Back to resultsSafety and Efficacy of Retifanlimab (INCMGA00012) Alone or in Combination With Other Therapies in Participants With Advanced or Metastatic Endometrial Cancer Who Have Progressed on or After Platinum-based Chemotherapy. (POD1UM-204)
Primary Purpose
Endometrial Cancer
Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
retifanlimab
epacadostat
pemigatinib
INCAGN02385
INCAGN02390
Sponsored by
About this trial
This is an interventional treatment trial for Endometrial Cancer focused on measuring Endometrial Carcinoma, Endometrium Cancer, Neoplasms Endometrial, Advanced, Metastatic, PD-1, PD-L1, retifanlimab, INCMGA0012, INCAGN02385, INCAGN02390, PODIUM, LAG-3, TIM-3
Eligibility Criteria
Inclusion Criteria:
- Ability to comprehend and willingness to sign a written ICF for the study. Note for Germany: This excludes individuals who are housed in an institution due to official or court order Women 18 years of age or older (or as applicable per local country requirements).
- Histologically confirmed diagnosis of advanced or metastatic endometrial cancer with disease progression on or after treatment with at least 1 platinum-containing regimen for advanced or metastatic disease.
- Groups A, B, and E: Have not been previously treated with a PD-(L)1 inhibitor.
- Group A only: Tumor tissue tested as MSI-High
- Group B only: Tumor tissue tested as deficient MMR or an ultra-mutated POLE tumor.
- Group D only: Tumor tissue tested as having an FGFR 1,2,3 mutation or alteration characterized as per protocol.
- Group E: Tumor tissue tested as MSS and PD-L1 positive.
- Group F: Radiological evidence of disease progression on or after prior PD (L)1 therapy and Tumor tissue tested as MSI-H
- Must have at least 1 measurable tumor lesion per RECIST v1.1.
- Willing to provide tumor tissue sample (fresh or archived).
- ECOG performance status 0 to 1.
- Willingness to avoid pregnancy.
Exclusion Criteria:
- Group A, B and E only: Histologically confirmed diagnosis of carcinosarcoma of the uterus.
- Histologically confirmed diagnosis of sarcoma of the uterus.
- Has disease eligible for potentially curative treatment.
- Receipt of anticancer therapy within 28 days of the first administration of study treatment, with the exception of localized radiotherapy.
- Toxicity of prior therapy that has not recovered to ≤ Grade 1 or baseline unless approved by the medical monitor.
- Groups C, D and F (combinations): limiting immune-related toxicity during prior checkpoint inhibitor therapy.
- Group F only: Previous treatment with LAG-# or TIM-3 therapy or lenvatinib; multiple metastases that achieved mixed tumor response to prior anti-PD-(L)1 therapy
- Has an active autoimmune disease requiring systemic immunosuppression with corticosteroids (> 10 mg/day of prednisone or equivalent) or immunosuppressive drugs within 14 days before the first dose of study treatment.
- Receiving chronic systemic steroids (> 10 mg/day of prednisone or equivalent):
- Known active CNS metastases and/or carcinomatous meningitis.
- Has known active hepatitis B or C.
- Has received a live vaccine within 28 days of the planned start of study treatment.
- Evidence of interstitial lung disease or active, noninfectious pneumonitis.
- Participants who are known to be HIV-positive with some protocol exceptions.
