Phase
Condition
Endometriosis
Endometrial Cancer
Vaginal Cancer
Treatment
epacadostat
INCAGN02390
pemigatinib
Clinical Study ID
Ages > 18 Female
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Ability to comprehend and willingness to sign a written ICF for the study. Note forGermany: This excludes individuals who are housed in an institution due to officialor court order Women 18 years of age or older (or as applicable per local countryrequirements).
Histologically confirmed diagnosis of advanced or metastatic endometrial cancer withdisease progression on or after treatment with at least 1 platinum-containingregimen 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 alterationcharacterized 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)1therapy 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
Exclusion Criteria:
Group A, B and E only: Histologically confirmed diagnosis of carcinosarcoma of theuterus.
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 studytreatment, with the exception of localized radiotherapy.
Toxicity of prior therapy that has not recovered to ≤ Grade 1 or baseline unlessapproved by the medical monitor.
Groups C, D and F (combinations): limiting immune-related toxicity during priorcheckpoint inhibitor therapy.
Group F only: Previous treatment with LAG-# or TIM-3 therapy or lenvatinib; multiplemetastases that achieved mixed tumor response to prior anti-PD-(L)1 therapy
Has an active autoimmune disease requiring systemic immunosuppression withcorticosteroids (> 10 mg/day of prednisone or equivalent) or immunosuppressive drugswithin 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.
Study Design
Connect with a study center
O.L.V Ziekenhuis
Aalst, 09300
BelgiumSite Not Available
Institut Jules Bordet
Brussels, 01000
BelgiumSite Not Available
Institut Jules Bordet
Bruxelles, 01000
BelgiumSite Not Available
Ghent University Hospital
Gent, 09000
BelgiumSite Not Available
Centre Hospitalier Universitaire de Liege - Sart Tilman
LI�GE, 04000
BelgiumSite Not Available
Universitaire Ziekenhuis Leuven - Gasthuisberg
Leuven, 03000
BelgiumSite Not Available
Centre Hospitalier Universitaire de Liege - Sart Tilman
Liege, 04000
BelgiumSite Not Available
Centre Hospitalier Universitaire de Liege - Sart Tilman
Liã¨ge, 04000
BelgiumSite Not Available
Centre Hospitalier Universitaire de Liege - Sart Tilman
Liège, 04000
BelgiumSite Not Available
Chu Ucl Namur de Saint Elisabeth
Namur, 05000
BelgiumSite Not Available
Beijing Cancer Hospital
Beijing, 100044
ChinaSite Not Available
Xiangya Hospital Central South University
Changsha, 410000
ChinaSite Not Available
West China Second University Hospital, Sichuan University
Chengdu, 610066
ChinaSite Not Available
Chongqing University Cancer Hospital
Chongqing, 400030
ChinaSite Not Available
Sun Yat-Sen Memorial Hospital Sun Yat-Sen University
Guangzhou, 510000
ChinaSite Not Available
University of Science and Technology of China-First Affiliated Hospital (Anhui Provincial Hospital)
Hefei, 230001
ChinaSite Not Available
Qilu Hospital of Shandong University
Jinan, 250000
ChinaSite Not Available
The Affiliated Drum Tower Hospital of Nanjing University
Nanjing, 210008
ChinaSite Not Available
Tsingdao Central Hospital
Qingdao, 266042
ChinaSite Not Available
Obstetrics and Gynecology Hospital of Fudan University
Shanghai, 200011
ChinaSite Not Available
The Second Hospital of Shanxi Medical University
Taiyuan, 30001
ChinaSite Not Available
The First Affiliated Hospital of Xian Jiaotong University
