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NCT04590326 · ClinicalTrials.gov registry record · Phase 1
A Study to Find Out How Safe REGN5668 is and How Well it Works In Adult Women When Given With Either Cemiplimab, or Cemiplimab + Fianlimab, or Ubamatamab
A Phase 1 study of Ovarian Cancer and Endometrial Cancer, sponsored by Regeneron Pharmaceuticals.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 612
- Enrollment target
- 20
- Study locations
NCT04590326 is a Phase 1 study of Ovarian Cancer and Endometrial Cancer that is actively recruiting participants, run by Regeneron Pharmaceuticals. The registered enrollment target is 612 participants, below the 727-participant average among 322 other Ovarian Cancer trials with a reported enrollment target (16% lower). The trial reports 20 study locations across 16 states.
The verdict
NCT04590326, a Phase 1 study of Ovarian Cancer and Endometrial Cancer, is actively recruiting participants, sponsored by Regeneron Pharmaceuticals.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 612 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study is researching an investigational drug called REGN5668 : * alone or, * combined with cemiplimab (also known as REGN2810) or, * combined with both cemiplimab and fianlimab (also known as REGN3767), or * combined with ubamatamab (also known as REGN4018), with or without sarilumab. The main purposes of this study are to: * Learn about the safety and profile of any side effects from the study drugs and to determine the highest, safe dose that can be given to participants with ovarian cancer or cancer of the uterus * Look for signs that the study drugs can treat ovarian cancer or cancer of the uterus This study has 2 parts. The purpose of Part 1 (Escalation) is to find the highest, safe dose of the study drug(s). The purpose of Part 2 (Expansion) is to use the doses chosen in Part 1. Participants with cancer of the uterus will only participate in Part 2. The study is looking at several other research questions, including: * Side effects that may be experienced by participants taking REGN5668 alone and/or in combination with cemiplimab, cemiplimab and fianlimab, or ubamatamab * How REGN5668 works in the body either alone and/or in combination with cemiplimab, cemiplimab and fianlimab, or ubamatamab * How much of the study drugs (REGN5668, cemiplimab, fianlimab, ubamatamab) are in the blood * To see if REGN5668 in combination with cemiplimab, cemiplimab and fianlimab, or ubamatamab works to treat cancer
Conditions Studied
Interventions
- DRUG Cemiplimab
- DRUG Ubamatamab
- DRUG REGN5668
- DRUG Sarilumab
- DRUG Cemiplimab + Fianlimab [Fixed Dose Combination (FDC)]
Study Locations (20)
California
- City of Hope Comprehensive Cancer Center - Duarte
- The City of Hope Orange County Lennar Foundation Cancer Center - Irvine
- Chao Family Comprehensive Cancer Center - Orange
Illinois
- Robert H. Lurie Comprehensive Cancer Center of Northwestern University - Chicago
- University of Chicago Medical Center - Chicago
Massachusetts
- Massachusetts General Hospital - Boston
- Dana Farber Cancer Institute Brookline Avenue - Boston
Florida
- H. Lee Moffitt Cancer Center - Tampa
Michigan
- Karmanos Cancer Institute - Detroit
New York
- Memorial Sloan Kettering Cancer Center - New York
Ohio
- The Ohio State University Wexner Medical Center - Columbus
Pennsylvania
- Perelman School of Medicine at the University of Pennsylvania - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 612 participants |
| Start Date | 2020-12-08 |
| Est. Completion | 2027-11-30 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04590326
The ClinicalTrials.gov registry entry for NCT04590326 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 612 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 727-participant average among 322 other Ovarian Cancer trials with a reported enrollment target (16% lower). The listed sponsor is Regeneron Pharmaceuticals, which has 280 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Ovarian Cancer appearing as the primary indexed condition, and to 5 interventions - of which Cemiplimab is the first listed.
NCT04590326 reports 20 study locations spanning 16 distinct geographic areas - top geographies include California, Illinois, Massachusetts.
Frequently Asked Questions
What is clinical trial NCT04590326 about?
NCT04590326 is a clinical study titled "A Study to Find Out How Safe REGN5668 is and How Well it Works In Adult Women When Given With Either Cemiplimab, or Cemiplimab + Fianlimab, or Ubamatamab". This study is researching an investigational drug called REGN5668 : * alone or, * combined with cemiplimab (also known as REGN2810) or, * combined with both cemiplimab and fianlimab (also known as REGN3767), or * combined with ubamatamab (also known as REGN4018), with or without sarilumab. The mai...
What is the current status of trial NCT04590326?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 612 participants. The study started on 2020-12-08. Estimated completion is 2027-11-30.
What conditions does trial NCT04590326 study?
This clinical trial studies the following conditions: Ovarian Cancer, Endometrial Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer.
What interventions are being tested in trial NCT04590326?
The interventions under investigation include: Cemiplimab (DRUG), Ubamatamab (DRUG), REGN5668 (DRUG), Sarilumab (DRUG), Cemiplimab + Fianlimab [Fixed Dose Combination (FDC)] (DRUG).
Who is sponsoring clinical trial NCT04590326?
This trial is sponsored by Regeneron Pharmaceuticals, which has 280 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04590326 being conducted?
This trial has 20 study locations across California, Florida, Illinois, Massachusetts, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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