Phase
Condition
Ovarian Cysts
Pelvic Cancer
Endometriosis
Treatment
Cemiplimab
Ubamatamab
Cemiplimab + Fianlimab [Fixed Dose Combination (FDC)]
Clinical Study ID
Ages > 18 Female
Study Summary
Eligibility Criteria
Inclusion
Key Inclusion Criteria:
Ovarian Cancer Cohorts Only: Has histologically or cytologically confirmed diagnosisof advanced epithelial ovarian cancer (except carcinosarcoma), primary peritoneal,or fallopian tube cancer that has received at least 1 line of platinum-basedsystemic therapy as defined in the protocol
Expansion cohorts only: Has at least 1 lesion that is measurable by RECIST 1.1 asdescribed in the protocol.
Has a serum CA-125 level ≥2x ULN (in screening, not applicable to endometrialcohorts)
Has adequate organ and bone marrow function as defined in the protocol
Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Has a life expectancy of at least 3 months
Endometrial Cancer Cohorts Only: histologically confirmed endometrial cancer thathas progressed or recurrent after prior anti-PD-1 therapy and platinum-basedchemotherapy as described in the protocol
Exclusion
Key Exclusion Criteria:
Current or recent (as defined in the protocol) treatment with an investigationalagent, systemic biologic therapy, or anti-cancer immunotherapy
Has had another malignancy within the last 5 years that is progressing, requiresactive treatment, or has a high likelihood of recurrence as defined in the protocol
Prior treatment with a Mucin 16 (MUC16)-targeted therapy
Ovarian Expansion cohorts only: More than 5 prior lines of systemic therapy
Has any condition that requires ongoing/continuous corticosteroid therapy as definedin the protocol within 1 week prior to the first dose of study drug
Has ongoing or recent (within 5 years) evidence of significant autoimmune diseasethat required treatment with systemic immunosuppressive treatments as defined in theprotocol
Has untreated or active primary brain tumor, CNS metastases, leptomeningeal disease,or spinal cord compression as defined in the protocol
Has history of clinically significant cardiovascular disease as defined in theprotocol
Has known allergy or hypersensitivity to cemiplimab and/or components of studydrug(s).
Note: Other protocol-defined Inclusion/Exclusion criteria apply
Study Design
Connect with a study center
Universitair Ziekenhuis Leuven
Leuven, Vlaams Brabant 3000
BelgiumSite Not Available
Universitair Ziekenhuis Leuven
Leuven 2792482, Vlaams-Brabant 3000
BelgiumActive - Recruiting
Hopital Lyon Sud
Pierre-Bénite 2987314, Auvergne-Rhône 69310
FranceActive - Recruiting
Centre Georges Francois Leclerc
Dijon, Bourgogne 21000
FranceSite Not Available
Centre Georges Francois Leclerc
Dijon 3021372, Bourgogne-Franche-Comté 11071619 21000
FranceActive - Recruiting
Hopital Lyon Sud
Pierre-Benite, Lyon 69310
FranceSite Not Available
Centre Francois Baclesse (CFB)
Caen, Normandy 14076
FranceSite Not Available
Centre Francois Baclesse (CFB)
Caen 3029241, Normandy 11071621 14076
FranceActive - Recruiting
Institut Bergonie
Bordeaux 3031582, Nouvelle-Aquitaine 11071620 33076
FranceActive - Recruiting
Institut Bergonie
Bordeaux, 33076
FranceSite Not Available
Institut Gustave Roussy
Villejuif, 94805
FranceSite Not Available
Institut Gustave Roussy
Villejuif 2968705, 94805
FranceActive - Recruiting
Hospital Clinico Universitario Santiago de Compostela
Santiago de Compostela, A Coruna 15706
SpainSite Not Available
Hospital Clinico Universitario Santiago de Compostela
Santiago de Compostela 3109642, A Coruna 15706
SpainActive - Recruiting
Institut Catala dOncologia Girona
Girona, 17007
SpainSite Not Available
Institut Catala dOncologia Girona
Girona 3121456, 17007
SpainActive - Recruiting
Ciudad Universitaria
Madrid, 28040
SpainSite Not Available
Hospital Universitario 12 de Octubre Universidad Complutense de Madrid UCM
Madrid, 28041
SpainActive - Recruiting
Hospital Universitario Fundacion Jimenez
Madrid, 28040
SpainActive - Recruiting
Ciudad Universitaria
