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Taking people in NetherlandsPhase 1/2

Tests ubamatamab alone or with cemiplimab in recurrent ovarian and uterine cancers

Tests ubamatamab, alone or with cemiplimab, in adults with recurrent ovarian or uterine cancer.

Key facts

Who runs it
Regeneron Pharmaceuticals
Where
Groningen, Nijmegen, and Rotterdam, NetherlandsSee the 3 sitesAlso in 9 other countries, 50 sites
Registry title
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
Status
Recruiting
Phase
Phase 1/2
People taking part
890 people, planned
Started
21 May 2018
Expected to end
10 May 2027
Type of study
Interventional, 2 groups
Treatments tested
  • Ubamatamab
  • Cemiplimab
  • Sarilumab
  • Tocilizumab
Record updated
25 September 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adult women with advanced ovarian, fallopian tube, primary peritoneal or endometrial cancer that has come back or got worse, and who have no standard treatment likely to help.

Age
18 years or older
Sex
Women only
Disease stage
Ovarian, fallopian tube or primary peritoneal cancer: advanced epithelial cancer (not carcinosarcoma) that came back or got worse after the latest treatment, with no standard therapy likely to help. Endometrial cancer: confirmed cancer that got worse or came back after anti-PD-1 treatment and platinum-based chemotherapy.
Earlier treatment
Ovarian, fallopian tube or primary peritoneal cancer: at least 1 line of platinum-containing therapy, or cannot tolerate platinum. One group needs platinum-resistant cancer after 2 to 4 lines of platinum-based therapy. Endometrial cancer: 1-4 earlier lines of systemic therapy, including anti-PD-1 therapy and platinum-based chemotherapy.
Biomarker or test result
Ovarian, fallopian tube or primary peritoneal cancer: serum CA-125 level at least 2 x the upper limit of normal at screening (not required for low-grade serous cancer). Endometrial cancer: MUC16 in at least 25% of tumor cells by immunohistochemistry.

Main reasons for not taking part

  • Earlier anti-PD-1 or PD-L1 treatment (as described in the protocol)
  • Earlier treatment aimed at MUC16
  • Untreated or active brain tumor, spread to the brain or spinal cord, or spinal cord compression
  • Past or current heart or blood vessel disease (as defined in the protocol)
  • Severe or uncontrolled high blood pressure

The registry criteria, word for word

Show all 11 criteriaShow less

Who can take part

  • 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:; 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 escalation and non-randomized dose expansion cohorts); 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
  • Life expectancy of at least 3 months
  • 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
  • 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:; MUC16 positivity of tumor cells ≥25% by immunohistochemistry (IHC), as defined in the protocol; 1-4 prior lines of systemic therapy, as described 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 chemotherapy (does not apply to low-grade serous ovarian cancer cohort)
  • Prior treatment with a MUC16 - targeted therapy
  • History and/or current cardiovascular disease, as defined in the protocol
  • 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
  • Untreated or active primary brain tumor, central nervous system (CNS) metastases, or spinal cord compression, as described in the protocol

Where in Netherlands

Also in 9 other countries, 50 sites

  • Universitair Medisch Centrum GroningenGroningen, NetherlandsTaking people
  • Stichting Radboud Universitair Medisch CentrumNijmegen, NetherlandsTaking people
  • Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)Rotterdam, NetherlandsTaking people

About the trial

What the trial wants to find out

The main purpose of this study is to:

Read full original descriptionShow less

* 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)

The 2 groups in the trial

  • MonotherapyTreatment being tested

    REGN4018 administration

    Treatment: Ubamatamab, Sarilumab, and Tocilizumab

  • Combination TherapyTreatment being tested

    REGN4018 and cemiplimab administration

    Treatment: Ubamatamab and Cemiplimab

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
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
Plain-language title
Tests ubamatamab alone or with cemiplimab in recurrent ovarian and uterine cancersGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
25 September 2026