Investigating the safety and effectiveness of REGN5668 with other drugs for advanced ovarian and uterine cancers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial is evaluating the investigational drug REGN5668 in combination with either cemiplimab or REGN4018 for patients with advanced ovarian cancer or cancer of the uterus. The study is divided into two parts: the first part focuses on determining the highest safe dose of the drugs, while the second part aims to assess the effectiveness of these doses in treating the targeted cancers. Participants will be monitored for safety and side effects, as well as any signs of treatment efficacy. The trial includes specific eligibility criteria to ensure that participants have measurable disease and adequate organ function.

Why it matters

Who can join: the full rules

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. Current or recent (as defined in the protocol) treatment with an investigational agent, systemic biologic therapy, or anti-cancer immunotherapy
2. 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
3. Prior treatment with a Mucin 16 (MUC16)-targeted therapy
4. Ovarian Expansion cohorts only: More than 5 prior lines of systemic therapy
5. 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
6. Has ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments as defined in the protocol
7. Has untreated or active primary brain tumor, CNS metastases, leptomeningeal disease, or spinal cord compression as defined in the protocol
8. Has history of clinically significant cardiovascular disease as defined in the protocol
9. Has known allergy or hypersensitivity to cemiplimab and/or components of study drug(s).

Note: Other protocol-defined Inclusion/Exclusion criteria apply

Where it's running

• City of Hope Comprehensive Cancer Center
  Duarte, California, United States Recruiting
• The City of Hope Orange County Lennar Foundation Cancer Center
  Irvine, California, United States Recruiting
• Chao Family Comprehensive Cancer Center
  Orange, California, United States Recruiting
• Robert H. Lurie Comprehensive Cancer Center of Northwestern University
  Chicago, Illinois, United States Recruiting
• University of Chicago Medical Center
  Chicago, Illinois, United States Recruiting
• Massachusetts General Hospital
  Boston, Massachusetts, United States Recruiting

Study contacts

• Study coordinator: Clinical Trials Administrator
• Email: clinicaltrials@regeneron.com
• Phone: 844-734-6643

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.