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

Phase 1

Recruiting

• Conditions: Primary Peritoneal Cancer, Endometrial Cancer, Fallopian Tube Cancer, Ovarian Cancer; MedDRA version: 20.1Level: PTClassification code: 10080244Term: Peritoneal cancer index Class: 100000004848; MedDRA version: 21.0Level: PTClassification code: 10014733Term: Endometrial cancer Class: 100000004864; MedDRA version: 21.1Level: PTClassification code: 10066697Term: Ovarian cancer recurrent Class: 100000004864; MedDRA version: 20.0Level: PTClassification code: 10016180Term: Fallopian tube cancer Class: 100000004864; Therapeutic area: Diseases [C] - Neoplasms [C04]

• Registration Number: CTIS2024-510783-23-00
• Lead Sponsor: Regeneron Pharmaceuticals Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-05-28
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 689

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: 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, Other protocol-defined inclusion criteria apply

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 cardiac findings 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, Other protocol-defined exclusion criteria apply

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified