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Trial record 1 of 1 for:    AT148004
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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 : Not yet recruiting
First Posted : December 19, 2020
Last Update Posted : January 19, 2021
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
ALX Oncology Inc.

Study Description
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Brief Summary:
A Phase 2 Study of 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: ALX148 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 ALX148 + pembrolizumab + 5FU and platinum and of pembrolizumab + 5FU and platinum alone 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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 112 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Study of ALX148 in Combination With Pembrolizumab and Chemotherapy in Patients With Advanced Head and Neck Squamous Cell Carcinoma (ASPEN-04)
Estimated Study Start Date : January 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: ALX148 + Pembrolizumab + Chemotherapy
ALX148 45 mg/kg IV, pembrolizumab 200 mg IV, and chemotherapy given every 3 weeks.
 Drug: ALX148
IV Q3W

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
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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. ]

Eligibility Criteria
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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:

  • Previously untreated metastatic or unresectable, recurrent head and neck squamous cell carcinoma.
  • 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 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): NCT04675333


Contacts
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Contact: Katherine Ruffner, MD 650-466-7125 info@alxoncology.com
Contact: Philip Fanning, PhD 650-466-7125 info@alxoncology.com

Sponsors and Collaborators
ALX Oncology Inc.
Merck Sharp & Dohme Corp.
More Information
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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: January 19, 2021
Last Verified: January 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
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
Cisplatin
Carboplatin
Pembrolizumab
Antineoplastic Agents
Antineoplastic Agents, Immunological