Sites / Locations
- Alaska Womens Cancer Care AkwccRecruiting
- HonorhealthRecruiting
- Arizona Oncology AssociatesRecruiting
- UCLA Medical Hematology & Oncology
- Olive View Med Ctr
- Broward Health Medical CenterRecruiting
- Mount Sinai Medical Center Comprehensive Cancer CenterRecruiting
- Miami Cancer InstituteRecruiting
- Advent Health Medical Group-Orlando 2501
- H. Lee Moffitt Cancer Center and Research Institute HospitalRecruiting
- Georgia Cancer Center
- Barbara Ann Karmanos Cancer Hospital
- Minnesota Oncology-MaplewoodRecruiting
- Midwest Cancer Care
- Washington UniversityRecruiting
- Billings Clinic Cancer Center
- Comprehensive Cancer Centers of NevadaRecruiting
- New Mexico Cancer Care Alliance
- Columbia University Hervert Irving Comprehensive Cancer CenterRecruiting
- University of North Carolina At Chapel Hill
- The Ohio State University Wexner Medical Center Division of Gynecologic OncologyRecruiting
- Willamette Valley Cancer InstituteRecruiting
- Texas Oncology-TylerRecruiting
- Tennessee OncologyRecruiting
- Texas Oncology-Austin CenterRecruiting
- Texas OncologyRecruiting
- Texas Oncology San AntonioRecruiting
- Texas Oncology the WoodlandsRecruiting
- Virginia Commonwealth University
- O.L.V Ziekenhuis
- Institut Jules BordetRecruiting
- Ghent University HospitalRecruiting
- Universitaire Ziekenhuis Leuven - GasthuisbergRecruiting
- Centre Hospitalier Universitaire de Liege - Sart TilmanRecruiting
- Chu Ucl Namur de Saint ElisabethRecruiting
- The Affiliated Drum Tower Hospital of Nanjing University
- Chu Besancon Hospital Jean MinjozRecruiting
- Institut BergonieRecruiting
- Hospital Cochin CancerologieRecruiting
- Cario - Centre Armoricain de Radiotherapie Imagerie Medicale Et OncologieRecruiting
- Centre de Lutte Contre Le Cancer - Institut de Cancerologie de L'Ouest - Rene GauducheauRecruiting
- Institut Gustave RoussyRecruiting
- High Technology Hospital MedcenterRecruiting
- Jsc Evex HospitalsRecruiting
- Todua Clinic, LlcRecruiting
- Caucasus Medical Centre LlcRecruiting
- Ltd InnovaRecruiting
- Multiprofile Clinic Consilium Medulla LlcRecruiting
- Charite - Campus Virchow-Klinikum
- University Clinic Carl Gustav Carus Technical University Dresden
- Klinikum Kassel Gmbh
- Universitarsfrauenklinik Ulm
- Alexandra General Hospital of AthensRecruiting
- University Hospital of West Attica - AttikonRecruiting
- Hygeia HospitalRecruiting
- Euromedica General Clinic of ThessalonikiRecruiting
- L Azienda Ospedaliero-Universitaria Di Bologna Policlinico S. Orsola - MalpighiRecruiting
- Presidio Ospedaliero Di Summa Antonio Perrino
- Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei TumoriRecruiting
- Istituto Di Ricovero E Cura A Carattere Scientifico (Irccs) Ospedale San RaffaeleRecruiting
- Comitato Etico Fondazione Irccs Istituto Nazionale Dei Tumori MilanoRecruiting
- European Institute of OncologyRecruiting
- Istituto Nazionale Tumori Irccs Fondazione PascaleRecruiting
- Iov - Istituto Oncologico Veneto Irccs
- Fondazione Policlinico Universitario Agostino Gemelli IrccsRecruiting
- Ospedale Santa Maria Ca FoncelloRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
Group A - retifanlimab
Group B - retifanlimab
Group C - retifanlimab + epacadostat
Group D - retifanlimab + pemigatinib
Group E - retifanlimab + epacadostat
Group F - retifanlimab + INCAGN02385 and INCAGN02390
Arm Description
Select participants naïve to checkpoint inhibitors will be administered retifanlimab intravenously
Select participants naïve to checkpoint inhibitors will be administered retifanlimab intravenously
Select participants who are allowed on prior checkpoint inhibitors will be administered retifanlimab intravenously in combination with oral epacadostat (IDO1 inhibitor)
Select participants who are allowed on prior checkpoint inhibitors will be administered retifanlimab intravenously in combination with oral pemigatininb (FGFR 1,2,3 inhibitor)
Select participants naïve to checkpoint inhibitors will be administered retifanlimab intravenously in combination with oral epacadostat
Select participants who are allowed on prior checkpoint inhibitors will be administered retifanlimab in combination with INCAGN02385 and INCAGN02390 intravenously
Outcomes
Primary Outcome Measures
Group A - Objective Response Rate
Defined as the proportion of participants having a CR or PR according to RECIST v1.1, as assessed by Independent Central Review committee
Secondary Outcome Measures
Group A -Duration of Response
Defined as the time from the first documented objective response (CR or PR) according to RECIST v1.1 (as determined by ICR) until disease progression or death due to any cause.
