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Pembrolizumab for Head and Neck Neoplasms (INDUCE-4 Trial)

Phase 2 & 3

Waitlist Available

Research Sponsored by GlaxoSmithKline

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up months 12, 24 and 36

Awards & highlights

INDUCE-4 Trial Summary

This trial is testing whether adding the drug GSK3359609 to standard chemotherapy and pembrolizumab improves treatment of head and neck squamous cell carcinoma.

Eligible Conditions

Head and Neck Neoplasms

INDUCE-4 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ months 12, 24 and 36

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~months 12, 24 and 36

This trial's timeline: 3 weeks for screening, Varies for treatment, and months 12, 24 and 36 for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

OS in Programmed Death Receptor-ligand 1 (PD-L1) Combined Positive Score (CPS) ≥1 Population

Overall Survival (OS) in mITT Population

Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v)1.1 in mITT Population

Secondary outcome measures

DCR Per RECIST v1.1 in PD-L1 CPS ≥1 Population

Disease Control Rate (DCR) Per RECIST v1.1 in mITT Population

DoR Per RECIST v1.1 in PD-L1 CPS ≥1 Population

+24 more

INDUCE-4 Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Feladilimab + Pembrolizumab + 5-FU-platinum chemotherapyExperimental Treatment4 Interventions

Group II: Placebo + Pembrolizumab + 5-FU-platinum chemotherapyPlacebo Group4 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Feladilimab

2019

Completed Phase 2

~110

Pembrolizumab

2017

Completed Phase 2

~2010

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme LLCIndustry Sponsor

3,888 Previous Clinical Trials

5,054,939 Total Patients Enrolled

31 Trials studying Head and Neck Neoplasms

7,704 Patients Enrolled for Head and Neck Neoplasms

GlaxoSmithKlineLead Sponsor

4,753 Previous Clinical Trials

8,069,340 Total Patients Enrolled

15 Trials studying Head and Neck Neoplasms

2,879 Patients Enrolled for Head and Neck Neoplasms

GSK Clinical TrialsStudy DirectorGlaxoSmithKline

3,595 Previous Clinical Trials

6,143,812 Total Patients Enrolled

5 Trials studying Head and Neck Neoplasms

1,444 Patients Enrolled for Head and Neck Neoplasms

Frequently Asked Questions

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

What is the FDA-approved indication for Pembrolizumab?

"Pembrolizumab can be used as an treatment for patients with unresectable melanoma, microsatellite instability high, and rectal carcinoma."

Answered by AI

Are there different test sites for this research?

"At the moment, this clinical trial is running at 10 different sites. The locations include Nashville, Pittsburgh, Atlanta and 10 other sites. If you are considering participating in this trial, it might be helpful to choose a location near you to cut down on travel."

Answered by AI

Could you please share Pembrolizumab's clinical trial history?

"Pembrolizumab is being studied in 1437 active clinical trials, with 270 of those trials in Phase 3. While Pembrolizumab clinical trials are prominent in Houston, Texas, there are a total of 68679 locations conducting studies on the medication."

Answered by AI

What primary goals does this research hope to realize?

"The primary goal of this clinical trial, which will last for approximately 7.5 months, is to evaluate the impact of the intervention on overall survival rates in the total population. Additionally, the study will assess the severity of adverse events and serious adverse events in the total population, time to deterioration in pain in the total population, and milestone overall survival rates at 12, 24, and 36 months in the total population."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study of GSK3359609 With Pembrolizumab and 5-fluorouracil (5-FU)-Platinum Chemotherapy in Participants With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

2020. "Study of GSK3359609 With Pembrolizumab and 5-fluorouracil (5-FU)-Platinum Chemotherapy in Participants With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04428333.