A Trial to Find Out How Safe REGN5668 is and How Well it Works When Given With Either Cemiplimab or REGN4018

Launched by REGENERON PHARMACEUTICALS · Oct 9, 2020

Keywords

ClinConnect Summary

This clinical trial is looking at a new drug called REGN5668 to see how safe it is and how well it works when combined with other treatments for cancers like ovarian cancer, fallopian tube cancer, primary peritoneal cancer, and endometrial cancer. Participants will take REGN5668 along with one of two other investigational drugs, cemiplimab or REGN4018. The study has two parts: the first part will focus on finding the highest safe dose of the drugs, while the second part will test those doses in participants with endometrial cancer.

To be eligible for this trial, participants need to be female and have a confirmed diagnosis of advanced ovarian or endometrial cancer. They should have also received at least one previous treatment involving platinum-based chemotherapy. The trial is designed for those who are generally healthy enough to tolerate new treatments, with specific requirements about their overall health and cancer history. Participants will be monitored closely for any side effects and how well the treatments work, providing a valuable opportunity to contribute to cancer research and potentially benefit from new therapies.

Gender

FEMALE

Eligibility criteria

• Key Inclusion Criteria:
• • 1. Ovarian Cancer Cohorts Only: 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
• • 2. Expansion cohorts only: Has at least 1 lesion that is measurable by RECIST 1.1 as described in the protocol.
• • 3. Has a serum CA-125 level ≥2x ULN (in screening, not applicable to endometrial cohorts)
• • 4. Has adequate organ and bone marrow function as defined in the protocol
• • 5. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• • 6. Has a life expectancy of at least 3 months
• • 7. Endometrial Cancer Cohorts Only: histologically confirmed endometrial cancer that has progressed or recurrent after prior anti-PD-1 therapy and platinum-based chemotherapy as described in the protocol
• Key Exclusion Criteria:
• • 1. Prior anti-cancer immunotherapy as defined in the protocol
• • 2. Recent treatment with anti-Programmed Cell Death (PD-1)/PDL-1 therapy
• • 3. 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
• • 4. Prior treatment with a MUC16-targeted therapy
• • 5. Expansion cohorts only: More than 4 prior lines of cytotoxic chemotherapy (including antibody drug conjugates)
• • 6. 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
• • 7. Has ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments as defined in the protocol
• • 8. Has untreated or active primary brain tumor, CNS metastases, leptomeningeal disease, or spinal cord compression as defined in the protocol
• • 9. Has history of clinically significant cardiovascular disease as defined in the protocol
• • 10. Has known allergy or hypersensitivity to cemiplimab and/or components of study drug(s).
• • Note: Other protocol-defined Inclusion/Exclusion criteria apply