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 is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
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
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Potwierdzony zaawansowany rak jajnika (oprócz określonego typu), rak otrzewnej lub rak jajnika przebiegły - co najmniej jedno wcześniejsze leczenie chemioterapią platynową
- •Możliwość zmierzenia guza zmianami widocznymi w badaniach obrazowych (tylko w części rozszerzającej badania)
- •Podwyższony poziom markera CA-125 w krwi (co najmniej 2 razy norma) - nie dotyczy raka macicy
- •Prawidłowe funkcjonowanie narządów i szpiku kostnego
- •Dobry ogólny stan zdrowia (możliwość wykonywania zwykłych czynności)
- •Prognoza przeżycia co najmniej 3 miesiące
- •Potwierdzony rak macicy, który powrócił po wcześniejszym leczeniu immunoterapią i chemioterapią platynową
✗ Disqualifies
- •Bieżące lub niedawne leczenie innymi badawczymi lekami przeciwnowotworowymi
- •Inny nowotwór w ostatnich 5 latach wymagający leczenia lub zagrażający powrotem
- •Wcześniejsze leczenie lekami skierowanymi przeciwko białku MUC16
- •Więcej niż 5 poprzednich linii chemioterapii (tylko rak jajnika)
- •Konieczność stałego stosowania leków steroidowych
- •Historia choroby autoimmunologicznej wymagającej immunosupresji
- •Nielechony lub aktywny guz mózgu, przerzuty do mózgu lub rdzenia kręgowego
- •Istotna choroba serca w historii medycznej
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- August 20, 2026
- Sex
- Female only
Therapies / drugs in trial
Locations (28)
City of Hope Comprehensive Cancer Center
Duarte, United States
The City of Hope Orange County Lennar Foundation Cancer Center
Irvine, United States
Chao Family Comprehensive Cancer Center
Orange, United States
H. Lee Moffitt Cancer Center
Tampa, United States
Robert H. Lurie Comprehensive Cancer Center of Northwestern University
Chicago, United States
University of Chicago Medical Center
Chicago, United States
Massachusetts General Hospital
Boston, United States
Dana Farber Cancer Institute Brookline Avenue
Boston, United States
Karmanos Cancer Institute
Detroit, United States
Memorial Sloan Kettering Cancer Center
New York, United States
The Ohio State University Wexner Medical Center
Columbus, United States
Perelman School of Medicine at the University of Pennsylvania
Philadelphia, United States
Seattle Cancer Care Alliance at South Lake Union - G3630
Seattle, United States
Universitair Ziekenhuis Leuven
Leuven, Belgium
Centro de Pesquisa em Oncologia PUCRS
Porto Alegre, Brazil
Fundacao Pio XII - Hospital de Cancer de Barretos
Barretos, Brazil
Unimed Sorocaba
Sorocaba, Brazil
AC Camargo Cancer Center, Fundacao Antonio Prudente
São Paulo, Brazil
Hopital Lyon Sud
Pierre-Bénite, France
Centre Georges Francois Leclerc
Dijon, France
Institut Bergonie
Bordeaux, France
Centre Francois Baclesse (CFB)
Caen, France
Institut Gustave Roussy
Villejuif, France
Hospital Clinico Universitario Santiago de Compostela
Santiago de Compostela, Spain
Institut Catala dOncologia Girona
Girona, Spain
Ciudad Universitaria
Madrid, Spain
Hospital Universitario Fundacion Jimenez
Madrid, Spain
Hospital Universitario 12 de Octubre Universidad Complutense de Madrid UCM
Madrid, Spain
Trial contact
Clinical Trials Administrator
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 8/21/2026.
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