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NCT05287113 · ClinicalTrials.gov registry record · Phase 2
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
A Phase 2 study of Head and Neck Cancer, sponsored by Incyte Biosciences International Sàrl.
- Active
- Registry status
- Phase 2
- Development phase
- 176
- Enrollment target
- 20
- Study locations
NCT05287113: Active Phase 2 study of Head and Neck Cancer, sponsored by Incyte Biosciences International Sàrl.
NCT05287113 is a Phase 2 study of Head and Neck Cancer that is active but no longer recruiting, run by Incyte Biosciences International Sàrl. The registered enrollment target is 176 participants, below the 260-participant average among 250 other Head and Neck Cancer trials with a reported enrollment target (32% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05287113, a Phase 2 study of Head and Neck Cancer, is active but no longer recruiting, sponsored by Incyte Biosciences International Sàrl.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 176 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to evaluate the safety and efficacy of the combination of retifanlimab plus INCAGN02385 and retifanlimab plus INCAGN02385 and INCAGN02390 compared with retifanlimab alone as first-line treatment in PD-L1-positive and systemic therapy-naive recurrent/metastatic (R/M) squamous cell carcinoma of the head and neck (SCCHN).
Primary Outcome
PFS was defined as the time from the date of randomization to the date of the first documented progression, as determined by investigator assessment per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), or death due to any cause, whichever occurred first.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Retifanlimab
- DRUG INCAGN02385
- DRUG INCAGN02390
Study Locations (20)
California
- City of Hope National Medical Center - Duarte
- City of Hope Orange County - Irvine
- University of California San Diego Medical Center, Moores Cancer Center - La Jolla
- City of Hope-Antelope Valley - Lancaster
- Innovative Clinical Research Institute - Long Beach
- City of Hope National Medical Center - Long Beach
- University of California San Francisco Comprehensive Cancer Center - San Francisco
Florida
- Mayo Clinic Jacksonville - Jacksonville
- Blessed Health Care - Miami
- Moffitt Cancer Center - Tampa
Michigan
- University of Michigan Cancer Center - Ann Arbor
- Barbara Ann Karmanos Cancer Hospital - Detroit
Arizona
- Mayo Clinic Rochester - Scottsdale
District of Columbia
- Georgetown University - Washington D.C.
Illinois
- University of Illinois At Chicago - Chicago
Iowa
- University of Iowa - Iowa City
Kansas
- University of Kansas Hospital Authority - Kansas City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 176 participants |
| Start Date | 2022-11-14 |
| Est. Completion | 2026-07-10 |
| Phase | Phase 2 |
What the registry record for NCT05287113 still lists
NCT05287113 is an interventional study that assigns participants to a tested intervention. The registered 176 participants enrollment target is mid-sized for trials with a published cap, below the 260-participant average among 250 other Head and Neck Cancer trials with a reported enrollment target (32% lower).
The record links to 1 condition, with Head and Neck Cancer appearing as the primary indexed condition, and to 4 interventions - of which Placebo is the first listed.
NCT05287113 names 20 study sites across 11 states, led by California, Florida, Michigan.
Frequently Asked Questions
What is clinical trial NCT05287113 about?
NCT05287113 is a clinical study titled "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". The purpose of this study is to evaluate the safety and efficacy of the combination of retifanlimab plus INCAGN02385 and retifanlimab plus INCAGN02385 and INCAGN02390 compared with retifanlimab alone as first-line treatment in PD-L1-positive and systemic therapy-naive recurrent/metastatic (R/M) squa...
What is the current status of trial NCT05287113?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 176 participants. The study started on 2022-11-14. Estimated completion is 2026-07-10.
What conditions does trial NCT05287113 study?
This clinical trial studies the following conditions: Head and Neck Cancer.
What interventions are being tested in trial NCT05287113?
The interventions under investigation include: Placebo (DRUG), Retifanlimab (DRUG), INCAGN02385 (DRUG), INCAGN02390 (DRUG).
Who is sponsoring clinical trial NCT05287113?
This trial is sponsored by Incyte Biosciences International Sàrl, which has 7 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05287113 being conducted?
This trial has 20 study locations across Arizona, California, District of Columbia, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05287113's enrollment target sits among peer trials
176 54th of 250 higher than 197 of 250 other Head and Neck Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Head and Neck Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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