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Studie van retinfanlimab in combinatie met INCAGN02385 en INCAGN02390 als eerstelijnsbehandeling bij deelnemers met PD-L1-positief (CPS ≥ 1) recidiverend/gemetastaseerd plaveiselcelcarcinoom van het hoofd-halsgebied

1 september 2026 bijgewerkt door: Incyte Biosciences International Sàrl

Een gerandomiseerde, dubbelblinde, multicenter, fase 2-studie van retifanlimab in combinatie met INCAGN02385 (Anti-LAG-3) en INCAGN02390 (Anti-TIM-3) als eerstelijnsbehandeling bij deelnemers met PD-L1-positief (CPS ≥ 1) Recidiverend/gemetastaseerd plaveiselcelcarcinoom van het hoofd en de hals

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).

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Werkelijk)

176

Fase

  • Fase 2

Uitgebreide toegang

Verkrijgbaar buiten de klinische proef. Zie uitgebreid toegangsrecord.

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • België
      • Charleroi, België, 06000
        • Grand Hospital de Charleroi
      • Hasselt, België, 03500
        • Jessa Ziekenhuis
      • Wilrijk, België, 02610
        • Gza Sint Augustinus
  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H3T 1E2
        • McGill University Jewish General Hospital
      • Montreal, Quebec, Canada, H2X 3E4
        • McGill University Health Centre/Glen Site/Cedars Cancer Centre
      • Montreal, Quebec, Canada, H2X3E4
        • Chum Hospital Notre Dame
  • Duitsland
      • Cologne, Duitsland, 50937
        • University of Cologne
      • Hamburg, Duitsland, 22763
        • Asklepios Klinik Altona
      • Hamburg, Duitsland, 20246
        • Universitatsklinikum Hamburg Eppendorf
      • Mainz, Duitsland, 55131
        • Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii
  • Frankrijk
      • Bordeaux, Frankrijk, 33000
        • Centre Hospitalier Universitaire de Bordeaux
      • Paris, Frankrijk, 75248
        • Institut Curie
      • Rennes, Frankrijk, 35042
        • Centre Eugene Marquis
      • Saint-Herblain, Frankrijk, 44805
        • Centre de Lutte Contre Le Cancer - Institut de Cancerologie de L'Ouest - Rene Gauducheau
      • Strasbourg, Frankrijk, 67200
        • Icans - Institut de Cancerologie Strasbourg Europe
  • Georgië
      • K'ut'aisi, Georgië, 04600
        • Jsc Evex Hospitals
      • Tbilisi, Georgië, 00114
        • New Hospitals
      • Tbilisi, Georgië, 00159
        • Jsc Evex Corporation-Caraps Medline
      • Tbilisi, Georgië, 0159
        • Ltd Cancer Research Centre
  • Griekenland
      • Chaïdári, Griekenland, 12462
        • University Hospital of West Attica - Attikon
      • Thessaloniki, Griekenland, 54007
        • Theagenio Anticancer Hospital
      • Thessaloniki, Griekenland, 54622
        • Bioclinic Thessaloniki (Galinos Clinic)
      • Thessaloniki, Griekenland, 55236
        • Saint Lukas Clinic
  • Italië
      • Candiolo, Italië, 10060
        • Fondazione Del Piemonte Per L Oncologia Ircc Candiolo
      • Milan, Italië, 20133
        • Fondazione Irccs Istituto Nazionale Del Tumori Di Milano
      • Milan, Italië, 20141
        • European Institute of Oncology
      • Naples, Italië, 80131
        • Istituto Nazionale Tumori Irccs Fondazione Pascale
      • Padova, Italië, 35128
        • Iov - Istituto Oncologico Veneto Irccs
      • Pavia, Italië, 27100
        • Fondazione Irccs Policlinico San Matteo
      • Reggio Emilia, Italië, 42123
        • Ausl-Irccs Di Reggio Emilia
  • Nederland
      • Amsterdam, Nederland, 1066 CX
        • The Dutch Cancer Institue
      • Leiden, Nederland, 02333
        • Leids Universitair Medisch Centrum (Lumc) (Leiden University Medical Center)
  • Polen
      • Bydgoszcz, Polen, 85-796
        • Centrum Onkologii Im. Prof. Franciszka Lukaszczyka
      • Konin, Polen, 62-500
        • Przychodnia Lekarska Komed Roman Karaszewski
      • Lublin, Polen, 20-090
        • Centrum Onkologii Ziemi Lubelskiej Im. SW. Jana Z Dukli
      • Poznan, Polen, 60-780
        • Poznan University of Medical Sciences
      • Tomaszów Mazowiecki, Polen, 97-200
        • Nzoz Provita Prolife Centrum Medyczne
      • Warsaw, Polen, 02-781
        • Centrum Onkologii - Instytut Im. Marii Sklodowskiej - Curie
  • Portugal
      • Braga, Portugal, 4710-243
        • Hospital de Braga
      • Faro, Portugal, 8000-386
        • Centro Hospitalar Universitario Algarve
      • Lisbon, Portugal, 1649-035
        • Centro Hospitalar de Lisboa Norte E.P.E. - Hospital de Santa Maria
      • Porto, Portugal, 4200-319
        • Centro Hospitalar de Sao Joao Alameda
      • Porto, Portugal, 4200-072
        • Instituto Portugues de Oncologia Do Porto Francisco Gentil E.P.E.
      • Vila Nova de Gaia, Portugal, 4434-502
