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

NCT03599713 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: INCMGA 0012-2012018-001627-39
• Study Type: interventional
• Target: 107
• Locations: 12 countries
• Sites: 65

Brief 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).

Conditions

Metastatic Merkel Cell Carcinoma

Keywords

Metastatic merkel cell carcinoma; anti-PD-1 antibody; immunoglobulin G4 (IgG4) monoclonal antibody; INCMGA00012

Outcome Measures

Primary Outcomes (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.

  up to 26.8 months

Secondary Outcomes (8)

• Duration of Response (DOR)

  up to 55.3 months

• Disease Control Rate (DCR)

  up to 57.1 months

• Progression-free Survival (PFS)

  up to 57.1 months

• Overall Survival

  up to 60.4 months

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

  up to 846 days (up to approximately 2.3 years)

Study Arms (2)

Retifanlimab: Chemotherapy: Naïve

EXPERIMENTAL

Drug: Retifanlimab

Retifanlimab: Chemotherapy: Refractory

EXPERIMENTAL

Drug: Retifanlimab

Interventions

Retifanlimab DRUG

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

Also known as: MGA012, INCMGA00012

Retifanlimab: Chemotherapy: Naïve; Retifanlimab: Chemotherapy: Refractory

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• Incyte Corporation: lead

Study Sites (65)

