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Study details
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REGN5668 Trial for Ovarian Cancer

Regeneron Pharmaceuticals
NCT IDNCT04590326ClinicalTrials.gov data as of Apr 2026
Phase

Phase 1/2

Target enrollment

612

Study length

about 7 years

Ages

18+

Sex

Female only

Locations

13 sites in CA, FL, IL +6

About this study

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.

Based on ClinicalTrials.gov records.

What participants do

  • 1.Take Cemiplimab
  • 2.Take Cemiplimab + Fianlimab [Fixed Dose Combination (FDC)]
  • 3.Take REGN5668
  • +2 more
PhasePhase 1/Phase 2
DrugCemiplimab
Primary goalIncidence of Dose Limiting Toxicities (DLT)

Participation effort

Estimated from trial records. Details can vary by site.

Time + visits
Low9%
Logistics
Moderate50%

Logistics difficulty varies by site location and availability.

Trial highlights

Treatment details

Auto-extracted from trial records to preview treatments and outcomes.

Drug classes

cemiplimab, sarilumab, monoclonal antibody

Endpoints

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

Body systems

Oncology