        • Centro Hospitalar de Vila Nova de Gaia/Espinho, Epe-Unidade L
  • Spanje
      • Barcelona, Spanje, 08916
        • Catalans Institute of Oncology Barcelona
      • Girona, Spanje, 17007
        • Ico Girona Hospital Universitari de Girona Dr Josep Trueta
      • Madrid, Spanje, 28223
        • Hospital Universitario Quironsalud Madrid
      • Madrid, Spanje, 00034
        • Fundacion Jimenez Diaz University Hospital
      • Madrid, Spanje, 28036
        • Hospital Universitario Ramon Y Cajal
      • Málaga, Spanje, 29010
        • Hospital Regional Universitario Carlos Haya
      • Pamplona, Spanje, 31008
        • Complejo Hospitalario de Navarra
      • Santander, Spanje, 39008
        • Hospital Universitario Marques de Valdecilla
      • Valencia, Spanje, 46014
        • Hospital General Universitario de Valencia
      • Valencia, Spanje, 46026
        • Hospital Universitari I Politecnic La Fe
  • Taiwan
      • Kaohsiung City, Taiwan, 80708
        • Kaohsiung Medical University Chung-Ho Memorial Hospital
      • Kaohsiung City, Taiwan, 83301
        • Chang Gung Medical Foundation. Kaohsiung Branch
      • Taichung, Taiwan, 00112
        • China Medical University Hospital
      • Taipei, Taiwan, 10002
        • National Taiwan University Hospital
      • Taipei, Taiwan, 00112
        • Institutional Review Board Taipei Veterans General Hospital
  • Verenigde Staten
    • Arizona
      • Scottsdale, Arizona, Verenigde Staten, 85259
        • Mayo Clinic Rochester
    • California
      • Duarte, California, Verenigde Staten, 91010-9200
        • City of Hope National Medical Center
      • Irvine, California, Verenigde Staten, 92618
        • City of Hope Orange County
      • La Jolla, California, Verenigde Staten, 92093
        • University of California San Diego Medical Center, Moores Cancer Center
      • Lancaster, California, Verenigde Staten, 93534
        • City of Hope-Antelope Valley
      • Long Beach, California, Verenigde Staten, 90813
        • City of Hope National Medical Center
      • Long Beach, California, Verenigde Staten, 90805
        • Innovative Clinical Research Institute
      • San Francisco, California, Verenigde Staten, 94115
        • University of California San Francisco Comprehensive Cancer Center
    • District of Columbia
      • Washington D.C., District of Columbia, Verenigde Staten, 20057
        • Georgetown University
    • Florida
      • Jacksonville, Florida, Verenigde Staten, 32224
        • Mayo Clinic Jacksonville
      • Miami, Florida, Verenigde Staten, 33174
        • Blessed Health Care
      • Tampa, Florida, Verenigde Staten, 33612-9416
        • Moffitt Cancer Center
    • Illinois
      • Chicago, Illinois, Verenigde Staten, 60612
        • University of Illinois At Chicago
    • Iowa
      • Iowa City, Iowa, Verenigde Staten, 52242-1316
        • University of Iowa
    • Kansas
      • Kansas City, Kansas, Verenigde Staten, 66103
        • University of Kansas Hospital Authority
    • Maryland
      • Baltimore, Maryland, Verenigde Staten, 21201
        • University of Maryland-Greenebaum Cancer Center
    • Massachusetts
      • Boston, Massachusetts, Verenigde Staten, 02215
        • Dana Farber Cancer Institute
    • Michigan
      • Ann Arbor, Michigan, Verenigde Staten, 48109
        • University of Michigan Cancer Center
      • Detroit, Michigan, Verenigde Staten, 48201
        • Barbara Ann Karmanos Cancer Hospital
    • New Jersey
      • Hackensack, New Jersey, Verenigde Staten, 07601
        • Hackensack University Medical Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, Verenigde Staten, 19111
        • Fox Chase Cancer Center
    • Utah
      • Salt Lake City, Utah, Verenigde Staten, 84112
        • Huntsman Cancer Institute At University of Utah
    • Virginia
      • Charlottesville, Virginia, Verenigde Staten, 22903
        • University of Virginia - Emily Couric Clinical Cancer Center
    • Washington
      • Kennewick, Washington, Verenigde Staten, 99336
        • Kadlec Clinic Hematology and Oncology
  • Zuid -Korea
      • Busan, Zuid -Korea, 49241
        • Pusan National University Yangsan Hospital
      • Gwangju, Zuid -Korea, 58128
        • Chonnam National University Hwasun Hospital
      • Seongnam-si, Zuid -Korea, 13496
        • Cha Bundang Medical Center
      • Seoul, Zuid -Korea, 05505
        • Asan Medical Center
      • Seoul, Zuid -Korea, 03181
        • Kangbuk Samsung Hospital
      • Seoul, Zuid -Korea, 02841
        • Korea University Anam Hospital
      • Seoul, Zuid -Korea, 05030
        • Kunkuk University Medical Center
      • Yangsan, Zuid -Korea, 50612
        • Pusan National University Yangsan Hospital