Group A - Disease Control Rate
Defined as the proportion of participants with CR, PR, or SD (as determined by ICR) as best response.
Group A - Overall Survival
Defined as the time from the first dose of study treatment until death due to any cause.
Group A - Progression Free Survival
Defined as the time from the first dose of study treatment until disease progression (as determined by ICR) or death due to any cause.
Group B -Duration of Response
Defined as the time from the first documented objective response (CR or PR) according to RECIST v1.1 (as determined by ICR) until disease progression or death due to any cause.
Group B - Disease Control Rate
Defined as the proportion of participants with CR, PR, or SD (as determined by ICR) as best response.
Group B - Overall Survival
Defined as the time from the first dose of study treatment until death due to any cause.
Groups B - Objective Response Rate
Defined as the proportion of participants having a CR or PR according to RECIST v1.1, as assessed by Independent Central Review committee
Group B - Progression Free Survival
Defined as the time from the first dose of study treatment until disease progression (as determined by ICR) or death due to any cause.
Groups C, D, E and F - Objective Response Rate
Defined as the proportion of participants having a CR or PR according to RECIST v1.1, as assessed by Independent Central Review committee
Number of Treatment-Related Adverse Events
Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment.
Full Information
NCT ID
NCT04463771
First Posted
July 6, 2020
Last Updated
July 6, 2023
Sponsor
Incyte Corporation
Collaborators
GOG Foundation, European Network of Gynaecological Oncological Trial Groups (ENGOT)
1. Study Identification
Unique Protocol Identification Number
NCT04463771
Brief Title
Safety and Efficacy of Retifanlimab (INCMGA00012) Alone or in Combination With Other Therapies in Participants With Advanced or Metastatic Endometrial Cancer Who Have Progressed on or After Platinum-based Chemotherapy.
Acronym
POD1UM-204
Official Title
An Umbrella Study of INCMGA00012 Alone and in Combination With Other Therapies in Participants With Advanced or Metastatic Endometrial Cancer Who Have Progressed on or After Platinum-Based Chemotherapy (POD1UM-204)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 26, 2021 (Actual)
Primary Completion Date
August 25, 2023 (Anticipated)
Study Completion Date
June 22, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Incyte Corporation
Collaborators
GOG Foundation, European Network of Gynaecological Oncological Trial Groups (ENGOT)
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
This is a multicenter, open-label, nonrandomized, Phase 2 umbrella study of retifanlimab in participants who have advanced or metastatic endometrial cancer that has progressed on or after platinum-based chemotherapy. retifanlimab will be administered as monotherapy or in combination with other immunotherapy or targeted agents.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometrial Cancer
Keywords
Endometrial Carcinoma, Endometrium Cancer, Neoplasms Endometrial, Advanced, Metastatic, PD-1, PD-L1, retifanlimab, INCMGA0012, INCAGN02385, INCAGN02390, PODIUM, LAG-3, TIM-3
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group A - retifanlimab
Arm Type
Experimental
Arm Description
Select participants naïve to checkpoint inhibitors will be administered retifanlimab intravenously
Arm Title
Group B - retifanlimab
Arm Type
Experimental
Arm Description
Select participants naïve to checkpoint inhibitors will be administered retifanlimab intravenously
Arm Title
Group C - retifanlimab + epacadostat
Arm Type
Experimental
Arm Description
Select participants who are allowed on prior checkpoint inhibitors will be administered retifanlimab intravenously in combination with oral epacadostat (IDO1 inhibitor)
Arm Title
Group D - retifanlimab + pemigatinib
Arm Type
Experimental
Arm Description
Select participants who are allowed on prior checkpoint inhibitors will be administered retifanlimab intravenously in combination with oral pemigatininb (FGFR 1,2,3 inhibitor)
Arm Title
Group E - retifanlimab + epacadostat
Arm Type
Experimental
Arm Description
Select participants naïve to checkpoint inhibitors will be administered retifanlimab intravenously in combination with oral epacadostat
Arm Title
Group F - retifanlimab + INCAGN02385 and INCAGN02390
Arm Type
Experimental
Arm Description
Select participants who are allowed on prior checkpoint inhibitors will be administered retifanlimab in combination with INCAGN02385 and INCAGN02390 intravenously
Intervention Type
Drug
Intervention Name(s)
retifanlimab
Other Intervention Name(s)
INCMGA00012
Intervention Description
INCMGA00012 administered intravenously on Day 1 of each 28-day cycle for up to 26 cycles.
