A Study to Find Out How Safe REGN5668 is and How Well it Works In Adult Women When Given With Either Cemiplimab, or Cemiplimab + Fianlimab, or Ubamatamab
NCT ID: NCT04590326
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
612 participants
INTERVENTIONAL
2020-12-08
2027-11-30
Brief Summary
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* alone or,
* combined with cemiplimab (also known as REGN2810) or,
* combined with both cemiplimab and fianlimab (also known as REGN3767), or
* combined with ubamatamab (also known as REGN4018), with or without sarilumab.
The main purposes of this study are to:
* Learn about the safety and profile of any side effects from the study drugs and to determine the highest, safe dose that can be given to participants with ovarian cancer or cancer of the uterus
* Look for signs that the study drugs can treat ovarian cancer or cancer of the uterus
This study has 2 parts. The purpose of Part 1 (Escalation) is to find the highest, safe dose of the study drug(s). The purpose of Part 2 (Expansion) is to use the doses chosen in Part 1. Participants with cancer of the uterus will only participate in Part 2.
The study is looking at several other research questions, including:
* Side effects that may be experienced by participants taking REGN5668 alone and/or in combination with cemiplimab, cemiplimab and fianlimab, or ubamatamab
* How REGN5668 works in the body either alone and/or in combination with cemiplimab, cemiplimab and fianlimab, or ubamatamab
* How much of the study drugs (REGN5668, cemiplimab, fianlimab, ubamatamab) are in the blood
* To see if REGN5668 in combination with cemiplimab, cemiplimab and fianlimab, or ubamatamab works to treat cancer
Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Module 1
REGN5668 in combination with cemiplimab, or cemiplimab + fianlimab
REGN5668
Administer per the protocol
Cemiplimab
Administer per the protocol
Cemiplimab + Fianlimab [Fixed Dose Combination (FDC)]
Administer per the protocol
Module 2
REGN5668 and ubamatamab
REGN5668
Administer per the protocol
Ubamatamab
Administer per the protocol
Sarilumab
Administer per the protocol
Interventions
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REGN5668
Administer per the protocol
Cemiplimab
Administer per the protocol
Ubamatamab
Administer per the protocol
Sarilumab
Administer per the protocol
Cemiplimab + Fianlimab [Fixed Dose Combination (FDC)]
Administer per the protocol
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Expansion cohorts only: Has at least 1 lesion that is measurable by RECIST 1.1 as described in the protocol.
3. Has a serum CA-125 level ≥2x ULN (in screening, not applicable to endometrial cohorts)
4. Has adequate organ and bone marrow function as defined in the protocol
5. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
6. Has a life expectancy of at least 3 months
7. Endometrial Cancer Cohorts Only: histologically confirmed endometrial cancer that has progressed or recurrent after prior anti-PD-1 therapy and platinum-based chemotherapy as described in the protocol
Exclusion Criteria
2. Has had another malignancy within the last 5 years that is progressing, requires active treatment, or has a high likelihood of recurrence as defined in the protocol
3. Prior treatment with a Mucin 16 (MUC16)-targeted therapy
4. Ovarian Expansion cohorts only: More than 5 prior lines of systemic therapy
5. Has any condition that requires ongoing/continuous corticosteroid therapy as defined in the protocol within 1 week prior to the first dose of study drug
6. Has ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments as defined in the protocol
7. Has untreated or active primary brain tumor, CNS metastases, leptomeningeal disease, or spinal cord compression as defined in the protocol
8. Has history of clinically significant cardiovascular disease as defined in the protocol
9. Has known allergy or hypersensitivity to cemiplimab and/or components of study drug(s).
18 Years
FEMALE
No
Sponsors
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Regeneron Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trial Management
Role: STUDY_DIRECTOR
Regeneron Pharmaceuticals
Locations
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City of Hope Comprehensive Cancer Center
Duarte, California, United States
The City of Hope Orange County Lennar Foundation Cancer Center
Irvine, California, United States
Chao Family Comprehensive Cancer Center
Orange, California, United States
H. Lee Moffitt Cancer Center
Tampa, Florida, United States
Robert H. Lurie Comprehensive Cancer Center of Northwestern University
Chicago, Illinois, United States
University of Chicago Medical Center
Chicago, Illinois, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Dana Farber Cancer Institute Brookline Avenue
Boston, Massachusetts, United States
Karmanos Cancer Institute
Detroit, Michigan, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States
Perelman School of Medicine at the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Seattle Cancer Care Alliance at South Lake Union - G3630
Seattle, Washington, United States
Universitair Ziekenhuis Leuven
Leuven, Vlaams-Brabant, Belgium
Centre Georges Francois Leclerc
Dijon, Bourgogne-Franche-Comté, France
Hopital Lyon Sud
Pierre-Bénite, Lyon, France
Centre Francois Baclesse (CFB)
Caen, Normandy, France
Institut Bergonie
Bordeaux, , France
Institut Gustave Roussy
Villejuif, , France
Hospital Clinico Universitario Santiago de Compostela
Santiago de Compostela, A Coruna, Spain
Institut Catala dOncologia Girona
Girona, , Spain
Ciudad Universitaria
Madrid, , Spain
Hospital Universitario Fundacion Jimenez
Madrid, , Spain
Hospital Universitario 12 de Octubre Universidad Complutense de Madrid UCM
Madrid, , Spain
Countries
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Central Contacts
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Other Identifiers
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2022-501904-83-00
Identifier Type: CTIS
Identifier Source: secondary_id
R5668-ONC-1938
Identifier Type: -
Identifier Source: org_study_id