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 99 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Verdrievoudigen

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Treatment Group 1: Retifanlimab Monotherapy

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

Retifanlimab 500mg will be administered intravenously every 4 weeks.

Geneesmiddel: Placebo

Placebo will be administered intravenously.
Experimenteel: Treatment Group 2: Retifanlimab + INCAGN02385

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

Retifanlimab 500mg will be administered intravenously every 4 weeks.

Geneesmiddel: Placebo

Placebo will be administered intravenously.

Geneesmiddel: INCAGN02385

INCAGN02385 350mg will be administered intravenously every 2 weeks.
Experimenteel: Treatment Group 3: Retifanlimab + INCAGN02385 + INCAGN02390

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.
Geneesmiddel: Retifanlimab

Retifanlimab 500mg will be administered intravenously every 4 weeks.

Geneesmiddel: INCAGN02385

INCAGN02385 350mg will be administered intravenously every 2 weeks.

Geneesmiddel: INCAGN02390

INCAGN02390 400 mg will be administered intravenously every 2 weeks.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Progeression-free Survival (PFS)
Tijdsspanne: up to 738 days

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.
up to 738 days

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Objective Response
Tijdsspanne: up to approximately 44 months

Objective response was defined as having a complete response (CR) or partial response (PR), determined based on investigator assessment per RECIST v1.1, recorded post-baseline before and including the first progressive disease, and before new anticancer therapy. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 millimeters (mm). PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions.
up to approximately 44 months
Duration of Response (DOR)
Tijdsspanne: up to approximately 44 months

DOR was defined as the time from earliest date of disease response (CR or PR) until the earliest date of disease progression, based on investigator assessment per RECIST v1.1, or death from any cause if occurring sooner than progression.
up to approximately 44 months
Disease Control
Tijdsspanne: up to approximately 44 months

Disease control was defined as having CR, PR, or stable disease (SD) as best response on or after Day 180, based on investigator assessment per RECIST v1.1. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion. SD: no change in target lesions to qualify for CR, PR, or PD.
up to approximately 44 months
Overall Survival
Tijdsspanne: up to approximately 44 months

Overall survival was defined as the time from the date of randomization to the date of death due to any cause.
up to approximately 44 months
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Tijdsspanne: up to approximately 44 months

Adverse events (AEs) were defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug related. An AE could therefore be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug and within 90 days of the last administration of study drug.
up to approximately 44 months
Number of Participants With TEAEs Leading to Treatment Interruption, Dose Delay, and Withdrawal of Study Treatment
Tijdsspanne: up to approximately 44 months

AEs were defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug related. An AE could therefore be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug and within 90 days of the last administration of study drug.
up to approximately 44 months

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Incyte Biosciences International Sàrl

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Nuttige links

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

14 november 2022

Primaire voltooiing (Werkelijk)

14 maart 2025

Studie voltooiing (Werkelijk)

23 juni 2026

Studieregistratiedata

Eerst ingediend

11 maart 2022

Eerst ingediend dat voldeed aan de QC-criteria

11 maart 2022

Eerst geplaatst (Werkelijk)

18 maart 2022

Updates van studierecords

Laatste update geplaatst (Werkelijk)

25 september 2026

Laatste update ingediend die voldeed aan QC-criteria

1 september 2026

Laatst geverifieerd

1 september 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • INCAGN 2385-203
  • 2021-005775-39 (EudraCT-nummer)
  • 2023-504270-38-00 (Register-ID: EU CT Number)
  • 2023 (Subsidie/contract van de Amerikaanse NIH)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency

IPD-tijdsbestek voor delen

Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.

IPD-toegangscriteria voor delen

Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.

IPD delen Ondersteunend informatietype

  • LEERPROTOCOOL
  • SAP

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Ja

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Abonneren