Intervention Type
Drug
Intervention Name(s)
epacadostat
Intervention Description
epacadostat will be administered orally BID.
Intervention Type
Drug
Intervention Name(s)
pemigatinib
Intervention Description
pemigatinib will be administered orally QD.
Intervention Type
Drug
Intervention Name(s)
INCAGN02385
Intervention Description
INCAGN2385 will be administered every 2 weeks
Intervention Type
Drug
Intervention Name(s)
INCAGN02390
Intervention Description
INCAGN2390 will be administered every 2 weeks
Primary Outcome Measure Information:
Title
Group A - Objective Response Rate
Description
Defined as the proportion of participants having a CR or PR according to RECIST v1.1, as assessed by Independent Central Review committee
Time Frame
up to 2.5 years
Secondary Outcome Measure Information:
Title
Group A -Duration of Response
Description
Defined as the time from the first documented objective response (CR or PR) according to RECIST v1.1 (as determined by ICR) until disease progression or death due to any cause.
Time Frame
up to 2.5 years
Title
Group A - Disease Control Rate
Description
Defined as the proportion of participants with CR, PR, or SD (as determined by ICR) as best response.
Time Frame
up to 2.5 years
Title
Group A - Overall Survival
Description
Defined as the time from the first dose of study treatment until death due to any cause.
Time Frame
up to 3.5 years
Title
Group A - Progression Free Survival
Description
Defined as the time from the first dose of study treatment until disease progression (as determined by ICR) or death due to any cause.
Time Frame
up to 3.5 years
Title
Group B -Duration of Response
Description
Defined as the time from the first documented objective response (CR or PR) according to RECIST v1.1 (as determined by ICR) until disease progression or death due to any cause.
Time Frame
up to 2.5 years
Title
Group B - Disease Control Rate
Description
Defined as the proportion of participants with CR, PR, or SD (as determined by ICR) as best response.
Time Frame
up to 2.5 years
Title
Group B - Overall Survival
Description
Defined as the time from the first dose of study treatment until death due to any cause.
Time Frame
up to 3.5 years
Title
Groups B - Objective Response Rate
Description
Defined as the proportion of participants having a CR or PR according to RECIST v1.1, as assessed by Independent Central Review committee
Time Frame
up to 2 years
Title
Group B - Progression Free Survival
Description
Defined as the time from the first dose of study treatment until disease progression (as determined by ICR) or death due to any cause.
Time Frame
up to 3.5 years
Title
Groups C, D, E and F - Objective Response Rate
Description
Defined as the proportion of participants having a CR or PR according to RECIST v1.1, as assessed by Independent Central Review committee
Time Frame
up to 2 years
Title
Number of Treatment-Related Adverse Events
Description
Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment.
Time Frame
up to 4 years
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Ability to comprehend and willingness to sign a written ICF for the study. Note for Germany: This excludes individuals who are housed in an institution due to official or court order Women 18 years of age or older (or as applicable per local country requirements).
