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

Part of paid clinical trials in Duarte, California.

Sponsor
Regeneron Pharmaceuticals
Study ID
NCT04590326
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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

Key Dates

Start date
Dec 8, 2020
Status verified
Aug 2025
Primary completion
Mar 25, 2027
Completion
Nov 30, 2027

Study Design

Enrollment
612 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Module 1
    REGN5668 in combination with cemiplimab, or cemiplimab + fianlimab
  • Experimental: Module 2
    REGN5668 and ubamatamab

Primary Outcome Measure

Incidence of Dose Limiting Toxicities (DLT) [ Time Frame: 42 days ]

Central Contacts

Locations (13)

FacilityCityStateZIPSite coordinators
City of Hope Comprehensive Cancer CenterDuarteCalifornia91010-
The City of Hope Orange County Lennar Foundation Cancer CenterIrvineCalifornia92618-
Chao Family Comprehensive Cancer CenterOrangeCalifornia92868-
H. Lee Moffitt Cancer CenterTampaFlorida33612-
Robert H. Lurie Comprehensive Cancer Center of Northwestern UniversityChicagoIllinois60611-
University of Chicago Medical CenterChicagoIllinois60637-
Dana Farber Cancer Institute Brookline AvenueBostonMassachusetts02215-
Massachusetts General HospitalBostonMassachusetts02114-
Karmanos Cancer InstituteDetroitMichigan48201-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
The Ohio State University Wexner Medical CenterColumbusOhio43210-
Perelman School of Medicine at the University of PennsylvaniaPhiladelphiaPennsylvania19104-
Seattle Cancer Care Alliance at South Lake Union - G3630SeattleWashington98109-

Find similar trials in Duarte, CA

By condition
Endometrial cancerOvarian cancer
By specialty
OncologyGynecologic oncologyWomen's health
By research site
City of Hope Comprehensive Cancer Center· Duarte, CAThe City of Hope Orange County Lennar Foundation Cancer Center· Irvine, CAChao Family Comprehensive Cancer Center· Orange, CAH. Lee Moffitt Cancer Center· Tampa, FLRobert H. Lurie Comprehensive Cancer Center of Northwestern University· Chicago, ILUniversity of Chicago Medical Center· Chicago, IL

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