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

Who is this study for? Patients with recurrent ovarian cancer
Status: Recruiting
Location: See all (51) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

⁃ 1-4 prior lines of systemic therapy, as described in the protocol

Locations
United States
Alabama
University of Alabama_6th Ave
RECRUITING
Birmingham
Massachusetts
Dana Farber / Harvard Cancer Center
RECRUITING
Boston
Massachusetts General Hospital
RECRUITING
Boston
Minnesota
Mayo Clinic - Rochester
RECRUITING
Rochester
New York
Roswell Park Cancer Institute
WITHDRAWN
Buffalo
Columbia University Medical Center
RECRUITING
New York
Memorial Sloan Kettering Cancer Center
RECRUITING
New York
Ohio
The Ohio State University Wexner Medical Center James Comprehensive Cancer Center
RECRUITING
Hilliard
Oklahoma
Stephenson Cancer Center
RECRUITING
Oklahoma City
Tennessee
Sarah Cannon Research Institute
RECRUITING
Nashville
Virginia
Virginia Commonwealth University
RECRUITING
Richmond
Other Locations
Australia
Peter MacCallum Cancer Center
COMPLETED
Melbourne
Prince of Wales Hospital
COMPLETED
Randwick
Belgium
Grand Hopital de Charleroi
RECRUITING
Charleroi
Universitair Ziekenhuis Antwerpen
RECRUITING
Edegem
UZLeuven
RECRUITING
Leuven
France
Institut Bergonie
RECRUITING
Bordeaux
Centre Francois Baclesse (CFB)
RECRUITING
Caen
Centre Georges Francois Leclerc
RECRUITING
Dijon
Centre Antoine Lacassagne
RECRUITING
Nice
Hopital Lyon Sud
RECRUITING
Pierre-bénite
Institut Gustave Roussy
RECRUITING
Villejuif
Israel
Rambam Health Care Campus
RECRUITING
Haifa
Sharet Institute of Oncology
RECRUITING
Jerusalem
Sheba Medical Center
RECRUITING
Tel Litwinsky
Italy
Istituto Europeo di Oncologia
RECRUITING
Milan
Instituto Nazionale Tumori- Fondazione Pascale
RECRUITING
Naples
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
RECRUITING
Rome
Netherlands
University Medical Center Groningen
RECRUITING
Groningen
Radboudumc
RECRUITING
Nijmegen
Erasmus MC
RECRUITING
Rotterdam
Republic of Korea
Asan Medical Center, Univ. of Ulsan
RECRUITING
Seoul
Korea University Guro Hospital
RECRUITING
Seoul
Samsung Medical Center
RECRUITING
Seoul
Seoul National University Hospital
RECRUITING
Seoul
Yonsei University Health System
RECRUITING
Seoul
Spain
Institut Catala dOncologia Badalona
RECRUITING
Badalona
Hospital Universitari Vall d'Hebron
RECRUITING
Barcelona
Institut Catala d'Oncologia
RECRUITING
Barcelona
Clinica Universidad Navarra (CUN) Madrid
RECRUITING
Madrid
Fundacion Jimenez Diaz
RECRUITING
Madrid
Hospital Universitario San Carlos
RECRUITING
Madrid
Clinica Universidad de Navarra
RECRUITING
Pamplona
Hospital Clinico Universitatio Santiago de Compostela
RECRUITING
Santiago De Compostela
United Kingdom
Guys Hospital
RECRUITING
London
Imperial College Healthcare NHS Trust
RECRUITING
London
University College London Hospitals
RECRUITING
London
The Christie NHS Foundation Trust
RECRUITING
Manchester
University of Oxford
RECRUITING
Oxford
Royal Marsden Hospital - Sutton
WITHDRAWN
Sutton
The Royal Marsden NHS Foundation Trust
RECRUITING
Sutton
Contact Information
Primary
Clinical Trials Administrator
clinicaltrials@regeneron.com
844-734-6643
Time Frame
Start Date: 2018-05-21
Estimated Completion Date: 2027-01-31
Participants
Target number of participants: 890
Treatments
Experimental: Monotherapy
REGN4018 administration
Experimental: Combination Therapy
REGN4018 and cemiplimab administration
Related Therapeutic Areas
Sponsors
Leads: Regeneron Pharmaceuticals

This content was sourced from clinicaltrials.gov