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CompletedNCT05287113Updated Sep 25, 2026Results posted

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

A Phase 2 interventional study of Retifanlimab and INCAGN02385 in Head and Neck Cancer, sponsored by Incyte Biosciences International Sàrl. Completed at 91 sites in 14 countries. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2026-09-25.

Primary conditionSquamous Cell Carcinoma of Head and NeckRegistry: Head and Neck NeoplasmsReclassifiedWhy we changed it
Registry
Head and Neck Neoplasms — the first condition term the registry derived for this study.
ClinicalTrials.gg
Squamous Cell Carcinoma of Head and Neck
Why
  1. The study's title name Squamous Cell Carcinoma of Head and Neck, a narrower term within Head and Neck Neoplasms.
Confidence
High: the new condition is named in the study's own title. Of 46 hand-checked studies reclassified this way, 72% were exactly right and 89% in the right disease family; the registry's first term was right for 4% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Incyte Biosciences International Sàrl (part of Incyte Corporation) · Phase 2, Interventional, and Treatment

Updated Sep 25, 2026Now CompletedStudy completion movedGo to Updates ↓
Phase
Phase 2
Study type
Interventional
Enrollment
176
Allocation
Randomized
Ages
18 Years to 99 Years
Sex
All
01

Study 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).

02

Conditions studied

  • Head and Neck Cancer

Browse trials for

Keywords

  • squamous cell carcinoma of the head and neck (SCCHN)
  • INCAGN02385
  • INCAGN02390
  • Retifanlimab
  • IgG1κ monoclonal antibody
  • LAG-3
  • TIM-3
  • PD-1
  • PD-L1
03

In context

Squamous Cell Carcinoma of Head and Neck Reclassified

2,018 studies on the registry are indexed under Squamous Cell Carcinoma of Head and Neck; 573 are open to participants now.

This study's enrollment of 176 is above the median of 48 across 1,653 interventional studies indexed under Squamous Cell Carcinoma of Head and Neck.

Browse Squamous Cell Carcinoma of Head and Neck studies →

Lead sponsor

Incyte Biosciences International Sàrl is the lead sponsor of 10 studies on the registry; 1 is open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 5 (83%) have results posted.

First submitted after Incyte Biosciences International Sàrl became part of Incyte Corporation.

Browse Incyte Biosciences International Sàrl studies →All Incyte Corporation studies →

Compared within Squamous Cell Carcinoma of Head and Neck, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Head and Neck Neoplasms. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.
  • 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 v1.1.
  • Availability of for biomarker analysis from a core or excisional biopsy or willingness to undergo a fresh biopsy.
  • performance status of 0 or 1.
  • Willingness to avoid pregnancy or fathering children.

Exclusion criteria

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 therapy, for SCCHN or any other .
  • 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 .
  • 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 and/or carcinomatous meningitis. Participants will be excluded if it has been \< 4 weeks since radiation therapy was delivered to the CNS.
Terms in these criteria, in plain language(8)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

PD-1, PD-L1 and checkpoint inhibitors

PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.

PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.

RECIST

The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.

“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

Brain metastases

Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).

Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
176 participants (actual)

Study arms

  • 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 · Drug: Placebo

  • 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 · Drug: INCAGN02385 · Drug: Placebo

  • 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 · Drug: INCAGN02385 · Drug: INCAGN02390

Interventions

  • DrugRetifanlimab

    Retifanlimab 500mg will be administered intravenously every 4 weeks.

  • DrugINCAGN02385

    INCAGN02385 350mg will be administered intravenously every 2 weeks.

  • DrugINCAGN02390

    INCAGN02390 400 mg will be administered intravenously every 2 weeks.

  • DrugPlacebo

    Placebo will be administered intravenously.

06

What researchers measure

Primary outcomes

  1. Progeression-free Survival (PFS)

    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.

    Time frame: up to 738 days

Secondary outcomes

  1. Objective Response

    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.

