Study on REGN4018 Alone or with Cemiplimab for Adults with Recurrent Ovarian Cancer or Other MUC16+ Cancers

Sponsor: Regeneron Pharmaceuticals

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT03564340

Provider View

This clinical trial is testing the safety and effectiveness of a new drug, REGN4018, given alone or with another drug, cemiplimab, in adults with recurrent ovarian cancer or other cancers that express MUC16. The study will also assess how the body processes these drugs and the safety of adding sarilumab to the treatment.

Patient Parameters

Program Overview

The main goals of this study are to determine the safety of the drug REGN4018, find the best dose when used alone or with cemiplimab, and see if it can help treat recurrent ovarian or uterine cancer. Researchers will also study how the body absorbs and eliminates these drugs, known as pharmacokinetics. Additionally, the study will evaluate the safety of using sarilumab before REGN4018 and cemiplimab.

Eligibility Criteria

Inclusion Criteria

  • For Ovarian Cancer: Must have advanced ovarian, primary peritoneal, or fallopian tube cancer confirmed by tests, with a high CA-125 level, and have tried at least one platinum-based treatment or be unable to tolerate it. The cancer must have returned or worsened after the last treatment, and no standard treatments should be available that are likely to help.
  • Must have adequate organ and bone marrow function.
  • Must have a life expectancy of at least 3 months.
  • For the randomized phase 2 group: Must have platinum-resistant ovarian cancer and have had 1 to 3 lines of platinum-based therapy.
  • For Endometrial Cancer: Must have confirmed endometrial cancer that has worsened or returned after previous PD-1 therapy and platinum-based chemotherapy, with at least 25% of tumor cells showing MUC16 positivity.
  • Must have had 1-2 prior lines of systemic therapy.

Exclusion Criteria

  • Have had previous treatment with PD-1/PD-L1 therapy.
  • For Ovarian Cancer: Have had more than 4 prior lines of chemotherapy.
  • Have had previous treatment targeting MUC16.
  • Have untreated or active brain tumors, cancer spread to the brain, or spinal cord compression.
  • Have a history of heart disease.
  • Have severe or uncontrolled high blood pressure at screening, even if taking medication for it.

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