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Immunomodulatory Agent

Evorpacept + Pembrolizumab for Head and Neck Cancer

Phase 2
Waitlist Available
Research Sponsored by ALX Oncology Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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.
Be older than 18 years old
Must not have
Patients with known symptomatic CNS metastases or leptomeningeal disease requiring steroids.
Prior treatment with anti-PD-1 or PD-L1.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new drug, Evorpacept, in combination with pembrolizumab, to see if it is effective in treating patients with advanced head and neck squamous cell carcinoma.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Possible side effects include immune-related reactions since both drugs work by boosting the immune system to fight cancer. This can sometimes cause inflammation in various organs or skin rashes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My head/neck cancer is advanced, hasn't been treated yet, and tests positive for PD-L1.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I need steroids for my brain or spinal cord cancer symptoms.
Select...
I have been treated with anti-PD-1 or PD-L1 therapy before.
Select...
I have had or currently have lung inflammation treated with steroids.
Select...
I have not been treated with anti-CD47 or anti-SIRPα agents.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
pembrolizumab
2017
Completed Phase 3
~5890

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme LLCIndustry Sponsor
4,010 Previous Clinical Trials
5,185,054 Total Patients Enrolled
ALX Oncology Inc.Lead Sponsor
8 Previous Clinical Trials
1,120 Total Patients Enrolled

Media Library

Evorpacept (Immunomodulatory Agent) Clinical Trial Eligibility Overview. Trial Name: NCT04675294 — Phase 2
Head and Neck Squamous Cell Carcinoma Research Study Groups: pembrolizumab, evorpacept (ALX148) + pembrolizumab
Head and Neck Squamous Cell Carcinoma Clinical Trial 2023: Evorpacept Highlights & Side Effects. Trial Name: NCT04675294 — Phase 2
Evorpacept (Immunomodulatory Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04675294 — Phase 2
~4 spots leftby Dec 2024
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