Actively Recruiting
Study of REGN4018 (Ubamatamab) Administered Alone or in Combination With Cemiplimab in Adult Patients With Recurrent Ovarian Cancer or Other Recurrent Mucin-16 Expressing (MUC16+) Cancers
Led by Regeneron Pharmaceuticals · Updated on 2026-05-08
890
Participants Needed
52
Research Sites
468 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The main purpose of this study is to: * Learn about the safety of ubamatamab and to find out what dose of ubamatamab can be given alone or with cemiplimab to patients with ovarian cancer or cancer of the uterus * The study will also look at the levels of ubamatamab and/or cemiplimab in the body and measure how well the body can remove the study drug(s). This is called pharmacokinetics * The study will also look at any signs that ubamatamab alone or with cemiplimab can treat recurrent advanced ovarian cancer or cancer of the uterus * To find out how safe and tolerable pretreatment is in combination with ubamatamab and to see how well it works to prevent or minimize Cytokine Release Syndrome (CRS)
CONDITIONS
Official Title
Study of REGN4018 (Ubamatamab) Administered Alone or in Combination With Cemiplimab in Adult Patients With Recurrent Ovarian Cancer or Other Recurrent Mucin-16 Expressing (MUC16+) Cancers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women 18 years or older with histologically or cytologically confirmed advanced epithelial ovarian cancer (except carcinosarcoma), primary peritoneal, or fallopian tube cancer
- Serum CA-125 level at least 2 times the upper limit of normal (not needed for low-grade serous carcinoma)
- At least one prior line of platinum-containing therapy received or platinum intolerance
- Documented relapse or progression after most recent therapy
- No standard therapy options expected to provide clinical benefit
- Adequate organ and bone marrow function as defined in the protocol
- Life expectancy of at least 3 months
- Platinum-resistant ovarian cancer patients with 2 to 4 prior lines of platinum-based therapy for randomized phase 2 expansion
- For endometrial cancer cohorts: confirmed endometrial cancer progressed or recurred after prior anti-PD-1 therapy and platinum chemotherapy
- Tumor cells with at least 25% MUC16 positivity by immunohistochemistry
- One to four prior lines of systemic therapy as specified in the protocol
You will not qualify if you...
- Prior treatment with anti-PD-1 or PD-L1 therapy as described in the protocol
- More than 4 prior lines of cytotoxic chemotherapy for ovarian cancer expansion cohorts (except low-grade serous ovarian cancer)
- Prior treatment with any MUC16-targeted therapy
- Untreated or active primary brain tumor, central nervous system metastases, or spinal cord compression as described in the protocol
- History or current cardiovascular disease as defined in the protocol
- Severe or uncontrolled hypertension at screening; stable anti-hypertensive medication allowed
- Other protocol-defined exclusion criteria apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 52 locations
1
University of Alabama_6th Ave
Birmingham, Alabama, United States, 35294
Actively Recruiting
2
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
3
Dana Farber / Harvard Cancer Center
Boston, Massachusetts, United States, 02215
Actively Recruiting
4
Mayo Clinic - Rochester
Rochester, Minnesota, United States, 55901
Actively Recruiting
5
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Withdrawn
6
Columbia University Medical Center
New York, New York, United States, 10032
Actively Recruiting
7
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
8
The Ohio State University Wexner Medical Center James Comprehensive Cancer Center
Hilliard, Ohio, United States, 43026
Actively Recruiting
9
