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

Primary Purpose

Metastatic Merkel Cell Carcinoma

Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Retifanlimab
Sponsored by
Incyte Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Merkel Cell Carcinoma focused on measuring Metastatic merkel cell carcinoma, anti-PD-1 antibody, immunoglobulin G4 (IgG4) monoclonal antibody, INCMGA00012

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Stanford Cancer Institute
  • University of California San Francisco Comprehensive Cancer Center
  • University of Colorado Cancer Center
  • Georgetown University Hospital
  • Rush University
  • Norton Cancer Institute
  • Mayo Clinic Rochester
  • John Theurer Cancer Center, Hackensack University Medical Center
  • Rutgers Cancer Institute of Nj
  • Roswell Park Cancer Institute
  • University of Rochester Medical Center
  • The Christ Hospital
  • Upmc Cancercenter
  • Inova Fairfax Hospital
  • University of Washington - Seattle Cancer Care Alliance
  • West Virginia University Hospitals Inc
  • St Vincent'S Hospital Sydney
  • Cross Cancer Institute
  • Tom Baker Cancer Centre
  • London Health Sciences Centre Lhsc - South Street Hospital
  • Sir Mortimer B. Davis Jewish General Hospital Segal Cancer Ctr
  • McGill University Health Centre/Glen Site/Cedars Cancer Centre
  • Fakultni Nemocnice Olomouc
  • Thomayerova Nemocnice
  • Prof Mudr Petr Arenberger Drsc Mba
  • Nemocnice Na Bulovce
  • H�PITAL AMBROISE PAR
  • Chu Hopital de La Timone
  • Centre Hospitalier Universitaire de Nantes (Chu de Nantes) - Hotel-Dieu
  • CHU DE NICE - H�PITAL L'ARCHET 1
  • Hospital Saint Louis
  • HOPITAL CHARLES NICOLLE CHU ROUEN - H�PITAL DE BOIS-GUILLAUME
  • Institut Gustave Roussy
  • Charite Universitaetsmedizin Berlin - Campus Charite Mitte
  • Elbe Klinikum Buxtehude
  • Helios Klinikum Erfurt
  • Universitatsklinikum Essen
  • Universitatsklinikum Schleswig-Holstein
  • Universitatsklinikum Giessen Und Marburg Gmbh, Klinik Für Innere Medizin
  • University Hospital Regensburg
  • Universitaetsklinikum in Tubingen
  • National Institute of Oncology
  • Debreceni Egyetem Klinikai Kozpon Belgyogy Klinika
  • Szte Borgyogyszati Es Allergologiai Klinika
  • Istituto Tumori Giovanni Paolo Ii Irccs Ospedale Oncologico Bari
  • Fondazione Del Piemonte Per L'Oncologia Ircc Candiolo
  • Irccs Azienda Ospedaliera Universitaria San Martino
  • Fondazione Irccs Istituto Nazionale Dei Tumori
  • European Institute of Oncology
  • A.O.U. Di Modena - Policlinico
  • Istituto Nazionale Tumori Irccs Fondazione Pascale
  • Iov - Istituto Oncologico Veneto Irccs
  • ONCOLOGIA � IDI IRCCS ISTITUTO DERMOPATICO DELL'IMMACOLATA
  • Azienda Ospedaliera Universitaria Senese Policlinico Santa Maria Alle Scotte
  • Centrum Onkologii - Instytut Im. Marii Sklodowskiej - Curie
  • Hospital General Universitario Vall D Hebron
  • Hospital Clinic I Provincial
  • Hospital General Universitario Gregorio Maranon
  • Centre Hospitalier Universitaire Vaudois (Chuv)
  • Universitatsspital Zurich
  • Castle Hill Hospital
  • Royal Free London Nhs Foundation Trust
  • The Royal Marsden Nhs Foundation Trust
  • The Royal Marsden Nhs Foundation Trust - Sutton
  • Royal Cornwall Hospital Truro Sunrise Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Retifanlimab: Chemotherapy: Naïve

Retifanlimab: Chemotherapy: Refractory

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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).
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.
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.
First-dose Cmax of Retifanlimab
Cmax was defined as the maximum observed plasma concentration.
First-dose Cmin of Retifanlimab
Cmin was defined as the minimum observed plasma concentration over the dose interval.
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.

