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Recurrent Ovarian CancerCancerWomen's healthDrugPhase 1, Phase 2

What this study is

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)

What's being tested

  • Ubamatamab

    Intervention · DRUG

  • Cemiplimab

    Intervention · DRUG

  • Sarilumab

    Intervention · DRUG

  • Tocilizumab

    Intervention · DRUG

All interventions

Administered per the protocol

Study details

Official title
A Phase 1/2 Study of REGN4018 (Ubamatamab), a MUC16×CD3 Bispecific Antibody, Administered Alone or in Combination With Cemiplimab in Patients With Recurrent Ovarian Cancer or Other Recurrent MUC16+ Cancers
Sponsor
Regeneron Pharmaceuticals
Conditions
Recurrent Ovarian Cancer · Recurrent Fallopian Tube Cancer · Recurrent Primary Peritoneal Cancer · Recurrent Endometrial Cancer · Endometrial Cancer · Low-grade Serous Ovarian Cancer
Enrolling
890 people
Starts
2018-05-21
Est. completion
2027-05-10
Design
Open-label, non-randomized, sequential groups, Phase 1, Phase 2
Record
View on ClinicalTrials.gov ↗