Stanford Cancer Institute

Palo Alto, California, 94304, United States

Location

University of California San Francisco Comprehensive Cancer Center

San Francisco, California, 94143, United States

Location

University of Colorado Cancer Center

Aurora, Colorado, 80045, United States

Location

Georgetown University Hospital

Washington D.C., District of Columbia, 20007, United States

Location

Rush University

Chicago, Illinois, 60612, United States

Location

Norton Cancer Institute

Louisville, Kentucky, 40241, United States

Location

Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States

Location

John Theurer Cancer Center, Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

Rutgers Cancer Institute of Nj

New Brunswick, New Jersey, 08901, United States

Location

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

The Christ Hospital

Cincinnati, Ohio, 45219, United States

Location

Upmc Cancercenter

Pittsburgh, Pennsylvania, 15232, United States

Location

Inova Fairfax Hospital

Fairfax, Virginia, 22031, United States

Location

University of Washington - Seattle Cancer Care Alliance

Seattle, Washington, 98109, United States

Location

West Virginia University Hospitals Inc

Morgantown, West Virginia, 26506, United States

Location

St Vincent'S Hospital Sydney

Darlinghurst, New South Wales, 02010, Australia

Location

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

Location

Tom Baker Cancer Centre

Calgary AB, CA, T2N 4N2, Canada

Location

London Health Sciences Centre Lhsc - South Street Hospital

London, Ontario, N6A 4G5, Canada

Location

Sir Mortimer B. Davis Jewish General Hospital Segal Cancer Ctr

Montreal, Quebec, H3T1E2, Canada

Location

McGill University Health Centre/Glen Site/Cedars Cancer Centre

Montreal, Quebec, H4A 3J1, Canada

Location

Fakultni Nemocnice Olomouc

Olomouc, 775 20, Czechia

Location

Prof Mudr Petr Arenberger Drsc Mba

Prague, 110 00, Czechia

Location

Nemocnice Na Bulovce

Prague, 180-81, Czechia

Location

Thomayerova Nemocnice

Praha 4-krc, 140 59, Czechia

Location

H�PITAL AMBROISE PAR

Boulogne-Billancourt, 92100, France

Location

Chu Hopital de La Timone

Marseille, 13385, France

Location

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

Nantes, 44093, France

Location

CHU DE NICE - H�PITAL L'ARCHET 1

Nice, 06202, France

Location

Hospital Saint Louis

Paris, 75 010, France

Location

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

Rouen, 76031, France

Location

Institut Gustave Roussy

Villejuif, 94805, France

Location

Charite Universitaetsmedizin Berlin - Campus Charite Mitte

Berlin, 10117, Germany

Location

Elbe Klinikum Buxtehude

Buxtehude, 21614, Germany

Location

Helios Klinikum Erfurt

Erfurt, Germany

Location

Universitatsklinikum Essen

Essen, 45122, Germany

Location

Universitatsklinikum Schleswig-Holstein

Kiel, 24105, Germany

Location

Universitatsklinikum Giessen Und Marburg Gmbh, Klinik Für Innere Medizin

Marburg, 35043, Germany

Location

University Hospital Regensburg

Regensburg, 93053, Germany

Location

Universitaetsklinikum in Tubingen

Tübingen, 72076, Germany

Location

National Institute of Oncology

Budapest, 01122, Hungary

Location

Debreceni Egyetem Klinikai Kozpon Belgyogy Klinika

Debrecen, 04032, Hungary

Location

Szte Borgyogyszati Es Allergologiai Klinika

Szeged, 06720, Hungary

Location

Istituto Tumori Giovanni Paolo Ii Irccs Ospedale Oncologico Bari

Bari, 70124, Italy

Location

Fondazione Del Piemonte Per L'Oncologia Ircc Candiolo

Candiolo, 10060, Italy

Location

Irccs Azienda Ospedaliera Universitaria San Martino

Genova, 16132, Italy

Location

Fondazione Irccs Istituto Nazionale Dei Tumori

Milan, 20133, Italy

Location

European Institute of Oncology

Milan, 20141, Italy

Location

A.O.U. Di Modena - Policlinico

Modena, 41124, Italy

Location

Istituto Nazionale Tumori Irccs Fondazione Pascale

Naples, 80131, Italy

Location

Iov - Istituto Oncologico Veneto Irccs

Padua, 35128, Italy

Location

ONCOLOGIA � IDI IRCCS ISTITUTO DERMOPATICO DELL'IMMACOLATA

Rome, 00167, Italy

Location

Azienda Ospedaliera Universitaria Senese Policlinico Santa Maria Alle Scotte

Siena, 53100, Italy

Location

Centrum Onkologii - Instytut Im. Marii Sklodowskiej - Curie

Warsaw, 02-781, Poland

Location

Hospital General Universitario Vall D Hebron

Barcelona, 08035, Spain

Location

Hospital Clinic I Provincial

Barcelona, 08036, Spain

Location

Hospital General Universitario Gregorio Maranon

Madrid, 28007, Spain

Location

Centre Hospitalier Universitaire Vaudois (Chuv)

Lausanne, 01011, Switzerland

Location

Universitatsspital Zurich

Zurich, 08091, Switzerland

Location

Castle Hill Hospital

Cottingham, HU16 5JQ, United Kingdom

Location

Royal Free London Nhs Foundation Trust

London, NW3 2QG, United Kingdom

Location

The Royal Marsden Nhs Foundation Trust

London, SW3 6JJ, United Kingdom

Location

The Royal Marsden Nhs Foundation Trust - Sutton

Sutton, SM2 5PT, United Kingdom

Location

Royal Cornwall Hospital Truro Sunrise Centre

Truro, TR1 3LJ, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 40796223 DERIVED

MeSH Terms

Conditions

Carcinoma, Merkel Cell

Condition Hierarchy (Ancestors)

Polyomavirus Infections; DNA Virus Infections; Virus Diseases; Infections; Tumor Virus Infections; Carcinoma, Neuroendocrine; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Results Point of Contact

• Title: Study Director
• Organization: Incyte Corporation

medinfo@incyte.com

1-855-463-3463

Study Officials

• Incyte Medical Monitor

  Incyte Corporation

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2018
• First Posted: July 26, 2018
• Study Start: February 25, 2019
• Primary Completion: January 21, 2022
• Study Completion: June 28, 2024
• Last Updated: August 5, 2025
• Results First Posted: May 3, 2023

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (16); FR (7); HU (3); AU (1); PL (1); ES (3); CZ (4); IT (10); CH (2); GB (5); DE (8); CA (5)