Histologically confirmed diagnosis of advanced or metastatic endometrial cancer with disease progression on or after treatment with at least 1 platinum-containing regimen for advanced or metastatic disease.
Groups A, B, and E: Have not been previously treated with a PD-(L)1 inhibitor.
Group A only: Tumor tissue tested as MSI-High
Group B only: Tumor tissue tested as deficient MMR or an ultra-mutated POLE tumor.
Group D only: Tumor tissue tested as having an FGFR 1,2,3 mutation or alteration characterized as per protocol.
Group E: Tumor tissue tested as MSS and PD-L1 positive.
Group F: Radiological evidence of disease progression on or after prior PD (L)1 therapy and Tumor tissue tested as MSI-H
Must have at least 1 measurable tumor lesion per RECIST v1.1.
Willing to provide tumor tissue sample (fresh or archived).
ECOG performance status 0 to 1.
Willingness to avoid pregnancy.
Exclusion Criteria:
Group A, B and E only: Histologically confirmed diagnosis of carcinosarcoma of the uterus.
Histologically confirmed diagnosis of sarcoma of the uterus.
Has disease eligible for potentially curative treatment.
Receipt of anticancer therapy within 28 days of the first administration of study treatment, with the exception of localized radiotherapy.
Toxicity of prior therapy that has not recovered to ≤ Grade 1 or baseline unless approved by the medical monitor.
Groups C, D and F (combinations): limiting immune-related toxicity during prior checkpoint inhibitor therapy.
Group F only: Previous treatment with LAG-# or TIM-3 therapy or lenvatinib; multiple metastases that achieved mixed tumor response to prior anti-PD-(L)1 therapy
Has an active autoimmune disease requiring systemic immunosuppression with corticosteroids (> 10 mg/day of prednisone or equivalent) or immunosuppressive drugs within 14 days before the first dose of study treatment.
Receiving chronic systemic steroids (> 10 mg/day of prednisone or equivalent):
Known active CNS metastases and/or carcinomatous meningitis.
Has known active hepatitis B or C.
Has received a live vaccine within 28 days of the planned start of study treatment.
Evidence of interstitial lung disease or active, noninfectious pneumonitis.
Participants who are known to be HIV-positive with some protocol exceptions.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Incyte Corporation Call Center (US)
Phone
1.855.463.3463
Email
medinfo@incyte.com
First Name & Middle Initial & Last Name or Official Title & Degree
Incyte Corporation Call Center (ex-US)
Phone
+800 00027423
Email
eumedinfo@incyte.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Cornfield
Organizational Affiliation
Incyte Corporation
Official's Role
Study Director
Facility Information:
Facility Name
Alaska Womens Cancer Care Akwcc
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99508
Country
United States
Individual Site Status
Recruiting
Facility Name
Honorhealth
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
Individual Site Status
Recruiting
Facility Name
Arizona Oncology Associates
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85711
Country
United States
Individual Site Status
Recruiting
Facility Name
UCLA Medical Hematology & Oncology
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Individual Site Status
Completed
Facility Name
Olive View Med Ctr
City
Sylmar
State/Province
California
ZIP/Postal Code
91342
Country
United States
Individual Site Status
Completed
Facility Name
Broward Health Medical Center
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33316
Country
United States
Individual Site Status
Recruiting
Facility Name
Mount Sinai Medical Center Comprehensive Cancer Center
City
Miami Beach
State/Province
Florida
ZIP/Postal Code
33140
Country
United States
Individual Site Status
Recruiting
Facility Name
Miami Cancer Institute
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Individual Site Status
Recruiting
Facility Name
Advent Health Medical Group-Orlando 2501
City
Orlando
State/Province
Florida
ZIP/Postal Code
32804
Country
United States
Individual Site Status
Completed
Facility Name
H. Lee Moffitt Cancer Center and Research Institute Hospital
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612-9497
