A Study of INCMGA00012 in Metastatic Merkel Cell Carcinoma (POD1UM-201)
NCT ID: NCT03599713
Last Updated: 2025-08-05
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
107 participants
INTERVENTIONAL
2019-02-25
2024-06-28
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Phase 1/2a Study of IMM-1-104 in Participants With Advanced or Metastatic Solid Tumors
NCT05585320
Chemo-immunotherapy in Patients With Resectable Merkel Cell Carcinoma Prior to Surgery
NCT05594290
Domatinostat in Combination With Avelumab in Patients With Advanced Merkel Cell Carcinoma Progressing on Anti-PD-(L)1
NCT04393753
Evaluation of a New Anti-cancer Immunotherapy in Patients With Non-operable and Progressing Metastatic Cutaneous Melanoma
NCT01213472
A Study to Test the Benefit of a New Anti-cancer Treatment in Patients With Unresectable Advanced Melanoma
NCT00942162
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Retifanlimab: Chemotherapy: Naïve
Retifanlimab
INCMGA00012 administered at 500 milligrams (mg) by intravenous infusion once every 4 weeks
Retifanlimab: Chemotherapy: Refractory
Retifanlimab
INCMGA00012 administered at 500 milligrams (mg) by intravenous infusion once every 4 weeks
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Retifanlimab
INCMGA00012 administered at 500 milligrams (mg) by intravenous infusion once every 4 weeks
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Diagnosis of MCC with distant metastatic disease or recurrent, advanced locoregional disease not amenable to surgery or radiation
* Eastern Cooperative Oncology Group performance status of 0 to 1.
* Measurable disease according to RECIST v1.1.
* Availability of tumor tissue (fresh or archival) for central pathology review.
* Willingness to avoid pregnancy or fathering children based on protocol-defined criteria.
Exclusion Criteria
* Treatment with anticancer drugs or participation in another interventional clinical study within 21 days before the first administration of study drug.
* Has not recovered to ≤ Grade 1 or baseline from toxic effects of prior therapy (with the exceptions for anemia not requiring transfusion support and any grade of alopecia) and/or complications from prior surgical intervention within 7 days before starting study treatment.
* Radiation therapy administered within 2 weeks of first dose of study treatment or radiation therapy to the thoracic region that is \> 30 Gy within 6 months of the first dose of study treatment.
* Known central nervous system (CNS) metastases and/or carcinomatous meningitis.
* History of second malignancy within 3 years (with exceptions).
* Laboratory values outside the protocol-defined range at screening.
* Clinically significant pulmonary, cardiac, gastrointestinal or autoimmune disorders.
* Active bacterial, fungal, or viral infections, including hepatitis A, B, and C.
* Receipt of a live vaccine within 28 days of planned start of study therapy.
* Current use of protocol-defined prohibited medication.
* Known hypersensitivity to another monoclonal antibody that cannot be controlled with standard measures (eg, antihistamines and corticosteroids).
* Inability or unlikely, in the opinion of the investigator, to comply with the Protocol requirements.
* Participant who is pregnant or breastfeeding.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Incyte Corporation
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Incyte Medical Monitor
Role: STUDY_DIRECTOR
Incyte Corporation
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Stanford Cancer Institute
Palo Alto, California, United States
University of California San Francisco Comprehensive Cancer Center
San Francisco, California, United States
University of Colorado Cancer Center
Aurora, Colorado, United States
Georgetown University Hospital
Washington D.C., District of Columbia, United States
Rush University
Chicago, Illinois, United States
Norton Cancer Institute
Louisville, Kentucky, United States
Mayo Clinic Rochester
Rochester, Minnesota, United States
John Theurer Cancer Center, Hackensack University Medical Center
Hackensack, New Jersey, United States
