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
Public ClinicalTrials.gov record NCT05287113. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized, Double-Blind, Multicenter, Phase 2 Study of Retifanlimab in Combination With INCAGN02385 (Anti-LAG-3) and INCAGN02390 (Anti-TIM-3) as First-Line Treatment in Participants With PD-L1-Positive (CPS ≥ 1) Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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).
Study identification
- NCT ID
- NCT05287113
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 176 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 99 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 14, 2022 (Actual)
- Primary completion
- Mar 14, 2025 (Actual)
- Completion
- Jun 23, 2026 (Actual)
- Last update posted
- Sep 25, 2026
2022 – 2026
United States locations
- U.S. sites
- 24
- U.S. states
- 15
- U.S. cities
- 23
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Mayo Clinic Rochester | Scottsdale | Arizona | 85259 | — |
| City of Hope National Medical Center | Duarte | California | 91010-9200 | — |
| City of Hope Orange County | Irvine | California | 92618 | — |
| University of California San Diego Medical Center, Moores Cancer Center | La Jolla | California | 92093 | — |
| City of Hope-Antelope Valley | Lancaster | California | 93534 | — |
| Innovative Clinical Research Institute | Long Beach | California | 90805 | — |
| City of Hope National Medical Center | Long Beach | California | 90813 | — |
| University of California San Francisco Comprehensive Cancer Center | San Francisco | California | 94115 | — |
| Georgetown University | Washington D.C. | District of Columbia | 20057 | — |
| Mayo Clinic Jacksonville | Jacksonville | Florida | 32224 | — |
| Blessed Health Care | Miami | Florida | 33174 | — |
| Moffitt Cancer Center | Tampa | Florida | 33612-9416 | — |
| University of Illinois At Chicago | Chicago | Illinois | 60612 | — |
| University of Iowa | Iowa City | Iowa | 52242-1316 | — |
| University of Kansas Hospital Authority | Kansas City | Kansas | 66103 | — |
| University of Maryland-Greenebaum Cancer Center | Baltimore | Maryland | 21201 | — |
| Dana Farber Cancer Institute | Boston | Massachusetts | 02215 | — |
| University of Michigan Cancer Center | Ann Arbor | Michigan | 48109 | — |
| Barbara Ann Karmanos Cancer Hospital | Detroit | Michigan | 48201 | — |
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | — |
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | 19111 | — |
| Huntsman Cancer Institute At University of Utah | Salt Lake City | Utah | 84112 | — |
| University of Virginia - Emily Couric Clinical Cancer Center | Charlottesville | Virginia | 22903 | — |
| Kadlec Clinic Hematology and Oncology | Kennewick | Washington | 99336 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 67 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05287113, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 25, 2026 · Synced Oct 17, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05287113 live on ClinicalTrials.gov.