Estudio de retinfanlimab en combinación con INCAGN02385 e INCAGN02390 como tratamiento de primera línea en participantes con carcinoma de células escamosas de cabeza y cuello recurrente/metastásico con PD-L1 positivo (CPS ≥ 1)
Un estudio aleatorizado, doble ciego, multicéntrico, de fase 2 de retifanlimab en combinación con INCAGN02385 (Anti-LAG-3) e INCAGN02390 (Anti-TIM-3) como tratamiento de primera línea en participantes con PD-L1-positivo (CPS ≥ 1) Carcinoma de células escamosas de cabeza y cuello recurrente/metastásico
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).
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 2
Acceso ampliado
Contactos y Ubicaciones
Ubicaciones de estudio
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Cologne, Alemania, 50937
- University of Cologne
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Hamburg, Alemania, 22763
- Asklepios Klinik Altona
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Hamburg, Alemania, 20246
- Universitatsklinikum Hamburg Eppendorf
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Mainz, Alemania, 55131
- Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii
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Charleroi, Bélgica, 06000
- Grand Hospital de Charleroi
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Hasselt, Bélgica, 03500
- Jessa Ziekenhuis
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Wilrijk, Bélgica, 02610
- Gza Sint Augustinus
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Quebec
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Montreal, Quebec, Canadá, H3T 1E2
- McGill University Jewish General Hospital
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Montreal, Quebec, Canadá, H2X 3E4
- McGill University Health Centre/Glen Site/Cedars Cancer Centre
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Montreal, Quebec, Canadá, H2X3E4
- Chum Hospital Notre Dame
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Busan, Corea del Sur, 49241
- Pusan National University Yangsan Hospital
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Gwangju, Corea del Sur, 58128
- Chonnam National University Hwasun Hospital
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Seongnam-si, Corea del Sur, 13496
- Cha Bundang Medical Center
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Seoul, Corea del Sur, 05505
- Asan Medical Center
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Seoul, Corea del Sur, 03181
- Kangbuk Samsung Hospital
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Seoul, Corea del Sur, 02841
- Korea University Anam Hospital
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Seoul, Corea del Sur, 05030
- Kunkuk University Medical Center
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Yangsan, Corea del Sur, 50612
- Pusan National University Yangsan Hospital
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Barcelona, España, 08916
- Catalans Institute of Oncology Barcelona
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Girona, España, 17007
- Ico Girona Hospital Universitari de Girona Dr Josep Trueta
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Madrid, España, 28223
- Hospital Universitario Quironsalud Madrid
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Madrid, España, 00034
- Fundacion Jimenez Diaz University Hospital
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Madrid, España, 28036
- Hospital Universitario Ramon Y Cajal
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Málaga, España, 29010
- Hospital Regional Universitario Carlos Haya
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Pamplona, España, 31008
- Complejo Hospitalario de Navarra
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Santander, España, 39008
- Hospital Universitario Marques de Valdecilla
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Valencia, España, 46014
- Hospital General Universitario de Valencia
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Valencia, España, 46026
- Hospital Universitari I Politecnic La Fe
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Arizona
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Scottsdale, Arizona, Estados Unidos, 85259
- Mayo Clinic Rochester
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California
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Duarte, California, Estados Unidos, 91010-9200
- City of Hope National Medical Center
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Irvine, California, Estados Unidos, 92618
- City of Hope Orange County
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La Jolla, California, Estados Unidos, 92093
- University of California San Diego Medical Center, Moores Cancer Center
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Lancaster, California, Estados Unidos, 93534
- City of Hope-Antelope Valley
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Long Beach, California, Estados Unidos, 90813
- City of Hope National Medical Center
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Long Beach, California, Estados Unidos, 90805
- Innovative Clinical Research Institute
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San Francisco, California, Estados Unidos, 94115
- University of California San Francisco Comprehensive Cancer Center
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District of Columbia
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Washington D.C., District of Columbia, Estados Unidos, 20057
- Georgetown University
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Florida
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Jacksonville, Florida, Estados Unidos, 32224
- Mayo Clinic Jacksonville
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Miami, Florida, Estados Unidos, 33174
- Blessed Health Care
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Tampa, Florida, Estados Unidos, 33612-9416
- Moffitt Cancer Center
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Illinois
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Chicago, Illinois, Estados Unidos, 60612
- University of Illinois At Chicago
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Iowa
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Iowa City, Iowa, Estados Unidos, 52242-1316
- University of Iowa
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Kansas
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Kansas City, Kansas, Estados Unidos, 66103
- University of Kansas Hospital Authority
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Maryland
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Baltimore, Maryland, Estados Unidos, 21201
- University of Maryland-Greenebaum Cancer Center
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02215
- Dana Farber Cancer Institute
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Michigan
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Ann Arbor, Michigan, Estados Unidos, 48109
- University of Michigan Cancer Center
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Detroit, Michigan, Estados Unidos, 48201
- Barbara Ann Karmanos Cancer Hospital
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New Jersey
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Hackensack, New Jersey, Estados Unidos, 07601
- Hackensack University Medical Center
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Pennsylvania
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Philadelphia, Pennsylvania, Estados Unidos, 19111
