Recruiting
Phase 1
Phase 2

REGN4018 & Cemiplimab

Sponsor:

Regeneron Pharmaceuticals

Code:

NCT03564340

Conditions

Recurrent Ovarian Cancer

Recurrent Fallopian Tube Cancer

Recurrent Primary Peritoneal Cancer

Recurrent Endometrial Cancer

Endometrial Cancer

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Ubamatamab

Cemiplimab

Sarilumab

Tocilizumab

Study Details

Brief 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

Study ID

NCT03564340

Start date

May 21, 2018

Status verified date

Jul, 2026

Completion date

May 10, 2027

Anticipated

Primary completion date

May 10, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Key Inclusion 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

Key Exclusion Criteria:

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

Note: Other protocol-defined Inclusion/Exclusion Criteria apply

Study Design

Enrollment

890 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Monotherapy

REGN4018 administration

experimental: Combination Therapy

REGN4018 and cemiplimab administration

Interventions

Ubamatamab

Administered per the protocol

Cemiplimab

Administered per the protocol

Sarilumab

Administered per the protocol

Tocilizumab

Administered per the protocol

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 ]
  • Number of participants with DLTs for ubamatamab with cemiplimab [ Time Frame: From Cycle 2, Day 1 up to 21 days ]
  • Number of participants with Treatment-emergent adverse event (TEAE)s (including immune-related adverse events (imAEs)) for ubamatamab monotherapy [ Time Frame: Up to 2 years ]
  • Number of participants with TEAEs (including imAEs) for ubamatamab with cemiplimab [ Time Frame: Up to 2 years ]
  • Number of participants with serious adverse events (SAEs) for ubamatamab monotherapy [ Time Frame: Up to 2 years ]
  • Number of participants with SAEs for ubamatamab with cemiplimab [ Time Frame: Up to 2 years ]
  • Number of deaths for ubamatamab monotherapy [ Time Frame: Up to 2 years ]
  • Number of deaths for ubamatamab with cemiplimab [ Time Frame: Up to 2 years ]
  • Number of participants with laboratory abnormalities (grade 3 or higher per Common Terminology Criteria for Adverse Events [CTCAE]) for ubamatamab monotherapy [ Time Frame: Up to 2 years ]
  • Number of participants with laboratory abnormalities (grade 3 or higher per CTCAE) for ubamatamab with cemiplimab [ Time Frame: Up to 2 years ]
  • Concentration of ubamatamab in serum over time for ubamatamab monotherapy [ Time Frame: Up to 2 years ]
  • Concentration of ubamatamab in serum over time for ubamatamab with cemiplimab [ Time Frame: Up to 2 years ]
  • Objective response rate (ORR) defined by Response Evaluation Criteria in Solid Tumors (RECIST 1.1) for ubamatamab monotherapy [ Time Frame: Up to 2 years ]
  • ORR defined by RECIST 1.1 for ubamatamab with cemiplimab [ Time Frame: Up to 2 years ]

Central Contacts and Locations

Central contacts

Clinical Trials Administrator

844-734-6643clinicaltrials@regeneron.com

Locations

University of Alabama_6th Ave

Recruiting

Birmingham, Alabama, United States, 35294

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Dana Farber / Harvard Cancer Center

Recruiting

Boston, Massachusetts, United States, 02215

Mayo Clinic - Rochester

Recruiting

Rochester, Minnesota, United States, 55901

Columbia University Medical Center

Recruiting

New York, New York, United States, 10032

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

The Ohio State University Wexner Medical Center

Recruiting

Columbus, Ohio, United States, 43210

Stephenson Cancer Center

Recruiting

Oklahoma City, Oklahoma, United States, 73104

Virginia Commonwealth University

Recruiting

Richmond, Virginia, United States, 23219

More Information

Sponsor

Regeneron Pharmaceuticals

Last update posted

Jul 22, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Regeneron Pharmaceuticals on 2026-07-22.