Estudo de Retinfanlimabe em combinação com INCAGN02385 e INCAGN02390 como tratamento de primeira linha em participantes com carcinoma de células escamosas recorrente/metastático positivo para PD-L1 (CPS ≥ 1) da cabeça e pescoço
Um estudo randomizado, duplo-cego, multicêntrico, de fase 2 de retifanlimabe em combinação com INCAGN02385 (Anti-LAG-3) e INCAGN02390 (Anti-TIM-3) como tratamento de primeira linha em participantes com PD-L1-positivo (CPS ≥ 1) Carcinoma de células escamosas recorrente/metastático da cabeça e pescoço
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).
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Real)
Estágio
- Fase 2
Acesso expandido
Contactos e Locais
Locais de estudo
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Cologne, Alemanha, 50937
- University of Cologne
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Hamburg, Alemanha, 22763
- Asklepios Klinik Altona
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Hamburg, Alemanha, 20246
- Universitatsklinikum Hamburg Eppendorf
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Mainz, Alemanha, 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, Coréia do Sul, 49241
- Pusan National University Yangsan Hospital
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Gwangju, Coréia do Sul, 58128
- Chonnam National University Hwasun Hospital
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Seongnam-si, Coréia do Sul, 13496
- Cha Bundang Medical Center
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Seoul, Coréia do Sul, 05505
- Asan Medical Center
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Seoul, Coréia do Sul, 03181
- Kangbuk Samsung Hospital
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Seoul, Coréia do Sul, 02841
- Korea University Anam Hospital
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Seoul, Coréia do Sul, 05030
- Kunkuk University Medical Center
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Yangsan, Coréia do Sul, 50612
- Pusan National University Yangsan Hospital
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Barcelona, Espanha, 08916
- Catalans Institute of Oncology Barcelona
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Girona, Espanha, 17007
- Ico Girona Hospital Universitari de Girona Dr Josep Trueta
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Madrid, Espanha, 28223
- Hospital Universitario Quironsalud Madrid
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Madrid, Espanha, 00034
- Fundacion Jimenez Diaz University Hospital
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Madrid, Espanha, 28036
- Hospital Universitario Ramon Y Cajal
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Málaga, Espanha, 29010
- Hospital Regional Universitario Carlos Haya
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Pamplona, Espanha, 31008
- Complejo Hospitalario de Navarra
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Santander, Espanha, 39008
- Hospital Universitario Marques de Valdecilla
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Valencia, Espanha, 46014
- Hospital General Universitario de Valencia
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Valencia, Espanha, 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, França, 33000
- Centre Hospitalier Universitaire de Bordeaux
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Paris, França, 75248
- Institut Curie
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Rennes, França, 35042
- Centre Eugene Marquis
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Saint-Herblain, França, 44805
- Centre de Lutte Contre Le Cancer - Institut de Cancerologie de L'Ouest - Rene Gauducheau
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Strasbourg, França, 67200
- Icans - Institut de Cancerologie Strasbourg Europe
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K'ut'aisi, Geórgia, 04600
- Jsc Evex Hospitals
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Tbilisi, Geórgia, 00114
- New Hospitals
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Tbilisi, Geórgia, 00159
- Jsc Evex Corporation-Caraps Medline
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Tbilisi, Geórgia, 0159
- Ltd Cancer Research Centre
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Chaïdári, Grécia, 12462
- University Hospital of West Attica - Attikon
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Thessaloniki, Grécia, 54007
- Theagenio Anticancer Hospital
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Thessaloniki, Grécia, 54622
- Bioclinic Thessaloniki (Galinos Clinic)
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Thessaloniki, Grécia, 55236
- Saint Lukas Clinic
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Amsterdam, Holanda, 1066 CX
- The Dutch Cancer Institue
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Leiden, Holanda, 02333
- Leids Universitair Medisch Centrum (Lumc) (Leiden University Medical Center)
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Candiolo, Itália, 10060
- Fondazione Del Piemonte Per L Oncologia Ircc Candiolo
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Milan, Itália, 20133
- Fondazione Irccs Istituto Nazionale Del Tumori Di Milano
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Milan, Itália, 20141
- European Institute of Oncology
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Naples, Itália, 80131
- Istituto Nazionale Tumori Irccs Fondazione Pascale
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Padova, Itália, 35128
- Iov - Istituto Oncologico Veneto Irccs
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Pavia, Itália, 27100
- Fondazione Irccs Policlinico San Matteo
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Reggio Emilia, Itália, 42123
- Ausl-Irccs Di Reggio Emilia
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Bydgoszcz, Polônia, 85-796
- Centrum Onkologii Im. Prof. Franciszka Lukaszczyka
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Konin, Polônia, 62-500
- Przychodnia Lekarska Komed Roman Karaszewski
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Lublin, Polônia, 20-090
- Centrum Onkologii Ziemi Lubelskiej Im. SW. Jana Z Dukli
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Poznan, Polônia, 60-780
- Poznan University of Medical Sciences
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Tomaszów Mazowiecki, Polônia, 97-200
- Nzoz Provita Prolife Centrum Medyczne
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Warsaw, Polônia, 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, Taiwan, 80708
- Kaohsiung Medical University Chung-Ho Memorial Hospital
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Kaohsiung City, Taiwan, 83301
- Chang Gung Medical Foundation. Kaohsiung Branch
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Taichung, Taiwan, 00112
- China Medical University Hospital
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Taipei, Taiwan, 10002
- National Taiwan University Hospital
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Taipei, Taiwan, 00112
- Institutional Review Board Taipei Veterans General Hospital
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Triplo
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
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. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Progeression-free Survival (PFS)
Prazo: 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
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Objective Response
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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
Prazo: 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
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- INCAGN 2385-203
- 2021-005775-39 (Número EudraCT)
- 2023-504270-38-00 (Identificador de registro: EU CT Number)
- 2023 (Concessão/Contrato do NIH dos EUA)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano 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
Prazo de Compartilhamento de IPD
Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
Critérios de acesso de compartilhamento 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 informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
- SEIVA
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
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