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
NCT ID: NCT03564340
Last Updated: 2025-12-03
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
890 participants
INTERVENTIONAL
2018-05-21
2027-01-31
Brief Summary
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* 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)
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Monotherapy
REGN4018 administration
Ubamatamab
Administered per the protocol
Sarilumab
Administered per the protocol
Tocilizumab
Administered per the protocol
Combination Therapy
REGN4018 and cemiplimab administration
Ubamatamab
Administered per the protocol
Cemiplimab
Administered per the protocol
Interventions
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Ubamatamab
Administered per the protocol
Cemiplimab
Administered per the protocol
Sarilumab
Administered per the protocol
Tocilizumab
Administered per the protocol
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
Exclusion Criteria
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
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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University of Alabama_6th Ave
Birmingham, Alabama, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Dana Farber / Harvard Cancer Center
Boston, Massachusetts, United States
Mayo Clinic - Rochester
Rochester, Minnesota, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
Columbia University Medical Center
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
The Ohio State University Wexner Medical Center James Comprehensive Cancer Center
Hilliard, Ohio, United States
Stephenson Cancer Center
Oklahoma City, Oklahoma, United States
Sarah Cannon Research Institute
Nashville, Tennessee, United States
Virginia Commonwealth University
Richmond, Virginia, United States
Prince of Wales Hospital
Randwick, New South Wales, Australia
Peter MacCallum Cancer Center
Melbourne, , Australia
Universitair Ziekenhuis Antwerpen
Edegem, Antwerp, Belgium
Grand Hopital de Charleroi
Charleroi, Hainaut, Belgium
UZLeuven
Leuven, Vlaams-Brabant, Belgium
Hopital Lyon Sud
Pierre-Bénite, Auvergne-Rhône, France
Centre Georges Francois Leclerc
Dijon, Bourgogne-Franche-Comté, France
Centre Francois Baclesse (CFB)
Caen, Normandy, France
Institut Bergonie
Bordeaux, Nouvelle-Aquitaine, France
Centre Antoine Lacassagne
Nice, Provence Alpes Cote dAzur, France
Institut Gustave Roussy
Villejuif, Île-de-France Region, France
Rambam Health Care Campus
Haifa, , Israel
Sharet Institute of Oncology
Jerusalem, , Israel
Sheba Medical Center
Tel Litwinsky, , Israel
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, Lazio, Italy
Istituto Europeo di Oncologia
Milan, , Italy
Instituto Nazionale Tumori- Fondazione Pascale
Naples, , Italy
Radboudumc
Nijmegen, Gelderland, Netherlands
Erasmus MC
Rotterdam, South Holland, Netherlands
University Medical Center Groningen
Groningen, , Netherlands
Yonsei University Health System
Seoul, , South Korea
Asan Medical Center, Univ. of Ulsan
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Korea University Guro Hospital
Seoul, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Clinica Universidad de Navarra
Pamplona, Navarre, Spain
Institut Catala dOncologia Badalona
Badalona, , Spain
Hospital Universitari Vall d'Hebron
Barcelona, , Spain
Institut Catala d'Oncologia
Barcelona, , Spain
Clinica Universidad Navarra (CUN) Madrid
Madrid, , Spain
Fundacion Jimenez Diaz
Madrid, , Spain
Hospital Universitario San Carlos
Madrid, , Spain
Hospital Clinico Universitatio Santiago de Compostela
Santiago de Compostela, , Spain
University of Oxford
Oxford, Oxfordshire, United Kingdom
Royal Marsden Hospital - Sutton
Sutton, Surrey, United Kingdom
The Royal Marsden NHS Foundation Trust
Sutton, Surrey, United Kingdom
University College London Hospitals
London, , United Kingdom
Guys Hospital
London, , United Kingdom
Imperial College Healthcare NHS Trust
London, , United Kingdom
The Christie NHS Foundation Trust
Manchester, , United Kingdom
Countries
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Central Contacts
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Other Identifiers
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2024-510783-23-00
Identifier Type: CTIS
Identifier Source: secondary_id
2019-003298-24
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
R4018-ONC-1721
Identifier Type: -
Identifier Source: org_study_id
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