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

NCT03564340 | Recruiting Phase 1 FDA Drug

• 3 other identifiers: R4018-ONC-17212024-510783-23-002019-003298-24
• Study Type: interventional
• Target: 890
• Locations: 10 countries
• Sites: 51

Brief 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)

Conditions

Recurrent Fallopian Tube Cancer; Recurrent Primary Peritoneal Cancer; Recurrent Ovarian Cancer; Recurrent Endometrial Cancer; Endometrial Cancer; Low-grade Serous Ovarian Cancer

Outcome Measures

Primary Outcomes (14)

• Number of participants with Dose-limiting toxicity (DLTs) for ubamatamab monotherapy

  Dose Escalation Phase

  From Cycle 1, Day 1 up to 35 days

• Number of participants with DLTs for ubamatamab with cemiplimab

  Dose Escalation Phase

  From Cycle 2, Day 1 up to 21 days

• Number of participants with Treatment-emergent adverse event (TEAE)s (including immune-related adverse events (imAEs)) for ubamatamab monotherapy

  Dose Escalation Phase

  Up to 2 years

• Number of participants with TEAEs (including imAEs) for ubamatamab with cemiplimab

  Dose Escalation Phase

  Up to 2 years

• Number of participants with serious adverse events (SAEs) for ubamatamab monotherapy

  Dose Escalation Phase

  Up to 2 years

• Number of participants with SAEs for ubamatamab with cemiplimab

  Dose Escalation Phase

  Up to 2 years

• Number of deaths for ubamatamab monotherapy

  Dose Escalation Phase

  Up to 2 years

• Number of deaths for ubamatamab with cemiplimab

  Dose Escalation Phase

  Up to 2 years

• Number of participants with laboratory abnormalities (grade 3 or higher per Common Terminology Criteria for Adverse Events [CTCAE]) for ubamatamab monotherapy

  Dose Escalation Phase

  Up to 2 years

• Number of participants with laboratory abnormalities (grade 3 or higher per CTCAE) for ubamatamab with cemiplimab

  Dose Escalation Phase

  Up to 2 years

• Concentration of ubamatamab in serum over time for ubamatamab monotherapy

  Dose Escalation Phase

  Up to 2 years

• Concentration of ubamatamab in serum over time for ubamatamab with cemiplimab

  Dose Escalation Phase

  Up to 2 years

• Objective response rate (ORR) defined by Response Evaluation Criteria in Solid Tumors (RECIST 1.1) for ubamatamab monotherapy

  Dose Expansion Phase

  Up to 2 years

• ORR defined by RECIST 1.1 for ubamatamab with cemiplimab

  Dose Expansion Phase

  Up to 2 years

Secondary Outcomes (52)

• ORR based on RECIST 1.1 for ubamatamab monotherapy

  Up to 2 years

• ORR based on RECIST 1.1 for ubamatamab with cemiplimab

  Up to 2 years

• Number of participants with TEAEs (including imAEs) for ubamatamab monotherapy

  Up to 2 years

• Number of participants with TEAEs (including imAEs) for ubamatamab with cemiplimab

  Up to 2 years

• Number of participants with SAEs for ubamatamab monotherapy

  Up to 2 years

Study Arms (2)

