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ICOS Agonist

Pembrolizumab for Head and Neck Neoplasms (INDUCE-3 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 24 months

Awards & highlights

INDUCE-3 Trial Summary

This trial is studying if adding GSK3359609 to pembrolizumab improves the efficacy of pembrolizumab in participants with recurrent or metastatic head and neck squamous cell carcinoma/cancer.

Eligible Conditions

Head and Neck Neoplasms

INDUCE-3 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 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

OS in the PD-L1 Expression High (CPS ≥20) Population

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

Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors (RECIST) in the PD-L1 CPS ≥1 Population

Secondary outcome measures

DCR Per RECIST v1.1 in the PD-L1 CPS ≥20 Population

Disease Control Rate (DCR) Per RECIST v1.1 in the PD-L1 CPS ≥1 Population

DoR Per RECIST v1.1 in the PD-L1 CPS ≥20 Population

+20 more

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183

21%

Fatigue

13%

Nausea

11%

Back pain

Shortness of Breath

Anemia

Abdominal pain

Diarrhea

Pneumonia

Kidney Injury and/or Infection

Dyspnea

Weight Loss

Malnutrition, Hypercalcemia and Weakness

Pneumothorax

Intractable pain, back pain, hip pain

Activated partial thromboplastin time prolonged

Pleural effusion

Atrial fibrillation with rapid ventricular response

Thrombocytopenia

Respiratory failure

Skin rash

colitis

100%

80%

60%

40%

20%

Study treatment Arm

Single Arm

INDUCE-3 Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Participants receiving feladilimab and pembrolizumabExperimental Treatment2 Interventions

Participants were administered feladilimab (humanized anti-ICOS immunoglobulin G4 [IgG4] monoclonal antibody [mAb]) and pembrolizumab (humanized anti-PD-1 IgG4 mAb) as an intravenous (IV) infusion once every three weeks.

Group II: Participants receiving placebo and pembrolizumabActive Control2 Interventions

Participants were administered placebo and pembrolizumab (humanized anti-PD-1 IgG4 mAb) as an IV infusion once every three weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 2

~2010

feladilimab

2018

Completed Phase 2

~30

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

GlaxoSmithKlineLead Sponsor

4,753 Previous Clinical Trials

8,069,143 Total Patients Enrolled

15 Trials studying Head and Neck Neoplasms

2,682 Patients Enrolled for Head and Neck Neoplasms

Merck Sharp & Dohme LLCIndustry Sponsor

3,888 Previous Clinical Trials

5,054,742 Total Patients Enrolled

31 Trials studying Head and Neck Neoplasms

7,507 Patients Enrolled for Head and Neck Neoplasms

GSK Clinical TrialsStudy DirectorGlaxoSmithKline

3,595 Previous Clinical Trials

6,143,615 Total Patients Enrolled

5 Trials studying Head and Neck Neoplasms

1,247 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 Pembrolizumab used to treat?

"Pembrolizumab can be used to effectively target and treat various cancers including malignant neoplasms, unresectable melanoma, and microsatellite instability high."

Answered by AI

What other clinical tests has Pembrolizumab been used in?

"City of Hope first ran clinical trials for pembrolizumab in 2010. Since then, there have been a total of 18480 completed trials worldwide. Out of the 1001 active trials, many are concentrated in Quebec City, Quebec."

Answered by AI

How many research facilities are handling this project?

"There are 30 sites currently running this trial, which are based in Quebec City, Vancouver, Rimouski, and other cities. To minimize travel, it is recommended that you select the site closest to you."

Answered by AI

Are there any patients presently enrolled in this clinical trial?

"The most recent information available on clinicaltrials.gov reveals that this study is not currently seeking patients. This trial was first posted on November 21st, 2019, and was last updated on September 7th, 2020. Although this study is not recruiting at this moment, there are 4033 other trials that are."

Answered by AI

What goals is this research trying to achieve?

"The primary outcome of this trial, which will be assessed over approximately Up to approximately 16 months, is progression-free survival (PFS) in the PD-L1 CPS >=1 population. Secondary outcomes include PFS Per Immune-based RECIST (iRECIST) in the PD-L1 CPS ≥1 Population which is defined as PFS per iRECIST was defined as the interval of time from the date of randomization to the date of the first documented disease progression confirmed consecutively per iRECIST based on investigator assessment, or death due to any cause, whichever occurs first. CPS was defined as the ratio of"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study of GSK3359609 and Pembrolizumab in Programmed Death Receptor 1-ligand 1 (PD-L1) Positive Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

2019. "Study of GSK3359609 and Pembrolizumab in Programmed Death Receptor 1-ligand 1 (PD-L1) Positive Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04128696.