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) — South Korea Trial Details

Condition(s) studied

Recurrent Ovarian CancerRecurrent Fallopian Tube CancerRecurrent Primary Peritoneal CancerRecurrent Endometrial CancerEndometrial CancerLow-grade Serous Ovarian Cancer

Investigational drug(s) / intervention(s)

Ubamatamab →Cemiplimab →Sarilumab →Tocilizumab →

Ubamatamab: Administered per the protocol

Cemiplimab: Administered per the protocol

Sarilumab: Administered per the protocol

Tocilizumab: Administered per the protocol

Study 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

FEMALE

Min age

18 Years

Max age

—

Healthy volunteers

No

Key Inclusion Criteria: 1. 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: 1. serum CA-125 level ≥2 x upper limit of normal (ULN) (in screening, not required for low-grade serous carcinoma) 2. 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) 3. documented relapse or progression on or after the most recent line of therapy 4. no standard therapy options likely to convey clinical benefit 2. Adequate organ and bone marrow function as defined in the protocol 3. Life expectancy of at least 3 months 4. 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. 5. 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: 1. MUC16 positivity of tumor cells ≥25% by immunohistochemistry (IHC), as defined in the protocol 2. 1-4 prior lines of systemic therapy, as described in the protocol Key Exclusion Criteria: 1. Prior treatment with anti-Programmed Cell Death (PD-1)/PD-L1 therapy, as described in the protocol 2. Ovarian Cancer Expansion cohorts only: More than 4 prior lines of cytotoxic chemotherapy (does not apply to low-grade serous ovarian cancer cohort) 3. Prior treatment with a MUC16 - targeted therapy 4. Untreated or active primary brain tumor, central nervous system (CNS) metastases, or spinal cord compression, as described in the protocol 5. History and/or current cardiovascular disease, as defined in the protocol 6. Severe and/or uncontrolled hypertension at screening. Patients taking anti-hypertensive medication must be on a stable anti-hypertensive regimen Note: Other protocol-defined Inclusion/Exclusion Criteria apply

Primary outcome measure(s)

Number of participants with Dose-limiting toxicity (DLTs) for ubamatamab monotherapy — From Cycle 1, Day 1 up to 35 days
Dose Escalation Phase
Number of participants with DLTs for ubamatamab with cemiplimab — From Cycle 2, Day 1 up to 21 days
Dose Escalation Phase
Number of participants with Treatment-emergent adverse event (TEAE)s (including immune-related adverse events (imAEs)) for ubamatamab monotherapy — Up to 2 years
Dose Escalation Phase
Number of participants with TEAEs (including imAEs) for ubamatamab with cemiplimab — Up to 2 years
Dose Escalation Phase
Number of participants with serious adverse events (SAEs) for ubamatamab monotherapy — Up to 2 years
Dose Escalation Phase
Number of participants with SAEs for ubamatamab with cemiplimab — Up to 2 years
Dose Escalation Phase
Number of deaths for ubamatamab monotherapy — Up to 2 years
Dose Escalation Phase
Number of deaths for ubamatamab with cemiplimab — Up to 2 years
Dose Escalation Phase
Number of participants with laboratory abnormalities (grade 3 or higher per Common Terminology Criteria for Adverse Events [CTCAE]) for ubamatamab monotherapy — Up to 2 years
Dose Escalation Phase
Number of participants with laboratory abnormalities (grade 3 or higher per CTCAE) for ubamatamab with cemiplimab — Up to 2 years
Dose Escalation Phase
Concentration of ubamatamab in serum over time for ubamatamab monotherapy — Up to 2 years
Dose Escalation Phase
Concentration of ubamatamab in serum over time for ubamatamab with cemiplimab — Up to 2 years
Dose Escalation Phase
Objective response rate (ORR) defined by Response Evaluation Criteria in Solid Tumors (RECIST 1.1) for ubamatamab monotherapy — Up to 2 years
Dose Expansion Phase
ORR defined by RECIST 1.1 for ubamatamab with cemiplimab — Up to 2 years
Dose Expansion Phase

Trial sites (54)

Facility	City	Region	Status
University of Alabama_6th Ave	Birmingham	Alabama	Recruiting
Massachusetts General Hospital	Boston	Massachusetts	Recruiting
Dana Farber / Harvard Cancer Center	Boston	Massachusetts	Recruiting
Mayo Clinic - Rochester	Rochester	Minnesota	Recruiting
Roswell Park Cancer Institute	Buffalo	New York	Withdrawn
Columbia University Medical Center	New York	New York	Recruiting
Memorial Sloan Kettering Cancer Center	New York	New York	Recruiting
The Ohio State University Wexner Medical Center	Columbus	Ohio	Recruiting
Stephenson Cancer Center	Oklahoma City	Oklahoma	Recruiting
Sarah Cannon Research Institute	Nashville	Tennessee	Completed
The University of Texas MD Anderson Cancer Center	Houston	Texas	Recruiting
Virginia Commonwealth University	Richmond	Virginia	Recruiting
Prince of Wales Hospital	Randwick	New South Wales	Completed
Peter MacCallum Cancer Center	Melbourne	Australia	Completed
Universitair Ziekenhuis Antwerpen	Edegem	Antwerp	Recruiting
Grand Hopital de Charleroi	Charleroi	Hainaut	Recruiting
UZLeuven	Leuven	Vlaams-Brabant	Recruiting
Hopital Lyon Sud	Pierre-Bénite	Auvergne-Rhône	Recruiting
Centre Georges Francois Leclerc	Dijon	Bourgogne-Franche-Comté	Recruiting
Institut Bergonie	Bordeaux	New Aquitaine	Recruiting
Centre Francois Baclesse (CFB)	Caen	Normandy	Recruiting
Centre Antoine Lacassagne	Nice	Provence Alpes Cote dAzur	Recruiting
Centre Leon Berard	Lyon	France	Recruiting
Institut Gustave Roussy	Villejuif	Île-de-France Region	Recruiting
Rambam Health Care Campus	Haifa	Israel	Recruiting
Sharet Institute of Oncology	Jerusalem	Israel	Recruiting
Sheba Medical Center	Tel Litwinsky	Israel	Recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Lazio	Recruiting
Humanitas S. Pio X	Milan	Italy	Recruiting
Istituto Europeo di Oncologia	Milan	Italy	Recruiting
Instituto Nazionale Tumori- Fondazione Pascale	Naples	Italy	Recruiting
Radboudumc	Nijmegen	Gelderland	Recruiting
Erasmus MC	Rotterdam	South Holland	Recruiting
University Medical Center Groningen	Groningen	Netherlands	Recruiting
Yonsei University Health System	Seoul	South Korea	Recruiting
Asan Medical Center, Univ. of Ulsan	Seoul	South Korea	Recruiting
Samsung Medical Center	Seoul	South Korea	Recruiting
Korea University Guro Hospital	Seoul	South Korea	Recruiting
Seoul National University Hospital	Seoul	South Korea	Recruiting
Clinica Universidad de Navarra	Pamplona	Navarre	Recruiting

+ 14 more sites — see the full list on the official registry below.

On this site

📄 Libtayo (cemiplimab) drug profile → 📄 Kevzara (sarilumab) drug profile → 📄 Actemra (tocilizumab) drug profile →

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