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

Launched by REGENERON PHARMACEUTICALS · Jun 8, 2018

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called REGN4018, both on its own and in combination with another drug called cemiplimab, for adult patients with recurrent ovarian cancer or certain other types of cancer that express a protein called MUC16. The main goals of the study are to understand how safe these treatments are, determine the right dosage, and see if they can help treat these cancers. Researchers will also look at how the body processes these drugs and how well they work in patients who have not had success with other treatments.

To participate in this trial, patients must be adult females with advanced forms of epithelial ovarian cancer, primary peritoneal cancer, or recurrent endometrial cancer who have received specific prior treatments. They should have a certain level of a tumor marker in their blood and must not have other effective treatment options available. Participants can expect regular health check-ups and monitoring throughout the study to ensure their safety and to gather information about how the treatments are working. It's important for potential participants to know that there are specific eligibility criteria, so they should talk to their doctor to see if they qualify.

Gender

FEMALE

Eligibility 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:
• • 1. serum CA-125 level ≥2 x upper limit of normal (ULN) (in screening)
• • 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 1 to 3 lines of platinum-based therapy as defined in the protocol.
• 5. 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:
• • 1. MUC16 positivity of tumor cells ≥25% by immunohistochemistry (IHC)
• • 2. 1-2 prior lines of systemic therapy
• Key Exclusion Criteria:
• • 1. Prior treatment with anti-Programmed Cell Death (PD-1)/PD-L1 therapy, as described in the protocol
• • 2. Ovarian Cancer Expansion cohorts only: More than 4 prior lines of cytotoxic chemotherapy
• • 3. Prior treatment with a MUC16 - targeted therapy
• • 4. Untreated or active primary brain tumor, central nervous system (CNS) metastases, or spinal cord compression, as described in the protocol
• • 5. History and/or current cardiovascular disease, as defined in the protocol
• • 6. 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