Country
United States
Individual Site Status
Recruiting
Facility Name
Georgia Cancer Center
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Individual Site Status
Completed
Facility Name
Barbara Ann Karmanos Cancer Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Individual Site Status
Completed
Facility Name
Minnesota Oncology-Maplewood
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55404
Country
United States
Individual Site Status
Recruiting
Facility Name
Midwest Cancer Care
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64132
Country
United States
Individual Site Status
Completed
Facility Name
Washington University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Name
Billings Clinic Cancer Center
City
Billings
State/Province
Montana
ZIP/Postal Code
59101
Country
United States
Individual Site Status
Completed
Facility Name
Comprehensive Cancer Centers of Nevada
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89148
Country
United States
Individual Site Status
Recruiting
Facility Name
New Mexico Cancer Care Alliance
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States
Individual Site Status
Completed
Facility Name
Columbia University Hervert Irving Comprehensive Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Recruiting
Facility Name
University of North Carolina At Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States
Individual Site Status
Completed
Facility Name
The Ohio State University Wexner Medical Center Division of Gynecologic Oncology
City
Hilliard
State/Province
Ohio
ZIP/Postal Code
43026
Country
United States
Individual Site Status
Recruiting
Facility Name
Willamette Valley Cancer Institute
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401-8122
Country
United States
Individual Site Status
Recruiting
Facility Name
Texas Oncology-Tyler
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57104
Country
United States
Individual Site Status
Recruiting
Facility Name
Tennessee Oncology
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Individual Site Status
Recruiting
Facility Name
Texas Oncology-Austin Center
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Individual Site Status
Recruiting
Facility Name
Texas Oncology
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104-3902
Country
United States
Individual Site Status
Recruiting
Facility Name
Texas Oncology San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240
Country
United States
Individual Site Status
Recruiting
Facility Name
Texas Oncology the Woodlands
City
Shenandoah
State/Province
Texas
ZIP/Postal Code
77380
Country
United States
Individual Site Status
Recruiting
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Individual Site Status
Completed
Facility Name
O.L.V Ziekenhuis
City
Aalst
ZIP/Postal Code
09300
Country
Belgium
Individual Site Status
Completed
Facility Name
Institut Jules Bordet
City
Brussels
ZIP/Postal Code
01000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Ghent University Hospital
City
Gent
ZIP/Postal Code
09000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Universitaire Ziekenhuis Leuven - Gasthuisberg
City
Leuven
ZIP/Postal Code
03000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Centre Hospitalier Universitaire de Liege - Sart Tilman
City
Liège
ZIP/Postal Code
04000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Chu Ucl Namur de Saint Elisabeth
City
Namur
ZIP/Postal Code
05000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
The Affiliated Drum Tower Hospital of Nanjing University
City
Nanjing
ZIP/Postal Code
210008
Country
China
Individual Site Status
Withdrawn
Facility Name
Chu Besancon Hospital Jean Minjoz
City
Besancon
ZIP/Postal Code
25030
Country
France
Individual Site Status
Recruiting
Facility Name
Institut Bergonie
City
Bordeaux Cedex
ZIP/Postal Code
33076
Country
France
Individual Site Status
Recruiting
Facility Name
Hospital Cochin Cancerologie
City
Paris
ZIP/Postal Code
75006
Country
France
Individual Site Status
Recruiting
Facility Name
Cario - Centre Armoricain de Radiotherapie Imagerie Medicale Et Oncologie
City
Plérin
ZIP/Postal Code
22190
Country
France
Individual Site Status
Recruiting
Facility Name
