Study of REGN4018 (Ubamatamab) Administered Alone or in Combination With Cemiplimab in Adult Patients With Recurrent Ovarian Cancer or Other Recurrent Mucin-16 Expressing (MUC16+) Cancers

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Regeneron Pharmaceuticals
Study ID
NCT03564340
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Endometrial Cancer
  • Low-grade Serous Ovarian Cancer
  • Recurrent Endometrial Cancer
  • Recurrent Fallopian Tube Cancer
  • Recurrent Ovarian Cancer
  • Recurrent Primary Peritoneal Cancer

Eligibility Criteria

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

Interventions

  • Ubamatamab — DRUG
    Administered per the protocol
  • Cemiplimab — DRUG
    Administered per the protocol
  • Sarilumab — DRUG
    Administered per the protocol
  • Tocilizumab — DRUG
    Administered per the protocol

Study Details

The main purpose of this study is to: * Learn about the safety of ubamatamab and to find out what dose of ubamatamab can be given alone or with cemiplimab to patients with ovarian cancer or cancer of the uterus * The study will also look at the levels of ubamatamab and/or cemiplimab in the body and measure how well the body can remove the study drug(s). This is called pharmacokinetics * The study will also look at any signs that ubamatamab alone or with cemiplimab can treat recurrent advanced ovarian cancer or cancer of the uterus * To find out how safe and tolerable pretreatment is in combination with ubamatamab and to see how well it works to prevent or minimize Cytokine Release Syndrome (CRS)

Key Dates

Start date
May 21, 2018
Status verified
May 2026
Primary completion
May 10, 2027
Completion
May 10, 2027

Study Design

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

Arms

  • Experimental: Monotherapy
    REGN4018 administration
  • Experimental: Combination Therapy
    REGN4018 and cemiplimab administration

Primary Outcome Measure

Number of participants with Dose-limiting toxicity (DLTs) for ubamatamab monotherapy [ Time Frame: From Cycle 1, Day 1 up to 35 days ]

Central Contacts

Locations (11)

FacilityCityStateZIPSite coordinators
University of Alabama_6th AveBirminghamAlabama35294-
Dana Farber / Harvard Cancer CenterBostonMassachusetts02215-
Massachusetts General HospitalBostonMassachusetts02114-
Mayo Clinic - RochesterRochesterMinnesota55901-
Roswell Park Cancer InstituteBuffaloNew York14263-
Columbia University Medical CenterNew YorkNew York10032-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
The Ohio State University Wexner Medical Center James Comprehensive Cancer CenterHilliardOhio43026-
Stephenson Cancer CenterOklahoma CityOklahoma73104-
Sarah Cannon Research InstituteNashvilleTennessee37203-
Virginia Commonwealth UniversityRichmondVirginia23219-

Find similar trials in Birmingham, AL

By condition
Endometrial cancer
By specialty
OncologyGynecologic oncologyWomen's health
By research site
University of Alabama_6th Ave· Birmingham, ALDana Farber / Harvard Cancer Center· Boston, MAMassachusetts General Hospital· Boston, MAMayo Clinic - Rochester· Rochester, MNRoswell Park Cancer Institute· Buffalo, NYColumbia University Medical Center· New York, NY

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