Monotherapy

EXPERIMENTAL

REGN4018 administration

Drug: Ubamatamab; Drug: Sarilumab; Drug: Tocilizumab

Combination Therapy

EXPERIMENTAL

REGN4018 and cemiplimab administration

Drug: Ubamatamab; Drug: Cemiplimab

Interventions

Ubamatamab DRUG

Administered per the protocol

Also known as: REGN4018

Combination Therapy; Monotherapy

Cemiplimab DRUG

Administered per the protocol

Also known as: REGN2810, Libtayo®

Combination Therapy

Sarilumab DRUG

Administered per the protocol

Also known as: Kevzara®, REGN88, SAR153191

Monotherapy

Tocilizumab DRUG

Administered per the protocol

Also known as: ACTEMRA®, Biosimilar

Monotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ovarian Cancer Cohorts Only: Patients with histologically or cytologically confirmed diagnosis of advanced, epithelial ovarian cancer (except carcinosarcoma), primary peritoneal, or fallopian tube cancer who have all of the following:
• serum CA-125 level ≥2 x upper limit of normal (ULN) (in screening, not required for low-grade serous carcinoma)
• has received at least 1 line of platinum-containing therapy or must be platinum-intolerant (applicable for dose escalation and non-randomized dose expansion cohorts)
• documented relapse or progression on or after the most recent line of therapy
• no standard therapy options likely to convey clinical benefit
• Adequate organ and bone marrow function as defined in the protocol
• Life expectancy of at least 3 months
• Randomized phase 2 expansion cohort (Ovarian Cancer only): Platinum-resistant ovarian cancer patients who have had 2 to 4 lines of platinum-based therapy as defined in the protocol.
• Endometrial Cancer Cohorts Only: histologically confirmed endometrial cancer that has progressed or recurrent after prior anti-Programmed Cell Death Ligand 1 (PD-1) therapy and platinum-based chemotherapy:
• MUC16 positivity of tumor cells ≥25% by immunohistochemistry (IHC), as defined in the protocol
• prior lines of systemic therapy, as described in the protocol

You may not qualify if:

• Prior treatment with anti-Programmed Cell Death (PD-1)/PD-L1 therapy, as described in the protocol
• Ovarian Cancer Expansion cohorts only: More than 4 prior lines of cytotoxic chemotherapy (does not apply to low-grade serous ovarian cancer cohort)
• Prior treatment with a MUC16 - targeted therapy
• Untreated or active primary brain tumor, central nervous system (CNS) metastases, or spinal cord compression, as described in the protocol
• History and/or current cardiovascular disease, as defined in the protocol
• Severe and/or uncontrolled hypertension at screening. Patients taking anti-hypertensive medication must be on a stable anti-hypertensive regimen

Sponsors & Collaborators

• Regeneron Pharmaceuticals: lead

Study Sites (51)

University of Alabama_6th Ave

Birmingham, Alabama, 35294, United States

RECRUITING

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

Dana Farber / Harvard Cancer Center

Boston, Massachusetts, 02215, United States

RECRUITING

Mayo Clinic - Rochester

Rochester, Minnesota, 55901, United States

RECRUITING

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

WITHDRAWN

Columbia University Medical Center

New York, New York, 10032, United States

RECRUITING

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

RECRUITING

The Ohio State University Wexner Medical Center James Comprehensive Cancer Center

Hilliard, Ohio, 43026, United States

RECRUITING

Stephenson Cancer Center

Oklahoma City, Oklahoma, 73104, United States

RECRUITING

Sarah Cannon Research Institute

Nashville, Tennessee, 37203, United States

RECRUITING

Virginia Commonwealth University

Richmond, Virginia, 23219, United States

RECRUITING

Prince of Wales Hospital

Randwick, New South Wales, 2031, Australia

COMPLETED

Peter MacCallum Cancer Center

Melbourne, 3000, Australia

COMPLETED

Universitair Ziekenhuis Antwerpen

Edegem, Antwerp, 2650, Belgium

RECRUITING

Grand Hopital de Charleroi

Charleroi, Hainaut, 6000, Belgium

RECRUITING

UZLeuven

Leuven, Vlaams-Brabant, 3000, Belgium

RECRUITING

Hopital Lyon Sud

Pierre-Bénite, Auvergne-Rhône, 69310, France

RECRUITING

Centre Georges Francois Leclerc

Dijon, Bourgogne-Franche-Comté, 21000, France

RECRUITING

Institut Bergonie

Bordeaux, New Aquitaine, 33076, France

RECRUITING

Centre Francois Baclesse (CFB)

