Study of REGN4018 (Ubamatamab) Administered Alone or in Combination With Cemiplimab in Adult Patients With Recurrent Ovarian Cancer or Other Recurrent Mucin-16 Expressing (MUC16+) Cancers

The main purpose of this study is to: * Learn about the safety of ubamatamab and to find out what dose of ubamatamab can be given alone or with cemiplimab to patients with ovarian cancer or cancer of the uterus * The study will also look at the levels of ubamatamab and/or cemiplimab in the body and measure how well the body can remove the study drug(s). This is called pharmacokinetics * The study will also look at any signs that ubamatamab alone or with cemiplimab can treat recurrent advanced ovarian cancer or cancer of the uterus * To find out how safe and tolerable pretreatment is in combin

Trial Details

NCT ID
NCT03564340
Phase
PHASE1 / PHASE2
Sponsor
Regeneron Pharmaceuticals
Status
RECRUITING
Cancer Type
High-Grade Serous Ovarian Cancer
Interventions
  • Ubamatamab
  • Cemiplimab
  • Sarilumab
  • Tocilizumab
Locations (sample)
  • Birmingham, Alabama, United States|33.52066,-86.80249
  • Boston, Massachusetts, United States|42.35843,-71.05977
  • Rochester, Minnesota, United States|44.02163,-92.4699
  • Buffalo, New York, United States|42.88645,-78.87837
  • Columbus, Ohio, United States|39.96118,-82.99879

Key Eligibility Criteria

  • Ovarian Cancer Cohorts Only: Patients with histologically or cytologically confirmed diagnosis of advanced, epithelial ovarian cancer (except carci…
  • serum CA-125 level ≥2 x upper limit of normal (ULN) (in screening, not required for low-grade serous carcinoma)
  • has received at least 1 line of platinum-containing therapy or must be platinum-intolerant (applicable for dose escalation and non-randomized dose …
  • documented relapse or progression on or after the most recent line of therapy

For full eligibility, visit ClinicalTrials.gov.

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