Xi'an, 710061
ChinaSite Not Available
The First Affiliated Hospital of Xiamen University
Xiamen, 361003
ChinaSite Not Available
Henan Cancer Hostipal
Zhengzhou, 450008
ChinaSite Not Available
Chu Besancon Hospital Jean Minjoz
Besancon, 25000
FranceSite Not Available
Institut Bergonie
Bordeaux Cedex, 33076
FranceSite Not Available
Cario - Centre Armoricain de Radiotherapie Imagerie Medicale Et Oncologie
PL�RIN, 22198
FranceSite Not Available
Hospital Cochin Cancerologie
Paris, 75006
FranceSite Not Available
Cario - Centre Armoricain de Radiotherapie Imagerie Medicale Et Oncologie
Plerin, 22198
FranceSite Not Available
Cario - Centre Armoricain de Radiotherapie Imagerie Medicale Et Oncologie
Plã©rin, 22190
FranceSite Not Available
Cario - Centre Armoricain de Radiotherapie Imagerie Medicale Et Oncologie
Plérin, 22190
FranceSite Not Available
Centre de Lutte Contre Le Cancer - Institut de Cancerologie de L'Ouest - Rene Gauducheau
Saint Herblain, 44800
FranceSite Not Available
Institut Gustave Roussy
Villejuif Cedex, 94805
FranceSite Not Available
High Technology Hospital Medcenter
Batumi, 06000
GeorgiaSite Not Available
Jsc Evex Hospitals
Kutaisi, 04600
GeorgiaSite Not Available
Caucasus Medical Centre Llc
Tbilisi, 00186
GeorgiaSite Not Available
INNOVA
Tbilisi, 00186
GeorgiaSite Not Available
Ltd Innova
Tbilisi, 00186
GeorgiaActive - Recruiting
Multiprofile Clinic Consilium Medulla Llc
Tbilisi, 00186
GeorgiaSite Not Available
Todua Clinic, Llc
Tbilisi, 00112
GeorgiaSite Not Available
Charite - Campus Virchow-Klinikum
Berlin, 13353
GermanySite Not Available
Universitatsklinikum Bonn Aoer
Bonn, 53127
GermanySite Not Available
University Clinic Carl Gustav Carus Technical University Dresden
Dresden, 01307
GermanySite Not Available
Klinikum Kassel Gmbh
Kassel, 34125
GermanySite Not Available
Universitarsfrauenklinik Ulm
ULM, 89075
GermanySite Not Available
Alexandra General Hospital of Athens
Athens, 11528
GreeceSite Not Available
University Hospital of West Attica - Attikon
Athens, 12462
GreeceSite Not Available
Hygeia Hospital
Marousi, 15123
GreeceSite Not Available
Euromedica General Clinic of Thessaloniki
Thessaloniki, 54645
GreeceSite Not Available
Azienda Ospedaliero-Universitaria Di Bologna Policlinico S. Orsola - Malpighi
Bologna, 40138
ItalySite Not Available
L AZIENDA OSPEDALIERO-UNIVERSITARIA DI BOLOGNA POLICLINICO S. ORSOLA � MALPIGHI
Bologna, 40138
ItalyActive - Recruiting
L Azienda Ospedaliero-Universitaria Di Bologna Policlinico S. Orsola - Malpighi
Bologna, 40138
ItalyActive - Recruiting
Presidio Ospedaliero Di Summa Antonio Perrino
Brindisi, 72100
ItalySite Not Available
Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori
Meldola, 47014
ItalySite Not Available
Comitato Etico Fondazione Irccs Istituto Nazionale Dei Tumori Milano
Milano, 20133
ItalySite Not Available
European Institute of Oncology
Milano, 20141
ItalySite Not Available
Istituto Di Ricovero E Cura A Carattere Scientifico (Irccs) Ospedale San Raffaele
Milano, 20132
ItalySite Not Available
Istituto Nazionale Tumori Irccs Fondazione Pascale
Napoli, 80131
ItalySite Not Available
Iov - Istituto Oncologico Veneto Irccs
Padova, 35128
ItalySite Not Available
Fondazione Policlinico Universitario Agostino Gemelli Irccs
Roma, 00168
ItalySite Not Available
Ospedale Santa Maria Ca Foncello
Treviso, 31100
ItalySite Not Available
Alaska Womens Cancer Care Akwcc
Anchorage, Alaska 99508
United StatesSite Not Available
Honorhealth