    Time frame: up to approximately 44 months

  2. Duration of Response (DOR)

    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.

    Time frame: up to approximately 44 months

  3. Disease Control

    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.

    Time frame: up to approximately 44 months

  4. Overall Survival

    Overall survival was defined as the time from the date of randomization to the date of death due to any cause.

    Time frame: up to approximately 44 months

  5. Number of Participants With Treatment-emergent Adverse Events (TEAEs)

    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.

    Time frame: up to approximately 44 months

  6. Number of Participants With TEAEs Leading to Treatment Interruption, Dose Delay, and Withdrawal of Study Treatment

    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.

    Time frame: up to approximately 44 months

07

Results

Posted Mar 27, 2026

Participant flow

Participant flow — Overall Study
MilestoneRetifanlimabRetifanlimab Plus INCAGN02385Retifanlimab Plus INCAGN02385 Plus INCAGN02390
Started596057
Completed000
Not completed596057
Withdrew: Death222328
Withdrew: Lost to follow-up001
Withdrew: Withdrawal by subject254
Withdrew: Ongoing353224

Outcome measures

PrimaryProgeression-free Survival (PFS)

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.

Time frame:
up to 738 days
Reported as:
Median · months
Progeression-free Survival (PFS)
monthsRetifanlimabRetifanlimab Plus INCAGN02385Retifanlimab Plus INCAGN02385 Plus INCAGN02390
Progeression-free Survival (PFS)5.6 (3.5 to 9.7)5.8 (3.7 to 7.6)5.3 (2.1 to 7.9)
Statistical analysis
  • Retifanlimab vs Retifanlimab Plus INCAGN02385 · Log Rank · p = 0.5856 · Hazard ratio (hr): 1.05 · 95% CI 0.66 to 1.67The hazard ratio and its 95% confidence interval were estimated using a stratified Cox proportional hazard model with Efron method accounting for ties in event times. The strata information was based on the IRT randomization data.
  • Retifanlimab vs Retifanlimab Plus INCAGN02385 Plus INCAGN02390 · Log Rank · p = 0.6434 · Hazard ratio (hr): 1.09 · 95% CI 0.69 to 1.72The strata information was based on the IRT randomization data.
SecondaryObjective Response

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.

Time frame:
up to approximately 44 months

Results for this outcome have not been posted.

SecondaryDuration of Response (DOR)

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.

Time frame:
up to approximately 44 months

Results for this outcome have not been posted.

SecondaryDisease Control

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.

Time frame:
up to approximately 44 months

Results for this outcome have not been posted.

SecondaryOverall Survival

Overall survival was defined as the time from the date of randomization to the date of death due to any cause.

Time frame:
up to approximately 44 months

Results for this outcome have not been posted.

SecondaryNumber of Participants With Treatment-emergent Adverse Events (TEAEs)

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.

Time frame:
up to approximately 44 months

Results for this outcome have not been posted.

SecondaryNumber of Participants With TEAEs Leading to Treatment Interruption, Dose Delay, and Withdrawal of Study Treatment

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.

Time frame:
up to approximately 44 months

Results for this outcome have not been posted.

