Evorpacept + Pembrolizumab for Head and Neck Cancer

Recruiting in Palo Alto (17 mi)

+55 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: ALX Oncology Inc.

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?A Phase 2 Study of evorpacept (ALX148) in Combination With pembrolizumab in Patients With Advanced Head and Neck Squamous Cell Carcinoma.

Eligibility Criteria

This trial is for adults with advanced head and neck squamous cell carcinoma that hasn't spread too far, is PD-L1 positive, and who haven't had systemic therapy before. They need to be relatively healthy in terms of bone marrow, kidney, liver function, and overall activity level.

Inclusion Criteria

My head/neck cancer is advanced, hasn't been treated yet, and tests positive for PD-L1.

My kidney and liver are working well.

My bone marrow is working well.

+1 more

Exclusion Criteria

I need steroids for my brain or spinal cord cancer symptoms.

I have been treated with anti-PD-1 or PD-L1 therapy before.

I have had or currently have lung inflammation treated with steroids.

+1 more

Participant Groups

The study tests Evorpacept (ALX148) combined with Pembrolizumab on patients. It's a Phase 2 trial which means they're looking at how effective this combo is against head and neck cancer and gathering more info on safety.

2Treatment groups

Experimental Treatment

Active Control

Group I: evorpacept (ALX148) + pembrolizumabExperimental Treatment2 Interventions

evorpacept (ALX148) 45 mg/kg IV and pembrolizumab 200 mg IV given every 3 weeks.

Group II: pembrolizumabActive Control1 Intervention

pembrolizumab 200 mg IV given every 3 weeks.