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PD-L1 Inhibitor

Triple Drug Combo for Head and Neck Cancer

Phase 2

Recruiting

Research Sponsored by Incyte Biosciences International Sàrl

Eligibility Criteria Checklist

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

Must have

Eligible primary tumor locations are oropharynx, oral cavity, hypopharynx, and larynx.

ECOG performance status of 0 or 1.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 36 months

Awards & highlights

Study Summary

This trialtests if a combination of 3 drugs is more effective than one drug for treating advanced head and neck cancer.

Who is the study for?

This trial is for adults with PD-L1-positive recurrent or metastatic squamous cell carcinoma of the head and neck, who haven't had systemic therapy before. They should have a performance status indicating they can care for themselves and not be expected to need curative treatment. Participants must avoid pregnancy, have measurable tumors per specific criteria, provide tissue samples, and not have certain health conditions that could affect their participation.Check my eligibility

What is being tested?

The study tests retifanlimab combined with INCAGN02385 and possibly INCAGN02390 against retifanlimab alone in first-line treatment. It aims to find out how safe this combination is and how well it works compared to just using retifanlimab by itself in patients who are new to systemic therapy.See study design

What are the potential side effects?

Potential side effects may include immune-related reactions due to the drugs' action on the immune system, infusion-related responses during drug administration, fatigue from treatment burden, as well as other drug-specific adverse effects which will be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

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

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My cancer is in my throat, mouth, or voice box.

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I am fully active or can carry out light work.

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My head or neck cancer can't be treated with the intent to cure, and I haven't refused surgery that could potentially cure a recurrence.

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My tumor is PD-L1 positive with a score of 1% or higher.

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I have not had any drug treatments for my recurrent or metastatic head and neck cancer.

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

Progression Free Survival (PFS)

Secondary outcome measures

Disease Control Rate (DCR)

Duration of Response (DOR)

Objective Response Rate (ORR)

+2 more

Trial Design

3Treatment groups

Experimental Treatment

Group I: Treatment Group 3: Retifanlimab + INCAGN02385 + INCAGN02390Experimental Treatment3 Interventions

Retifanlimab plus INCAGN02385 and INCAGN02390 will be administered intravenously. Retifanlimab will be administered intravenously every 4 weeks. INCAGN02385 and INCAGN02390 will be administered every 2 weeks.

Group II: Treatment Group 2: Retifanlimab + INCAGN02385Experimental Treatment3 Interventions

Retifanlimab will be administered intravenously every 4 weeks. INCAGN02385 and Placebo for INCAGN02390 will be administered intravenously every 2 weeks.

Group III: Treatment Group 1: Retifanlimab MonotherapyExperimental Treatment2 Interventions

Retifanlimab will be administered intravenously every 4 weeks. Placebos for INCAGN02385 and INCAGN02390 will be administered intravenously every 2 weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

INCAGN02385

2018

Completed Phase 1

~30

Retifanlimab

2018

Completed Phase 2

~320

INCAGN02390

2018

Completed Phase 1

~40

Placebo

1995

Completed Phase 3

~2670

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Incyte Biosciences International SàrlLead Sponsor

15 Previous Clinical Trials

630 Total Patients Enrolled

Matthias Bartenstein, MDStudy DirectorIncyte Corporation

Media Library

INCAGN02385 (PD-L1 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05287113 — Phase 2

Head and Neck Cancers Research Study Groups: Treatment Group 2: Retifanlimab + INCAGN02385, Treatment Group 3: Retifanlimab + INCAGN02385 + INCAGN02390, Treatment Group 1: Retifanlimab Monotherapy

Head and Neck Cancers Clinical Trial 2023: INCAGN02385 Highlights & Side Effects. Trial Name: NCT05287113 — Phase 2

INCAGN02385 (PD-L1 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05287113 — Phase 2

Frequently Asked Questions

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

How many human subjects are involved in this experiment?

"The sponsor, Incyte Biosciences International Sàrl, needs 162 patients that match the clinical trial's inclusion criteria to begin. The trial will be conducted at different locations including Innovative Clinical Research Institute in Long Beach, California and Fox Chase Cancer Center in Philadelphia, Pennsylvania."

Answered by AI

Which age group is this research project meant for?

"This research is only enrolling patients aged 18 to 99, which differentiates it from the 94 other trials conducted for minors and the 2971 senior citizen studies."

Answered by AI

Are we still enrolling people for this experiment?

"Yes, that is accurate. The listing on clinicaltrials.gov includes information suggesting that the trial is still open for recruitment. This particular study was posted on November 14th, 2020 and updated on the 15th of November, 2020. They are looking to have a total of 162 patients enrolled from 22 different sites."

Answered by AI

Are there different groups of patients being studied in various parts of the country?

"There are 22 clinical trial sites for this study, which are situated in Long Beach, Philadelphia, Montreal and other various locations. To limit travel costs and time, please select the location nearest you."

Answered by AI

What is the FDA's official stance on the use of Retifanlimab + INCAGN02385 + INCAGN02390?

"This is a Phase 2 trial, so while there is some data supporting safety, none of it supports efficacy. Therefore, our team at Power has given Treatment Group 3: Retifanlimab + INCAGN02385 + INCAGN02390 a score of 2 for safety."

Answered by AI

Who would be an ideal candidate for this research project?

"This clinical trial is looking for 162 participants that have been diagnosed with head and neck cancer. The age range for applicants is 18 to 99 years old. There are several notable eligibility requirements that potential participants should be aware of, which are listed below: •Histologically or cytologically confirmed R/M SCCHN that is not amenable to therapy with curative intent •Participants who refuse potentially curative salvage surgery for recurrent disease are ineligible •Eligible primary tumor locations are oropharynx, oral cavity, hypopharynx, and larynx •Participants must not"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study of Retinfanlimab in Combination With INCAGN02385 and INCAGN02390 as First-Line Treatment in Participants With PD-L1-Positive (CPS ≥ 1) Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck

2022. "Study of Retinfanlimab in Combination With INCAGN02385 and INCAGN02390 as First-Line Treatment in Participants With PD-L1-Positive (CPS ≥ 1) Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05287113.

All > Squamous Cell Carcinoma