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
- Conditions
- Head and Neck Cancer
- Interventions
- Registration Number
- NCT05287113
- Lead Sponsor
- Incyte Biosciences International Sàrl
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 176
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Treatment Group 2: Retifanlimab + INCAGN02385 Placebo Retifanlimab will be administered intravenously every 4 weeks. INCAGN02385 and Placebo for INCAGN02390 will be administered intravenously every 2 weeks. Treatment Group 3: Retifanlimab + INCAGN02385 + INCAGN02390 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. Treatment Group 1: Retifanlimab Monotherapy Placebo Retifanlimab will be administered intravenously every 4 weeks. Placebos for INCAGN02385 and INCAGN02390 will be administered intravenously every 2 weeks. Treatment Group 3: Retifanlimab + INCAGN02385 + INCAGN02390 INCAGN02385 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. Treatment Group 2: Retifanlimab + INCAGN02385 INCAGN02385 Retifanlimab will be administered intravenously every 4 weeks. INCAGN02385 and Placebo for INCAGN02390 will be administered intravenously every 2 weeks. Treatment Group 2: Retifanlimab + INCAGN02385 Retifanlimab Retifanlimab will be administered intravenously every 4 weeks. INCAGN02385 and Placebo for INCAGN02390 will be administered intravenously every 2 weeks. Treatment Group 1: Retifanlimab Monotherapy Retifanlimab Retifanlimab will be administered intravenously every 4 weeks. Placebos for INCAGN02385 and INCAGN02390 will be administered intravenously every 2 weeks. Treatment Group 3: Retifanlimab + INCAGN02385 + INCAGN02390 Retifanlimab 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.
- Primary Outcome Measures
Name Time Method Progression Free Survival (PFS) Up to 24 months Defined as the interval between the date of first dose of study treatment and the earliest date of disease progression, based on investigator assessment per RECIST v1.1, or death due to any cause.
- Secondary Outcome Measures
Name Time Method Duration of Response (DOR) Up to 24 months Defined as the time from earliest date of disease response (CR or PR) until earliest date of disease progression, based on investigator assessment per RECIST v1.1, or death from any cause if occurring sooner than progression.
Disease Control Rate (DCR) Up to 24 months Defined as having CR, PR, or SD (≥ 6 months) as best response, based on investigator assessment per RECIST v1.1.
Objective Response Rate (ORR) Up to 24 months Defined as having a Complete Response (CR) or Partial Response (PR), determined based on investigator assessment per RECIST v1.1.
Overall Survival (OS) Up to 36 months Defined as the interval between the date of the date of first dose of study treatment until death due to any cause.
Participants with treatment-emergent adverse events (TEAE) Up to 24 months TEAE is defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug
Trial Locations
- Locations (89)
Saint Lukas Clinic
🇬🇷Thessaloniki, Greece
Przychodnia Lekarska Komed Roman Karaszewski
🇵🇱Konin, Poland
Nzoz Provita Prolife Centrum Medyczne
🇵🇱Tomaszow Mazowiecki, Poland
Centrum Onkologii - Instytut Im. Marii Sklodowskiej - Curie
🇵🇱Warszawa, Poland
Poznan University of Medical Sciences
🇵🇱Poznan, Poland
Instituto Portugues de Oncologia Do Porto Francisco Gentil E.P.E.
🇵🇹Porto, Portugal
Hospital de Braga
🇵🇹Braga, Portugal
University of California San Francisco Comprehensive Cancer Center
🇺🇸San Francisco, California, United States
University of Illinois At Chicago
🇺🇸Chicago, Illinois, United States
Dana Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Fondazione Irccs Policlinico San Matteo
🇮🇹Pavia, Italy
Ausl-Irccs Di Reggio Emilia
🇮🇹Reggio Emilia, Italy
City of Hope Orange County
🇺🇸Irvine, California, United States
Centre Hospitalier Universitaire de Bordeaux
🇫🇷Bordeaux, France
Centre Eugene Marquis
🇫🇷Rennes, France
Jessa Ziekenhuis
🇧🇪Hasselt, Belgium
Gza Sint Augustinus
🇧🇪Wilrijk, Belgium
Blessed Health Care
🇺🇸Miami, Florida, United States
University of Kansas Hospital Authority
🇺🇸Kansas City, Kansas, United States
Huntsman Cancer Institute At University of Utah
🇺🇸Salt Lake City, Utah, United States
Institut Curie
🇫🇷Paris, France
Jsc Evex Hospitals
🇬🇪K'ut'aisi, Georgia
New Hospitals
🇬🇪Tbilisi, Georgia
Jsc Evex Corporation-Caraps Medline
🇬🇪Tbilisi, Georgia
Centre de Lutte Contre Le Cancer - Institut de Cancerologie de L'Ouest - Rene Gauducheau
🇫🇷St Herblain, France
Icans - Institut de Cancerologie Strasbourg Europe
🇫🇷Strasbourg, France
European Institute of Oncology
🇮🇹Milano, Italy
Fondazione Irccs Istituto Nazionale Del Tumori Di Milano
🇮🇹Milan, Italy
Fondazione Del Piemonte Per L Oncologia Ircc Candiolo
🇮🇹Candiolo, Italy
University Hospital of West Attica - Attikon
🇬🇷Chaidari, Greece
Centro Hospitalar Universitario Algarve
🇵🇹Faro, Portugal
Centro Hospitalar de Lisboa Norte E.P.E. - Hospital de Santa Maria
🇵🇹Lisboa, Portugal
Centro Hospitalar de Sao Joao Alameda
🇵🇹Porto, Portugal
Centro Hospitalar de Vila Nova de Gaia/Espinho, Epe-Unidade L
🇵🇹Vila Nova de Gaia, Portugal
Hospital Regional Universitario Carlos Haya
🇪🇸Malaga, Spain
Chang Gung Medical Foundation. Kaohsiung Branch
🇨🇳Kaohsiung, Taiwan
China Medical University Hospital
🇨🇳Taichung City, Taiwan
Korea University Anam Hospital
🇰🇷Seoul, Korea, Republic of
Asklepios Klinik Altona
🇩🇪Hamburg, Germany
Universitatsklinikum Hamburg Eppendorf
🇩🇪Hamburg, Germany
University of California San Diego Medical Center, Moores Cancer Center
🇺🇸La Jolla, California, United States
Mayo Clinic Jacksonville
🇺🇸Jacksonville, Florida, United States
Innovative Clinical Research Institute
🇺🇸Long Beach, California, United States
Barbara Ann Karmanos Cancer Hospital
🇺🇸Detroit, Michigan, United States
Iov - Istituto Oncologico Veneto Irccs
🇮🇹Padova, Italy
City of Hope-Antelope Valley
🇺🇸Lancaster, California, United States
University of Iowa
🇺🇸Iowa City, Iowa, United States
University of Maryland-Greenebaum Cancer Center
🇺🇸Baltimore, Maryland, United States
University of Virginia - Emily Couric Clinical Cancer Center
🇺🇸Charlottesville, Virginia, United States
Kadlec Clinic Hematology and Oncology
🇺🇸Kennewick, Washington, United States
Ltd Cancer Research Centre
🇬🇪Tbilisi, Georgia
University of Cologne
🇩🇪Cologne, Germany
Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii
🇩🇪Mainz, Germany
Bioclinic Thessaloniki (Galinos Clinic)
🇬🇷Thessaloniki, Greece
Istituto Nazionale Tumori Irccs Fondazione Pascale
🇮🇹Naples, Italy
Chonnam National University Hwasun Hospital
🇰🇷Gwangju, Korea, Republic of
Pusan National University Yangsan Hospital
🇰🇷Yangsan, Korea, Republic of
Kunkuk University Medical Center
🇰🇷Seoul, Korea, Republic of
Cha Bundang Medical Center
🇰🇷Seongnam-si, Korea, Republic of
Kangbuk Samsung Hospital
🇰🇷Seoul, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
The Dutch Cancer Institue
🇳🇱Amsterdam, Netherlands
Leids Universitair Medisch Centrum (Lumc) (Leiden University Medical Center)
🇳🇱Leiden, Netherlands
Catalans Institute of Oncology Barcelona
🇪🇸Barcelona, Spain
Ico Girona Hospital Universitari de Girona Dr Josep Trueta
🇪🇸Girona, Spain
Hospital Universitario Ramon Y Cajal
🇪🇸Madrid, Spain
Fundacion Jimenez Diaz University Hospital
🇪🇸Madrid, Spain
Hospital Universitario Quironsalud Madrid
🇪🇸Madrid, Spain
Complejo Hospitalario de Navarra
🇪🇸Pamplona, Spain
Hospital General Universitario de Valencia
🇪🇸Valencia, Spain
Hospital Universitario Marques de Valdecilla
🇪🇸Santander, Spain
Hospital Universitari I Politecnic La Fe
🇪🇸Valencia, Spain
Kaohsiung Medical University Chung-Ho Memorial Hospital
🇨🇳Kaohsiung City, Taiwan
Institutional Review Board Taipei Veterans General Hospital
🇨🇳Taipei, Taiwan
National Taiwan University Hospital
🇨🇳Taipei, Taiwan
McGill University Health Centre/Glen Site/Cedars Cancer Centre
🇨🇦Montreal, Quebec, Canada
Fox Chase Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
Theagenio Anticancer Hospital
🇬🇷Thessaloniki, Greece
City of Hope National Medical Center
🇺🇸Long Beach, California, United States
Centrum Onkologii Im. Prof. Franciszka Lukaszczyka
🇵🇱Bydgoszcz, Poland
Chum Hospital Notre Dame
🇨🇦Montreal, Quebec, Canada
McGill University Jewish General Hospital
🇨🇦Montreal, Quebec, Canada
Georgetown University
🇺🇸Washington, District of Columbia, United States
Grand Hospital de Charleroi
🇧🇪Charleroi, Belgium
Centrum Onkologii Ziemi Lubelskiej Im. SW. Jana Z Dukli
🇵🇱Lublin, Poland
Hackensack University Medical Center
🇺🇸Hackensack, New Jersey, United States
Moffitt Cancer Center
🇺🇸Tampa, Florida, United States
University of Michigan Cancer Center
🇺🇸Ann Arbor, Michigan, United States
Mayo Clinic Rochester
🇺🇸Scottsdale, Arizona, United States