Last updated 44 hours ago
A Study to Find Out How Safe REGN5668 is and How Well it Works In Adult Women When Given With Either Cemiplimab, or Cemiplimab + Fianlimab, or Ubamatamab
612 patients around the world
Available in Brazil, United States
Regeneron Pharmaceuticals
2Research sites
612Patients around the world
This study is for people with
Ovarian cancer
Fallopian tube cancer
Primary peritoneal cancer
Endometrial Cancer
Requirements for the patient
From 18 Years
Female
Medical requirements
- 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.Expansion cohorts only: Has at least 1 lesion that is measurable by RECIST 1.1 as described in the protocol.Has a serum CA-125 level ≥2x ULN (in screening, not applicable to endometrial cohorts).Has adequate organ and bone marrow function as defined in the protocol.Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.Has a life expectancy of at least 3 months.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.
- Current or recent (as defined in the protocol) treatment with an investigational agent, systemic biologic therapy, or anti-cancer immunotherapy.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.Prior treatment with a Mucin 16 (MUC16)-targeted therapy.Ovarian Expansion cohorts only: More than 5 prior lines of systemic therapy.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.Has ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments as defined in the protocol.Has untreated or active primary brain tumor, CNS metastases, leptomeningeal disease, or spinal cord compression as defined in the protocol.Has history of clinically significant cardiovascular disease as defined in the protocol.Has known allergy or hypersensitivity to cemiplimab and/or components of study drug(s).
Sites
AC Camargo Cancer Center
Recruiting
Hospital de Câncer de Barretos - Fundação PIO XII (Hospital de AMOR)
Recruiting
SponsorRegeneron Pharmaceuticals
Study typeInterventional
Conditions
Ovarian cancerFallopian tube cancerPrimary peritoneal cancerEndometrial Cancer
Requirements
From 18 YearsFemale
Unique study IDclinicaltrials.gov
NCT04590326
