Study of REGN4018 Administered Alone or in Combination With Cemiplimab in Adult Patients With Recurrent Ovarian Cancer or Other Recurrent Mucin-16 Expressing (MUC16+) Cancers
About the study
Who can take part
INCLUSION CRITERIA
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:
- serum CA-125 level ≥2 x upper limit of normal (ULN) (in screening)
- 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 1 to 3 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)
- 1-2 prior lines of systemic therapy
EXCLUSION CRITERIA
Key Exclusion Criteria:
- 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
- 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
Note: Other protocol Inclusion/Exclusion Criteria apply
Study Locations
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How to Apply
Study Details
Contition
Recurrent Ovarian Cancer,Recurrent Fallopian Tube Cancer,Recurrent Primary Peritoneal Cancer,Recurrent Endometrial Cancer
Age
18+
Phase
PHASE1/PHASE2
Participants Needed
690
Est. Completion Date
Jun 21, 2026
Treatment Type
INTERVENTIONAL
Sponsor
Regeneron Pharmaceuticals
ClinicalTrials.gov NCT Identifier
NCT03564340
Study Number
R4018-ONC-1721
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