Caen, Normandy, 14076, France

RECRUITING

Centre Antoine Lacassagne

Nice, Provence Alpes Cote dAzur, 06189, France

RECRUITING

Institut Gustave Roussy

Villejuif, Île-de-France Region, 94800, France

RECRUITING

Rambam Health Care Campus

Haifa, 3109601, Israel

RECRUITING

Sharet Institute of Oncology

Jerusalem, 9112001, Israel

RECRUITING

Sheba Medical Center

Tel Litwinsky, 5265601, Israel

RECRUITING

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Rome, Lazio, 00168, Italy

RECRUITING

Istituto Europeo di Oncologia

Milan, 20141, Italy

RECRUITING

Instituto Nazionale Tumori- Fondazione Pascale

Naples, 80131, Italy

RECRUITING

Radboudumc

Nijmegen, Gelderland, 6500HB, Netherlands

RECRUITING

Erasmus MC

Rotterdam, South Holland, 3000 DR, Netherlands

RECRUITING

University Medical Center Groningen

Groningen, 9713 GZ, Netherlands

RECRUITING

Yonsei University Health System

Seoul, 03722, South Korea

RECRUITING

Asan Medical Center, Univ. of Ulsan

Seoul, 05505, South Korea

RECRUITING

Samsung Medical Center

Seoul, 06351, South Korea

RECRUITING

Korea University Guro Hospital

Seoul, 08307, South Korea

RECRUITING

Seoul National University Hospital

Seoul, 3080, South Korea

RECRUITING

Clinica Universidad de Navarra

Pamplona, Navarre, 31008, Spain

RECRUITING

Institut Catala dOncologia Badalona

Badalona, 08916, Spain

RECRUITING

Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain

RECRUITING

Institut Catala d'Oncologia

Barcelona, 8908, Spain

RECRUITING

Clinica Universidad Navarra (CUN) Madrid

Madrid, 28027, Spain

RECRUITING

Fundacion Jimenez Diaz

Madrid, 28040, Spain

RECRUITING

Hospital Universitario San Carlos

Madrid, 28040, Spain

RECRUITING

Hospital Clinico Universitatio Santiago de Compostela

Santiago de Compostela, 15706, Spain

RECRUITING

University of Oxford

Oxford, Oxfordshire, OX1 2JD, United Kingdom

RECRUITING

Royal Marsden Hospital - Sutton

Sutton, Surrey, SM2 5PT, United Kingdom

WITHDRAWN

The Royal Marsden NHS Foundation Trust

Sutton, Surrey, SM2 5PT, United Kingdom

RECRUITING

University College London Hospitals

London, NW1 2PG, United Kingdom

RECRUITING

Guys Hospital

London, SE1 9RT, United Kingdom

RECRUITING

Imperial College Healthcare NHS Trust

London, W12 0HS, United Kingdom

RECRUITING

The Christie NHS Foundation Trust

Manchester, M20 4BX, United Kingdom

RECRUITING

MeSH Terms

Conditions

Ovarian Neoplasms; Fallopian Tube Neoplasms; Endometrial Neoplasms

Interventions

cemiplimab; sarilumab; tocilizumab; Biosimilar Pharmaceuticals

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Fallopian Tube Diseases; Uterine Neoplasms; Uterine Diseases

Intervention Hierarchy (Ancestors)

Biological Products; Complex Mixtures

Study Officials

• Clinical Trial Management

  Regeneron Pharmaceuticals

  STUDY DIRECTOR

Central Study Contacts

Clinical Trials Administrator

CONTACT

844-734-6643; clinicaltrials@regeneron.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2018
• First Posted: June 20, 2018
• Study Start: May 21, 2018
• Primary Completion (Estimated): May 10, 2027
• Study Completion (Estimated): May 10, 2027
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: When Regeneron has: * received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication or has globally discontinued development of the product for all indications on or after April 2020 and has no plans for future development * made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry) * the legal authority to share the data, and * ensured the ability to protect participant privacy
• Access Criteria: Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf

Locations

AU (2); NL (3); US (11); KR (5); ES (8); FR (6); GB (7); IT (3); IL (3); BE (3)