- Fox Chase Cancer Center
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Utah
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Salt Lake City, Utah, Estados Unidos, 84112
- Huntsman Cancer Institute At University of Utah
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Virginia
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Charlottesville, Virginia, Estados Unidos, 22903
- University of Virginia - Emily Couric Clinical Cancer Center
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Washington
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Kennewick, Washington, Estados Unidos, 99336
- Kadlec Clinic Hematology and Oncology
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Bordeaux, Francia, 33000
- Centre Hospitalier Universitaire de Bordeaux
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Paris, Francia, 75248
- Institut Curie
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Rennes, Francia, 35042
- Centre Eugene Marquis
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Saint-Herblain, Francia, 44805
- Centre de Lutte Contre Le Cancer - Institut de Cancerologie de L'Ouest - Rene Gauducheau
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Strasbourg, Francia, 67200
- Icans - Institut de Cancerologie Strasbourg Europe
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K'ut'aisi, Georgia, 04600
- Jsc Evex Hospitals
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Tbilisi, Georgia, 00114
- New Hospitals
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Tbilisi, Georgia, 00159
- Jsc Evex Corporation-Caraps Medline
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Tbilisi, Georgia, 0159
- Ltd Cancer Research Centre
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Chaïdári, Grecia, 12462
- University Hospital of West Attica - Attikon
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Thessaloniki, Grecia, 54007
- Theagenio Anticancer Hospital
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Thessaloniki, Grecia, 54622
- Bioclinic Thessaloniki (Galinos Clinic)
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Thessaloniki, Grecia, 55236
- Saint Lukas Clinic
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Candiolo, Italia, 10060
- Fondazione Del Piemonte Per L Oncologia Ircc Candiolo
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Milan, Italia, 20133
- Fondazione Irccs Istituto Nazionale Del Tumori Di Milano
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Milan, Italia, 20141
- European Institute of Oncology
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Naples, Italia, 80131
- Istituto Nazionale Tumori Irccs Fondazione Pascale
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Padova, Italia, 35128
- Iov - Istituto Oncologico Veneto Irccs
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Pavia, Italia, 27100
- Fondazione Irccs Policlinico San Matteo
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Reggio Emilia, Italia, 42123
- Ausl-Irccs Di Reggio Emilia
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Amsterdam, Países Bajos, 1066 CX
- The Dutch Cancer Institue
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Leiden, Países Bajos, 02333
- Leids Universitair Medisch Centrum (Lumc) (Leiden University Medical Center)
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Bydgoszcz, Polonia, 85-796
- Centrum Onkologii Im. Prof. Franciszka Lukaszczyka
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Konin, Polonia, 62-500
- Przychodnia Lekarska Komed Roman Karaszewski
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Lublin, Polonia, 20-090
- Centrum Onkologii Ziemi Lubelskiej Im. SW. Jana Z Dukli
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Poznan, Polonia, 60-780
- Poznan University of Medical Sciences
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Tomaszów Mazowiecki, Polonia, 97-200
- Nzoz Provita Prolife Centrum Medyczne
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Warsaw, Polonia, 02-781
- Centrum Onkologii - Instytut Im. Marii Sklodowskiej - Curie
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Braga, Portugal, 4710-243
- Hospital de Braga
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Faro, Portugal, 8000-386
- Centro Hospitalar Universitario Algarve
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Lisbon, Portugal, 1649-035
- Centro Hospitalar de Lisboa Norte E.P.E. - Hospital de Santa Maria
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Porto, Portugal, 4200-319
- Centro Hospitalar de Sao Joao Alameda
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Porto, Portugal, 4200-072
- Instituto Portugues de Oncologia Do Porto Francisco Gentil E.P.E.
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Vila Nova de Gaia, Portugal, 4434-502
- Centro Hospitalar de Vila Nova de Gaia/Espinho, Epe-Unidade L
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Kaohsiung City, Taiwán, 80708
- Kaohsiung Medical University Chung-Ho Memorial Hospital
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Kaohsiung City, Taiwán, 83301
- Chang Gung Medical Foundation. Kaohsiung Branch
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Taichung, Taiwán, 00112
- China Medical University Hospital
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Taipei, Taiwán, 10002
- National Taiwan University Hospital
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Taipei, Taiwán, 00112
- Institutional Review Board Taipei Veterans General Hospital
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: 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. |
Retifanlimab 500mg will be administered intravenously every 4 weeks. Placebo will be administered intravenously. |
|
Experimental: 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. |
Retifanlimab 500mg will be administered intravenously every 4 weeks. Placebo will be administered intravenously. INCAGN02385 350mg will be administered intravenously every 2 weeks. |
|
Experimental: 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. |
Retifanlimab 500mg will be administered intravenously every 4 weeks. INCAGN02385 350mg will be administered intravenously every 2 weeks. INCAGN02390 400 mg will be administered intravenously every 2 weeks. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Progeression-free Survival (PFS)
Periodo de tiempo: up to 738 days
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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
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Objective Response
Periodo de tiempo: up to approximately 44 months
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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)
Periodo de tiempo: 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
|
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Disease Control
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
|
Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- INCAGN 2385-203
- 2021-005775-39 (Número EudraCT)
- 2023-504270-38-00 (Identificador de registro: EU CT Number)
- 2023 (Subvención/contrato del NIH de EE. UU.)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
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
Marco de tiempo para compartir IPD
Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
Criterios de acceso compartido de IPD
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.
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .