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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

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NCT04590326 · readout in 218 d

Sponsored by Regeneron Pharmaceuticals (industry) · REGN — their whole pipeline →.

Phase
Phase 1/2
Status
Recruiting
Study type
Interventional
Design
Non randomized · None · Treatment
Enrollment
612estimated
Sites
24
Countries
Belgium, France, Spain +1

Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →

Source: ClinicalTrials.gov, retrieved 2026-08-19

Dates

each axis at the precision it was filed, with the registry's own basis
DateFiledBasisWhat it is
Start2020-12-08actualWhen the study began enrolling
Primary completion2027-03-25estimatedThe date the last participant is measured for the primary outcome — the readout window
Study completion2027-11-30estimatedThe whole study's end, after follow-up
First posted2020-10-19actualWhen this record first appeared on the registry
Results postedWhen the sponsor posted results to the registry
Record updated2025-11-21actualThe sponsor's own last edit to this record — every projection above is as current as this date

What it studies

Conditions

  • Ovarian Cancer
  • Fallopian Tube Cancer
  • Primary Peritoneal Cancer
  • Endometrial Cancer

Interventions

  • Drug: REGN5668
  • Drug: Cemiplimab — also filed as REGN2810, Libtayo®
  • Drug: Ubamatamab — also filed as REGN4018
  • Drug: Sarilumab — also filed as Kevzara®
  • Drug: Cemiplimab + Fianlimab [Fixed Dose Combination (FDC)]

Primary outcomes

what the primary-completion date above is the date OF
Incidence of Dose Limiting Toxicities (DLT)
measured 42 days
Incidence of DLTs
measured 21 days post combination administration
Incidence of Treatment-Emergent Adverse Events (TEAEs)
measured Through study completion, up to 5 years
Incidence of Serious Adverse Events (SAEs)
measured Through study completion, up to 5 years
Incidence of deaths
measured Through study completion, up to 5 years
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])
measured Through study completion, up to 5 years
Concentrations of REGN5668 in serum when dosed alone and in combination with cemiplimab or ubamatamab
measured Through study completion, up to 5 years
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)
measured Through study completion, up to 5 years

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