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NCT03564340 · ClinicalTrials.gov registry record · Phase 1
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 study of Endometrial Cancer and Recurrent Ovarian Cancer, sponsored by Regeneron Pharmaceuticals.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 890
- Enrollment target
- 20
- Study locations
NCT03564340: Recruiting Phase 1 study of Endometrial Cancer and Recurrent Ovarian Cancer, sponsored by Regeneron Pharmaceuticals.
NCT03564340 is a Phase 1 study of Endometrial Cancer and Recurrent Ovarian Cancer that is actively recruiting participants, run by Regeneron Pharmaceuticals. The registered enrollment target is 890 participants, above the 519-participant average among 181 other Endometrial Cancer trials with a reported enrollment target (71% higher). The trial reports 20 study locations across 17 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03564340, a Phase 1 study of Endometrial Cancer and Recurrent Ovarian Cancer, is actively recruiting participants, sponsored by Regeneron Pharmaceuticals.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 890 participants
- Enrollment target
- 20
- Study locations
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)
Primary Outcome
Dose Escalation Phase
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 |
What NCT03564340 shows while recruiting
NCT03564340 is an interventional study that assigns participants to a tested intervention. The registered 890 participants enrollment target is mid-sized for trials with a published cap, above the 519-participant average among 181 other Endometrial Cancer trials with a reported enrollment target (71% higher).
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.
NCT03564340 names 20 study sites across 17 states, led by New York, Massachusetts, Alabama.
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, Low-Grade Serous Ovarian Cancer, Recurrent Endometrial Cancer.
What interventions are being tested in trial NCT03564340?
The interventions under investigation include: Cemiplimab (DRUG), Tocilizumab (DRUG), Ubamatamab (DRUG), Sarilumab (DRUG).
Who is sponsoring clinical trial NCT03564340?
This trial is sponsored by Regeneron Pharmaceuticals, which has 280 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03564340's enrollment target sits among peer trials
890 15th of 181 higher than 167 of 181 other Endometrial Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Endometrial Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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