RecruitingPhase 1Phase 2NCT03564340

Study of REGN4018 (Ubamatamab) Administered Alone or in Combination With Cemiplimab in Adult Patients With Recurrent Ovarian Cancer or Other Recurrent Mucin-16 Expressing (MUC16+) Cancers

A Phase 1/2 Study of REGN4018 (Ubamatamab), a MUC16×CD3 Bispecific Antibody, Administered Alone or in Combination With Cemiplimab in Patients With Recurrent Ovarian Cancer or Other Recurrent MUC16+ Cancers


Sponsor

Regeneron Pharmaceuticals

Enrollment

890 participants

Start Date

May 21, 2018

Study Type

INTERVENTIONAL

Conditions

Summary

The main purpose of this study is to: * Learn about the safety of ubamatamab and to find out what dose of ubamatamab can be given alone or with cemiplimab to patients with ovarian cancer or cancer of the uterus * The study will also look at the levels of ubamatamab and/or cemiplimab in the body and measure how well the body can remove the study drug(s). This is called pharmacokinetics * The study will also look at any signs that ubamatamab alone or with cemiplimab can treat recurrent advanced ovarian cancer or cancer of the uterus * To find out how safe and tolerable pretreatment is in combination with ubamatamab and to see how well it works to prevent or minimize Cytokine Release Syndrome (CRS)


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new drug called ubamatamab (REGN4018) — alone or combined with an immunotherapy drug called cemiplimab — in women with ovarian cancer or other cancers that carry a specific protein called MUC16 (also known as CA-125), where standard treatments are no longer working. **You may be eligible if...** - You have been diagnosed with advanced ovarian cancer, primary peritoneal cancer, or fallopian tube cancer that has come back after prior treatment - Your CA-125 blood level is at least twice the upper normal limit - You have already received at least one platinum-based chemotherapy treatment, or you cannot tolerate platinum-based chemotherapy - No standard treatment options remain that are likely to benefit you - Your organs (liver, kidneys, bone marrow) are functioning adequately **You may NOT be eligible if...** - Your cancer has not recurred or progressed after prior treatment - You have not yet tried standard therapies - Your organ function does not meet the required thresholds Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGUbamatamab

Administered per the protocol

DRUGCemiplimab

Administered per the protocol

DRUGSarilumab

Administered per the protocol

DRUGTocilizumab

Administered per the protocol


Locations(51)

University of Alabama_6th Ave

Birmingham, Alabama, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Dana Farber / Harvard Cancer Center

Boston, Massachusetts, United States

Mayo Clinic - Rochester

Rochester, Minnesota, United States

Roswell Park Cancer Institute

Buffalo, New York, United States

Columbia University Medical Center

New York, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

The Ohio State University Wexner Medical Center James Comprehensive Cancer Center

Hilliard, Ohio, United States

Stephenson Cancer Center

Oklahoma City, Oklahoma, United States

Sarah Cannon Research Institute

Nashville, Tennessee, United States

Virginia Commonwealth University

Richmond, Virginia, United States

Prince of Wales Hospital

Randwick, New South Wales, Australia

Peter MacCallum Cancer Center

Melbourne, Australia

Universitair Ziekenhuis Antwerpen

Edegem, Antwerp, Belgium

Grand Hopital de Charleroi

Charleroi, Hainaut, Belgium

UZLeuven

Leuven, Vlaams-Brabant, Belgium

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

Centre Antoine Lacassagne

Nice, Provence Alpes Cote dAzur, France

Institut Gustave Roussy

Villejuif, Île-de-France Region, France

Rambam Health Care Campus

Haifa, Israel

Sharet Institute of Oncology

Jerusalem, Israel

Sheba Medical Center

Tel Litwinsky, Israel

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Rome, Lazio, Italy

Istituto Europeo di Oncologia

Milan, Italy

Instituto Nazionale Tumori- Fondazione Pascale

Naples, Italy

Radboudumc

Nijmegen, Gelderland, Netherlands

Erasmus MC

Rotterdam, South Holland, Netherlands

University Medical Center Groningen

Groningen, Netherlands

Yonsei University Health System

Seoul, South Korea

Asan Medical Center, Univ. of Ulsan

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

Korea University Guro Hospital

Seoul, South Korea

Seoul National University Hospital

Seoul, South Korea

Clinica Universidad de Navarra

Pamplona, Navarre, Spain

Institut Catala dOncologia Badalona

Badalona, Spain

Hospital Universitari Vall d'Hebron

Barcelona, Spain

Institut Catala d'Oncologia

Barcelona, Spain

Clinica Universidad Navarra (CUN) Madrid

Madrid, Spain

Fundacion Jimenez Diaz

Madrid, Spain

Hospital Universitario San Carlos

Madrid, Spain

Hospital Clinico Universitatio Santiago de Compostela

Santiago de Compostela, Spain

University of Oxford

Oxford, Oxfordshire, United Kingdom

Royal Marsden Hospital - Sutton

Sutton, Surrey, United Kingdom

The Royal Marsden NHS Foundation Trust

Sutton, Surrey, United Kingdom

University College London Hospitals

London, United Kingdom

Guys Hospital

London, United Kingdom

Imperial College Healthcare NHS Trust

London, United Kingdom

The Christie NHS Foundation Trust

Manchester, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT03564340


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