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

Last updated: November 20, 2025
Sponsor: Regeneron Pharmaceuticals
Overall Status: Active - Recruiting

Phase

1/2

Condition

Ovarian Cysts

Pelvic Cancer

Endometriosis

Treatment

Cemiplimab

Ubamatamab

Cemiplimab + Fianlimab [Fixed Dose Combination (FDC)]

Clinical Study ID

NCT04590326
R5668-ONC-1938
2022-501904-83-00
  • Ages > 18
  • Female

Study Summary

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

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  1. Ovarian Cancer Cohorts Only: Has histologically or cytologically confirmed diagnosisof advanced epithelial ovarian cancer (except carcinosarcoma), primary peritoneal,or fallopian tube cancer that has received at least 1 line of platinum-basedsystemic therapy as defined in the protocol

  2. Expansion cohorts only: Has at least 1 lesion that is measurable by RECIST 1.1 asdescribed in the protocol.

  3. Has a serum CA-125 level ≥2x ULN (in screening, not applicable to endometrialcohorts)

  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 thathas progressed or recurrent after prior anti-PD-1 therapy and platinum-basedchemotherapy as described in the protocol

Exclusion

Key Exclusion Criteria:

  1. Current or recent (as defined in the protocol) treatment with an investigationalagent, systemic biologic therapy, or anti-cancer immunotherapy

  2. Has had another malignancy within the last 5 years that is progressing, requiresactive 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 definedin 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 diseasethat required treatment with systemic immunosuppressive treatments as defined in theprotocol

  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 theprotocol

  9. Has known allergy or hypersensitivity to cemiplimab and/or components of studydrug(s).

Note: Other protocol-defined Inclusion/Exclusion criteria apply

Study Design

Total Participants: 612
Treatment Group(s): 6
Primary Treatment: Cemiplimab
Phase: 1/2
Study Start date:
December 08, 2020
Estimated Completion Date:
November 30, 2027

Connect with a study center

  • Universitair Ziekenhuis Leuven

    Leuven, Vlaams Brabant 3000
    Belgium

    Site Not Available

  • Universitair Ziekenhuis Leuven

    Leuven 2792482, Vlaams-Brabant 3000
    Belgium

    Active - Recruiting

  • Hopital Lyon Sud

    Pierre-Bénite 2987314, Auvergne-Rhône 69310
    France

    Active - Recruiting

  • Centre Georges Francois Leclerc

    Dijon, Bourgogne 21000
    France

    Site Not Available

  • Centre Georges Francois Leclerc

    Dijon 3021372, Bourgogne-Franche-Comté 11071619 21000
    France

    Active - Recruiting

  • Hopital Lyon Sud

    Pierre-Benite, Lyon 69310
    France

    Site Not Available

  • Centre Francois Baclesse (CFB)

    Caen, Normandy 14076
    France

    Site Not Available

  • Centre Francois Baclesse (CFB)