Stephenson Cancer Center
Oklahoma City, Oklahoma, United States, 73104
Actively Recruiting
10
Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203
Actively Recruiting
11
Virginia Commonwealth University
Richmond, Virginia, United States, 23219
Actively Recruiting
12
Prince of Wales Hospital
Randwick, New South Wales, Australia, 2031
Completed
13
Peter MacCallum Cancer Center
Melbourne, Australia, 3000
Completed
14
Universitair Ziekenhuis Antwerpen
Edegem, Antwerp, Belgium, 2650
Actively Recruiting
15
Grand Hopital de Charleroi
Charleroi, Hainaut, Belgium, 6000
Actively Recruiting
16
UZLeuven
Leuven, Vlaams-Brabant, Belgium, 3000
Actively Recruiting
17
Hopital Lyon Sud
Pierre-Bénite, Auvergne-Rhône, France, 69310
Actively Recruiting
18
Centre Georges Francois Leclerc
Dijon, Bourgogne-Franche-Comté, France, 21000
Actively Recruiting
19
Institut Bergonie
Bordeaux, New Aquitaine, France, 33076
Actively Recruiting
20
Centre Francois Baclesse (CFB)
Caen, Normandy, France, 14076
Actively Recruiting
21
Centre Antoine Lacassagne
Nice, Provence Alpes Cote dAzur, France, 06189
Actively Recruiting
22
Institut Gustave Roussy
Villejuif, Île-de-France Region, France, 94800
Actively Recruiting
23
Rambam Health Care Campus
Haifa, Israel, 3109601
Actively Recruiting
24
Sharet Institute of Oncology
Jerusalem, Israel, 9112001
Actively Recruiting
25
Sheba Medical Center
Tel Litwinsky, Israel, 5265601
Actively Recruiting
26
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, Lazio, Italy, 00168
Actively Recruiting
27
Humanitas S. Pio X
Milan, Italy, 20159
Actively Recruiting
28
Istituto Europeo di Oncologia
Milan, Italy, 20141
Actively Recruiting
29
Instituto Nazionale Tumori- Fondazione Pascale
Naples, Italy, 80131
Actively Recruiting
30
Radboudumc
Nijmegen, Gelderland, Netherlands, 6500HB
Actively Recruiting
31
Erasmus MC
Rotterdam, South Holland, Netherlands, 3000 DR
Actively Recruiting
32
University Medical Center Groningen
Groningen, Netherlands, 9713 GZ
Actively Recruiting
33
Yonsei University Health System
Seoul, South Korea, 03722
Actively Recruiting
34
Asan Medical Center, Univ. of Ulsan
Seoul, South Korea, 05505
Actively Recruiting
35
Samsung Medical Center
Seoul, South Korea, 06351
Actively Recruiting
36
Korea University Guro Hospital
Seoul, South Korea, 08307
Actively Recruiting
37
Seoul National University Hospital
Seoul, South Korea, 3080
Actively Recruiting
38
Clinica Universidad de Navarra
Pamplona, Navarre, Spain, 31008
Actively Recruiting
39
Institut Catala dOncologia Badalona
Badalona, Spain, 08916
Actively Recruiting
40
Hospital Universitari Vall d'Hebron
Barcelona, Spain, 08035
Actively Recruiting
41
Institut Catala d'Oncologia
Barcelona, Spain, 8908
Actively Recruiting
42
Clinica Universidad Navarra (CUN) Madrid
Madrid, Spain, 28027
Actively Recruiting
43
Fundacion Jimenez Diaz
Madrid, Spain, 28040
Actively Recruiting
44
Hospital Universitario San Carlos
Madrid, Spain, 28040
Actively Recruiting
45
Hospital Clinico Universitatio Santiago de Compostela
Santiago de Compostela, Spain, 15706
Actively Recruiting
46
University of Oxford
Oxford, Oxfordshire, United Kingdom, OX1 2JD
Actively Recruiting
47
Royal Marsden Hospital - Sutton
Sutton, Surrey, United Kingdom, SM2 5PT
Withdrawn
48
The Royal Marsden NHS Foundation Trust
Sutton, Surrey, United Kingdom, SM2 5PT
Actively Recruiting
49
University College London Hospitals
London, United Kingdom, NW1 2PG
Actively Recruiting
50
Guys Hospital
London, United Kingdom, SE1 9RT
Actively Recruiting
51
Imperial College Healthcare NHS Trust
London, United Kingdom, W12 0HS
Actively Recruiting
52
The Christie NHS Foundation Trust
Manchester, United Kingdom, M20 4BX
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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