Phase
Condition
Prostate Cancer
Urologic Cancer
Prostate Disorders
Treatment
Cemiplimab
REGN5678
18F-DCFPyL
Clinical Study ID
Ages > 18 Male
Study Summary
Eligibility Criteria
Inclusion
Key Inclusion Criteria:
Histologically or cytologically confirmed adenocarcinoma of the prostate withoutpure small cell carcinoma
Metastatic, castration-resistant prostate cancer (mCRPC) with PSA value at screening ≥4 ng/mL that has progressed within 6 months prior to screening, according to 1 ofthe following:
PSA progression as defined by a rising PSA level confirmed with an interval of ≥1 week between each assessment
Radiographic disease progression in soft tissue based on Response EvaluationCriteria in Solid Tumors (RECIST) version 1.1 criteria with or without PSAprogression
Radiographic disease progression in bone defined as the appearance of 2 or morenew bone lesions on bone scan with or without PSA progression NOTE: Measurabledisease per RECIST version 1.1 per local reading at screening is not aneligibility criterion for enrollment
Has progressed upon or intolerant to ≥2 lines prior systemic therapy approved in themetastatic and/or castration-resistant setting (in addition to androgen deprivationtherapy [ADT]) including at least one second-generation anti-androgen therapy (e.g.abiraterone, enzalutamide, apalutamide, or darolutamide)
Exclusion
Key Exclusion Criteria:
Has received treatment with an approved systemic therapy within 3 weeks of dosing orhas not yet recovered (ie, grade ≤1 or baseline) from any acute toxicities
Has received any previous systemic biologic or immune-modulating therapy (except forSipuleucel-T) within 5 half-lives of first dose of study therapy, as described inthe protocol
Has received prior PSMA-targeting therapy. Exception: Prior therapy with approvedPSMA-targeted radioligand(s) is permitted
Any condition that requires ongoing/continuous corticosteroid therapy (>10 mgprednisone/day or anti-inflammatory equivalent) within 1 week prior to the firstdose of study therapy
Ongoing or recent (within 5 years) evidence of significant autoimmune disease thatrequired treatment with systemic immunosuppressive treatments
Encephalitis, meningitis, neurodegenerative disease (with the exception of milddementia that does not interfere with activities of daily living [ADLs]) oruncontrolled seizures in the year prior to first dose of study therapy
Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B orhepatitis C infection; or diagnosis of immunodeficiency, as described in theprotocol.
NOTE: Other protocol defined Inclusion/Exclusion Criteria apply
Study Design
Connect with a study center
Stanford Cancer Center
Palo Alto, California 94304
United StatesActive - Recruiting
Stanford University Medical Center - Blake Wilbur Drive
Palo Alto, California 94304
United StatesActive - Recruiting
Norton Cancer Institute
Louisville, Kentucky 40207
United StatesActive - Recruiting
University of Maryland Greenebaum Cancer Center
Baltimore, Maryland 21201
United StatesActive - Recruiting
University of Maryland, Greenebaum Comprehensive Cancer Center
Baltimore, Maryland 21201
United StatesActive - Recruiting
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey 08901
United StatesActive - Recruiting
Roswell Park Cancer Institute
Buffalo, New York 14263
United StatesActive - Recruiting
Atrium Health Levine Cancer Institute
Charlotte, North Carolina 28204
United StatesActive - Recruiting
James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer Center
Columbus, Ohio 43210
United StatesActive - Recruiting
The Ohio State University James Cancer Hospital
Columbus, Ohio 43210
United StatesActive - Recruiting
Fox Chase Cancer Center
Philadelphia, Pennsylvania 19111
United StatesActive - Recruiting
Penn Medicine University of Pennsylvania Health System
Philadelphia, Pennsylvania 19104
United StatesActive - Recruiting
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania 19107
United StatesActive - Recruiting
Thomas Jefferson University, Sidney Kimmel Center, Clinical Research Organization
Philadelphia, Pennsylvania 19107
United StatesActive - Recruiting
University of Pennsylvania Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania 19104
United StatesActive - Recruiting
MD Anderson Cancer Center
Houston, Texas 77030
United StatesActive - Recruiting
Froedtert and Medical College of Wisconsin
Milwaukee, Wisconsin 53226
United StatesActive - Recruiting
Medical College of Wisconsin
Milwaukee, Wisconsin 53226
United StatesActive - Recruiting
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