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New Triple-Drug cocktail aims to shrink head and neck tumors

NCT ID NCT05287113

Disease control Sponsor: Incyte Biosciences International Sàrl Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether adding two experimental drugs (INCAGN02385 and INCAGN02390) to the immunotherapy retifanlimab can better control advanced head and neck cancer that has returned or spread. About 176 adults with PD-L1-positive tumors who have not had prior systemic therapy will receive either the triple combination or retifanlimab alone. The main goal is to see if the combination delays cancer growth or death.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

176 people

The number who actually took part.

Started

Nov 2022

Expected to finish

Jul 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 99 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 have received prior systemic therapy for R/M SCCHN. * PD-L1 positive tumor status defined by CPS ≥ 1% per central laboratory determination. * For participants with primary oropharyngeal tumors, documentation of HPV p16 status based on local institutional standard is required. HPV p16 status is not required for other eligible SCCHN primary tumor sites. * Participant must have at least 1 measurable tumor lesion per RECIST v1.1. * Availability of archival tissue for biomarker analysis from a core or excisional biopsy or willingness to undergo a fresh biopsy. * ECOG performance status of 0 or 1. * Willingness to avoid pregnancy or fathering children. Exclusion Criteria: * Progressive or recurrent disease within 6 months of the last dose of systemic treatment for locally advanced SCCHN. Prior PD-(L)1, LAG-3, or TIM-3 directed therapy, or any other checkpoint inhibitor therapy, for SCCHN or any other malignancy. * Treatment with anticancer therapies or participation in another interventional clinical study within 21 days before the first administration of study treatment. * Presence of tumors that invade major blood vessels, as shown unequivocally by imaging, and with active bleeding. * Participants with primary tumors of the nasopharynx, sinonasal cavity, or salivary and are excluded. * Less than 3-month life expectancy. * Participant has not recovered to ≤ Grade 1 or baseline from residual toxicities of prior therapy. * Participant has not recovered adequately from toxicities and/or complications from surgical intervention before starting study treatment. * Palliative radiation therapy administered within 1 week before the first dose of study treatment or radiation therapy in the thoracic region that is \> 30 Gy within 6 months before the first dose of study treatment. * Known active CNS metastases and/or carcinomatous meningitis. Participants will be excluded if it has been \< 4 weeks since radiation therapy was delivered to the CNS.

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Conditions

The condition(s) this trial relates to.

head and neck cancer Head and Neck Neoplasms head and neck squamous cell carcinoma Squamous Cell Carcinoma of Head and Neck

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Head and neck cancer

Contacts and locations

Locations

  • Asan Medical Center

    Seoul, 05505, South Korea

  • Asklepios Klinik Altona

    Hamburg, 22763, Germany

  • Ausl-Irccs Di Reggio Emilia

    Reggio Emilia, 42123, Italy

  • Barbara Ann Karmanos Cancer Hospital

    Detroit, Michigan, 48201, United States

  • Bioclinic Thessaloniki (Galinos Clinic)

    Thessaloniki, 54622, Greece

  • Blessed Health Care

    Miami, Florida, 33174, United States

  • Catalans Institute of Oncology Barcelona

    Barcelona, 08916, Spain

  • Centre Eugene Marquis

    Rennes, 35042, France

  • Centre Hospitalier Universitaire de Bordeaux

    Bordeaux, 33000, France

  • Centre de Lutte Contre Le Cancer - Institut de Cancerologie de L'Ouest - Rene Gauducheau

