Study of REGN5668 with Other Immunotherapies for Gynecologic Cancers
This study is investigating REGN5668, an investigational drug, either alone or in combination with other drugs like cemiplimab, fianlimab, or ubamatamab, sometimes with sarilumab. It's for adult women with advanced ovarian, fallopian tube, primary peritoneal, or endometrial cancer that has already been treated with platinum-based therapy. The main goals are to understand the safety and side effects of these drugs, find the highest safe dose, and see if they can help treat these cancers. The study has two parts, with the first part focused on finding the right dose. This is an immunotherapy and targeted therapy study. The study is currently unclear on its recruitment status and plans to enroll 612 participants.
- Study design
- This is an interventional study, meaning participants will receive specific treatments. It plans to enroll 612 adult women.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- You would be followed for treatment-emergent adverse events (side effects) through the completion of the study, which could be up to 5 years.
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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
At a glance
Conditions
Where it's being run
28 sites across 20 statesStudy leadership
- Clinical Trial Management · STUDY_DIRECTOR · Regeneron Pharmaceuticals
Who to contact
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What this trial measures
- Incidence of Dose Limiting Toxicities (DLT)42 days
Dose escalation phase, Module 1
- Incidence of DLTs21 days post combination administration
Dose escalation phase, Module 2
- Incidence of Treatment-Emergent Adverse Events (TEAEs)Through study completion, up to 5 years
Primary: Dose escalation phase Secondary: Dose expansion phase
- Incidence of Serious Adverse Events (SAEs)Through study completion, up to 5 years
Primary: Dose escalation phase Secondary: Dose expansion phase
- Incidence of deathsThrough study completion, up to 5 years
Primary: Dose escalation phase Secondary: Dose expansion phase
- 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])Through study completion, up to 5 years
Primary: Dose escalation phase Secondary: Dose expansion phase
- Concentrations of REGN5668 in serum when dosed alone and in combination with cemiplimab or ubamatamabThrough study completion, up to 5 years
Primary: Dose escalation phase
- 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)Through study completion, up to 5 years
Primary: Dose expansion phase