Madrid 3117735, 28040
SpainActive - Recruiting
Hospital Universitario 12 de Octubre Universidad Complutense de Madrid UCM
Madrid 3117735, 28041
SpainActive - Recruiting
Hospital Universitario Fundacion Jimenez
Madrid 3117735, 28040
SpainActive - Recruiting
City of Hope
Duarte, California 91010
United StatesActive - Recruiting
City of Hope Comprehensive Cancer Center
Duarte, California 91010-3012
United StatesSite Not Available
The City of Hope Orange County Lennar Foundation Cancer Center
Irvine, California 92618
United StatesSite Not Available
Regeneron Research Site
San Francisco, California 94143
United StatesSite Not Available
City of Hope Comprehensive Cancer Center
Duarte 5344147, California 5332921 91010
United StatesActive - Recruiting
The City of Hope Orange County Lennar Foundation Cancer Center
Irvine 5359777, California 5332921 92618
United StatesActive - Recruiting
Chao Family Comprehensive Cancer Center
Orange 5379513, California 5332921 92868
United StatesActive - Recruiting
H. Lee Moffitt Cancer Center
Tampa, Florida 33612
United StatesSite Not Available
H. Lee Moffitt Cancer Center
Tampa 4174757, Florida 4155751 33612
United StatesCompleted
Northwestern Memorial Hospital
Chicago, Illinois 60611
United StatesActive - Recruiting
Robert H. Lurie Comprehensive Cancer Center of Northwestern University
Chicago, Illinois 60611
United StatesSite Not Available
University of Chicago
Chicago, Illinois 60637
United StatesActive - Recruiting
University of Chicago Medical Center
Chicago, Illinois 60637
United StatesActive - Recruiting
Robert H. Lurie Comprehensive Cancer Center of Northwestern University
Chicago 4887398, Illinois 4896861 60611
United StatesActive - Recruiting
University of Chicago Medical Center
Chicago 4887398, Illinois 4896861 60637
United StatesActive - Recruiting
Dana Farber Cancer Institute
Boston, Massachusetts 02215
United StatesActive - Recruiting
Dana Farber Cancer Institute Brookline Avenue
Boston, Massachusetts 02215
United StatesSite Not Available
Massachusetts General Hospital
Boston, Massachusetts 02114
United StatesActive - Recruiting
Massachusetts General Hospital Cancer Center
Boston, Massachusetts 02114
United StatesActive - Recruiting
Dana Farber Cancer Institute Brookline Avenue
Boston 4930956, Massachusetts 6254926 02215
United StatesActive - Recruiting
Massachusetts General Hospital
Boston 4930956, Massachusetts 6254926 02114
United StatesActive - Recruiting
Karmanos Cancer Institute
Detroit, Michigan 48201
United StatesSite Not Available
Karmanos Cancer Institute
Detroit 4990729, Michigan 5001836 48201
United StatesActive - Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York 10065
United StatesSite Not Available
Memorial Sloan Kettering Cancer Center
New York 5128581, New York 5128638 10065
United StatesActive - Recruiting
The Ohio State University Wexner Medical Center
Columbus, Ohio 43210
United StatesSite Not Available
The Ohio State University Wexner Medical Center
Columbus 4509177, Ohio 5165418 43210
United StatesActive - Recruiting
Perelman School of Medicine at the University of Pennsylvania
Philadelphia, Pennsylvania 19104
United StatesSite Not Available
University of Pennsylvania
Philadelphia, Pennsylvania 19104
United StatesActive - Recruiting
Perelman School of Medicine at the University of Pennsylvania
Philadelphia 4560349, Pennsylvania 6254927 19104
United StatesActive - Recruiting
Regeneron Research Site
Providence, Rhode Island 02905
United StatesSite Not Available
Regeneron Research Site
Salt Lake City, Utah 84112
United StatesSite Not Available
Seattle Cancer Care Alliance
Seattle, Washington 98109
United StatesActive - Recruiting
Seattle Cancer Care Alliance at South Lake Union - G3630
Seattle, Washington 98109
United StatesSite Not Available
Seattle Cancer Care Alliance at South Lake Union - G3630
Seattle 5809844, Washington 5815135 98109
United StatesActive - Recruiting

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