Study of REGN5668 Administered in Combination with Cemiplimab or REGN4018 in Adult Women with Recurrent Ovarian Cancer

Phase 1

Recruiting

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

• Registration Number: CTIS2022-501904-83-00
• Lead Sponsor: Regeneron Pharmaceuticals Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-03-27
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 224

Inclusion Criteria

Has histologically or cytologically confirmed diagnosis of advanced epithelial ovarian cancer (except carcinosarcoma), primary peritoneal, or fallopian tube cancer that has received at least 1 line of platinum-based systemic therapy as defined in the protocol, Has a serum CA-125 level =2x ULN (in screening), Has adequate organ and bone marrow function as defined in the protocol, Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1., Has a life expectancy of at least 3 months, Note: Other protocol-defined Inclusion criteria apply

Exclusion Criteria

Prior anti-cancer immunotherapy as defined in the protocol, Note: Other protocol-defined Exclusion criteria apply, Recent treatment with anti-Programmed Cell Death (PD-1)/PDL-1 therapy, Has had another malignancy within the last 5 years that is progressing, requires active treatment, or has a high likelihood of recurrence as defined in the protocol, Prior treatment with a MUC16-targeted therapy, Expansion cohorts only: More than 3 prior lines of cytotoxic chemotherapy for platinum-experienced and/or intolerant disease, Has any condition that requires ongoing/continuous corticosteroid therapy as defined in the protocol within 1 week prior to the first dose of study drug, Has ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments as defined in the protocol, Has untreated or active primary brain tumor, CNS metastases, leptomeningeal disease, or spinal cord compression as defined in the protocol, Has history of clinically significant cardiovascular disease as defined in the protocol

Study & Design

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