NCT03564340 · Regeneron Pharmaceuticals
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
What this study is about
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).
View original scientific description
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).
Interventions
DRUG
Ubamatamab
Administered per the protocol
DRUG
Cemiplimab
Administered per the protocol
DRUG
Sarilumab
Administered per the protocol
DRUG
Tocilizumab
Administered per the protocol
Primary outcome measures
Number of participants with Dose-limiting toxicity (DLTs) for ubamatamab monotherapy
Time frame: From Cycle 1, Day 1 up to 35 days
Dose Escalation Phase
Number of participants with DLTs for ubamatamab with cemiplimab
Time frame: 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
Time frame: Up to 2 years
Dose Escalation Phase
Number of participants with TEAEs (including imAEs) for ubamatamab with cemiplimab
Time frame: Up to 2 years
Dose Escalation Phase
Number of participants with serious adverse events (SAEs) for ubamatamab monotherapy
Time frame: Up to 2 years
Dose Escalation Phase
Number of participants with SAEs for ubamatamab with cemiplimab
Time frame: Up to 2 years
Dose Escalation Phase
Number of deaths for ubamatamab monotherapy
Time frame: Up to 2 years
Dose Escalation Phase
Number of deaths for ubamatamab with cemiplimab
Time frame: 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
Time frame: Up to 2 years
Dose Escalation Phase
Number of participants with laboratory abnormalities (grade 3 or higher per CTCAE) for ubamatamab with cemiplimab
Time frame: Up to 2 years
Dose Escalation Phase
Concentration of ubamatamab in serum over time for ubamatamab monotherapy
Time frame: Up to 2 years
Dose Escalation Phase
Concentration of ubamatamab in serum over time for ubamatamab with cemiplimab
Time frame: 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
Time frame: Up to 2 years
Dose Expansion Phase
ORR defined by RECIST 1.1 for ubamatamab with cemiplimab
Time frame: Up to 2 years
Dose Expansion Phase
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
Where
- Birmingham, Alabama
- Boston, Massachusetts
- Rochester, Minnesota
- Buffalo, New York
- New York, New York
- Hilliard, Ohio
- Oklahoma City, Oklahoma
- Nashville, Tennessee
- Richmond, Virginia
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 8, 2026 · Source of record for eligibility and locations