    Saint-Herblain, 44805, France

  • Centro Hospitalar Universitario Algarve

    Faro, 8000-386, Portugal

  • Centro Hospitalar de Lisboa Norte E.P.E. - Hospital de Santa Maria

    Lisbon, 1649-035, Portugal

  • Centro Hospitalar de Sao Joao Alameda

    Porto, 4200-319, Portugal

  • Centro Hospitalar de Vila Nova de Gaia/Espinho, Epe-Unidade L

    Vila Nova de Gaia, 4434-502, Portugal

  • Centrum Onkologii - Instytut Im. Marii Sklodowskiej - Curie

    Warsaw, 02-781, Poland

  • Centrum Onkologii Im. Prof. Franciszka Lukaszczyka

    Bydgoszcz, 85-796, Poland

  • Centrum Onkologii Ziemi Lubelskiej Im. SW. Jana Z Dukli

    Lublin, 20-090, Poland

  • Cha Bundang Medical Center

    Seongnam-si, 13496, South Korea

  • Chang Gung Medical Foundation. Kaohsiung Branch

    Kaohsiung City, 83301, Taiwan

  • China Medical University Hospital

    Taichung, 00112, Taiwan

  • Chonnam National University Hwasun Hospital

    Gwangju, 58128, South Korea

  • Chum Hospital Notre Dame

    Montreal, Quebec, H2X3E4, Canada

  • City of Hope National Medical Center

    Duarte, California, 91010-9200, United States

  • City of Hope National Medical Center

    Long Beach, California, 90813, United States

  • City of Hope Orange County

    Irvine, California, 92618, United States

  • City of Hope-Antelope Valley

    Lancaster, California, 93534, United States

  • Complejo Hospitalario de Navarra

    Pamplona, 31008, Spain

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215, United States

  • European Institute of Oncology

    Milan, 20141, Italy

  • Fondazione Del Piemonte Per L Oncologia Ircc Candiolo

    Candiolo, 10060, Italy

  • Fondazione Irccs Istituto Nazionale Del Tumori Di Milano

    Milan, 20133, Italy

  • Fondazione Irccs Policlinico San Matteo

    Pavia, 27100, Italy

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111, United States

  • Fundacion Jimenez Diaz University Hospital

    Madrid, 00034, Spain

  • Georgetown University

    Washington D.C., District of Columbia, 20057, United States

  • Grand Hospital de Charleroi

    Charleroi, 06000, Belgium

  • Gza Sint Augustinus

    Wilrijk, 02610, Belgium

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601, United States

  • Hospital General Universitario de Valencia

    Valencia, 46014, Spain

  • Hospital Regional Universitario Carlos Haya

    Málaga, 29010, Spain

  • Hospital Universitari I Politecnic La Fe

    Valencia, 46026, Spain

  • Hospital Universitario Marques de Valdecilla

    Santander, 39008, Spain

  • Hospital Universitario Quironsalud Madrid

    Madrid, 28223, Spain

  • Hospital Universitario Ramon Y Cajal

    Madrid, 28036, Spain

  • Hospital de Braga

    Braga, 4710-243, Portugal

  • Huntsman Cancer Institute At University of Utah

    Salt Lake City, Utah, 84112, United States

  • Icans - Institut de Cancerologie Strasbourg Europe

    Strasbourg, 67200, France

  • Ico Girona Hospital Universitari de Girona Dr Josep Trueta

    Girona, 17007, Spain

  • Innovative Clinical Research Institute

    Long Beach, California, 90805, United States

  • Institut Curie

    Paris, 75248, France

  • Institutional Review Board Taipei Veterans General Hospital

    Taipei, 00112, Taiwan

  • Instituto Portugues de Oncologia Do Porto Francisco Gentil E.P.E.

    Porto, 4200-072, Portugal

  • Iov - Istituto Oncologico Veneto Irccs

    Padova, 35128, Italy

  • Istituto Nazionale Tumori Irccs Fondazione Pascale

    Naples, 80131, Italy

  • Jessa Ziekenhuis

    Hasselt, 03500, Belgium

  • Jsc Evex Corporation-Caraps Medline

    Tbilisi, 00159, Georgia

  • Jsc Evex Hospitals

    K'ut'aisi, 04600, Georgia

  • Kadlec Clinic Hematology and Oncology

    Kennewick, Washington, 99336, United States

  • Kangbuk Samsung Hospital

    Seoul, 03181, South Korea

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City, 80708, Taiwan

  • Korea University Anam Hospital

    Seoul, 02841, South Korea

  • Kunkuk University Medical Center

    Seoul, 05030, South Korea

  • Leids Universitair Medisch Centrum (Lumc) (Leiden University Medical Center)

    Leiden, 02333, Netherlands

  • Ltd Cancer Research Centre

    Tbilisi, 0159, Georgia

  • Mayo Clinic Jacksonville

    Jacksonville, Florida, 32224, United States

  • Mayo Clinic Rochester

    Scottsdale, Arizona, 85259, United States

  • McGill University Health Centre/Glen Site/Cedars Cancer Centre

    Montreal, Quebec, H2X 3E4, Canada

  • McGill University Jewish General Hospital

    Montreal, Quebec, H3T 1E2, Canada

  • Moffitt Cancer Center

    Tampa, Florida, 33612-9416, United States

  • National Taiwan University Hospital

    Taipei, 10002, Taiwan

  • New Hospitals

    Tbilisi, 00114, Georgia

  • Nzoz Provita Prolife Centrum Medyczne

    Tomaszów Mazowiecki, 97-200, Poland

  • Poznan University of Medical Sciences

    Poznan, 60-780, Poland

  • Przychodnia Lekarska Komed Roman Karaszewski

    Konin, 62-500, Poland

  • Pusan National University Yangsan Hospital

    Busan, 49241, South Korea

  • Pusan National University Yangsan Hospital

    Yangsan, 50612, South Korea

  • Saint Lukas Clinic

    Thessaloniki, 55236, Greece

  • The Dutch Cancer Institue

    Amsterdam, 1066 CX, Netherlands

  • Theagenio Anticancer Hospital

    Thessaloniki, 54007, Greece

  • Universitatsklinikum Hamburg Eppendorf

    Hamburg, 20246, Germany

  • Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii

    Mainz, 55131, Germany

  • University Hospital of West Attica - Attikon

    Chaïdári, 12462, Greece

  • University of California San Diego Medical Center, Moores Cancer Center

    La Jolla, California, 92093, United States

  • University of California San Francisco Comprehensive Cancer Center

    San Francisco, California, 94115, United States

  • University of Cologne

    Cologne, 50937, Germany

  • University of Illinois At Chicago

    Chicago, Illinois, 60612, United States

  • University of Iowa

    Iowa City, Iowa, 52242-1316, United States

  • University of Kansas Hospital Authority

    Kansas City, Kansas, 66103, United States

  • University of Maryland-Greenebaum Cancer Center

    Baltimore, Maryland, 21201, United States

  • University of Michigan Cancer Center

    Ann Arbor, Michigan, 48109, United States

  • University of Virginia - Emily Couric Clinical Cancer Center

    Charlottesville, Virginia, 22903, United States

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Other studies related to the condition(s) this trial covers.