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Metastatic Merkel Cell CarcinomaPhase 2NCT03599713

A Study of INCMGA00012 in Metastatic Merkel Cell Carcinoma (POD1UM-201)

A Phase 2 study testing Retifanlimab in people with Metastatic Merkel Cell Carcinoma, run by Incyte Corporation at 65 sites in 12 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study is to assess the clinical activity and safety of INCMGA00012 in participants with advanced/metastatic Merkel cell carcinoma (MCC). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Metastatic Merkel Cell Carcinoma
What is being tested?
Retifanlimab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
107 participants
Where
65 sitesin 12 countries
Study dates
25 Feb 2019to 28 Jun 2024
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signed informed consent.
  • 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.

Who cannot join

  • Prior systemic therapy for MCC, including chemotherapy and prior PD-1 or PD-L1-directed therapy.
  • 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).
Show all 14Show fewer
  • 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.

Trial locations and contacts

65 sites in 12 countries.

65 sites in 12 countries

United States16 sites

  • University of Colorado Cancer Center

    Aurora, Colorado, 80045

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

  • Rush University

    Chicago, Illinois, 60612

  • The Christ Hospital

    Cincinnati, Ohio, 45219

  • Inova Fairfax Hospital

    Fairfax, Virginia, 22031

  • John Theurer Cancer Center, Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • Norton Cancer Institute

    Louisville, Kentucky, 40241

  • West Virginia University Hospitals Inc

    Morgantown, West Virginia, 26506

  • Rutgers Cancer Institute of Nj

    New Brunswick, New Jersey, 08901

  • Stanford Cancer Institute

    Palo Alto, California, 94304

  • Upmc Cancercenter

    Pittsburgh, Pennsylvania, 15232

  • Mayo Clinic Rochester

    Rochester, Minnesota, 55905

  • University of Rochester Medical Center

    Rochester, New York, 14642

  • University of California San Francisco Comprehensive Cancer Center

    San Francisco, California, 94143

  • University of Washington - Seattle Cancer Care Alliance

    Seattle, Washington, 98109

  • Georgetown University Hospital

    Washington D.C., District of Columbia, 20007

Other trials in United States

Italy10 sites

  • Istituto Tumori Giovanni Paolo Ii Irccs Ospedale Oncologico Bari

    Bari, 70124

  • Fondazione Del Piemonte Per L'Oncologia Ircc Candiolo

    Candiolo, 10060

  • Irccs Azienda Ospedaliera Universitaria San Martino

    Genova, 16132

  • Fondazione Irccs Istituto Nazionale Dei Tumori

    Milan, 20133

  • European Institute of Oncology

    Milan, 20141

  • A.O.U. Di Modena - Policlinico

    Modena, 41124

  • Istituto Nazionale Tumori Irccs Fondazione Pascale

    Naples, 80131

  • Iov - Istituto Oncologico Veneto Irccs

    Padova, 35128

  • ONCOLOGIA � IDI IRCCS ISTITUTO DERMOPATICO DELL'IMMACOLATA

    Rome, 00167

  • Azienda Ospedaliera Universitaria Senese Policlinico Santa Maria Alle Scotte

    Siena, 53100

Other trials in Italy

Germany8 sites

  • Charite Universitaetsmedizin Berlin - Campus Charite Mitte

    Berlin, 10117

  • Elbe Klinikum Buxtehude

    Buxtehude, 21614

  • Helios Klinikum Erfurt

    Erfurt

  • Universitatsklinikum Essen

    Essen, 45122

  • Universitatsklinikum Schleswig-Holstein

    Kiel, 24105

  • Universitatsklinikum Giessen Und Marburg Gmbh, Klinik Für Innere Medizin

    Marburg, 35043

  • University Hospital Regensburg

    Regensburg, 93053

  • Universitaetsklinikum in Tubingen

    Tübingen, 72076

Other trials in Germany

France7 sites

  • H�PITAL AMBROISE PAR

    Boulogne-Billancourt, 92100

  • Chu Hopital de La Timone

    Marseille, 13385

  • Centre Hospitalier Universitaire de Nantes (Chu de Nantes) - Hotel-Dieu

    Nantes, 44093

  • CHU DE NICE - H�PITAL L'ARCHET 1

    Nice, 06202

  • Hospital Saint Louis

    Paris, 75 010

  • HOPITAL CHARLES NICOLLE CHU ROUEN - H�PITAL DE BOIS-GUILLAUME

    Rouen, 76031

  • Institut Gustave Roussy

    Villejuif, 94805

Other trials in France

Canada5 sites

  • Tom Baker Cancer Centre

    Calgary AB, CA, T2N 4N2

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2

  • London Health Sciences Centre Lhsc - South Street Hospital

    London, Ontario, N6A 4G5

  • Sir Mortimer B. Davis Jewish General Hospital Segal Cancer Ctr

    Montreal, Quebec, H3T1E2

  • McGill University Health Centre/Glen Site/Cedars Cancer Centre

    Montreal, Quebec, H4A 3J1

Other trials in Canada

United Kingdom5 sites

  • Castle Hill Hospital

    Cottingham, HU16 5JQ

  • Royal Free London Nhs Foundation Trust

    London, NW3 2QG

  • The Royal Marsden Nhs Foundation Trust

    London, SW3 6JJ

  • The Royal Marsden Nhs Foundation Trust - Sutton

    Sutton, SM2 5PT

  • Royal Cornwall Hospital Truro Sunrise Centre

    Truro, TR1 3LJ

Other trials in United Kingdom

Czechia4 sites

  • Fakultni Nemocnice Olomouc

    Olomouc, 775 20

  • Prof Mudr Petr Arenberger Drsc Mba

    Prague, 110 00

  • Nemocnice Na Bulovce

    Prague, 180-81

  • Thomayerova Nemocnice

    Praha 4-krc, 140 59

Other trials in Czechia

Hungary3 sites

  • National Institute of Oncology

    Budapest, 01122

  • Debreceni Egyetem Klinikai Kozpon Belgyogy Klinika

    Debrecen, 04032

  • Szte Borgyogyszati Es Allergologiai Klinika

    Szeged, 06720

Other trials in Hungary

Spain3 sites

  • Hospital General Universitario Vall D Hebron

    Barcelona, 08035

  • Hospital Clinic I Provincial

    Barcelona, 08036

  • Hospital General Universitario Gregorio Maranon

    Madrid, 28007

Other trials in Spain

Switzerland2 sites

  • Centre Hospitalier Universitaire Vaudois (Chuv)

