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
Recruiting now · Phase 1/Phase 2
Conditions studied: Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer, Endometrial Cancer
In brief
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
Key facts
- Study ID
- NCT04590326
- Run by
- Regeneron Pharmaceuticals
- People needed
- 612
- Starts
- 2020-12-08
- Expected to finish
- 2027-11-30
- Last updated by the study team
- 2025-11-21
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
Where it is running
- Hospital Universitario 12 de Octubre Universidad Complutense de Madrid UCM — Madrid, Spain (enrolling)
- The City of Hope Orange County Lennar Foundation Cancer Center — Irvine, California, United States (enrolling)
- Chao Family Comprehensive Cancer Center — Orange, California, United States (enrolling)
- City of Hope Comprehensive Cancer Center — Duarte, California, United States (enrolling)
- Robert H. Lurie Comprehensive Cancer Center of Northwestern University — Chicago, Illinois, United States (enrolling)
- University of Chicago Medical Center — Chicago, Illinois, United States (enrolling)
- Massachusetts General Hospital — Boston, Massachusetts, United States (enrolling)
- Dana Farber Cancer Institute Brookline Avenue — Boston, Massachusetts, United States (enrolling)
- Karmanos Cancer Institute — Detroit, Michigan, United States (enrolling)
- Memorial Sloan Kettering Cancer Center — New York, New York, United States (enrolling)
- The Ohio State University Wexner Medical Center — Columbus, Ohio, United States (enrolling)
- Perelman School of Medicine at the University of Pennsylvania — Philadelphia, Pennsylvania, United States (enrolling)
- Seattle Cancer Care Alliance at South Lake Union - G3630 — Seattle, Washington, United States (enrolling)
- Universitair Ziekenhuis Leuven — Leuven, Vlaams-Brabant, Belgium (enrolling)
- Hopital Lyon Sud — Pierre-Bénite, Auvergne-Rhône, France (enrolling)
- Centre Georges Francois Leclerc — Dijon, Bourgogne-Franche-Comté, France (enrolling)
- Institut Bergonie — Bordeaux, New Aquitaine, France (enrolling)
- Centre Francois Baclesse (CFB) — Caen, Normandy, France (enrolling)
- Institut Gustave Roussy — Villejuif, France (enrolling)
- Hospital Clinico Universitario Santiago de Compostela — Santiago de Compostela, A Coruna, Spain (enrolling)
- Institut Catala dOncologia Girona — Girona, Spain (enrolling)
- Ciudad Universitaria — Madrid, Spain (enrolling)
- Hospital Universitario Fundacion Jimenez — Madrid, Spain (enrolling)
- H. Lee Moffitt Cancer Center — Tampa, Florida, United States
Full record on ClinicalTrials.gov
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