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

  • STATUS
    Recruiting
  • End date
    Oct 19, 2024
  • participants needed
    168
  • sponsor
    ALX Oncology Inc.
Updated on 19 November 2021
carcinoma
squamous cell carcinoma
carboplatin
pembrolizumab
advanced head and neck squamous cell carcinoma

Summary

A Phase 2 Study of Evorpacept (ALX148) in Combination With Pembrolizumab and Chemotherapy in Patients With Advanced Head and Neck Squamous Cell Carcinoma.

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.

Details
Condition Head and Neck Cancer, Squamous Cell Carcinoma of Head and Neck, head and neck cancer, cancer of the head and neck, Squamous Cell Carcinoma of the Head and Neck, Head and Neck Squamous Cell Carcinoma
Treatment Pembrolizumab, ALX148, Cisplatin/Carboplatin; 5FU, Evorpacept
Clinical Study IdentifierNCT04675333
SponsorALX Oncology Inc.
Last Modified on19 November 2021

Eligibility

Yes No Not Sure

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-SIRP agent
Prior treatment with anti-PD-1 or PD-L1
Clear my responses

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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