    Caen 3029241, Normandy 11071621 14076
    France

    Active - Recruiting

  • Institut Bergonie

    Bordeaux 3031582, Nouvelle-Aquitaine 11071620 33076
    France

    Active - Recruiting

  • Institut Bergonie

    Bordeaux, 33076
    France

    Site Not Available

  • Institut Gustave Roussy

    Villejuif, 94805
    France

    Site Not Available

  • Institut Gustave Roussy

    Villejuif 2968705, 94805
    France

    Active - Recruiting

  • Hospital Clinico Universitario Santiago de Compostela

    Santiago de Compostela, A Coruna 15706
    Spain

    Site Not Available

  • Hospital Clinico Universitario Santiago de Compostela

    Santiago de Compostela 3109642, A Coruna 15706
    Spain

    Active - Recruiting

  • Institut Catala dOncologia Girona

    Girona, 17007
    Spain

    Site Not Available

  • Institut Catala dOncologia Girona

    Girona 3121456, 17007
    Spain

    Active - Recruiting

  • Ciudad Universitaria

    Madrid, 28040
    Spain

    Site Not Available

  • Hospital Universitario 12 de Octubre Universidad Complutense de Madrid UCM

    Madrid, 28041
    Spain

    Active - Recruiting

  • Hospital Universitario Fundacion Jimenez

    Madrid, 28040
    Spain

    Active - Recruiting

  • Ciudad Universitaria

    Madrid 3117735, 28040
    Spain

    Active - Recruiting

  • Hospital Universitario 12 de Octubre Universidad Complutense de Madrid UCM

    Madrid 3117735, 28041
    Spain

    Active - Recruiting

  • Hospital Universitario Fundacion Jimenez

    Madrid 3117735, 28040
    Spain

    Active - Recruiting

  • City of Hope

    Duarte, California 91010
    United States

    Active - Recruiting

  • City of Hope Comprehensive Cancer Center

    Duarte, California 91010-3012
    United States

    Site Not Available

  • The City of Hope Orange County Lennar Foundation Cancer Center

    Irvine, California 92618
    United States

    Site Not Available

  • Regeneron Research Site

    San Francisco, California 94143
    United States

    Site Not Available

  • City of Hope Comprehensive Cancer Center

    Duarte 5344147, California 5332921 91010
    United States

    Active - Recruiting

  • The City of Hope Orange County Lennar Foundation Cancer Center

    Irvine 5359777, California 5332921 92618
    United States

    Active - Recruiting

  • Chao Family Comprehensive Cancer Center

    Orange 5379513, California 5332921 92868
    United States

    Active - Recruiting

  • H. Lee Moffitt Cancer Center

    Tampa, Florida 33612
    United States

    Site Not Available

  • H. Lee Moffitt Cancer Center

    Tampa 4174757, Florida 4155751 33612
    United States

    Completed

  • Northwestern Memorial Hospital

    Chicago, Illinois 60611
    United States

    Active - Recruiting

  • Robert H. Lurie Comprehensive Cancer Center of Northwestern University

    Chicago, Illinois 60611
    United States

    Site Not Available

  • University of Chicago

    Chicago, Illinois 60637
    United States

    Active - Recruiting

  • University of Chicago Medical Center

    Chicago, Illinois 60637
    United States

    Active - Recruiting

  • Robert H. Lurie Comprehensive Cancer Center of Northwestern University

    Chicago 4887398, Illinois 4896861 60611
    United States

    Active - Recruiting

  • University of Chicago Medical Center

    Chicago 4887398, Illinois 4896861 60637
    United States

    Active - Recruiting

  • Dana Farber Cancer Institute

    Boston, Massachusetts 02215
    United States

    Active - Recruiting

  • Dana Farber Cancer Institute Brookline Avenue

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Active - Recruiting

  • Massachusetts General Hospital Cancer Center

    Boston, Massachusetts 02114
    United States

    Active - Recruiting

  • Dana Farber Cancer Institute Brookline Avenue

    Boston 4930956, Massachusetts 6254926 02215
    United States

    Active - Recruiting

  • Massachusetts General Hospital

    Boston 4930956, Massachusetts 6254926 02114
    United States

    Active - Recruiting

  • Karmanos Cancer Institute

    Detroit, Michigan 48201
    United States

    Site Not Available

  • Karmanos Cancer Institute

    Detroit 4990729, Michigan 5001836 48201
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Cancer Center

    New York, New York 10065
    United States

    Site Not Available

  • Memorial Sloan Kettering Cancer Center

    New York 5128581, New York 5128638 10065
    United States

    Active - Recruiting

  • The Ohio State University Wexner Medical Center

    Columbus, Ohio 43210
    United States

    Site Not Available

  • The Ohio State University Wexner Medical Center

    Columbus 4509177, Ohio 5165418 43210
    United States

    Active - Recruiting

  • Perelman School of Medicine at the University of Pennsylvania

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • University of Pennsylvania

    Philadelphia, Pennsylvania 19104
    United States

    Active - Recruiting

  • Perelman School of Medicine at the University of Pennsylvania

    Philadelphia 4560349, Pennsylvania 6254927 19104
    United States

    Active - Recruiting

  • Regeneron Research Site

    Providence, Rhode Island 02905
    United States

    Site Not Available

  • Regeneron Research Site

    Salt Lake City, Utah 84112
    United States

    Site Not Available

  • Seattle Cancer Care Alliance

    Seattle, Washington 98109
    United States

    Active - Recruiting

  • Seattle Cancer Care Alliance at South Lake Union - G3630

    Seattle, Washington 98109
    United States

    Site Not Available

  • Seattle Cancer Care Alliance at South Lake Union - G3630

    Seattle 5809844, Washington 5815135 98109
    United States

    Active - Recruiting

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