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RecruitingLast updated: 2 February 2024

ASPEN 03: This phase II study is trying to understand the effect of a combination of two immunotherapies (evorpacept and pembrolizumab), compared to pembrolizumab alone, in people with head and neck squamous cell carcinomaA Phase 2 Study of Evorpacept (ALX148) in Combination With Pembrolizumab in Patients With Advanced Head and Neck Squamous Cell Carcinoma (ASPEN-03)

Clinical summary

Summary

Eligible participants will be randomly assigned to either the Experimental Arm or the Active Comparator Arm. In the Experimental Arm, participants will receive evorpacept (45mg/kg) administered via intravenous infusion, as well as pembrolizumab (200mg), also administered via intravenous infusion, every 3 weeks. In the Active Comparator Arm, participants will receive pembrolizumab (200mg) administered via intravenous infusion every 3 weeks.

Conditions

This trial is treating patients with head and neck squamous cell carcinoma.

Cancer

Head and Neck Cancers Head and Neck

Age

People18+

Phase

II

Trial Acronym

ASPEN 03

More information

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Trial sponsor

ALX Oncology Inc.

Scientific Title

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

Eligibility

Inclusion

  • 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.
  • Adequate bone marrow function.
  • Adequate renal and liver function.
  • Adequate ECOG performance status.

Exclusion

  • 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-SIRPα agent.
  • Prior treatment with anti-PD-1 or PD-L1.

Inclusion

  • You have been diagnosed with cancer, but have not received any treatment.
  • You have had treatment, but your cancer has come back.
  • Your cancer has spread to other parts of the body.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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