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Anti-metabolites

Pembrolizumab + Epacadostat for Head and Neck Cancer

Phase 3

Waitlist Available

Research Sponsored by Incyte Corporation

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Documentation of results from testing of human papilloma virus (HPV) status for oropharyngeal cancer

Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 14 months

Awards & highlights

Study Summary

This trial found that pembrolizumab plus epacadostat was more effective than the EXTREME regimen or pembrolizumab monotherapy for treating HNSCC.

Who is the study for?

This trial is for adults with recurrent or metastatic head and neck squamous cell carcinoma who have measurable disease, are in good physical condition (ECOG 0-1), have proper organ function, and can provide a tumor specimen. It's not for those with recent other cancers, active autoimmune diseases treated within the last 2 years, HIV or hepatitis B/C infections, CNS metastases, or certain types of head and neck cancer.Check my eligibility

What is being tested?

The study compares three treatments: pembrolizumab plus epacadostat; pembrolizumab alone; and the EXTREME regimen (cetuximab with cisplatin/carboplatin plus 5-fluorouracil). The goal is to see which treatment works best as a first-line therapy for this type of cancer.See study design

What are the potential side effects?

Possible side effects include immune-related reactions due to pembrolizumab or epacadostat, infusion reactions from cetuximab, kidney issues from cisplatin/carboplatin use, mouth sores and low blood counts from 5-fluorouracil. Each patient may experience different side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My oropharyngeal cancer has been tested for HPV.

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I am fully active or restricted in physically strenuous activity but can do light work.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 14 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 14 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 14 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

Objective Response Rate (ORR) of Pembrolizumab + Epacadostat, Pembrolizumab Monotherapy and the EXTREME Regimen

Secondary outcome measures

Safety and Tolerability of Pembrolizumab + Epacadostat Versus Pembrolizumab Versus the EXTREME Regimen as Measured by Number of Participants Discontinuing Study Treatment Due to AEs

Safety and Tolerability of Pembrolizumab + Epacadostat Versus Pembrolizumab Versus the EXTREME Regimen as Measured by Number of Participants Experiencing Adverse Events (AEs)

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Pembrolizumab + EpacadostatExperimental Treatment2 Interventions

Group II: PembrolizumabExperimental Treatment1 Intervention

Group III: EXTREMEActive Control4 Interventions

EXTREME regimen includes cetuximab + cisplatin or carboplatin + 5-fluorouracil.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Epacadostat

2018

Completed Phase 3

~1080

Pembrolizumab

2017

Completed Phase 2

~2010

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme LLCIndustry Sponsor

3,892 Previous Clinical Trials

5,061,053 Total Patients Enrolled

Incyte CorporationLead Sponsor

366 Previous Clinical Trials

55,326 Total Patients Enrolled

Mark Jones, MDStudy DirectorIncyte Corporation

8 Previous Clinical Trials

1,906 Total Patients Enrolled

Media Library

5-Fluorouracil (Anti-metabolites) Clinical Trial Eligibility Overview. Trial Name: NCT03358472 — Phase 3

Head and Neck Cancers Research Study Groups: Pembrolizumab + Epacadostat, Pembrolizumab, EXTREME

Head and Neck Cancers Clinical Trial 2023: 5-Fluorouracil Highlights & Side Effects. Trial Name: NCT03358472 — Phase 3

5-Fluorouracil (Anti-metabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03358472 — Phase 3

Frequently Asked Questions

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

Are there any open slots for new volunteers in this clinical trial?

"Unfortunately, this study is not seeking participants at the moment. The listing was created on December 1st, 2017 and edited most recently on July 28th, 2022. However, there are 2990 other trials for oral squamous cell carcinoma and 2330 Pembrolizumab trials that are still admitting patients if you're interested in participating in clinical research."

Answered by AI

What are the possible side effects of Pembrolizumab?

"Pembrolizumab has received a score of 3 for safety. This is because it is in Phase 3 trials, suggesting that not only is there some evidence supporting its efficacy, but also multiple rounds of data affirming its safety."

Answered by AI

What other experience do we have with Pembrolizumab?

"City of Hope Comprehensive Cancer Center first studied pembrolizumab in 1997 and, as of now, there have been 2565 completed clinical trials. 2330 studies are actively recruiting patients across the globe with a significant portion taking place in Sacramento, California."

Answered by AI

Where are the patients being recruited for this test?

"This study is being conducted in 18 different locations, some of which include UC Davis Comprehensive Cancer Center in Sacramento, Baptist Health in Louisville, and St. Joseph Heritage Healthcare in Santa Rosa."

Answered by AI

What is the main disease that Pembrolizumab helps patients with?

"Pembrolizumab is a medication that oncologists often prescribe to treat cancer. It can also help patients who are suffering from other conditions such as unresectable melanoma, microsatellite instability high, and rectal carcinoma."

Answered by AI

How many people are currently enrolled in this clinical trial?

"Unfortunately, this particular trial is no longer looking for new patients. The listing was created on December 1st 2017 but the most recent update was on July 28th 2022. However, there are 2990 other trials related to oral squamous cell carcinoma and 2330 studies investigating Pembrolizumab that are still enrolling participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Pembrolizumab Plus Epacadostat, Pembrolizumab Monotherapy, and the EXTREME Regimen in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (KEYNOTE-669/ECHO-304)

2017. "Pembrolizumab Plus Epacadostat, Pembrolizumab Monotherapy, and the EXTREME Regimen in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (KEYNOTE-669/ECHO-304)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03358472.

All > Squamous Cell Carcinoma