Rutgers Cancer Institute of Nj
New Brunswick, New Jersey, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
University of Rochester Medical Center
Rochester, New York, United States
The Christ Hospital
Cincinnati, Ohio, United States
Upmc Cancercenter
Pittsburgh, Pennsylvania, United States
Inova Fairfax Hospital
Fairfax, Virginia, United States
University of Washington - Seattle Cancer Care Alliance
Seattle, Washington, United States
West Virginia University Hospitals Inc
Morgantown, West Virginia, United States
St Vincent'S Hospital Sydney
Darlinghurst, New South Wales, Australia
Cross Cancer Institute
Edmonton, Alberta, Canada
Tom Baker Cancer Centre
Calgary AB, CA, Canada
London Health Sciences Centre Lhsc - South Street Hospital
London, Ontario, Canada
Sir Mortimer B. Davis Jewish General Hospital Segal Cancer Ctr
Montreal, Quebec, Canada
McGill University Health Centre/Glen Site/Cedars Cancer Centre
Montreal, Quebec, Canada
Fakultni Nemocnice Olomouc
Olomouc, , Czechia
Prof Mudr Petr Arenberger Drsc Mba
Prague, , Czechia
Nemocnice Na Bulovce
Prague, , Czechia
Thomayerova Nemocnice
Praha 4-krc, , Czechia
H�PITAL AMBROISE PAR
Boulogne-Billancourt, , France
Chu Hopital de La Timone
Marseille, , France
Centre Hospitalier Universitaire de Nantes (Chu de Nantes) - Hotel-Dieu
Nantes, , France
CHU DE NICE - H�PITAL L'ARCHET 1
Nice, , France
Hospital Saint Louis
Paris, , France
HOPITAL CHARLES NICOLLE CHU ROUEN - H�PITAL DE BOIS-GUILLAUME
Rouen, , France
Institut Gustave Roussy
Villejuif, , France
Charite Universitaetsmedizin Berlin - Campus Charite Mitte
Berlin, , Germany
Elbe Klinikum Buxtehude
Buxtehude, , Germany
Helios Klinikum Erfurt
Erfurt, , Germany
Universitatsklinikum Essen
Essen, , Germany
Universitatsklinikum Schleswig-Holstein
Kiel, , Germany
Universitatsklinikum Giessen Und Marburg Gmbh, Klinik Für Innere Medizin
Marburg, , Germany
University Hospital Regensburg
Regensburg, , Germany
Universitaetsklinikum in Tubingen
Tübingen, , Germany
National Institute of Oncology
Budapest, , Hungary
Debreceni Egyetem Klinikai Kozpon Belgyogy Klinika
Debrecen, , Hungary
Szte Borgyogyszati Es Allergologiai Klinika
Szeged, , Hungary
Istituto Tumori Giovanni Paolo Ii Irccs Ospedale Oncologico Bari
Bari, , Italy
Fondazione Del Piemonte Per L'Oncologia Ircc Candiolo
Candiolo, , Italy
Irccs Azienda Ospedaliera Universitaria San Martino
Genova, , Italy
Fondazione Irccs Istituto Nazionale Dei Tumori
Milan, , Italy
European Institute of Oncology
Milan, , Italy
A.O.U. Di Modena - Policlinico
Modena, , Italy
Istituto Nazionale Tumori Irccs Fondazione Pascale
Naples, , Italy
Iov - Istituto Oncologico Veneto Irccs
Padua, , Italy
ONCOLOGIA � IDI IRCCS ISTITUTO DERMOPATICO DELL'IMMACOLATA
Rome, , Italy
Azienda Ospedaliera Universitaria Senese Policlinico Santa Maria Alle Scotte
Siena, , Italy
Centrum Onkologii - Instytut Im. Marii Sklodowskiej - Curie
Warsaw, , Poland
Hospital General Universitario Vall D Hebron
Barcelona, , Spain
Hospital Clinic I Provincial
Barcelona, , Spain
Hospital General Universitario Gregorio Maranon
Madrid, , Spain
Centre Hospitalier Universitaire Vaudois (Chuv)
Lausanne, , Switzerland
Universitatsspital Zurich
Zurich, , Switzerland
Castle Hill Hospital
Cottingham, , United Kingdom
Royal Free London Nhs Foundation Trust
London, , United Kingdom
The Royal Marsden Nhs Foundation Trust
London, , United Kingdom
The Royal Marsden Nhs Foundation Trust - Sutton
Sutton, , United Kingdom
Royal Cornwall Hospital Truro Sunrise Centre
Truro, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Grignani G, Rutkowski P, Lebbe C, Guida M, Gaudy-Marqueste C, Spagnolo F, Burgess M, Morano F, Montaudie H, Depenni R, Spada F, Yeung CCS, Pulini J, Cornfeld M, Tian C, Bhatia S. Phase II study of retifanlimab in patients with recurrent locally advanced or metastatic Merkel cell carcinoma (POD1UM-201). J Immunother Cancer. 2025 Aug 11;13(8):e012478. doi: 10.1136/jitc-2025-012478.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2018-001627-39
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
INCMGA 0012-201
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.