REGN5668 Trial for Ovarian Cancer
Phase 1/2
612
about 7 years
18+
Female only
13 sites in CA, FL, IL +6
What this study is about
Researchers are testing REGN5668, either alone or with other medications, to see if it's safe and effective in treating ovarian cancer. The trial will also investigate side effects and how the drugs work within the body. Participants are adult women with ovarian cancer.
Simplified from trial records by PatientMatch.
What you may be asked to do
- 1.Take Cemiplimab
- 2.Take Cemiplimab + Fianlimab [Fixed Dose Combination (FDC)]
- 3.Take REGN5668
- +2 more
Participation Burden
What's physically and logistically required of participants.
Requires travel to a study site
How treatment is administered
Everyone gets the investigational treatment.
Extracted study details
Pulled from the trial record to show what is being tested and what the study is measuring.
cemiplimab, sarilumab, monoclonal antibody
Primary: Incidence of Dose Limiting Toxicities (DLT), Incidence of Serious Adverse Events (SAEs), Incidence of Treatment-Emergent Adverse Events (TEAEs), Incidence of laboratory abnormalities (Grade 3 or higher per National Cancer Institute Common Terminology Criteria for Adverse Events [NCI-CTCAE] version 5.0 [v5.0]), Objective Response Rate (ORR) defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 (Eisenhauer, 2009) of REGN5668 in combination with cemiplimab, cemiplimab + fianlimab, or ubamatamab (separately by cohort and combination)
Secondary: Best Overall Response (BOR) based on RECIST 1.1, Cancer Antigen 125 (CA-125) change from baseline after treatment with REGN5668 in combinations with cemiplimab, cemiplimab + fianlimab, or ubamatamab (separately by cohort and combination), Disease Control Rate (DCR) based on RECIST 1.1, Duration Of Response (DOR) based on RECIST 1.1, ORR based on RECIST 1.1, Progression-Free Survival (PFS) based on RECIST 1.1
Oncology