Phoenix, Arizona 85016
United StatesSite Not Available
Arizona Oncology Associates
Tucson, Arizona 85711
United StatesSite Not Available
UCLA Medical Hematology & Oncology
Los Angeles, California 90048
United StatesSite Not Available
Olive View Med Ctr
Sylmar, California 91342
United StatesSite Not Available
Broward Health Medical Center
Fort Lauderdale, Florida 33316
United StatesSite Not Available
Miami Cancer Institute
Miami, Florida 33176
United StatesSite Not Available
Mount Sinai Medical Center Comprehensive Cancer Center
Miami Beach, Florida 33140
United StatesSite Not Available
Advent Health Medical Group-Orlando 2501
Orlando, Florida 32804
United StatesSite Not Available
H. Lee Moffitt Cancer Center and Research Institute Hospital
Tampa, Florida 33612-9497
United StatesSite Not Available
Georgia Cancer Center
Augusta, Georgia 30912
United StatesSite Not Available
Barbara Ann Karmanos Cancer Hospital
Detroit, Michigan 48201
United StatesSite Not Available
Minnesota Oncology-Maplewood
Coon Rapids, Minnesota 55433
United StatesSite Not Available
Minnesota Oncology - Maplewood
Minneapolis, Minnesota 55404
United StatesActive - Recruiting
Minnesota Oncology-Maplewood
Minneapolis, Minnesota 55404
United StatesSite Not Available
Mayo Clinic
Rochester, Minnesota 55905
United StatesSite Not Available
Midwest Cancer Care
Kansas City, Missouri 64132
United StatesSite Not Available
Washington University
Saint Louis, Missouri 63110
United StatesSite Not Available
Billings Clinic Cancer Center
Billings, Montana 59101
United StatesSite Not Available
Comprehensive Cancer Centers of Nevada
Henderson, Nevada 89074
United StatesSite Not Available
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada 89148
United StatesSite Not Available
New Mexico Cancer Care Alliance
Albuquerque, New Mexico 87131
United StatesSite Not Available
Columbia University Hervert Irving Comprehensive Cancer Center
New York, New York 10032
United StatesActive - Recruiting
Laura & Isaac Perlmutter Cancer Ctr
New York, New York 10016
United StatesSite Not Available
Nyu Clinical Cancer Center
New York, New York 10032
United StatesActive - Recruiting
University of North Carolina At Chapel Hill
Chapel Hill, North Carolina 27514
United StatesSite Not Available
The Ohio State University Wexner Medical Center Division of Gynecologic Oncology
Hilliard, Ohio 43026
United StatesSite Not Available
Oklahoma University Medical Center
Oklahoma City, Oklahoma 73104-5418
United StatesSite Not Available
Willamette Valley Cancer Institute
Eugene, Oregon 97401-8122
United StatesSite Not Available
Texas Oncology - Tyler
Sioux Falls, South Dakota 57104
United StatesActive - Recruiting
Texas Oncology-Tyler
Sioux Falls, South Dakota 57104
United StatesSite Not Available
Tennessee Oncology
Nashville, Tennessee 37203
United StatesSite Not Available
Texas Oncology-Austin Center
Austin, Texas 78731
United StatesSite Not Available
Texas Oncology
Fort Worth, Texas 76104-3902
United StatesActive - Recruiting
Texas Oncology-Fort Worth South Henderson
Fort Worth, Texas 76104-3902
United StatesSite Not Available
Memorial Hermann Cancer Center
Houston, Texas 77030
United StatesSite Not Available
Texas Oncology San Antonio
San Antonio, Texas 78240
United StatesSite Not Available
Texas Oncology the Woodlands
Shenandoah, Texas 77380
United StatesSite Not Available
Virginia Commonwealth University
Richmond, Virginia 23298
United StatesSite Not Available
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