Adverse events

Collected over up to 828 days. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Retifanlimab22/58 (37.9%)24/58 (41.4%)52/58 (89.7%)
Retifanlimab Plus INCAGN0238523/60 (38.3%)20/60 (33.3%)51/60 (85%)
Retifanlimab Plus INCAGN02385 Plus INCAGN0239028/57 (49.1%)27/57 (47.4%)51/57 (89.5%)
Most frequent serious events
Showing 10 of 74
Most frequent serious events
EventRetifanlimabRetifanlimab Plus INCAGN02385Retifanlimab Plus INCAGN02385 Plus INCAGN02390
PneumoniaInfections and infestations5/583/607/57
Tumour haemorrhageNeoplasms benign, malignant and unspecified (incl cysts and polyps)4/582/601/57
DeathGeneral disorders3/582/603/57
SepsisInfections and infestations0/582/603/57
CellulitisInfections and infestations0/581/602/57
HyponatraemiaMetabolism and nutrition disorders0/580/602/57
MalnutritionMetabolism and nutrition disorders0/581/602/57
SyncopeNervous system disorders0/580/602/57
COVID-19Infections and infestations2/580/600/57
Respiratory tract infectionInfections and infestations0/582/600/57
Most frequent other events
Showing 10 of 79
Most frequent other events
EventRetifanlimabRetifanlimab Plus INCAGN02385Retifanlimab Plus INCAGN02385 Plus INCAGN02390
HypothyroidismEndocrine disorders9/5813/6018/57
AnaemiaBlood and lymphatic system disorders13/5816/6010/57
FatigueGeneral disorders10/5810/6011/57
DiarrhoeaGastrointestinal disorders11/589/609/57
ConstipationGastrointestinal disorders10/583/609/57
RashSkin and subcutaneous tissue disorders3/5810/606/57
CoughRespiratory, thoracic and mediastinal disorders9/586/606/57
HyponatraemiaMetabolism and nutrition disorders9/589/607/57
NauseaGastrointestinal disorders9/587/605/57
StomatitisGastrointestinal disorders9/581/603/57

Baseline characteristics

Age, Continuous
Age, Continuous(years)RetifanlimabRetifanlimab Plus INCAGN02385Retifanlimab Plus INCAGN02385 Plus INCAGN02390Total
Mean64.85 ± 9.03665.48 ± 8.95762.14 ± 10.19964.19 ± 9.459
Sex: Female, Male
Sex: Female, Male(Participants)RetifanlimabRetifanlimab Plus INCAGN02385Retifanlimab Plus INCAGN02385 Plus INCAGN02390Total
Female139729
Male465150147
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)RetifanlimabRetifanlimab Plus INCAGN02385Retifanlimab Plus INCAGN02385 Plus INCAGN02390Total
Hispanic or Latino1225
Not Hispanic or Latino545751162
Unknown or Not Reported4149
Race (NIH/OMB)
Race (NIH/OMB)(Participants)RetifanlimabRetifanlimab Plus INCAGN02385Retifanlimab Plus INCAGN02385 Plus INCAGN02390Total
American Indian or Alaska Native0000
Asian14171748
Native Hawaiian or Other Pacific Islander0000
Black or African American1034
White404034114
More than one race0000
Unknown or Not Reported43310
08

