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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
NotablePrimary completion pushed from Mar 25, 2027 to Nov 8, 2028Completion pushed from Nov 30, 2027 to Nov 8, 2028 · Eligibility criteria expanded, about 16 wordsShow 2 more changesShow less
Completion pushed from Nov 30, 2027 to Nov 8, 2028
Eligibility criteria expanded, about 16 words
MinorTrial sites expanded: 24 → 28 locationsv24
MinorSite details revised at 3 of 24 sitesv23
MinorSite details revised at 1 of 24 sitesv22
MinorStudy sites: 23 to 24v21
Show 19 earlier versionsHide 19 earlier versions
NotablePrimary endpoints revised (8)Primary completion date: Apr 27, 2027 to Mar 25, 2027 · Completion date: Apr 27, 2027 to Nov 30, 2027 · Start date: Dec 9, 2020 to Dec 8, 2020 · 4 morev20Show 7 more changesShow less
Primary completion date: Apr 27, 2027 to Mar 25, 2027
MinorStudy sites: 8 to 9Primary completion date: Jul 28, 2026 to Jan 18, 2027 · Completion date: Jul 28, 2026 to Jul 19, 2027 · Eligibility criteria shortened, about 193 wordsv8Show 3 more changesShow less
Primary completion date: Jul 28, 2026 to Jan 18, 2027
NotablePrimary endpoints revised (8)Enrollment target: 290 to 326 · Primary and study completion dates: Feb 11, 2026 to Jul 28, 2026 · Eligibility criteria revised · 1 morev6Show 4 more changesShow less
Enrollment target: 290 to 326
Primary and study completion dates: Feb 11, 2026 to Jul 28, 2026
MinorStudy sites: 8 to 11Primary and study completion dates: Feb 26, 2026 to Feb 11, 2026 · Eligibility criteria expanded, about 12 wordsv4Show 2 more changesShow less
Primary and study completion dates: Feb 26, 2026 to Feb 11, 2026
NotableTrial status: Not Yet Recruiting to RecruitingStudy sites: 0 to 8 · Start date changed from estimate of Nov 20, 2020 to Dec 9, 2020v2Show 2 more changesShow less
Study sites: 0 to 8
Start date changed from estimate of Nov 20, 2020 to Dec 9, 2020
MinorStudy First Submitted
Stopped: an ongoing trial was terminated, suspended or withdrawn.
Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This study is researching an investigational drug called REGN5668 :
* alone or,
* combined with cemiplimab (also known as REGN2810) or,
* combined with both cemiplimab and fianlimab (also known as REGN3767), or
* combined with ubamatamab (also known as REGN4018), with or without sarilumab.
The main purposes of this study are to:
* Learn about the safety and profile of any side effects from the study drugs and to determine the highest, safe dose that can be given to participants with ovarian cancer or cancer of the uterus
* Look for signs that the study drugs can treat ovarian cancer or cancer of the uterus
This study has 2 parts. The purpose of Part 1 (Escalation) is to find the highest, safe dose of the study drug(s). The purpose of Part 2 (Expansion) is to use the doses chosen in Part 1. Participants with cancer of the uterus will only participate in Part 2.
The study is looking at several other research questions, including:
* Side effects that may be experienced by participants taking REGN5668 alone and/or in combination with cemiplimab, cemiplimab and fianlimab, or ubamatamab
* How REGN5668 works in the body either alone and/or in combination with cemiplimab, cemiplimab and fianlimab, or ubamatamab
* How much of the study drugs (REGN5668, cemiplimab, fianlimab, ubamatamab) are in the blood
* To see if REGN5668 in combination with cemiplimab, cemiplimab and fianlimab, or ubamatamab works to treat cancer