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Evorpacept + Immunotherapy + Chemotherapy 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
Previously untreated metastatic or unresectable, recurrent head and neck squamous cell carcinoma.
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 cancer drug, in combination with an existing immunotherapy drug and chemotherapy, to see if it is effective in treating 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 who haven't been treated before. They should be physically able to undergo treatment (good ECOG status) and have their major organs like kidneys, liver, and bone marrow working well. People can't join if they've had certain previous cancer treatments or have brain metastases needing steroids.
What is being tested?
The study tests Evorpacept combined with Pembrolizumab (an immunotherapy drug) and chemotherapy drugs Cisplatin/Carboplatin; 5FU in patients with advanced head and neck cancer. It's a Phase 2 trial, which means it's checking the effectiveness of this combination therapy.
What are the potential side effects?
Possible side effects include immune-related reactions such as inflammation in various organs, infusion reactions from the drugs being given through veins, fatigue, nausea from chemotherapy, blood-related issues like anemia or clotting problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My head or neck cancer has not been treated and cannot be removed by surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have brain metastases or leptomeningeal disease and need steroids.
Select...
I have been treated with anti-PD-1 or PD-L1 therapy before.
Select...
I have not been treated with anti-CD47 or anti-SIRPα agents.
Select...
I have had pneumonitis treated with steroids or have it now.

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) + pembrolizumab + ChemotherapyExperimental Treatment3 Interventions
evorpacept (ALX148) 45 mg/kg IV, pembrolizumab 200 mg IV, and chemotherapy given every 3 weeks.
Group II: pembrolizumab + ChemotherapyActive Control2 Interventions
pembrolizumab 200 mg IV and chemotherapy 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
4,007 Previous Clinical Trials
5,184,931 Total Patients Enrolled
ALX Oncology Inc.Lead Sponsor
8 Previous Clinical Trials
1,137 Total Patients Enrolled

Media Library

Head and Neck Squamous Cell Carcinoma Clinical Trial 2023: Cisplatin/Carboplatin; 5FU Highlights & Side Effects. Trial Name: NCT04675333 — Phase 2
~4 spots leftby Dec 2024
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