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NCT04590326PHASE1, PHASE2Recruiting

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

Regeneron Pharmaceuticals

Start Date

12/8/2020

Completion Date

11/30/2027

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

Age Range: 18 years to No maximum

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

Interventions

DRUG

REGN5668

DRUG

Cemiplimab

DRUG

Ubamatamab

DRUG

Sarilumab

DRUG

Cemiplimab + Fianlimab [Fixed Dose Combination (FDC)]

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Conditions

Ovarian CancerFallopian Tube CancerPrimary Peritoneal CancerEndometrial Cancer

Locations

City of Hope Comprehensive Cancer Center

Duarte, California 91010

United States

The City of Hope Orange County Lennar Foundation Cancer Center

Irvine, California 92618

United States

Chao Family Comprehensive Cancer Center

Orange, California 92868

United States

H. Lee Moffitt Cancer Center

Tampa, Florida 33612

United States

Robert H. Lurie Comprehensive Cancer Center of Northwestern University

Chicago, Illinois 60611

United States

University of Chicago Medical Center

Chicago, Illinois 60637

United States

Massachusetts General Hospital

Boston, Massachusetts 02114

United States

Dana Farber Cancer Institute Brookline Avenue

Boston, Massachusetts 02215

United States

Karmanos Cancer Institute

Detroit, Michigan 48201

United States

Memorial Sloan Kettering Cancer Center

New York, New York 10065

United States

The Ohio State University Wexner Medical Center

Columbus, Ohio 43210

United States

Perelman School of Medicine at the University of Pennsylvania

Philadelphia, Pennsylvania 19104

United States

Seattle Cancer Care Alliance at South Lake Union - G3630

Seattle, Washington 98109

United States

Universitair Ziekenhuis Leuven

Leuven, Vlaams-Brabant 3000

Belgium

Hopital Lyon Sud

Pierre-Bénite, Auvergne-Rhône 69310

France

Centre Georges Francois Leclerc

Dijon, Bourgogne-Franche-Comté 21000

France

Institut Bergonie

Bordeaux, New Aquitaine 33076

France

Centre Francois Baclesse (CFB)

Caen, Normandy 14076

France

Institut Gustave Roussy

Villejuif, 94805

France

Hospital Clinico Universitario Santiago de Compostela

Santiago de Compostela, A Coruna 15706

Spain

Institut Catala dOncologia Girona

Girona, 17007

Spain

Ciudad Universitaria

Madrid, 28040

Spain

Hospital Universitario Fundacion Jimenez

Madrid, 28040

Spain

Hospital Universitario 12 de Octubre Universidad Complutense de Madrid UCM

Madrid, 28041

Spain