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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

NCT03564340 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 890

Last updated 2026-05-08

No results posted yet for this study

Summary

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)

Conditions

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

Interventions

DRUG

Ubamatamab

Administered per the protocol

DRUG

Cemiplimab

Administered per the protocol

DRUG

Sarilumab

Administered per the protocol

DRUG

Tocilizumab

Administered per the protocol

Sponsors & Collaborators

Principal Investigators

  • Clinical Trial Management · Regeneron Pharmaceuticals

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-21
Primary Completion
2027-05-10
Completion
2027-05-10
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Belgium
  • France
  • Israel
  • Italy
  • Netherlands
  • South Korea
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03564340 on ClinicalTrials.gov