Study on the Safety and Effectiveness of REGN5668 with Cemiplimab or REGN4018 for Ovarian and Uterine Cancer

Sponsor: Regeneron Pharmaceuticals

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT04590326

Provider View

This clinical trial is testing a new drug called REGN5668, combined with other investigational drugs, to see if it is safe and effective for treating ovarian and uterine cancer. The study aims to find the best dose and observe any side effects.

Patient Parameters

Program Overview

This study is exploring a new drug, REGN5668, to see if it is safe and effective when used with other drugs like cemiplimab or REGN4018, for treating ovarian and uterine cancer. The study has two parts: Part 1 focuses on finding the safest dose, while Part 2 uses the chosen doses to further test the treatment. Participants with uterine cancer will only join in Part 2. The study will also look at how the drugs work in the body, their levels in the blood, and if they can help treat cancer. Additionally, it will assess the safety of using sarilumab before REGN4018 to manage a side effect called Cytokine Release Syndrome (CRS).

Eligibility Criteria

Inclusion Criteria

  • For ovarian cancer: Must have advanced ovarian, primary peritoneal, or fallopian tube cancer that has been treated with at least one round of platinum-based therapy.
  • For expansion groups: Must have at least one tumor that can be measured by scans.
  • Must have a CA-125 blood level at least twice the normal limit (not required for uterine cancer groups).
  • Must have good organ and bone marrow function.
  • Must be in good general health with an ECOG performance status of 0 or 1.
  • Must have a life expectancy of at least 3 months.
  • For uterine cancer: Must have uterine cancer that has worsened or returned after previous treatments with anti-PD-1 therapy and platinum-based chemotherapy.

Exclusion Criteria

  • Have had previous cancer immunotherapy treatments.
  • Have recently received PD-1/PDL-1 therapy.
  • Have another cancer within the last 5 years that is active or likely to return.
  • Have been treated with a MUC16-targeted therapy before.
  • For expansion groups: Have had more than 4 previous chemotherapy treatments.
  • Require ongoing steroid treatment within a week before starting the study.
  • Have a significant autoimmune disease needing treatment in the last 5 years.
  • Have untreated or active brain tumors or spinal cord issues.
  • Have a history of serious heart disease.
  • Have an allergy to cemiplimab or any study drug components.

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