Trial purpose
Cancer treatment
Tumor type
Head and Neck
Age
18+
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 people with advanced head and neck squamous cell carcinoma
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 (relapsed or recurrent).
- Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
Exclusion
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
- 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)
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