RecruitingPhase I/IIFemale onlyEN originalOvarian cancerOther cancers

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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