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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

View on ClinicalTrials.gov ↗

At a glance

What the study gets you: Access to the study treatment being tested
Type of study: Interventional (receives a drug or procedure)
Time in hospital: In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention: Ubamatamab (drug), Cemiplimab (drug), Sarilumab (drug), Tocilizumab (drug)
How long the study runs: Study runs about 108 months (dates as stated)
About the drug or intervention: Ubamatamab — drug: Administered per the protocol · Cemiplimab — drug: Administered per the protocol · Sarilumab — drug: Administered per the protocol · Tocilizumab — drug: Administered per the protocol
Patient visit burden: Not specified by the sponsor

Type of study: Testing a treatment
Ages: 18 Years and over
Who: Female
Number of participants: 890
Started: 2018-05-21
Last checked: 2026-09

Plain English Summary

What is this study?

• Testing a new treatment for recurrent ovarian cancer
• Phase1/Phase2 - 890 participants
• 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)

Who can take part?

• Ages 18 Years and over
• Diagnosed with recurrent ovarian cancer
• Female only

Where?

• Oxford - University of Oxford
• Sutton - Royal Marsden Hospital - Sutton
• Sutton - The Royal Marsden NHS Foundation Trust
• London - University College London Hospitals
• +3 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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)

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

How this trial compares with your answers

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What we know so far

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

Age: 18 Years and over
Who can join: Female only

Biomarkers mentioned

CA-125PD-L1

Treatment history

Treatments you must have had:

✓ for low-grade serous carcinoma)

What the study is looking for

✓serum CA-125 level ≥2 x upper limit of normal (ULN) (in screening, not required for low-grade serous carcinoma)
✓has received at least 1 line of platinum-containing therapy or must be platinum-intolerant (applicable for dose...
✓documented relapse or progression on or after the most recent line of therapy
✓no standard therapy options likely to convey clinical benefit
✓Adequate organ and bone marrow function as defined in the protocol

Who cannot take part

✗Prior treatment with anti-Programmed Cell Death (PD-1)/PD-L1 therapy, as described in the protocol
✗Ovarian Cancer Expansion cohorts only: More than 4 prior lines of cytotoxic drug treatment (does not apply to...
✗Prior treatment with a MUC16 - treatment that targets specific changes in the cancer
✗Untreated or active primary brain tumor, central nervous system (CNS) metastases, or spinal cord compression, as...
✗History and/or current cardiovascular disease, as defined in the protocol

See the full criteria

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