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

March 9, 2026 updated by: Incyte Biosciences International Sàrl

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

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
176

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Expanded Access

Expanded Access

A way for patients with serious diseases or conditions who cannot participate in a clinical trial to gain access to a medical product that has not been approved by the U.S. Food and Drug Administration (FDA). Also called compassionate use. There are different expanded access types.
Available

Available

  • Available: Expanded access is currently available for this investigational treatment, and patients who are not participants in the clinical study may be able to gain access to the drug, biologic, or medical device being studied.
  • No longer available: Expanded access was available for this intervention previously but is not currently available and will not be available in the future.
  • Temporarily not available: Expanded access is not currently available for this intervention but is expected to be available in the future.
  • Approved for marketing: The intervention has been approved by the U.S. Food and Drug Administration for use by the public.
 outside the clinical trial. See expanded access record.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Incyte Corporation Call Center (US)
  • Phone Number: 1.855.463.3463
  • Email: medinfo@incyte.com

Study Contact Backup

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 95 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Drug: Retifanlimab
Retifanlimab 500mg will be administered intravenously every 4 weeks.
Drug: Placebo
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.
Drug: Retifanlimab
Retifanlimab 500mg will be administered intravenously every 4 weeks.
Drug: Placebo
Placebo will be administered intravenously.
Drug: INCAGN02385
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.
Drug: Retifanlimab
Retifanlimab 500mg will be administered intravenously every 4 weeks.
Drug: INCAGN02385
INCAGN02385 350mg will be administered intravenously every 2 weeks.
Drug: INCAGN02390
INCAGN02390 400 mg will be administered intravenously every 2 weeks.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Progeression-free Survival (PFS)
Time Frame: 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

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Objective Response
Time Frame: 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)
Time Frame: 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
Time Frame: 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
Time Frame: 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)
Time Frame: 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
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Incyte Biosciences International Sàrl

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 14, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 14, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 10, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 11, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 11, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 18, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 27, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 9, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • INCAGN 2385-203
  • 2021-005775-39 (EudraCT Number)
  • 2023-504270-38-00 (Registry Identifier: EU CT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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 Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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