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Evorpacept + Immunotherapy + Chemotherapy for Head and Neck Cancer

Phase 2

Recruiting

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 36 months

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

My head or neck cancer has not been treated and cannot be removed by surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 36 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 36 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 36 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

12-month overall survival rate

Objective response rate per RECIST 1.1

Secondary outcome measures

Adverse events

Duration of response

Overall survival

+1 more

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

~5750

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme LLCIndustry Sponsor

3,892 Previous Clinical Trials

5,060,978 Total Patients Enrolled

ALX Oncology Inc.Lead Sponsor

8 Previous Clinical Trials

1,172 Total Patients Enrolled

Media Library

Head and Neck Cancers Clinical Trial 2023: Cisplatin/Carboplatin; 5FU Highlights & Side Effects. Trial Name: NCT04675333 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the research team still accepting participants for this experiment?

"According to the details provided on clinicaltrials.gov, this medical trial is in its recruitment phase. Initially unveiled on May 10th 2021 and most recently updated by November 4th of that same year."

Answered by AI

Has Evorpacept been examined in any other experiments?

"Evorpacept was first explored at City of Hope Comprehensive Cancer Center back in 1997. To date, 2336 trials have been finalized and there are presently 2142 live clinical tests ongoing, the majority being held in Louisville, Kentucky."

Answered by AI

To what degree can Evorpacept be hazardous for human beings?

"Evorpacept's safety rating is a 2 on the scale of 1-3, since there are some risk assessments in place but no efficacy data has been collected."

Answered by AI

What medical conditions is Evorpacept typically employed to alleviate?

"Evorpacept can be used to treat dangerous tumours, such as malignant neoplasms and unresectable melanoma, alongside microsatellite instability high."

Answered by AI

How many participants are being monitored as part of this experiment?

"This clinical trial requires 168 suitable participants, and those interested can sign up at the University of Louisville in Kentucky or Rush University Medical Center in Illinois."

Answered by AI

How many venues are involved in the execution of this scientific experiment?

"This trial is currently occurring in 7 different locales. Such places include Louisville, Chicago and Miami alongside 4 other cities. To avoid extensive commuting, it is recommended to join a centre nearby your current residence if you decide to take part."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Evorpacept (ALX148) in Combination With Pembrolizumab and Chemotherapy in Patients With Advanced Head and Neck Squamous Cell Carcinoma (ASPEN-04)

2021. "Evorpacept (ALX148) in Combination With Pembrolizumab and Chemotherapy in Patients With Advanced Head and Neck Squamous Cell Carcinoma (ASPEN-04)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04675333.

All > Squamous Cell Carcinoma