Actively Recruiting
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
Led by Regeneron Pharmaceuticals · Updated on 2025-11-21
612
Participants Needed
24
Research Sites
364 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is researching an investigational drug called REGN5668 : * 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
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female adults aged 18 years or older
- Histologically or cytologically confirmed advanced epithelial ovarian cancer (except carcinosarcoma), primary peritoneal, or fallopian tube cancer with at least 1 prior line of platinum-based systemic therapy (for ovarian cancer cohorts only)
- At least one measurable lesion by RECIST 1.1 (for expansion cohorts only)
- Serum CA-125 level at least 2 times the upper limit of normal (screening, not applicable to endometrial cohorts)
- Adequate organ and bone marrow function as defined by the protocol
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Life expectancy of at least 3 months
- Histologically confirmed endometrial cancer that has progressed or recurred after prior anti-PD-1 therapy and platinum-based chemotherapy (for endometrial cancer cohorts only)
You will not qualify if you...
- Current or recent treatment with investigational agents, systemic biologic therapy, or anti-cancer immunotherapy
- Another malignancy within the last 5 years that is progressing, requires active treatment, or has a high likelihood of recurrence
- Prior treatment with Mucin 16 (MUC16)-targeted therapy
- More than 5 prior lines of systemic therapy (for ovarian expansion cohorts only)
- Ongoing or continuous corticosteroid therapy within 1 week prior to first study drug dose
- Ongoing or recent significant autoimmune disease requiring systemic immunosuppressive treatments within 5 years
- Untreated or active primary brain tumor, central nervous system metastases, leptomeningeal disease, or spinal cord compression
- History of clinically significant cardiovascular disease
- Known allergy or hypersensitivity to cemiplimab or components of study drugs
AI-Screening
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Trial Site Locations
Total: 24 locations
1
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010
Actively Recruiting
2
The City of Hope Orange County Lennar Foundation Cancer Center
Irvine, California, United States, 92618
Actively Recruiting
3
Chao Family Comprehensive Cancer Center
Orange, California, United States, 92868
Actively Recruiting
4
H. Lee Moffitt Cancer Center
Tampa, Florida, United States, 33612
Completed
5
Robert H. Lurie Comprehensive Cancer Center of Northwestern University
Chicago, Illinois, United States, 60611
Actively Recruiting
6
University of Chicago Medical Center
Chicago, Illinois, United States, 60637
Actively Recruiting
7
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
8
Dana Farber Cancer Institute Brookline Avenue
Boston, Massachusetts, United States, 02215
Actively Recruiting
9
Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Actively Recruiting
10
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
11
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States, 43210
Actively Recruiting
12
Perelman School of Medicine at the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
13
Seattle Cancer Care Alliance at South Lake Union - G3630
Seattle, Washington, United States, 98109
Actively Recruiting
14
Universitair Ziekenhuis Leuven
Leuven, Vlaams-Brabant, Belgium, 3000
Actively Recruiting
15
Hopital Lyon Sud
Pierre-Bénite, Auvergne-Rhône, France, 69310
Actively Recruiting
16
Centre Georges Francois Leclerc
Dijon, Bourgogne-Franche-Comté, France, 21000
Actively Recruiting
17
Institut Bergonie
Bordeaux, New Aquitaine, France, 33076
Actively Recruiting
18
Centre Francois Baclesse (CFB)
Caen, Normandy, France, 14076
Actively Recruiting
19
Institut Gustave Roussy
Villejuif, France, 94805
Actively Recruiting
20
Hospital Clinico Universitario Santiago de Compostela
Santiago de Compostela, A Coruna, Spain, 15706
Actively Recruiting
21
Institut Catala dOncologia Girona
Girona, Spain, 17007
Actively Recruiting
22
Ciudad Universitaria
Madrid, Spain, 28040
Actively Recruiting
23
Hospital Universitario Fundacion Jimenez
Madrid, Spain, 28040
Actively Recruiting
24
Hospital Universitario 12 de Octubre Universidad Complutense de Madrid UCM
Madrid, Spain, 28041
Actively Recruiting
Research Team
C
Clinical Trials Administrator
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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