OncoMatch/Clinical Trials/NCT03564340
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
Is NCT03564340 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including Ubamatamab and Cemiplimab for recurrent ovarian cancer.
Treatment: Ubamatamab · Cemiplimab · Sarilumab · Tocilizumab — 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)
Check if I qualifyExtracted eligibility criteria
Cancer type
Ovarian Cancer
Endometrial Cancer
Biomarker criteria
Required: MUC16 positivity of tumor cells ≥25% by immunohistochemistry (IHC) (≥25% by IHC)
MUC16 positivity of tumor cells ≥25% by immunohistochemistry (IHC), as defined in the protocol
Prior therapy
Must have received: platinum-containing therapy
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)
Must have received: anti-PD-1 therapy
endometrial cancer that has progressed or recurrent after prior anti-Programmed Cell Death Ligand 1 (PD-1) therapy and platinum-based chemotherapy
Must have received: platinum-based chemotherapy
endometrial cancer that has progressed or recurrent after prior anti-Programmed Cell Death Ligand 1 (PD-1) therapy and platinum-based chemotherapy
Cannot have received: anti-PD-1/PD-L1 therapy
Prior treatment with anti-Programmed Cell Death (PD-1)/PD-L1 therapy, as described in the protocol
Cannot have received: MUC16-targeted therapy
Prior treatment with a MUC16 - targeted therapy
Cannot have received: cytotoxic chemotherapy
Exception: does not apply to low-grade serous ovarian cancer cohort
Ovarian Cancer Expansion cohorts only: More than 4 prior lines of cytotoxic chemotherapy (does not apply to low-grade serous ovarian cancer cohort)
Lab requirements
Blood counts
Kidney function
Liver function
Cardiac function
History and/or current cardiovascular disease, as defined in the protocol; severe and/or uncontrolled hypertension at screening
Adequate organ and bone marrow function as defined in the protocol; History and/or current cardiovascular disease, as defined in the protocol; Severe and/or uncontrolled hypertension at screening
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of Alabama_6th Ave · Birmingham, Alabama
- Massachusetts General Hospital · Boston, Massachusetts
- Dana Farber / Harvard Cancer Center · Boston, Massachusetts
- Mayo Clinic - Rochester · Rochester, Minnesota
- Roswell Park Cancer Institute · Buffalo, New York
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify