Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 · View on ClinicalTrials.gov ↗
Study Summary
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 Studied
Interventions
- DRUG Cemiplimab
- DRUG Tocilizumab
- DRUG Ubamatamab
- DRUG Sarilumab
Study Locations (20)
New York
- Roswell Park Cancer Institute — Buffalo
- Columbia University Medical Center — New York
- Memorial Sloan Kettering Cancer Center — New York
Massachusetts
- Massachusetts General Hospital — Boston
- Dana Farber / Harvard Cancer Center — Boston
Alabama
- University of Alabama_6th Ave — Birmingham
Minnesota
- Mayo Clinic - Rochester — Rochester
Ohio
- The Ohio State University Wexner Medical Center James Comprehensive Cancer Center — Hilliard
Oklahoma
- Stephenson Cancer Center — Oklahoma City
Tennessee
- Sarah Cannon Research Institute — Nashville
Virginia
- Virginia Commonwealth University — Richmond
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 890 participants |
| Start Date | 2018-05-21 |
| Est. Completion | 2027-01-31 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03564340
The ClinicalTrials.gov registry entry for NCT03564340 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 890 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Regeneron Pharmaceuticals, which has 290 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 6 conditions, with Endometrial Cancer appearing as the primary indexed condition, and to 4 interventions — of which Cemiplimab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03564340 reports 20 study locations spanning 17 distinct geographic areas — top geographies include New York, Massachusetts, Alabama. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT03564340 about?
NCT03564340 is a clinical study titled "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". 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...
What is the current status of trial NCT03564340?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 890 participants. The study started on 2018-05-21. Estimated completion is 2027-01-31.
What conditions does trial NCT03564340 study?
This clinical trial studies the following conditions: Endometrial Cancer, Recurrent Ovarian Cancer, Recurrent Fallopian Tube Cancer, Recurrent Endometrial Cancer, Recurrent Primary Peritoneal Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03564340?
The interventions under investigation include: Cemiplimab (DRUG), Tocilizumab (DRUG), Ubamatamab (DRUG), Sarilumab (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03564340?
This trial is sponsored by Regeneron Pharmaceuticals, which has 290 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03564340 being conducted?
This trial has 20 study locations across Alabama, Massachusetts, Minnesota, New York, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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