RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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)

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

Quick Facts

Study Start:2018-05-21
Study Completion:2027-01-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03564340

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Ovarian Cancer Cohorts Only: Patients with histologically or cytologically confirmed diagnosis of advanced, epithelial ovarian cancer (except carcinosarcoma), primary peritoneal, or fallopian tube cancer who have all of the following:
  2. 1. serum CA-125 level ≥2 x upper limit of normal (ULN) (in screening, not required for low-grade serous carcinoma)
  3. 2. has received at least 1 line of platinum-containing therapy or must be platinum-intolerant (applicable for dose escalation and non-randomized dose expansion cohorts)
  4. 3. documented relapse or progression on or after the most recent line of therapy
  5. 4. no standard therapy options likely to convey clinical benefit
  6. 2. Adequate organ and bone marrow function as defined in the protocol
  7. 3. Life expectancy of at least 3 months
  8. 4. Randomized phase 2 expansion cohort (Ovarian Cancer only): Platinum-resistant ovarian cancer patients who have had 2 to 4 lines of platinum-based therapy as defined in the protocol.
  9. 5. Endometrial Cancer Cohorts Only: histologically confirmed endometrial cancer that has progressed or recurrent after prior anti-Programmed Cell Death Ligand 1 (PD-1) therapy and platinum-based chemotherapy:
  10. 1. MUC16 positivity of tumor cells ≥25% by immunohistochemistry (IHC), as defined in the protocol
  11. 2. 1-4 prior lines of systemic therapy, as described in the protocol
  1. 1. Prior treatment with anti-Programmed Cell Death (PD-1)/PD-L1 therapy, as described in the protocol
  2. 2. Ovarian Cancer Expansion cohorts only: More than 4 prior lines of cytotoxic chemotherapy (does not apply to low-grade serous ovarian cancer cohort)
  3. 3. Prior treatment with a MUC16 - targeted therapy
  4. 4. Untreated or active primary brain tumor, central nervous system (CNS) metastases, or spinal cord compression, as described in the protocol
  5. 5. History and/or current cardiovascular disease, as defined in the protocol
  6. 6. Severe and/or uncontrolled hypertension at screening. Patients taking anti-hypertensive medication must be on a stable anti-hypertensive regimen

Contacts and Locations

Study Contact

Clinical Trials Administrator
CONTACT
844-734-6643
clinicaltrials@regeneron.com

Principal Investigator

Clinical Trial Management
STUDY_DIRECTOR
Regeneron Pharmaceuticals

Study Locations (Sites)

University of Alabama_6th Ave
Birmingham, Alabama, 35294
United States
Massachusetts General Hospital
Boston, Massachusetts, 02214
United States
Dana Farber / Harvard Cancer Center
Boston, Massachusetts, 02215
United States
Mayo Clinic - Rochester
Rochester, Minnesota, 55905
United States
Roswell Park Cancer Institute
Buffalo, New York, 14263
United States
Columbia University Medical Center
New York, New York, 10032
United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
United States
The Ohio State University Wexner Medical Center James Comprehensive Cancer Center
Hilliard, Ohio, 43026
United States
Stephenson Cancer Center
Oklahoma City, Oklahoma, 73104
United States
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
United States
Virginia Commonwealth University
Richmond, Virginia, 23219
United States

Collaborators and Investigators

Sponsor: Regeneron Pharmaceuticals

  • Clinical Trial Management, STUDY_DIRECTOR, Regeneron Pharmaceuticals

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2018-05-21
Study Completion Date2027-01-31

Study Record Updates

Study Start Date2018-05-21
Study Completion Date2027-01-31

Terms related to this study

Additional Relevant MeSH Terms

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