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

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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.

Tracking Information
First Submitted Date  ICMJE December 15, 2020
First Posted Date  ICMJE December 19, 2020
Last Update Posted Date November 11, 2021
Actual Study Start Date  ICMJE May 10, 2021
Estimated Primary Completion Date October 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 4, 2021)
  • Objective response rate per RECIST 1.1 [ Time Frame: 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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: December 17, 2020)
Objective response rate per RECIST 1.1 [ Time Frame: Last randomized patient reaching at least 24 weeks of follow-up. ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 4, 2021)
  • Duration of response [ Time Frame: Up to 36 months ]
  • Progression-free survival [ Time Frame: Up to 36 months ]
  • Overall survival [ Time Frame: Up to 36 months ]
  • Adverse events [ Time Frame: Up to 36 months ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evorpacept (ALX148) in Combination With Pembrolizumab and Chemotherapy in Patients With Advanced Head and Neck Squamous Cell Carcinoma (ASPEN-04)
Official Title  ICMJE 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)
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Head and Neck Cancer
  • Head and Neck Squamous Cell Carcinoma
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: Evorpacept (ALX148) + Pembrolizumab + Chemotherapy
    Evorpacept (ALX148) 45 mg/kg IV, pembrolizumab 200 mg IV, and chemotherapy given every 3 weeks.
    Interventions:
    • Drug: Evorpacept
    • Drug: Pembrolizumab
    • Drug: Cisplatin/Carboplatin; 5FU
  • Active Comparator: Pembrolizumab + Chemotherapy
    Pembrolizumab 200 mg IV and chemotherapy given every 3 weeks.
    Interventions:
    • Drug: Pembrolizumab
    • Drug: Cisplatin/Carboplatin; 5FU
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 4, 2021)
168
Original Estimated Enrollment  ICMJE
 (submitted: December 17, 2020)
112
Estimated Study Completion Date  ICMJE October 2024
Estimated Primary Completion Date October 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Tim Welliver, MD, PhD 650-466-7125 info@alxoncology.com
Listed Location Countries  ICMJE Australia,   Belgium,   Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04675333
Other Study ID Numbers  ICMJE AT148004
KEYNOTE-B88 ( Other Identifier: Merck & Co )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party ALX Oncology Inc.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE ALX Oncology Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Merck Sharp & Dohme LLC
Investigators  ICMJE Not Provided
PRS Account ALX Oncology Inc.
Verification Date November 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP