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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

Primary Purpose

Head and Neck Cancer

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Retifanlimab
INCAGN02385
INCAGN02390
Placebo
Sponsored by
Incyte Biosciences International Sàrl
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head and Neck Cancer focused on measuring squamous cell carcinoma of the head and neck (SCCHN), INCAGN02385, INCAGN02390, Retifanlimab, IgG1κ monoclonal antibody, LAG-3, TIM-3, PD-1, PD-L1

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Mayo Clinic Rochester
  • City of Hope National Medical Center
  • City of Hope Orange CountyRecruiting
  • University of California San Diego Medical Center, Moores Cancer Center
  • City of Hope-Antelope ValleyRecruiting
  • Innovative Clinical Research InstituteRecruiting
  • City of Hope National Medical CenterRecruiting
  • University of California San Francisco Comprehensive Cancer CenterRecruiting
  • Georgetown UniversityRecruiting
  • Mayo Clinic JacksonvilleRecruiting
  • Blessed Health CareRecruiting
  • Moffitt Cancer Center
  • University of Illinois At ChicagoRecruiting
  • University of IowaRecruiting
  • University of Kansas Hospital AuthorityRecruiting
  • University of Maryland-Greenebaum Cancer CenterRecruiting
  • Dana Farber Cancer InstituteRecruiting
  • University of Michigan Cancer Center
  • Barbara Ann Karmanos Cancer HospitalRecruiting
  • Hackensack University Medical CenterRecruiting
  • Fox Chase Cancer CenterRecruiting
  • Huntsman Cancer Institute At University of UtahRecruiting
  • University of Virginia - Emily Couric Clinical Cancer CenterRecruiting
  • Kadlec Clinic Hematology and OncologyRecruiting
  • Grand Hospital de Charleroi
  • Jessa Ziekenhuis
  • Gza Sint Augustinus
  • McGill University Health Centre/Glen Site/Cedars Cancer CentreRecruiting
  • Chum Hospital Notre Dame
  • McGill University Jewish General Hospital
  • Centre Hospitalier Universitaire de BordeauxRecruiting
  • Institut CurieRecruiting
  • Centre Eugene MarquisRecruiting
  • Centre de Lutte Contre Le Cancer - Institut de Cancerologie de L'Ouest - Rene Gauducheau
  • Icans - Institut de Cancerologie Strasbourg EuropeRecruiting
  • Jsc Evex HospitalsRecruiting
  • New Hospitals
  • Jsc Evex Corporation-Caraps MedlineRecruiting
  • Ltd Cancer Research CentreRecruiting
  • University of Cologne
  • Universitatsklinikum Hamburg Eppendorf
  • Asklepios Klinik Altona
  • Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii
  • University Hospital of West Attica - AttikonRecruiting
  • Theagenio Anticancer HospitalRecruiting
  • Bioclinic Thessaloniki (Galinos Clinic)Recruiting
  • Saint Lukas ClinicRecruiting
  • Fondazione Del Piemonte Per L Oncologia Ircc CandioloRecruiting
  • European Institute of OncologyRecruiting
  • Fondazione Irccs Istituto Nazionale Del Tumori Di MilanoRecruiting
  • Istituto Nazionale Tumori Irccs Fondazione PascaleRecruiting
  • Iov - Istituto Oncologico Veneto IrccsRecruiting
  • Fondazione Irccs Policlinico San Matteo
  • Ausl-Irccs Di Reggio EmiliaRecruiting
  • Pusan National University Yangsan HospitalRecruiting
  • Chonnam National University Hwasun HospitalRecruiting
  • Cha Bundang Medical Center
  • Korea University Anam HospitalRecruiting
  • Kangbuk Samsung Hospital
  • Kunkuk University Medical CenterRecruiting
  • Asan Medical CenterRecruiting
  • Pusan National University Yangsan HospitalRecruiting
  • The Dutch Cancer Institue
  • Leids Universitair Medisch Centrum (Lumc) (Leiden University Medical Center)
  • Centrum Onkologii Im. Prof. Franciszka Lukaszczyka
  • Przychodnia Lekarska Komed Roman Karaszewski
  • Centrum Onkologii Ziemi Lubelskiej Im. SW. Jana Z Dukli
  • Poznan University of Medical Sciences
  • Nzoz Provita Prolife Centrum Medyczne
  • Centrum Onkologii - Instytut Im. Marii Sklodowskiej - Curie
  • Hospital de Braga
  • Centro Hospitalar Universitario AlgarveRecruiting
  • Centro Hospitalar de Lisboa Norte E.P.E. - Hospital de Santa MariaRecruiting
  • Instituto Portugues de Oncologia Do Porto Francisco Gentil E.P.E.
  • Centro Hospitalar de Sao Joao AlamedaRecruiting
  • Centro Hospitalar de Vila Nova de Gaia/Espinho, Epe-Unidade LRecruiting
  • Catalans Institute of Oncology BarcelonaRecruiting
  • Ico Girona Hospital Universitari de Girona Dr Josep TruetaRecruiting
  • Fundacion Jimenez Diaz University HospitalRecruiting
  • Hospital Universitario Ramon Y CajalRecruiting
  • Hospital Universitario Quironsalud MadridRecruiting
  • Hospital Regional Universitario Carlos HayaRecruiting
  • Complejo Hospitalario de NavarraRecruiting
  • Hospital Universitario Marques de ValdecillaRecruiting
  • Hospital General Universitario de ValenciaRecruiting
  • Hospital Universitari I Politecnic La FeRecruiting
  • Kaohsiung Medical University Chung-Ho Memorial HospitalRecruiting
  • Chang Gung Medical Foundation. Kaohsiung BranchRecruiting
  • China Medical University HospitalRecruiting
  • Institutional Review Board Taipei Veterans General HospitalRecruiting
  • National Taiwan University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Treatment Group 1: Retifanlimab Monotherapy

Treatment Group 2: Retifanlimab + INCAGN02385

Treatment Group 3: Retifanlimab + INCAGN02385 + INCAGN02390

Arm Description

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

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

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.

Outcomes

Primary Outcome Measures

Progression Free Survival (PFS)
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

Objective Response Rate (ORR)
Defined as having a Complete Response (CR) or Partial Response (PR), determined based on investigator assessment per RECIST v1.1.
Duration of Response (DOR)
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)
Defined as having CR, PR, or SD (≥ 6 months) as best response, based on investigator assessment per RECIST v1.1.
Overall Survival (OS)
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)
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

Full Information

First Posted
March 11, 2022
Last Updated
October 18, 2023
Sponsor
Incyte Biosciences International Sàrl
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1. Study Identification

Unique Protocol Identification Number
NCT05287113
Brief Title
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
Official Title
A Randomized, Double-Blind, Multicenter, Phase 2 Study of Retifanlimab in Combination With INCAGN02385 (Anti-LAG-3) and INCAGN02390 (Anti-TIM-3) as First-Line Treatment in Participants With PD-L1-Positive (CPS ≥ 1) Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 14, 2022 (Actual)
Primary Completion Date
May 21, 2024 (Anticipated)
Study Completion Date
September 15, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Incyte Biosciences International Sàrl

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer
Keywords
squamous cell carcinoma of the head and neck (SCCHN), INCAGN02385, INCAGN02390, Retifanlimab, IgG1κ monoclonal antibody, LAG-3, TIM-3, PD-1, PD-L1

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Patients will be randomized to 1 of 3 treatment groups.
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
162 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment Group 1: Retifanlimab Monotherapy
Arm Type
Experimental
Arm Description
Retifanlimab will be administered intravenously every 4 weeks. Placebos for INCAGN02385 and INCAGN02390 will be administered intravenously every 2 weeks.
Arm Title
Treatment Group 2: Retifanlimab + INCAGN02385
Arm Type
Experimental
Arm Description
Retifanlimab will be administered intravenously every 4 weeks. INCAGN02385 and Placebo for INCAGN02390 will be administered intravenously every 2 weeks.
Arm Title
Treatment Group 3: Retifanlimab + INCAGN02385 + INCAGN02390
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Retifanlimab
Intervention Description
Retifanlimab 500mg will be administered intravenously every 4 weeks.
Intervention Type
Drug
Intervention Name(s)
INCAGN02385
Intervention Description
INCAGN02385 350mg will be administered intravenously every 2 weeks.
Intervention Type
Drug
Intervention Name(s)
INCAGN02390
Intervention Description
INCAGN02390 400 mg will be administered intravenously every 2 weeks.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo will be administered intravenously.
Primary Outcome Measure Information:
Title
Progression Free Survival (PFS)
Description
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.
Time Frame
Up to 24 months
Secondary Outcome Measure Information:
Title
Objective Response Rate (ORR)
Description
Defined as having a Complete Response (CR) or Partial Response (PR), determined based on investigator assessment per RECIST v1.1.
Time Frame
Up to 24 months
Title
Duration of Response (DOR)
Description
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.
Time Frame
Up to 24 months
Title
Disease Control Rate (DCR)
Description
Defined as having CR, PR, or SD (≥ 6 months) as best response, based on investigator assessment per RECIST v1.1.
Time Frame
Up to 24 months
Title
Overall Survival (OS)
Description
Defined as the interval between the date of the date of first dose of study treatment until death due to any cause.
Time Frame
Up to 36 months
Title
Participants with treatment-emergent adverse events (TEAE)
Description
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
Time Frame
Up to 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Incyte Corporation Call Center (US)
Phone
1.855.463.3463
Email
medinfo@incyte.com
First Name & Middle Initial & Last Name or Official Title & Degree
Incyte Corporation Call Center (ex-US)
Phone
+800 00027423
Email
globalmedinfo@incyte.com
Facility Information:
Facility Name
Mayo Clinic Rochester
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
City of Hope National Medical Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010-9200
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
City of Hope Orange County
City
Irvine
State/Province
California
ZIP/Postal Code
92618
Country
United States
Individual Site Status
Recruiting
Facility Name
University of California San Diego Medical Center, Moores Cancer Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
City of Hope-Antelope Valley
City
Lancaster
State/Province
California
ZIP/Postal Code
93534
Country
United States
Individual Site Status
Recruiting
Facility Name
Innovative Clinical Research Institute
City
Long Beach
State/Province
California
ZIP/Postal Code
90805
Country
United States
Individual Site Status
Recruiting
Facility Name
City of Hope National Medical Center
City
Long Beach
State/Province
California
ZIP/Postal Code
90813
Country
United States
Individual Site Status
Recruiting
Facility Name
University of California San Francisco Comprehensive Cancer Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Individual Site Status
Recruiting
Facility Name
Georgetown University
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20057
Country
United States
Individual Site Status
Recruiting
Facility Name
Mayo Clinic Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Individual Site Status
Recruiting
Facility Name
Blessed Health Care
City
Miami
State/Province
Florida
ZIP/Postal Code
33174
Country
United States
Individual Site Status
Recruiting
Facility Name
Moffitt Cancer Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612-9416
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
University of Illinois At Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242-1316
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Kansas Hospital Authority
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66103
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Maryland-Greenebaum Cancer Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Individual Site Status
Recruiting
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Michigan Cancer Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Barbara Ann Karmanos Cancer Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Individual Site Status
Recruiting
Facility Name
Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Individual Site Status
Recruiting
Facility Name
Fox Chase Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
Individual Site Status
Recruiting
Facility Name
Huntsman Cancer Institute At University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Virginia - Emily Couric Clinical Cancer Center
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States
Individual Site Status
Recruiting
Facility Name
Kadlec Clinic Hematology and Oncology
City
Kennewick
State/Province
Washington
ZIP/Postal Code
99336
Country
United States
Individual Site Status
Recruiting
Facility Name
Grand Hospital de Charleroi
City
Charleroi
ZIP/Postal Code
06000
Country
Belgium
Individual Site Status
Completed
Facility Name
Jessa Ziekenhuis
City
Hasselt
ZIP/Postal Code
03500
Country
Belgium
Individual Site Status
Completed
Facility Name
Gza Sint Augustinus
City
Wilrijk
ZIP/Postal Code
02610
Country
Belgium
Individual Site Status
Completed
Facility Name
McGill University Health Centre/Glen Site/Cedars Cancer Centre
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2X 3E4
Country
Canada
Individual Site Status
Recruiting
Facility Name
Chum Hospital Notre Dame
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2X3E4
Country
Canada
Individual Site Status
Not yet recruiting
Facility Name
McGill University Jewish General Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
Individual Site Status
Not yet recruiting
Facility Name
Centre Hospitalier Universitaire de Bordeaux
City
Bordeaux
ZIP/Postal Code
33000
Country
France
Individual Site Status
Recruiting
Facility Name
Institut Curie
City
Paris
ZIP/Postal Code
75248
Country
France
Individual Site Status
Recruiting
Facility Name
Centre Eugene Marquis
City
Rennes
ZIP/Postal Code
35042
Country
France
Individual Site Status
Recruiting
Facility Name
Centre de Lutte Contre Le Cancer - Institut de Cancerologie de L'Ouest - Rene Gauducheau
City
St Herblain
ZIP/Postal Code
44805
Country
France
Individual Site Status
Not yet recruiting
Facility Name
Icans - Institut de Cancerologie Strasbourg Europe
City
Strasbourg
ZIP/Postal Code
67200
Country
France
Individual Site Status
Recruiting
Facility Name
Jsc Evex Hospitals
City
K'ut'aisi
ZIP/Postal Code
04600
Country
Georgia
Individual Site Status
Recruiting
Facility Name
New Hospitals
City
Tbilisi
ZIP/Postal Code
00114
Country
Georgia
Individual Site Status
Completed
Facility Name
Jsc Evex Corporation-Caraps Medline
City
Tbilisi
ZIP/Postal Code
00159
Country
Georgia
Individual Site Status
Recruiting
Facility Name
Ltd Cancer Research Centre
City
Tbilisi
ZIP/Postal Code
0159
Country
Georgia
Individual Site Status
Recruiting
Facility Name
University of Cologne
City
Cologne
ZIP/Postal Code
50937
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Universitatsklinikum Hamburg Eppendorf
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Asklepios Klinik Altona
City
Hamburg
ZIP/Postal Code
22763
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
University Hospital of West Attica - Attikon
City
Chaidari
ZIP/Postal Code
12462
Country
Greece
Individual Site Status
Recruiting
Facility Name
Theagenio Anticancer Hospital
City
Thessaloniki
ZIP/Postal Code
54007
Country
Greece
Individual Site Status
Recruiting
Facility Name
Bioclinic Thessaloniki (Galinos Clinic)
City
Thessaloniki
ZIP/Postal Code
54622
Country
Greece
Individual Site Status
Recruiting
Facility Name
Saint Lukas Clinic
City
Thessaloniki
ZIP/Postal Code
55236
Country
Greece
Individual Site Status
Recruiting
Facility Name
Fondazione Del Piemonte Per L Oncologia Ircc Candiolo
City
Candiolo
ZIP/Postal Code
10060
Country
Italy
Individual Site Status
Recruiting
Facility Name
European Institute of Oncology
City
Milano
ZIP/Postal Code
20141
Country
Italy
Individual Site Status
Recruiting
Facility Name
Fondazione Irccs Istituto Nazionale Del Tumori Di Milano
City
Milan
ZIP/Postal Code
20133
Country
Italy
Individual Site Status
Recruiting
Facility Name
Istituto Nazionale Tumori Irccs Fondazione Pascale
City
Naples
ZIP/Postal Code
80131
Country
Italy
Individual Site Status
Recruiting
Facility Name
Iov - Istituto Oncologico Veneto Irccs
City
Padova
ZIP/Postal Code
35128
Country
Italy
Individual Site Status
Recruiting
Facility Name
Fondazione Irccs Policlinico San Matteo
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Individual Site Status
Completed
Facility Name
Ausl-Irccs Di Reggio Emilia
City
Reggio Emilia
ZIP/Postal Code
42123
Country
Italy
Individual Site Status
Recruiting
Facility Name
Pusan National University Yangsan Hospital
City
Busan
ZIP/Postal Code
49241
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Chonnam National University Hwasun Hospital
City
Gwangju
ZIP/Postal Code
58128
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Cha Bundang Medical Center
City
Seongnam-si
ZIP/Postal Code
13496
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Name
Korea University Anam Hospital
City
Seoul
ZIP/Postal Code
02841
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Kangbuk Samsung Hospital
City
Seoul
ZIP/Postal Code
03181
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Name
Kunkuk University Medical Center
City
Seoul
ZIP/Postal Code
05030
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Pusan National University Yangsan Hospital
City
Yangsan
ZIP/Postal Code
50612
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
The Dutch Cancer Institue
City
Amsterdam
ZIP/Postal Code
1066 CX
Country
Netherlands
Individual Site Status
Completed
Facility Name
Leids Universitair Medisch Centrum (Lumc) (Leiden University Medical Center)
City
Leiden
ZIP/Postal Code
02333
Country
Netherlands
Individual Site Status
Completed
Facility Name
Centrum Onkologii Im. Prof. Franciszka Lukaszczyka
City
Bydgoszcz
ZIP/Postal Code
85-796
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Przychodnia Lekarska Komed Roman Karaszewski
City
Konin
ZIP/Postal Code
62-500
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Centrum Onkologii Ziemi Lubelskiej Im. SW. Jana Z Dukli
City
Lublin
ZIP/Postal Code
20-090
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Poznan University of Medical Sciences
City
Poznan
ZIP/Postal Code
60-780
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Nzoz Provita Prolife Centrum Medyczne
City
Tomaszow Mazowiecki
ZIP/Postal Code
97-200
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Centrum Onkologii - Instytut Im. Marii Sklodowskiej - Curie
City
Warszawa
ZIP/Postal Code
02-781
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Hospital de Braga
City
Braga
ZIP/Postal Code
4710-243
Country
Portugal
Individual Site Status
Not yet recruiting
Facility Name
Centro Hospitalar Universitario Algarve
City
Faro
ZIP/Postal Code
8000-386
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Centro Hospitalar de Lisboa Norte E.P.E. - Hospital de Santa Maria
City
Lisboa
ZIP/Postal Code
1649-035
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Instituto Portugues de Oncologia Do Porto Francisco Gentil E.P.E.
City
Porto
ZIP/Postal Code
4200-072
Country
Portugal
Individual Site Status
Not yet recruiting
Facility Name
Centro Hospitalar de Sao Joao Alameda
City
Porto
ZIP/Postal Code
4200-319
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Centro Hospitalar de Vila Nova de Gaia/Espinho, Epe-Unidade L
City
Vila Nova de Gaia
ZIP/Postal Code
4434-502
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Catalans Institute of Oncology Barcelona
City
Barcelona
ZIP/Postal Code
08916
Country
Spain
Individual Site Status
Recruiting
Facility Name
Ico Girona Hospital Universitari de Girona Dr Josep Trueta
City
Girona
ZIP/Postal Code
17007
Country
Spain
Individual Site Status
Recruiting
Facility Name
Fundacion Jimenez Diaz University Hospital
City
Madrid
ZIP/Postal Code
00034
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Ramon Y Cajal
City
Madrid
ZIP/Postal Code
28036
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Quironsalud Madrid
City
Madrid
ZIP/Postal Code
28223
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Regional Universitario Carlos Haya
City
Málaga
ZIP/Postal Code
29010
Country
Spain
Individual Site Status
Recruiting
Facility Name
Complejo Hospitalario de Navarra
City
Pamplona
ZIP/Postal Code
31008
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Marques de Valdecilla
City
Santander
ZIP/Postal Code
39008
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital General Universitario de Valencia
City
Valencia
ZIP/Postal Code
46014
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitari I Politecnic La Fe
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Individual Site Status
Recruiting
Facility Name
Kaohsiung Medical University Chung-Ho Memorial Hospital
City
Kaohsiung City
ZIP/Postal Code
80708
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Chang Gung Medical Foundation. Kaohsiung Branch
City
Kaohsiung
ZIP/Postal Code
83301
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
China Medical University Hospital
City
Taichung City
ZIP/Postal Code
00112
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Institutional Review Board Taipei Veterans General Hospital
City
Taipei
ZIP/Postal Code
00112
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
10002
Country
Taiwan
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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 Sharing Time Frame
Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
IPD Sharing Access Criteria
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 Sharing URL
https://www.incyte.com/our-company/compliance-and-transparency

Learn more about this trial

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

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