Study locations

91 sites
  • Mayo Clinic Rochester
    Scottsdale, Arizona 85259, United States
  • City of Hope National Medical Center
    Duarte, California 91010-9200, United States
  • City of Hope Orange County
    Irvine, California 92618, United States
  • University of California San Diego Medical Center, Moores Cancer Center
    La Jolla, California 92093, United States
  • City of Hope-Antelope Valley
    Lancaster, California 93534, United States
  • Innovative Clinical Research Institute
    Long Beach, California 90805, United States
  • City of Hope National Medical Center
    Long Beach, California 90813, United States
  • University of California San Francisco Comprehensive Cancer Center
    San Francisco, California 94115, United States
  • Georgetown University
    Washington D.C., District of Columbia 20057, United States
  • Mayo Clinic Jacksonville
    Jacksonville, Florida 32224, United States
  • Blessed Health Care
    Miami, Florida 33174, United States
  • Moffitt Cancer Center
    Tampa, Florida 33612-9416, United States
  • University of Illinois At Chicago
    Chicago, Illinois 60612, United States
  • University of Iowa
    Iowa City, Iowa 52242-1316, United States
  • University of Kansas Hospital Authority
    Kansas City, Kansas 66103, United States
  • University of Maryland-Greenebaum Cancer Center
    Baltimore, Maryland 21201, United States
  • Dana Farber Cancer Institute
    Boston, Massachusetts 02215, United States
  • University of Michigan Cancer Center
    Ann Arbor, Michigan 48109, United States
  • Barbara Ann Karmanos Cancer Hospital
    Detroit, Michigan 48201, United States
  • Hackensack University Medical Center
    Hackensack, New Jersey 07601, United States
  • Fox Chase Cancer Center
    Philadelphia, Pennsylvania 19111, United States
  • Huntsman Cancer Institute At University of Utah
    Salt Lake City, Utah 84112, United States
  • University of Virginia - Emily Couric Clinical Cancer Center
    Charlottesville, Virginia 22903, United States
  • Kadlec Clinic Hematology and Oncology
    Kennewick, Washington 99336, United States
  • Grand Hospital de Charleroi
    Charleroi, 06000, Belgium
  • Jessa Ziekenhuis
    Hasselt, 03500, Belgium
  • Gza Sint Augustinus
    Wilrijk, 02610, Belgium
  • McGill University Health Centre/Glen Site/Cedars Cancer Centre
    Montreal, Quebec H2X 3E4, Canada
  • Chum Hospital Notre Dame
    Montreal, Quebec H2X3E4, Canada
  • McGill University Jewish General Hospital
    Montreal, Quebec H3T 1E2, Canada
  • Centre Hospitalier Universitaire de Bordeaux
    Bordeaux, 33000, France
  • Institut Curie
    Paris, 75248, France
  • Centre Eugene Marquis
    Rennes, 35042, France
  • Centre de Lutte Contre Le Cancer - Institut de Cancerologie de L'Ouest - Rene Gauducheau
    Saint-Herblain, 44805, France
  • Icans - Institut de Cancerologie Strasbourg Europe
    Strasbourg, 67200, France
  • Jsc Evex Hospitals
    K'ut'aisi, 04600, Georgia
  • New Hospitals
    Tbilisi, 00114, Georgia
  • Jsc Evex Corporation-Caraps Medline
    Tbilisi, 00159, Georgia
  • Ltd Cancer Research Centre
    Tbilisi, 0159, Georgia
  • University of Cologne
    Cologne, 50937, Germany
  • Universitatsklinikum Hamburg Eppendorf
    Hamburg, 20246, Germany
  • Asklepios Klinik Altona
    Hamburg, 22763, Germany
  • Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii
    Mainz, 55131, Germany
  • University Hospital of West Attica - Attikon
    Chaïdári, 12462, Greece
  • Theagenio Anticancer Hospital
    Thessaloniki, 54007, Greece
  • Bioclinic Thessaloniki (Galinos Clinic)
    Thessaloniki, 54622, Greece
  • Saint Lukas Clinic
    Thessaloniki, 55236, Greece
  • Fondazione Del Piemonte Per L Oncologia Ircc Candiolo
    Candiolo, 10060, Italy
  • Fondazione Irccs Istituto Nazionale Del Tumori Di Milano
    Milan, 20133, Italy
  • European Institute of Oncology
    Milan, 20141, Italy
  • Istituto Nazionale Tumori Irccs Fondazione Pascale
    Naples, 80131, Italy
  • Iov - Istituto Oncologico Veneto Irccs
    Padova, 35128, Italy
  • Fondazione Irccs Policlinico San Matteo
