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Clinical Trial 21078

Cancer Type: Head & Neck
Study Type: Treatment
NCT#: NCT04675333

Phase: Phase II
Prinicipal Investigator: Muzaffar, Jameel

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Overview

Study 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)

Summary

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

Objective

Primary Objective * To assess the effect of ALX148 plus pembrolizumab + chemotherapy on overall response rate (ORR) in patients with metastatic or unresectable, recurrent HNSCC who have not yet been treated for their advanced disease. Secondary Objectives * To assess secondary measures of efficacy for ALX148 administered in combination with pembrolizumab + chemotherapy and for pembrolizumab + chemotherapy alone. * To assess the safety and tolerability of ALX148 administered in combination with pembrolizumab + chemotherapy and for pembrolizumab + chemotherapy alone.

Treatments

Therapies

Immunotherapy; Therapy (NOS)

Medications

5-fluorouracil (); ALX148 (); Paraplatin (carboplatin); Pembrolizumab (Keytruda); carboplatin (); cisplatin ()

Inclusion 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.
  • Other criteria may apply

  • Exclusion Criteria

    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
  • Other criteria may apply

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