Full Information

First Posted
July 16, 2018
Last Updated
May 9, 2023
Sponsor
Incyte Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT03599713
Brief Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 25, 2019 (Actual)
Primary Completion Date
January 21, 2022 (Actual)
Study Completion Date
June 28, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Incyte Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Merkel Cell Carcinoma
Keywords
Metastatic merkel cell carcinoma, anti-PD-1 antibody, immunoglobulin G4 (IgG4) monoclonal antibody, INCMGA00012

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
107 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Retifanlimab: Chemotherapy: Naïve
Arm Type
Experimental
Arm Title
Retifanlimab: Chemotherapy: Refractory
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Retifanlimab
Other Intervention Name(s)
MGA012, INCMGA00012
Intervention Description
INCMGA00012 administered at 500 milligrams (mg) by intravenous infusion once every 4 weeks
Primary Outcome Measure Information:
Title
Objective Response Rate (ORR)
Description
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.
Time Frame
up to 26.8 months
Secondary Outcome Measure Information:
Title
Duration of Response (DOR)
Description
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.
Time Frame
up to 24.9 months
Title
Disease Control Rate (DCR)
Description
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.
Time Frame
up to 26.8 months
Title
Progression-free Survival (PFS)
Description
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).
Time Frame
up to 26.8 months
Title
Overall Survival
Description
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.
Time Frame
up to 33.9 months
Title
Number of Participants With Any Treatment-emergent Adverse Event (TEAE)
Description
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.
Time Frame
up to 823 days (up to approximately 2.3 years)
Title
First-dose Cmax of Retifanlimab
Description
Cmax was defined as the maximum observed plasma concentration.
Time Frame
preinfusion, 10 minutes postinfusion (± 10 minutes), and 4 hours postinfusion (± 10 minutes) on Day 1 of Cycle 1
Title
First-dose Cmin of Retifanlimab
Description
Cmin was defined as the minimum observed plasma concentration over the dose interval.
Time Frame
preinfusion, 10 minutes postinfusion (± 10 minutes), and 4 hours postinfusion (± 10 minutes) on Day 1 of Cycle 1
Title
First-dose AUC0-t of Retifanlimab
Description
AUC0-t was defined as the area under the plasma concentration-time curve from time zero to time t.
Time Frame
preinfusion, 10 minutes postinfusion (± 10 minutes), and 4 hours postinfusion (± 10 minutes) on Day 1 of Cycle 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Incyte Medical Monitor
Organizational Affiliation
Incyte Corporation
Official's Role
Study Director
Facility Information:
Facility Name
Stanford Cancer Institute
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
University of California San Francisco Comprehensive Cancer Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
University of Colorado Cancer Center
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Georgetown University Hospital
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Rush University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Norton Cancer Institute
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40241
Country
United States
Facility Name
Mayo Clinic Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
John Theurer Cancer Center, Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Rutgers Cancer Institute of Nj
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
The Christ Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Upmc Cancercenter
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
Inova Fairfax Hospital
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Facility Name
University of Washington - Seattle Cancer Care Alliance
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
West Virginia University Hospitals Inc
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States
Facility Name
St Vincent'S Hospital Sydney
City
Darlinghurst
State/Province
New South Wales
ZIP/Postal Code
02010
Country
Australia
Facility Name
Cross Cancer Institute
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Facility Name
Tom Baker Cancer Centre
City
Calgary Ab
State/Province
CA
ZIP/Postal Code
T2N 4N2
Country
Canada
Facility Name
London Health Sciences Centre Lhsc - South Street Hospital
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4G5
Country
Canada
Facility Name
Sir Mortimer B. Davis Jewish General Hospital Segal Cancer Ctr
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T1E2
Country
Canada
Facility Name
