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New antibody combo aims to fight back against recurrent ovarian cancer

NCT ID NCT03564340

Disease control Sponsor: Regeneron Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Sep 11, 2026 · Updated 5 times

Summary

This study is testing a new drug called ubamatamab, given alone or with another drug called cemiplimab, in people with ovarian cancer or other cancers that have come back after treatment. The main goals are to check safety, find the right dose, and see if the drugs can shrink tumors. About 890 participants will take part in this early-stage research.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Ubamatamab (a bispecific antibody) and cemiplimab (an immunotherapy drug)
What this could lead to
If successful, this could provide a new treatment option for people with recurrent ovarian cancer or other MUC16-positive cancers that have stopped responding to standard therapies.
What could go wrong
This is an early-phase trial (phase 1/2), so the main goals are safety and dosing, not yet proving effectiveness. Side effects, including cytokine release syndrome, are possible, and the drug may not work for everyone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 890 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2018

Expected to finish

May 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

borderline ovarian serous tumor endometrial cancer endometrial carcinoma endometrium neoplasm fallopian tube cancer fallopian tube neoplasm ovarian cancer ovarian serous adenocarcinoma primary peritoneal carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Endometrial cancer Low-grade serous ovarian cancer Recurrent endometrial cancer Recurrent fallopian tube cancer Recurrent ovarian cancer Recurrent primary peritoneal cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    48 sites in 9 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Asan Medical Center, Univ. of Ulsan

    RECRUITING

    Seoul, 05505, South Korea

  • Centre Antoine Lacassagne

    RECRUITING

    Nice, Provence Alpes Cote dAzur, 06189, France

  • Centre Francois Baclesse (CFB)

    RECRUITING

    Caen, Normandy, 14076, France

  • Centre Georges Francois Leclerc

    RECRUITING

    Dijon, Bourgogne-Franche-Comté, 21000, France

  • Centre Leon Berard

    RECRUITING

    Lyon, 69008, France

  • Clinica Universidad Navarra (CUN) Madrid

    RECRUITING

    Madrid, 28027, Spain

  • Clinica Universidad de Navarra

    RECRUITING

    Pamplona, Navarre, 31008, Spain

  • Columbia University Medical Center

    RECRUITING

    New York, New York, 10032, United States

  • Dana Farber / Harvard Cancer Center

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • Erasmus MC

    RECRUITING

    Rotterdam, South Holland, 3000 DR, Netherlands

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    RECRUITING

    Rome, Lazio, 00168, Italy

  • Fundacion Jimenez Diaz

    RECRUITING

    Madrid, 28040, Spain

  • Grand Hopital de Charleroi

    RECRUITING

    Charleroi, Hainaut, 6000, Belgium

  • Guys Hospital

    RECRUITING

    London, SE1 9RT, United Kingdom

  • Hopital Lyon Sud

    RECRUITING

    Pierre-Bénite, Auvergne-Rhône, 69310, France

  • Hospital Clinico Universitatio Santiago de Compostela

    RECRUITING

    Santiago de Compostela, 15706, Spain

  • Hospital Universitari Vall d'Hebron

    RECRUITING

    Barcelona, 08035, Spain

  • Hospital Universitario San Carlos

    RECRUITING

    Madrid, 28040, Spain

  • Humanitas S. Pio X

    RECRUITING

    Milan, 20159, Italy

  • Imperial College Healthcare NHS Trust

    RECRUITING

    London, W12 0HS, United Kingdom

  • Institut Bergonie

    RECRUITING

    Bordeaux, New Aquitaine, 33076, France

  • Institut Catala d'Oncologia

    RECRUITING

    Barcelona, 08908, Spain

  • Institut Catala dOncologia Badalona

    RECRUITING

    Badalona, 08916, Spain

  • Institut Gustave Roussy

    RECRUITING

    Villejuif, Île-de-France Region, 94800, France

  • Instituto Nazionale Tumori- Fondazione Pascale

    RECRUITING

    Naples, 80131, Italy

  • Istituto Europeo di Oncologia

    RECRUITING

    Milan, 20141, Italy

  • Korea University Guro Hospital

    RECRUITING

    Seoul, 08307, South Korea

  • Massachusetts General Hospital

    RECRUITING

    Boston, Massachusetts, 02114, United States

  • Mayo Clinic - Rochester

    RECRUITING

    Rochester, Minnesota, 55901, United States

  • Memorial Sloan Kettering Cancer Center

    RECRUITING

    New York, New York, 10065, United States

  • Peter MacCallum Cancer Center

    COMPLETED

    Melbourne, 3000, Australia

  • Prince of Wales Hospital

    COMPLETED

    Randwick, New South Wales, 2031, Australia

  • Radboudumc

    RECRUITING

    Nijmegen, Gelderland, 6500HB, Netherlands

  • Rambam Health Care Campus

    RECRUITING

    Haifa, 3109601, Israel

  • Roswell Park Cancer Institute

    WITHDRAWN

    Buffalo, New York, 14263, United States

  • Royal Marsden Hospital - Sutton

    WITHDRAWN

    Sutton, Surrey, SM2 5PT, United Kingdom

  • Samsung Medical Center

    RECRUITING

    Seoul, 06351, South Korea

  • Sarah Cannon Research Institute

    COMPLETED

    Nashville, Tennessee, 37203, United States

  • Seoul National University Hospital

    RECRUITING

    Seoul, 3080, South Korea

  • Sharet Institute of Oncology

    RECRUITING

    Jerusalem, 9112001, Israel

  • Sheba Medical Center

    RECRUITING

    Tel Litwinsky, 5265601, Israel

  • Stephenson Cancer Center

    RECRUITING

    Oklahoma City, Oklahoma, 73104, United States

  • The Christie NHS Foundation Trust

    RECRUITING

    Manchester, M20 4BX, United Kingdom

  • The Ohio State University Wexner Medical Center

    RECRUITING

    Columbus, Ohio, 43210, United States

  • The Royal Marsden NHS Foundation Trust

    RECRUITING

    Sutton, Surrey, SM2 5PT, United Kingdom

  • UZLeuven

    RECRUITING

    Leuven, Vlaams-Brabant, 3000, Belgium

  • Universitair Ziekenhuis Antwerpen

    RECRUITING

    Edegem, Antwerp, 2650, Belgium

  • University College London Hospitals

    RECRUITING

    London, NW1 2PG, United Kingdom

  • University Medical Center Groningen

    RECRUITING

    Groningen, 9713 GZ, Netherlands

  • University of Alabama_6th Ave

    RECRUITING

    Birmingham, Alabama, 35294, United States

  • University of Oxford

    RECRUITING

    Oxford, Oxfordshire, OX1 2JD, United Kingdom

  • Virginia Commonwealth University

    RECRUITING

    Richmond, Virginia, 23219, United States

  • Yonsei University Health System

    RECRUITING

    Seoul, 03722, South Korea

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