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

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)

Conditions

Recurrent Ovarian CancerRecurrent Fallopian Tube CancerRecurrent Primary Peritoneal CancerRecurrent Endometrial CancerEndometrial CancerLow-grade Serous Ovarian Cancer
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Related Conditions:

Recurrent Ovarian CancerRecurrent Fallopian Tube CancerRecurrent Primary Peritoneal CancerRecurrent Endometrial CancerEndometrial CancerLow-grade Serous Ovarian Cancer

Study Overview

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Study Details

Study overview

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)

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

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

Condition
Recurrent Ovarian Cancer
Intervention / Treatment

-

Contacts and Locations

Birmingham

University of Alabama_6th Ave, Birmingham, Alabama, United States, 35294

Boston

Massachusetts General Hospital, Boston, Massachusetts, United States, 02214

Boston

Dana Farber / Harvard Cancer Center, Boston, Massachusetts, United States, 02215

Rochester

Mayo Clinic - Rochester, Rochester, Minnesota, United States, 55905

Buffalo

Roswell Park Cancer Institute, Buffalo, New York, United States, 14263

New York

Columbia University Medical Center, New York, New York, United States, 10032

New York

Memorial Sloan Kettering Cancer Center, New York, New York, United States, 10065

Hilliard

The Ohio State University Wexner Medical Center James Comprehensive Cancer Center, Hilliard, Ohio, United States, 43026

Oklahoma City

Stephenson Cancer Center, Oklahoma City, Oklahoma, United States, 73104

Nashville

Sarah Cannon Research Institute, Nashville, Tennessee, United States, 37203

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 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:
  • 1. serum CA-125 level ≥2 x upper limit of normal (ULN) (in screening, not required for low-grade serous carcinoma)
  • 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)
  • 3. documented relapse or progression on or after the most recent line of therapy
  • 4. no standard therapy options likely to convey clinical benefit
  • 2. Adequate organ and bone marrow function as defined in the protocol
  • 3. Life expectancy of at least 3 months
  • 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.
  • 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:
  • 1. MUC16 positivity of tumor cells ≥25% by immunohistochemistry (IHC), as defined in the protocol
  • 2. 1-4 prior lines of systemic therapy, as described in the protocol
  • 1. Prior treatment with anti-Programmed Cell Death (PD-1)/PD-L1 therapy, as described in the protocol
  • 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. Prior treatment with a MUC16 - targeted therapy
  • 4. Untreated or active primary brain tumor, central nervous system (CNS) metastases, or spinal cord compression, as described in the protocol
  • 5. History and/or current cardiovascular disease, as defined in the protocol
  • 6. Severe and/or uncontrolled hypertension at screening. Patients taking anti-hypertensive medication must be on a stable anti-hypertensive regimen

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Regeneron Pharmaceuticals,

Clinical Trial Management, STUDY_DIRECTOR, Regeneron Pharmaceuticals

Study Record Dates

2027-01-31