pembrolizumab 200 mg IV and chemotherapy given every 3 weeks.
 Drug: Pembrolizumab
IV Q3W
Other Name: Keytruda

Drug: Cisplatin/Carboplatin; 5FU
IV Q3W
Other Name: Platinol/Paraplatin; Adrucil


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT04675333


Contacts
Layout table for location contacts
Contact: Tim Welliver, MD, PhD 650-466-7125 info@alxoncology.com

Locations
Layout table for location information
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, Florida
Sylvester Comprehensive Cancer Center Recruiting
Miami, Florida, United States, 33136
United States, Illinois
Rush University Medical Center Recruiting
Chicago, Illinois, United States, 60612
United States, Kentucky
University of Louisville Recruiting
Louisville, Kentucky, United States, 40202
United States, Maryland
University of Maryland Medical System Recruiting
Baltimore, Maryland, United States, 21201
United States, Tennessee
Vanderbilt - Ingram Cancer Center Recruiting
Nashville, Tennessee, United States, 37232
Australia, South Australia
Ashford Cancer Centre Recruiting
Adelaide, South Australia, Australia, 5037
Belgium
Cliniques Universitaires Saint-Luc Recruiting
Bruxelles, Belgium
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: ALX Oncology Inc.
ClinicalTrials.gov Identifier: NCT04675333    
Other Study ID Numbers: AT148004
KEYNOTE-B88 ( 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

Layout table for additional information
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:
Layout table for MeSH terms
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
Carboplatin
Pembrolizumab
Antineoplastic Agents
Antineoplastic Agents, Immunological
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action