    Pavia, 27100, Italy
  • Ausl-Irccs Di Reggio Emilia
    Reggio Emilia, 42123, Italy
  • The Dutch Cancer Institue
    Amsterdam, 1066 CX, Netherlands
  • Leids Universitair Medisch Centrum (Lumc) (Leiden University Medical Center)
    Leiden, 02333, Netherlands
  • Centrum Onkologii Im. Prof. Franciszka Lukaszczyka
    Bydgoszcz, 85-796, Poland
  • Przychodnia Lekarska Komed Roman Karaszewski
    Konin, 62-500, Poland
  • Centrum Onkologii Ziemi Lubelskiej Im. SW. Jana Z Dukli
    Lublin, 20-090, Poland
  • Poznan University of Medical Sciences
    Poznan, 60-780, Poland
  • Nzoz Provita Prolife Centrum Medyczne
    Tomaszów Mazowiecki, 97-200, Poland
  • Centrum Onkologii - Instytut Im. Marii Sklodowskiej - Curie
    Warsaw, 02-781, Poland
  • Hospital de Braga
    Braga, 4710-243, Portugal
  • Centro Hospitalar Universitario Algarve
    Faro, 8000-386, Portugal
  • Centro Hospitalar de Lisboa Norte E.P.E. - Hospital de Santa Maria
    Lisbon, 1649-035, Portugal
  • Instituto Portugues de Oncologia Do Porto Francisco Gentil E.P.E.
    Porto, 4200-072, Portugal
  • Centro Hospitalar de Sao Joao Alameda
    Porto, 4200-319, Portugal
  • Centro Hospitalar de Vila Nova de Gaia/Espinho, Epe-Unidade L
    Vila Nova de Gaia, 4434-502, Portugal
  • Pusan National University Yangsan Hospital
    Busan, 49241, South Korea
  • Chonnam National University Hwasun Hospital
    Gwangju, 58128, South Korea
  • Cha Bundang Medical Center
    Seongnam-si, 13496, South Korea
  • Korea University Anam Hospital
    Seoul, 02841, South Korea
  • Kangbuk Samsung Hospital
    Seoul, 03181, South Korea
  • Kunkuk University Medical Center
    Seoul, 05030, South Korea
  • Asan Medical Center
    Seoul, 05505, South Korea
  • Pusan National University Yangsan Hospital
    Yangsan, 50612, South Korea
  • Catalans Institute of Oncology Barcelona
    Barcelona, 08916, Spain
  • Ico Girona Hospital Universitari de Girona Dr Josep Trueta
    Girona, 17007, Spain
  • Fundacion Jimenez Diaz University Hospital
    Madrid, 00034, Spain
  • Hospital Universitario Ramon Y Cajal
    Madrid, 28036, Spain
  • Hospital Universitario Quironsalud Madrid
    Madrid, 28223, Spain
  • Hospital Regional Universitario Carlos Haya
    Málaga, 29010, Spain
  • Complejo Hospitalario de Navarra
    Pamplona, 31008, Spain
  • Hospital Universitario Marques de Valdecilla
    Santander, 39008, Spain
  • Hospital General Universitario de Valencia
    Valencia, 46014, Spain
  • Hospital Universitari I Politecnic La Fe
    Valencia, 46026, Spain
  • Kaohsiung Medical University Chung-Ho Memorial Hospital
    Kaohsiung City, 80708, Taiwan
  • Chang Gung Medical Foundation. Kaohsiung Branch
    Kaohsiung City, 83301, Taiwan
  • China Medical University Hospital
    Taichung, 00112, Taiwan
  • Institutional Review Board Taipei Veterans General Hospital
    Taipei, 00112, Taiwan
  • National Taiwan University Hospital
    Taipei, 10002, Taiwan
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: Yes — 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

Supporting information: Study protocol, Statistical analysis plan

Time frame: Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.

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.

Data sharing details ↗ · www.incyte.com

10

Updates

1 registry update since Sep 25, 2026
Status
Active, not recruiting→Completed
changed Sep 25, 2026
Study completion
Jul 10, 2026→Jun 23, 2026 (actual)
Sep 25, 2026
Show all 1 update
  1. Sep 25, 2026
    Active, not recruiting→Completed
    Study completion Jul 10, 2026→Jun 23, 2026 (now actual)
    + 2 other changes: identifiers and verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

11

Registry details

Key details

Study ID
NCT05287113
Lead sponsor
Incyte Biosciences International Sàrl
Responsible party
Sponsor
First posted
Mar 18, 2022
Start date
Nov 14, 2022
Primary completion
Mar 14, 2025
Completion
Jun 23, 2026
Results posted
Mar 27, 2026
Last update
Sep 25, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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