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 (NCT04590326)
A Phase 1/2 Study of REGN5668 (MUC16xCD28, a Costimulatory Bispecific Antibody) Administered in Combination With Other Agents in MUC16 + Malignancies
🩺 Plain-English Summary (8th-Grade Level)
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
Who can join: Review the eligibility criteria below.
Location: City of Hope Comprehensive Cancer Center — Duarte, California
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (28 Sites)
Showing the first 25 of 28 sites.
- City of Hope Comprehensive Cancer Center — Duarte, California
- The City of Hope Orange County Lennar Foundation Cancer Center — Irvine, California
- Chao Family Comprehensive Cancer Center — Orange, California
- H. Lee Moffitt Cancer Center — Tampa, Florida
- Robert H. Lurie Comprehensive Cancer Center of Northwestern University — Chicago, Illinois
- University of Chicago Medical Center — Chicago, Illinois
- Massachusetts General Hospital — Boston, Massachusetts
- Dana Farber Cancer Institute Brookline Avenue — Boston, Massachusetts
- Karmanos Cancer Institute — Detroit, Michigan
- Memorial Sloan Kettering Cancer Center — New York, New York
- The Ohio State University Wexner Medical Center — Columbus, Ohio
- Perelman School of Medicine at the University of Pennsylvania — Philadelphia, Pennsylvania
- Seattle Cancer Care Alliance at South Lake Union - G3630 — Seattle, Washington
- Universitair Ziekenhuis Leuven — Leuven, Vlaams-Brabant
- Centro de Pesquisa em Oncologia PUCRS — Porto Alegre, Rio Grande do Sul
- Fundacao Pio XII - Hospital de Cancer de Barretos — Barretos, São Paulo
- Unimed Sorocaba — Sorocaba, São Paulo
- AC Camargo Cancer Center, Fundacao Antonio Prudente — São Paulo,
- Hopital Lyon Sud — Pierre-Bénite, Auvergne-Rhône
- Centre Georges Francois Leclerc — Dijon, Bourgogne-Franche-Comté
- Institut Bergonie — Bordeaux, New Aquitaine
- Centre Francois Baclesse (CFB) — Caen, Normandy
- Institut Gustave Roussy — Villejuif,
- Hospital Clinico Universitario Santiago de Compostela — Santiago de Compostela, A Coruna
- Institut Catala dOncologia Girona — Girona,
📞 Contact the Study Coordinator
Phone: (844) 734-6643
Email: clinicaltrials@regeneron.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.