---
title: A Study of INCMGA00012 in Metastatic Merkel Cell Carcinoma (POD1UM-201)
nct_id: NCT03599713
overall_status: COMPLETED
phase: PHASE2
sponsor: Incyte Corporation
study_type: INTERVENTIONAL
primary_condition: Metastatic Merkel Cell Carcinoma
countries: United States, Australia, Canada, Czechia, France, Germany, Hungary, Italy, Poland, Spain, Switzerland, United Kingdom
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT03599713.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT03599713"
ct_last_update_post_date: 2025-08-05
last_seen_at: "2026-05-12T06:54:57.685Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# A Study of INCMGA00012 in Metastatic Merkel Cell Carcinoma (POD1UM-201)

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

**NCT ID:** [NCT03599713](https://clinicaltrials.gov/study/NCT03599713)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE2
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 107
- **Lead Sponsor:** Incyte Corporation
- **Conditions:** Metastatic Merkel Cell Carcinoma
- **Start Date:** 2019-02-25
- **Completion Date:** 2024-06-28
- **CT.gov Last Update:** 2025-08-05

## 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).

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.
```

## Arms

- **Retifanlimab: Chemotherapy: Naïve** (EXPERIMENTAL)
- **Retifanlimab: Chemotherapy: Refractory** (EXPERIMENTAL)

## Interventions

- **Retifanlimab** (DRUG) — INCMGA00012 administered at 500 milligrams (mg) by intravenous infusion once every 4 weeks

## Primary Outcomes

- **Objective Response Rate (ORR)** _(time frame: up to 26.8 months)_ — 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.

## Secondary Outcomes

- **Duration of Response (DOR)** _(time frame: up to 55.3 months)_
- **Disease Control Rate (DCR)** _(time frame: up to 57.1 months)_
- **Progression-free Survival (PFS)** _(time frame: up to 57.1 months)_
- **Overall Survival** _(time frame: up to 60.4 months)_
- **Number of Participants With Any Treatment-emergent Adverse Event (TEAE)** _(time frame: up to 846 days (up to approximately 2.3 years))_
- **First-dose Cmax of Retifanlimab** _(time frame: preinfusion, 10 minutes postinfusion (± 10 minutes), and 4 hours postinfusion (± 10 minutes) on Day 1 of Cycle 1)_
- **First-dose Cmin of Retifanlimab** _(time frame: preinfusion, 10 minutes postinfusion (± 10 minutes), and 4 hours postinfusion (± 10 minutes) on Day 1 of Cycle 1)_
- **First-dose AUC0-t of Retifanlimab** _(time frame: preinfusion, 10 minutes postinfusion (± 10 minutes), and 4 hours postinfusion (± 10 minutes) on Day 1 of Cycle 1)_

## Locations (65)

- 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, Padova, 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

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
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- `locations.georgetown university hospital|washington d.c.|district of columbia|united states` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.stanford cancer institute|palo alto|california|united states` — added _(2026-05-12)_
- `locations.university of california san francisco comprehensive cancer center|san francisco|california|united states` — added _(2026-05-12)_
- `locations.university of colorado cancer center|aurora|colorado|united states` — added _(2026-05-12)_
- `locations.rush university|chicago|illinois|united states` — added _(2026-05-12)_
- `locations.norton cancer institute|louisville|kentucky|united states` — added _(2026-05-12)_
- `locations.mayo clinic rochester|rochester|minnesota|united states` — added _(2026-05-12)_
- `locations.john theurer cancer center, hackensack university medical center|hackensack|new jersey|united states` — added _(2026-05-12)_
- `locations.rutgers cancer institute of nj|new brunswick|new jersey|united states` — added _(2026-05-12)_
- `locations.roswell park cancer institute|buffalo|new york|united states` — added _(2026-05-12)_
- `locations.university of rochester medical center|rochester|new york|united states` — added _(2026-05-12)_
- `locations.the christ hospital|cincinnati|ohio|united states` — added _(2026-05-12)_
- `locations.upmc cancercenter|pittsburgh|pennsylvania|united states` — added _(2026-05-12)_
- `locations.inova fairfax hospital|fairfax|virginia|united states` — added _(2026-05-12)_
- `locations.university of washington - seattle cancer care alliance|seattle|washington|united states` — added _(2026-05-12)_
- `locations.west virginia university hospitals inc|morgantown|west virginia|united states` — added _(2026-05-12)_
- `locations.st vincent's hospital sydney|darlinghurst|new south wales|australia` — added _(2026-05-12)_
- `locations.cross cancer institute|edmonton|alberta|canada` — added _(2026-05-12)_
- `locations.tom baker cancer centre|calgary ab|ca|canada` — added _(2026-05-12)_
- `locations.london health sciences centre lhsc - south street hospital|london|ontario|canada` — added _(2026-05-12)_
- `locations.sir mortimer b. davis jewish general hospital segal cancer ctr|montreal|quebec|canada` — added _(2026-05-12)_
- `locations.mcgill university health centre/glen site/cedars cancer centre|montreal|quebec|canada` — added _(2026-05-12)_
- `locations.fakultni nemocnice olomouc|olomouc||czechia` — added _(2026-05-12)_
- `locations.prof mudr petr arenberger drsc mba|prague||czechia` — added _(2026-05-12)_
- `locations.nemocnice na bulovce|prague||czechia` — added _(2026-05-12)_
- `locations.thomayerova nemocnice|praha 4-krc||czechia` — added _(2026-05-12)_
- `locations.h�pital ambroise par|boulogne-billancourt||france` — added _(2026-05-12)_
- `locations.chu hopital de la timone|marseille||france` — added _(2026-05-12)_
- `locations.centre hospitalier universitaire de nantes (chu de nantes) - hotel-dieu|nantes||france` — added _(2026-05-12)_
- `locations.chu de nice - h�pital l'archet 1|nice||france` — added _(2026-05-12)_
- `locations.hospital saint louis|paris||france` — added _(2026-05-12)_
- `locations.hopital charles nicolle chu rouen - h�pital de bois-guillaume|rouen||france` — added _(2026-05-12)_
- `locations.institut gustave roussy|villejuif||france` — added _(2026-05-12)_
- `locations.charite universitaetsmedizin berlin - campus charite mitte|berlin||germany` — added _(2026-05-12)_
- `locations.elbe klinikum buxtehude|buxtehude||germany` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT03599713.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT03599713*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*