RecruitingRecruiting
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
NCT03564340 · Regeneron Pharmaceuticals
In plain English
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Official title
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
About this study
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)
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
Study design
Enrollment target: 890 participants
Allocation: non_randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2018-05-21
Estimated completion: 2027-05-10
Last updated: 2026-05-08
Interventions
Drug: UbamatamabDrug: CemiplimabDrug: SarilumabDrug: Tocilizumab
Primary outcomes
- • Number of participants with Dose-limiting toxicity (DLTs) for ubamatamab monotherapy (From Cycle 1, Day 1 up to 35 days)
- • Number of participants with DLTs for ubamatamab with cemiplimab (From Cycle 2, Day 1 up to 21 days)
- • Number of participants with Treatment-emergent adverse event (TEAE)s (including immune-related adverse events (imAEs)) for ubamatamab monotherapy (Up to 2 years)
Sponsor
Regeneron Pharmaceuticals · industry
Contacts & investigators
ContactClinical Trials Administrator · contact · clinicaltrials@regeneron.com · 844-734-6643
InvestigatorClinical Trial Management · study_director, Regeneron Pharmaceuticals
All locations (52)
University of Alabama_6th AveRecruiting
Birmingham, Alabama, United States
Massachusetts General HospitalRecruiting
Boston, Massachusetts, United States
Dana Farber / Harvard Cancer CenterRecruiting
Boston, Massachusetts, United States
Mayo Clinic - RochesterRecruiting
Rochester, Minnesota, United States
Roswell Park Cancer InstituteWithdrawn
Buffalo, New York, United States
Columbia University Medical CenterRecruiting
New York, New York, United States
Memorial Sloan Kettering Cancer CenterRecruiting
New York, New York, United States
The Ohio State University Wexner Medical Center James Comprehensive Cancer CenterRecruiting
Hilliard, Ohio, United States
Stephenson Cancer CenterRecruiting
Oklahoma City, Oklahoma, United States
Sarah Cannon Research InstituteRecruiting
Nashville, Tennessee, United States
Virginia Commonwealth UniversityRecruiting
Richmond, Virginia, United States
Prince of Wales HospitalCompleted
Randwick, New South Wales, Australia
Peter MacCallum Cancer CenterCompleted
Melbourne, Australia
Universitair Ziekenhuis AntwerpenRecruiting
Edegem, Antwerp, Belgium
Grand Hopital de CharleroiRecruiting
Charleroi, Hainaut, Belgium
UZLeuvenRecruiting
Leuven, Vlaams-Brabant, Belgium
Hopital Lyon SudRecruiting
Pierre-Bénite, Auvergne-Rhône, France
Centre Georges Francois LeclercRecruiting
Dijon, Bourgogne-Franche-Comté, France
Institut BergonieRecruiting
Bordeaux, New Aquitaine, France
Centre Francois Baclesse (CFB)Recruiting
Caen, Normandy, France
Centre Antoine LacassagneRecruiting
Nice, Provence Alpes Cote dAzur, France
Institut Gustave RoussyRecruiting
Villejuif, Île-de-France Region, France
Rambam Health Care CampusRecruiting
Haifa, Israel
Sharet Institute of OncologyRecruiting
Jerusalem, Israel
Sheba Medical CenterRecruiting
Tel Litwinsky, Israel
Fondazione Policlinico Universitario Agostino Gemelli IRCCSRecruiting
Rome, Lazio, Italy
Humanitas S. Pio XRecruiting
Milan, Italy
Istituto Europeo di OncologiaRecruiting
Milan, Italy
Instituto Nazionale Tumori- Fondazione PascaleRecruiting
Naples, Italy
RadboudumcRecruiting
Nijmegen, Gelderland, Netherlands
Erasmus MCRecruiting
Rotterdam, South Holland, Netherlands
University Medical Center GroningenRecruiting
Groningen, Netherlands
Yonsei University Health SystemRecruiting
Seoul, South Korea
Asan Medical Center, Univ. of UlsanRecruiting
Seoul, South Korea
Samsung Medical CenterRecruiting
Seoul, South Korea
Korea University Guro HospitalRecruiting
Seoul, South Korea
Seoul National University HospitalRecruiting
Seoul, South Korea
Clinica Universidad de NavarraRecruiting
Pamplona, Navarre, Spain
Institut Catala dOncologia BadalonaRecruiting
Badalona, Spain
Hospital Universitari Vall d'HebronRecruiting
Barcelona, Spain
Institut Catala d'OncologiaRecruiting
Barcelona, Spain
Clinica Universidad Navarra (CUN) MadridRecruiting
Madrid, Spain
Fundacion Jimenez DiazRecruiting
Madrid, Spain
Hospital Universitario San CarlosRecruiting
Madrid, Spain
Hospital Clinico Universitatio Santiago de CompostelaRecruiting
Santiago de Compostela, Spain
University of OxfordRecruiting
Oxford, Oxfordshire, United Kingdom
Royal Marsden Hospital - SuttonWithdrawn
Sutton, Surrey, United Kingdom
The Royal Marsden NHS Foundation TrustRecruiting
Sutton, Surrey, United Kingdom
University College London HospitalsRecruiting
London, United Kingdom
Guys HospitalRecruiting
London, United Kingdom
Imperial College Healthcare NHS TrustRecruiting
London, United Kingdom
The Christie NHS Foundation TrustRecruiting
Manchester, United Kingdom