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Closed (no longer recruiting)Last updated: 19 September 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 had treatment, but your cancer has come back.
  • Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
  • Your cancer has not spread to other parts of the body.
  • You have been diagnosed with cancer, but have not received any treatment.

Exclusion

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

There may be additional criteria to what is listed here, speak to your doctor to confirm whether this trial is right for you.

Participating hospitals

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Closed hospitals

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The Victorian Cancer Trials Link is supported by the Victorian Government through the Victorian Cancer Agency.

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Cancer Council Victoria would like to acknowledge the traditional custodians of the land on which we live and work. We would also like to pay respect to the elders past and present and extend that respect to all other Aboriginal people.