Centre de Lutte Contre Le Cancer - Institut de Cancerologie de L'Ouest - Rene Gauducheau
City
Saint Herblain
ZIP/Postal Code
44800
Country
France
Individual Site Status
Recruiting
Facility Name
Institut Gustave Roussy
City
Villejuif Cedex
ZIP/Postal Code
94805
Country
France
Individual Site Status
Recruiting
Facility Name
High Technology Hospital Medcenter
City
Batumi
ZIP/Postal Code
06000
Country
Georgia
Individual Site Status
Recruiting
Facility Name
Jsc Evex Hospitals
City
Kutaisi
ZIP/Postal Code
04600
Country
Georgia
Individual Site Status
Recruiting
Facility Name
Todua Clinic, Llc
City
Tbilisi
ZIP/Postal Code
00112
Country
Georgia
Individual Site Status
Recruiting
Facility Name
Caucasus Medical Centre Llc
City
Tbilisi
ZIP/Postal Code
00186
Country
Georgia
Individual Site Status
Recruiting
Facility Name
Ltd Innova
City
Tbilisi
ZIP/Postal Code
00186
Country
Georgia
Individual Site Status
Recruiting
Facility Name
Multiprofile Clinic Consilium Medulla Llc
City
Tbilisi
ZIP/Postal Code
00186
Country
Georgia
Individual Site Status
Recruiting
Facility Name
Charite - Campus Virchow-Klinikum
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Individual Site Status
Completed
Facility Name
University Clinic Carl Gustav Carus Technical University Dresden
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Individual Site Status
Completed
Facility Name
Klinikum Kassel Gmbh
City
Kassel
ZIP/Postal Code
34125
Country
Germany
Individual Site Status
Completed
Facility Name
Universitarsfrauenklinik Ulm
City
ULM
ZIP/Postal Code
89075
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Alexandra General Hospital of Athens
City
Athens
ZIP/Postal Code
11528
Country
Greece
Individual Site Status
Recruiting
Facility Name
University Hospital of West Attica - Attikon
City
Athens
ZIP/Postal Code
12462
Country
Greece
Individual Site Status
Recruiting
Facility Name
Hygeia Hospital
City
Marousi
ZIP/Postal Code
15123
Country
Greece
Individual Site Status
Recruiting
Facility Name
Euromedica General Clinic of Thessaloniki
City
Thessaloniki
ZIP/Postal Code
54645
Country
Greece
Individual Site Status
Recruiting
Facility Name
L Azienda Ospedaliero-Universitaria Di Bologna Policlinico S. Orsola - Malpighi
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Individual Site Status
Recruiting
Facility Name
Presidio Ospedaliero Di Summa Antonio Perrino
City
Brindisi
ZIP/Postal Code
72100
Country
Italy
Individual Site Status
Completed
Facility Name
Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori
City
Meldola
ZIP/Postal Code
47014
Country
Italy
Individual Site Status
Recruiting
Facility Name
Istituto Di Ricovero E Cura A Carattere Scientifico (Irccs) Ospedale San Raffaele
City
Milano
ZIP/Postal Code
20132
Country
Italy
Individual Site Status
Recruiting
Facility Name
Comitato Etico Fondazione Irccs Istituto Nazionale Dei Tumori Milano
City
Milano
ZIP/Postal Code
20133
Country
Italy
Individual Site Status
Recruiting
Facility Name
European Institute of Oncology
City
Milano
ZIP/Postal Code
20141
Country
Italy
Individual Site Status
Recruiting
Facility Name
Istituto Nazionale Tumori Irccs Fondazione Pascale
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Individual Site Status
Recruiting
Facility Name
Iov - Istituto Oncologico Veneto Irccs
City
Padova
ZIP/Postal Code
35128
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
Fondazione Policlinico Universitario Agostino Gemelli Irccs
City
Roma
ZIP/Postal Code
00168
Country
Italy
Individual Site Status
Recruiting
Facility Name
Ospedale Santa Maria Ca Foncello
City
Treviso
ZIP/Postal Code
31100
Country
Italy
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency
IPD Sharing Time Frame
Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
IPD Sharing Access Criteria
Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.
IPD Sharing URL
https://www.incyte.com/our-company/compliance-and-transparency
Learn more about this trial
Safety and Efficacy of Retifanlimab (INCMGA00012) Alone or in Combination With Other Therapies in Participants With Advanced or Metastatic Endometrial Cancer Who Have Progressed on or After Platinum-based Chemotherapy.
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