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
A Phase 1/2 Study of REGN4018 (Ubamatamab), a MUC16×CD3 Bispecific Antibody, Administered Alone or in Combination With Cemiplimab in Patients With Recurrent Ovarian Cancer or Other Recurrent MUC16+ Cancers
- Recurrent Ovarian Cancer
- Recurrent Fallopian Tube Cancer
- Recurrent Primary Peritoneal Cancer
- Recurrent Endometrial Cancer
- Endometrial Cancer
- Low-grade Serous Ovarian Cancer
At a glance
- Phase
- Phase 1
- Study type
- Interventional
- Sponsor
- Regeneron Pharmaceuticals
- Enrolment target
- 890
- Started
- 21 May 2018
- Main results due
- 10 May 2027
- Study sites
- 54
- Registry updated
- 25 September 2026
Can you take part?
- Aged 18 years and over.
- Women only.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility criteria
Key Inclusion Criteria: 1. Ovarian Cancer Cohorts Only: Patients with histologically or cytologically confirmed diagnosis of advanced, epithelial ovarian cancer (except carcinosarcoma), primary peritoneal, or fallopian tube cancer who have all of the following: 1. serum CA-125 level ≥2 x upper limit of normal (ULN) (in screening, not required for low-grade serous carcinoma) 2. has received at least 1 line of platinum-containing therapy or must be platinum-intolerant (applicable for dose escalation and non-randomized dose expansion cohorts) 3. documented relapse or progression on or after the most recent line of therapy 4. no standard therapy options likely to convey clinical benefit 2. Adequate organ and bone marrow function as defined in the protocol 3. Life expectancy of at least 3 months 4. Randomized phase 2 expansion cohort (Ovarian Cancer only): Platinum-resistant ovarian cancer patients who have had 2 to 4 lines of platinum-based therapy as defined in the protocol. 5. Endometrial Cancer Cohorts Only: histologically confirmed endometrial cancer that has progressed or recurrent after prior anti-Programmed Cell Death Ligand 1 (PD-1) therapy and platinum-based chemotherapy: 1. MUC16 positivity of tumor cells ≥25% by immunohistochemistry (IHC), as defined in the protocol 2. 1-4 prior lines of systemic therapy, as described in the protocol Key Exclusion Criteria: 1. Prior treatment with anti-Programmed Cell Death (PD-1)/PD-L1 therapy, as described in the protocol 2. Ovarian Cancer Expansion cohorts only: More than 4 prior lines of cytotoxic chemotherapy (does not apply to low-grade serous ovarian cancer cohort) 3. Prior treatment with a MUC16 - targeted therapy 4. Untreated or active primary brain tumor, central nervous system (CNS) metastases, or spinal cord compression, as described in the protocol 5. History and/or current cardiovascular disease, as defined in the protocol 6. Severe and/or uncontrolled hypertension at screening. Patients taking anti-hypertensive medication must be on a stable anti-hypertensive regimen Note: Other protocol-defined Inclusion/Exclusion Criteria apply
What this study is about
In the sponsor’s own words, from the registry.
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)
Study sites(54)
University of Alabama_6th Ave
Birmingham, Alabama, United States
Recruiting
Massachusetts General Hospital
Boston, Massachusetts, United States
Recruiting
Dana Farber / Harvard Cancer Center
Boston, Massachusetts, United States
Recruiting
Mayo Clinic - Rochester
Rochester, Minnesota, United States
Recruiting
Roswell Park Cancer Institute
Buffalo, New York, United States
Withdrawn
Columbia University Medical Center
New York, New York, United States
Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Recruiting
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States
Recruiting
Stephenson Cancer Center
Oklahoma City, Oklahoma, United States
Recruiting
Sarah Cannon Research Institute
Nashville, Tennessee, United States
Completed
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Recruiting
Virginia Commonwealth University
Richmond, Virginia, United States
Recruiting
Prince of Wales Hospital
Randwick, New South Wales, Australia
Completed
Peter MacCallum Cancer Center
Melbourne, Australia
Completed
Universitair Ziekenhuis Antwerpen
Edegem, Antwerp, Belgium
Recruiting
Grand Hopital de Charleroi
Charleroi, Hainaut, Belgium
Recruiting
UZLeuven
Leuven, Vlaams-Brabant, Belgium
Recruiting
Hopital Lyon Sud
Pierre-Bénite, Auvergne-Rhône, France
Recruiting
Centre Georges Francois Leclerc
Dijon, Bourgogne-Franche-Comté, France
Recruiting
Institut Bergonie
Bordeaux, New Aquitaine, France
Recruiting
Centre Francois Baclesse (CFB)
Caen, Normandy, France
Recruiting
Centre Antoine Lacassagne
Nice, Provence Alpes Cote dAzur, France
Recruiting
Centre Leon Berard
Lyon, France
Recruiting
Institut Gustave Roussy
Villejuif, Île-de-France Region, France
Recruiting
Rambam Health Care Campus
Haifa, Israel
Recruiting
Sharet Institute of Oncology
Jerusalem, Israel
Recruiting
Sheba Medical Center
Tel Litwinsky, Israel
Recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, Lazio, Italy
Recruiting
Humanitas S. Pio X
Milan, Italy
Recruiting
Istituto Europeo di Oncologia
Milan, Italy
Recruiting
Instituto Nazionale Tumori- Fondazione Pascale
Naples, Italy
Recruiting
Radboudumc
Nijmegen, Gelderland, Netherlands
Recruiting
Erasmus MC
Rotterdam, South Holland, Netherlands
Recruiting
University Medical Center Groningen
Groningen, Netherlands
Recruiting
Yonsei University Health System
Seoul, South Korea
Recruiting
Asan Medical Center, Univ. of Ulsan
Seoul, South Korea
Recruiting
Samsung Medical Center
Seoul, South Korea
Recruiting
Korea University Guro Hospital
Seoul, South Korea
Recruiting
Seoul National University Hospital
Seoul, South Korea
Recruiting
Clinica Universidad de Navarra
Pamplona, Navarre, Spain
Recruiting
Institut Catala dOncologia Badalona
Badalona, Spain
Recruiting
Hospital Universitari Vall d'Hebron
Barcelona, Spain
Recruiting
Institut Catala d'Oncologia
Barcelona, Spain
Recruiting
Clinica Universidad Navarra (CUN) Madrid
Madrid, Spain
Recruiting
Fundacion Jimenez Diaz
Madrid, Spain
Recruiting
Hospital Universitario San Carlos
Madrid, Spain
Recruiting
Hospital Clinico Universitatio Santiago de Compostela
Santiago de Compostela, Spain
Recruiting
University of Oxford
Oxford, Oxfordshire, United Kingdom
Recruiting
Royal Marsden Hospital - Sutton
Sutton, Surrey, United Kingdom
Withdrawn
The Royal Marsden NHS Foundation Trust
Sutton, Surrey, United Kingdom
Recruiting
University College London Hospitals
London, United Kingdom
Recruiting
Guys Hospital
London, United Kingdom
Recruiting
Imperial College Healthcare NHS Trust
London, United Kingdom
Recruiting
The Christie NHS Foundation Trust
Manchester, United Kingdom
Recruiting
Showing 54 of 54 sites. 49 of the 54 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT03564340. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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