Clinical Trial 21077

• Overview

  Study Title:

  A Phase 2 Study of ALX148 in Combination with Pembrolizumab in Patients with Advanced Head and Neck Squamous Cell Carcinoma (ASPEN-03)

  Summary:

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

  Objective:

  Primary Objective * To assess the effect of ALX148 plus pembrolizumab on overall response rate (ORR) in patients with metastatic or with unresectable, recurrent HNSCC that is PD-L1 positive (CPS >/=1) and 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 and for pembrolizumab alone. * To assess the safety and tolerability of ALX148 administered in combination with pembrolizumab and for pembrolizumab alone.

• Treatments

  Therapies:

  Immunotherapy; Therapy (NOS)

  Medications:

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

• Inclusion Criteria

  Inclusion Criteria:
  • Patients with metastatic or unresectable, recurrent head and neck squamous cell carcinoma (HNSCC) that is PD-L1 positive (CPS > 1) and who have not received prior systemic therapy for their advanced disease. Patients cannot have received prior systemic therapy for the treatment of metastatic or recurrent disease. Patients can have received prior systemic therapy for the treatment of locoregionally advanced disease if it was completed more than 6 months prior to signing informed consent.
  • 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 has current pneumonitis.
  • Prior treatment with any anti-CD47 or anti-SIRP
  • Other criteria may apply

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