Evorpacept (ALX148) in Combination With Pembrolizumab in Patients With Advanced Head and Neck Squamous Cell Carcinoma (ASPEN-03)

Study Overview
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Brief Summary
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A Phase 2 Study of Evorpacept (ALX148) in Combination With Pembrolizumab in Patients With Advanced Head and Neck Squamous Cell Carcinoma.

Detailed Description
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This is a open-label, randomized phase 2 multi-center study of the anti-tumor efficacy of evorpacept (ALX148) + pembrolizumab and of pembrolizumab alone in patients with metastatic or unresectable, recurrent HNSCC that is PD-L1 positive (CPS ≥1 by an FDA-approved test) and who have not yet been treated for their advanced disease. The study comprises an initial safety lead-in cohort followed by a randomized portion.

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

Conditions
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Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma

Intervention / Treatment
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* Drug: Evorpacept
* Drug: Pembrolizumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Evorpacept (ALX148) + Pembrolizumab<br>Evorpacept (ALX148) 45 mg/kg IV and pembrolizumab 200 mg IV given every 3 weeks. | Drug: Evorpacept<br>* IV Q3W<br>* Other names: ALX148;Drug: Pembrolizumab<br>* IV Q3W<br>* Other names: Keytruda;|
| Active Comparator: Pembrolizumab<br>Pembrolizumab 200 mg IV given every 3 weeks. | Drug: Pembrolizumab<br>* IV Q3W<br>* Other names: Keytruda;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate per RECIST 1.1 |  | Last randomized patient reaching at least 24 weeks of follow-up | 
| 12-month overall survival rate |  | Last randomized patient reaching 12 months of follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of response |  | Up to 36 months | 
| Progression-free survival |  | Up to 36 months | 
| Overall survival |  | Up to 36 months | 
| Adverse events |  | Up to 36 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ALX148, CD47, SIRPα, HNSCC, Pembrolizumab, Evorpacept