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

Sponsor
ALX Oncology Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04675333
Collaborator
Merck Sharp & Dohme LLC (Industry)
168
Enrollment
11
Locations
2
Arms
40.7
Anticipated Duration (Months)
15.3
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

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
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

Study Type:
Interventional
Anticipated 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
Anticipated Primary Completion Date :
Oct 1, 2023
Anticipated Study Completion Date :
Oct 1, 2024

Arms and Interventions

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 Names:
  • ALX148

    • Drug: Pembrolizumab
    IV Q3W
    Other Names:
  • Keytruda

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

    		•
    Active Comparator: Pembrolizumab + Chemotherapy

    Pembrolizumab 200 mg IV and chemotherapy given every 3 weeks.

    Drug: Pembrolizumab
    IV Q3W
    Other Names:
  • Keytruda

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Objective response rate per RECIST 1.1 [Last randomized patient reaching at least 24 weeks of follow-up]

    2. 12-month overall survival rate [Last randomized patient reaching 12 months of follow-up]

    Secondary Outcome Measures

    1. Duration of response [Up to 36 months]

    2. Progression-free survival [Up to 36 months]

    3. Overall survival [Up to 36 months]

    4. Adverse events [Up to 36 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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-SIRPĪ± agent.

    • Prior treatment with anti-PD-1 or PD-L1.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hoag Hospital Irvine California United States 92618
    2 University of California San Diego La Jolla California United States 92037
    3 Sylvester Comprehensive Cancer Center Miami Florida United States 33136
    4 Rush University Medical Center Chicago Illinois United States 60612
    5 University of Louisville Louisville Kentucky United States 40202
    6 University of Maryland Medical System Baltimore Maryland United States 21201
    7 Vanderbilt - Ingram Cancer Center Nashville Tennessee United States 37232
    8 Ashford Cancer Centre Adelaide South Australia Australia 5037
    9 Cliniques Universitaires Saint-Luc Bruxelles Belgium
    10 Hospital Universitari Dexeus Barcelona Spain 08028
    11 Hospital Universitario La Paz Madrid Spain

    Sponsors and Collaborators

    • ALX Oncology Inc.
    • Merck Sharp & Dohme LLC

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    ALX Oncology Inc.
    ClinicalTrials.gov Identifier:
    NCT04675333
    Other Study ID Numbers:
    • AT148004
    • KEYNOTE-B88
    First Posted:
    Dec 19, 2020
    Last Update Posted:
    Nov 11, 2021
    Last Verified:
    Nov 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    SIRPĪ±
    HNSCC
    Pembrolizumab
    Evorpacept
    Additional relevant MeSH terms:
    Carcinoma
    Carcinoma, Squamous Cell
    Squamous Cell Carcinoma of Head and Neck
    Carboplatin
    Pembrolizumab

    Study Results

    No Results Posted as of Nov 11, 2021