RECRUITING Phase 1 / Phase 2 ClinicalTrials.gov

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

Sponsor: Regeneron Pharmaceuticals • ClinicalTrials.gov ID: NCT04590326

Registry updated: 2026-09-24

Recruiting for Similar Conditions?

Sponsors are looking for patients like you. See if you qualify for compensated research studies.

Description

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

Interventions

REGN5668 (Drug)
Administer per the protocol
Cemiplimab (Drug)
Administer per the protocol
Ubamatamab (Drug)
Administer per the protocol
Sarilumab (Drug)
Administer per the protocol
Cemiplimab + Fianlimab [Fixed Dose Combination (FDC)] (Drug)
Administer per the protocol

Eligibility criteria

Key Inclusion Criteria: 1. Ovarian Cancer Cohorts Only: Has histologically or cytologically confirmed diagnosis of advanced epithelial ovarian cancer (except carcinosarcoma), primary peritoneal, or fallopian tube cancer that has received at least 1 line of platinum-based systemic therapy as defined in the protocol 2. Expansion cohorts only: Has at least 1 lesion that is measurable by RECIST 1.1 as described in the protocol. 3. Has a serum CA-125 level ≥2x ULN (in screening, not applicable to endometrial cohorts) 4. Has adequate organ and bone marrow function as defined in the protocol 5. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 6. Has a life expectancy of at least 3 months 7. Endometrial Cancer Cohorts Only: histologically confirmed endometrial cancer that has progressed or recurrent after prior anti-PD-1 therapy and platinum-based chemotherapy as described in the protocol Key Exclusion Criteria: 1. Current or recent (as defined in the protocol) treatment with an investigational agent, systemic biologic therapy, or anti-cancer immunotherapy 2. Has had another malignancy within the last 5 years that is progressing, requires active treatment, or has a high likelihood of recurrence as defined in the protocol 3. Prior treatment with a Mucin 16 (MUC16)-targeted therapy 4. Ovarian Expansion cohorts only: More than 5 prior lines of systemic therapy 5. Has any condition that requires ongoing/continuous corticosteroid therapy as defined in the protocol within 1 week prior to the first dose of study drug 6. Has ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments as defined in the protocol 7. Has untreated or active primary brain tumor, CNS metastases, leptomeningeal disease, or spinal cord compression as defined in the protocol 8. Has history of clinically significant cardiovascular disease as defined in the protocol 9. Has known allergy or hypersensitivity to cemiplimab and/or components of study drug(s). Note: Other protocol-defined Inclusion/Exclusion criteria apply

Conditions

Ovarian Cancer Fallopian Tube Cancer Primary Peritoneal Cancer Endometrial Cancer

Locations

City of Hope Comprehensive Cancer Center — Duarte, California, United States
The City of Hope Orange County Lennar Foundation Cancer Center — Irvine, California, United States
Chao Family Comprehensive Cancer Center — Orange, California, United States
H. Lee Moffitt Cancer Center — Tampa, Florida, United States
Robert H. Lurie Comprehensive Cancer Center of Northwestern University — Chicago, Illinois, United States
University of Chicago Medical Center — Chicago, Illinois, United States
Massachusetts General Hospital — Boston, Massachusetts, United States
Dana Farber Cancer Institute Brookline Avenue — Boston, Massachusetts, United States
Karmanos Cancer Institute — Detroit, Michigan, United States
Memorial Sloan Kettering Cancer Center — New York, New York, United States
The Ohio State University Wexner Medical Center — Columbus, Ohio, United States
Perelman School of Medicine at the University of Pennsylvania — Philadelphia, Pennsylvania, United States
Seattle Cancer Care Alliance at South Lake Union - G3630 — Seattle, Washington, United States
Universitair Ziekenhuis Leuven — Leuven, Vlaams-Brabant, Belgium
Centro de Pesquisa em Oncologia PUCRS — Porto Alegre, Rio Grande do Sul, Brazil
Fundacao Pio XII - Hospital de Cancer de Barretos — Barretos, São Paulo, Brazil
Unimed Sorocaba — Sorocaba, São Paulo, Brazil
AC Camargo Cancer Center, Fundacao Antonio Prudente — São Paulo, Brazil
Hopital Lyon Sud — Pierre-Bénite, Auvergne-Rhône, France
Centre Georges Francois Leclerc — Dijon, Bourgogne-Franche-Comté, France
Institut Bergonie — Bordeaux, New Aquitaine, France
Centre Francois Baclesse (CFB) — Caen, Normandy, France
Institut Gustave Roussy — Villejuif, France
Hospital Clinico Universitario Santiago de Compostela — Santiago de Compostela, A Coruna, 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

Partner with Nurenyx

Showcase your study to thousands of motivated patients matching your criteria.

Learn More

Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record

Accelerate Your Clinical Trial Recruitment