    Lausanne, 01011

  • Universitatsspital Zurich

    Zurich, 08091

Other trials in Switzerland

Australia1 site

  • St Vincent'S Hospital Sydney

    Darlinghurst, New South Wales, 02010

Other trials in Australia

Poland1 site

  • Centrum Onkologii - Instytut Im. Marii Sklodowskiej - Curie

    Warsaw, 02-781

Other trials in Poland

About this study

Official title: A Phase 2 Study of INCMGA00012 in Participants With Metastatic Merkel Cell Carcinoma (POD1UM-201)

The purpose of this study is to assess the clinical activity and safety of INCMGA00012 in participants with advanced/metastatic Merkel cell carcinoma (MCC).

Being tested
Retifanlimab
Keywords
Metastatic merkel cell carcinoma, anti-PD-1 antibody, immunoglobulin G4 (IgG4) monoclonal antibody, INCMGA00012
Medical subject headings
Carcinoma, Merkel Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RetifanlimabDrug

    Also called MGA012, INCMGA00012

    INCMGA00012 administered at 500 milligrams (mg) by intravenous infusion once every 4 weeks

Study groups in NCT03599713
Study groupRoleWhat they receive
Retifanlimab: Chemotherapy: NaïveExperimentalNot described
Receives: Drug: Retifanlimab
Retifanlimab: Chemotherapy: RefractoryExperimentalNot described
Receives: Drug: Retifanlimab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective Response Rate (ORR)

    ORR was defined as the percentage of participants with a confirmed overall response of complete response (CR) or partial response (PR), per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (v1.1), as determined by Independent Central Radiographic Review (ICR), at any post-Baseline visit until the first progressive disease (PD) or new anti-cancer 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.

    Measured: up to 26.8 months

Secondary outcomes (8)

  1. Duration of Response (DOR)

    DOR was defined as the time from an initial objective response (CR or PR) per RECIST v1.1 until PD, or death due to any cause, as determined by ICR. 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. A Kaplan-Meier estimate (estimated median) of the distribution function is reported.

    Measured: up to 55.3 months

  2. Disease Control Rate (DCR)

    DCR was defined as the percentage of participants with a confirmed overall response (CR and PR) or stable disease (SD) (non-CR/non-PD) lasting at least 6 months from the start of treatment, until the first PD or new anti-cancer therapy, per RECIST v1.1 as determined by ICR. 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.

    Measured: up to 57.1 months

  3. Progression-free Survival (PFS)

    According to RESIST v1.1, PFS was defined the time from the start of therapy until disease progression, or death due to any cause, as determined by ICR. Evaluation of target lesions: PD: ≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. The sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered PD). Evaluation of non-target lesions: PD: Unequivocal progression of existing non-target lesions. (Note: the appearance of one or more new lesions is also considered PD).

    Measured: up to 57.1 months

  4. Overall Survival

    Overall survival was defined as the time in months between the first dose date (Day 1) and the date of death due to any cause.

    Measured: up to 60.4 months

  5. Number of Participants With Any Treatment-emergent Adverse Event (TEAE)

    An adverse event (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE can therefore be any unfavorable and 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 either an AE reported for the first time or a worsening of a pre-existing event after the first dose of study drug until 90 days after the last dose of study drug. An AE with onset on/after starting a new anticancer therapy was not summarized as a TEAE.

    Measured: up to 846 days (up to approximately 2.3 years)

  6. First-dose Cmax of Retifanlimab

    Cmax was defined as the maximum observed plasma concentration.

    Measured: preinfusion, 10 minutes postinfusion (± 10 minutes), and 4 hours postinfusion (± 10 minutes) on Day 1 of Cycle 1

  7. First-dose Cmin of Retifanlimab

    Cmin was defined as the minimum observed plasma concentration over the dose interval.

    Measured: preinfusion, 10 minutes postinfusion (± 10 minutes), and 4 hours postinfusion (± 10 minutes) on Day 1 of Cycle 1

  8. First-dose AUC0-t of Retifanlimab

    AUC0-t was defined as the area under the plasma concentration-time curve from time zero to time t.

    Measured: preinfusion, 10 minutes postinfusion (± 10 minutes), and 4 hours postinfusion (± 10 minutes) on Day 1 of Cycle 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jul 2018
  2. Study start25 Feb 2019
  3. Primary completion21 Jan 2022
  4. Study completion28 Jun 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
107 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03599713
Sponsor's protocol ID
INCMGA 0012-201
Other IDs
2018-001627-39, 2018
Status last verified
Aug 2025
First submitted
16 Jul 2018
Last updated
5 Aug 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 40796223

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Retifanlimab in people with Metastatic Merkel Cell Carcinoma, run by Incyte Corporation at 65 sites in 12 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 65 sites in United States, Italy, Germany, France, Canada and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 May 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) (time frame: up to 26.8 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03599713, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2025.

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