McGill University Health Centre/Glen Site/Cedars Cancer Centre
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4A 3J1
Country
Canada
Facility Name
Fakultni Nemocnice Olomouc
City
Olomouc
ZIP/Postal Code
775 20
Country
Czechia
Facility Name
Thomayerova Nemocnice
City
Praha 4-krc
ZIP/Postal Code
140 59
Country
Czechia
Facility Name
Prof Mudr Petr Arenberger Drsc Mba
City
Praha
ZIP/Postal Code
110 00
Country
Czechia
Facility Name
Nemocnice Na Bulovce
City
Praha
ZIP/Postal Code
180-81
Country
Czechia
Facility Name
H�PITAL AMBROISE PAR
City
Boulogne-billancourt
ZIP/Postal Code
92100
Country
France
Facility Name
Chu Hopital de La Timone
City
Marseille Cedex 5
ZIP/Postal Code
13385
Country
France
Facility Name
Centre Hospitalier Universitaire de Nantes (Chu de Nantes) - Hotel-Dieu
City
Nantes Cedex
ZIP/Postal Code
44093
Country
France
Facility Name
CHU DE NICE - H�PITAL L'ARCHET 1
City
Nice Cedex 3
ZIP/Postal Code
06202
Country
France
Facility Name
Hospital Saint Louis
City
Paris
ZIP/Postal Code
75 010
Country
France
Facility Name
HOPITAL CHARLES NICOLLE CHU ROUEN - H�PITAL DE BOIS-GUILLAUME
City
Rouen
ZIP/Postal Code
76031
Country
France
Facility Name
Institut Gustave Roussy
City
Villejuif Cedex
ZIP/Postal Code
94805
Country
France
Facility Name
Charite Universitaetsmedizin Berlin - Campus Charite Mitte
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Elbe Klinikum Buxtehude
City
Buxtehude
ZIP/Postal Code
21614
Country
Germany
Facility Name
Helios Klinikum Erfurt
City
Erfurt
Country
Germany
Facility Name
Universitatsklinikum Essen
City
Essen
ZIP/Postal Code
45122
Country
Germany
Facility Name
Universitatsklinikum Schleswig-Holstein
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Facility Name
Universitatsklinikum Giessen Und Marburg Gmbh, Klinik Für Innere Medizin
City
Marburg
ZIP/Postal Code
35043
Country
Germany
Facility Name
University Hospital Regensburg
City
Regensburg
ZIP/Postal Code
93053
Country
Germany
Facility Name
Universitaetsklinikum in Tubingen
City
Tubingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
National Institute of Oncology
City
Budapest
ZIP/Postal Code
01122
Country
Hungary
Facility Name
Debreceni Egyetem Klinikai Kozpon Belgyogy Klinika
City
Debrecen
ZIP/Postal Code
04032
Country
Hungary
Facility Name
Szte Borgyogyszati Es Allergologiai Klinika
City
Szeged
ZIP/Postal Code
06720
Country
Hungary
Facility Name
Istituto Tumori Giovanni Paolo Ii Irccs Ospedale Oncologico Bari
City
Bari
ZIP/Postal Code
70124
Country
Italy
Facility Name
Fondazione Del Piemonte Per L'Oncologia Ircc Candiolo
City
Candiolo
ZIP/Postal Code
10060
Country
Italy
Facility Name
Irccs Azienda Ospedaliera Universitaria San Martino
City
Genova
ZIP/Postal Code
16132
Country
Italy
Facility Name
Fondazione Irccs Istituto Nazionale Dei Tumori
City
Milan
ZIP/Postal Code
20133
Country
Italy
Facility Name
European Institute of Oncology
City
Milan
ZIP/Postal Code
20141
Country
Italy
Facility Name
A.O.U. Di Modena - Policlinico
City
Modena
ZIP/Postal Code
41124
Country
Italy
Facility Name
Istituto Nazionale Tumori Irccs Fondazione Pascale
City
Naples
ZIP/Postal Code
80131
Country
Italy
Facility Name
Iov - Istituto Oncologico Veneto Irccs
City
Padova
ZIP/Postal Code
35128
Country
Italy
Facility Name
ONCOLOGIA � IDI IRCCS ISTITUTO DERMOPATICO DELL'IMMACOLATA
City
Rome
ZIP/Postal Code
00167
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria Senese Policlinico Santa Maria Alle Scotte
City
Siena
ZIP/Postal Code
53100
Country
Italy
Facility Name
Centrum Onkologii - Instytut Im. Marii Sklodowskiej - Curie
City
Warsaw
ZIP/Postal Code
02-781
Country
Poland
Facility Name
Hospital General Universitario Vall D Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Clinic I Provincial
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital General Universitario Gregorio Maranon
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Centre Hospitalier Universitaire Vaudois (Chuv)
City
Lausanne
ZIP/Postal Code
01011
Country
Switzerland
Facility Name
Universitatsspital Zurich
City
Zuerich
ZIP/Postal Code
08091
Country
Switzerland
Facility Name
Castle Hill Hospital
City
Cottingham
ZIP/Postal Code
HU16 5JQ
Country
United Kingdom
Facility Name
Royal Free London Nhs Foundation Trust
City
London
ZIP/Postal Code
NW3 2QG
Country
United Kingdom
Facility Name
The Royal Marsden Nhs Foundation Trust
City
London
ZIP/Postal Code
SW3 6JJ
Country
United Kingdom
Facility Name
The Royal Marsden Nhs Foundation Trust - Sutton
City
Sutton
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Facility Name
Royal Cornwall Hospital Truro Sunrise Centre
City
Truro
ZIP/Postal Code
TR1 3LJ
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

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

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