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A Phase 2 Study of ALX148 in Combination with Pembrolizumab and Chemotherapy in Patients with Advanced Head and Neck Squamous Cell Carcinoma (ASPEN-04)

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Trial Profile

A Phase 2 Study of ALX148 in Combination with Pembrolizumab and Chemotherapy in Patients with Advanced Head and Neck Squamous Cell Carcinoma (ASPEN-04)

Status: Active, no longer recruiting
Phase of Trial: Phase II

Latest Information Update: 02 May 2025

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At a glance

  • Drugs Carboplatin (Primary) ; Cisplatin (Primary) ; Evorpacept (Primary) ; Fluorouracil (Primary) ; Pembrolizumab (Primary)
  • Indications Carcinoma; Head and neck cancer; Squamous cell cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms ASPEN-04
  • Sponsors ALX Oncology

Most Recent Events

  • 25 Apr 2025 Results presented in an ALX Oncology Media Release.
  • 25 Apr 2025 According to an ALX Oncology media release, efficacy data from ASPEN-03 and ASPEN-04 trials do not support advancing evorpacept in combination with Merck's anti-PD-1 therapy, KEYTRUDA (pembrolizumab), into a registrational study. Detailed findings from the ASPEN-03 and ASPEN-04 trials will be submitted to a future medical meeting.
  • 25 Apr 2025 Primary endpoint has not been met. (Objective response rate per RECIST 1.1), according to an ALX Oncology media release.

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