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RecruitingLast updated: 2 February 2024

ASPEN 04: This phase II trial is trying to understand the effectiveness of immunotherapy (Pembrolizumab) and chemotherapy (Cisplatin/Carboplatin, 5FU) with or without targeted therapy (Evorpacept) in people with head and neck squamous cell carcinomaA Phase 2 Study of Evorpacept (ALX148) in Combination With Pembrolizumab and Chemotherapy in Patients With Advanced Head and Neck Squamous Cell Carcinoma (ASPEN-04)

Clinical summary

Summary

This is a randomised trial with two arms for people with metastatic or unresectable, recurrent head and neck squamous cell carcinoma who have not yet been treated for their advanced disease. In the Experimental Arm, participants will receive Evorpacept (ALX148) + Pembrolizumab + Chemotherapy (Cisplatin/Carboplatin; 5FU). Evorpacept will be administered intravenously (via IV) at a dose of 45mg/kg every three weeks. Pembrolizumab will be administered via IV at a dose of 200mg every three weeks. Chemotherapy will be given every three weeks via IV. In the Active Comparator Arm, participants will receive Pembrolizumab + Chemotherapy. Pembrolizumab will be administered via IV every three weeks at a dose of 200mg. Chemotherapy will be given every three weeks via IV.

Conditions

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

Cancer

Head and Neck Cancers Head and Neck

Age

People18+

Phase

II

Trial Acronym

ASPEN 04

More information

Trial Identifiers

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

  • NCT04675333
  • 21/172 ALX ONCOLOGY - AT148004 - ASPEN-04 - CT1424

Trial sponsor

ALX Oncology Inc.

Scientific Title

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

Eligibility

Inclusion

  • 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

  • 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.

Inclusion

  • 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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