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New antibody cocktail takes on tough ovarian cancers

NCT ID NCT04590326

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Aug 21, 2026 · Updated 2 times

Summary

This study tests an experimental drug called REGN5668, alone or combined with other drugs, in people with ovarian, fallopian tube, peritoneal, or endometrial cancer. The trial has two parts: first to find the safest dose, then to see if the drug shrinks tumors. About 612 participants will take part.

What this could mean

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

Active substance
REGN5668 (a bispecific antibody) alone or combined with cemiplimab, fianlimab, ubamatamab, or sarilumab
What this could lead to
If successful, this could point toward a new treatment option for ovarian and related cancers that have not responded to standard therapy.
What could go wrong
This is an early-phase trial (Phase 1/2) focused on safety and dosing, so it is not yet known if the drug combination will effectively shrink tumors. Side effects may be significant, and the results may not apply to all patients.

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 612 people

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

Started

Dec 2020

Expected to finish

Nov 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: Has histologically or cytologically confirmed diagnosis of advanced epithelial ovarian cancer (except carcinosarcoma), primary peritoneal, or fallopian tube cancer that has received at least 1 line of platinum-based systemic therapy as defined in the protocol 2. Expansion cohorts only: Has at least 1 lesion that is measurable by RECIST 1.1 as described in the protocol. 3. Has a serum CA-125 level ≥2x ULN (in screening, not applicable to endometrial cohorts) 4. Has adequate organ and bone marrow function as defined in the protocol 5. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 6. Has a life expectancy of at least 3 months 7. Endometrial Cancer Cohorts Only: histologically confirmed endometrial cancer that has progressed or recurrent after prior anti-PD-1 therapy and platinum-based chemotherapy as described in the protocol Key Exclusion Criteria: 1. Current or recent (as defined in the protocol) treatment with an investigational agent, systemic biologic therapy, or anti-cancer immunotherapy 2. Has had another malignancy within the last 5 years that is progressing, requires active treatment, or has a high likelihood of recurrence as defined in the protocol 3. Prior treatment with a Mucin 16 (MUC16)-targeted therapy 4. Ovarian Expansion cohorts only: More than 5 prior lines of systemic therapy 5. Has any condition that requires ongoing/continuous corticosteroid therapy as defined in the protocol within 1 week prior to the first dose of study drug 6. Has ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments as defined in the protocol 7. Has untreated or active primary brain tumor, CNS metastases, leptomeningeal disease, or spinal cord compression as defined in the protocol 8. Has history of clinically significant cardiovascular disease as defined in the protocol 9. Has known allergy or hypersensitivity to cemiplimab and/or components of study drug(s). Note: Other protocol-defined Inclusion/Exclusion criteria apply

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Conditions

The condition(s) this trial relates to.

endometrial cancer endometrium neoplasm fallopian tube cancer fallopian tube neoplasm ovarian cancer ovarian carcinoma primary peritoneal carcinoma Recurrence

As listed by the trial registrant

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

Endometrial cancer Fallopian tube cancer Ovarian cancer 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

    27 sites in 5 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

  • AC Camargo Cancer Center, Fundacao Antonio Prudente

    RECRUITING

    São Paulo, 01509-010, Brazil

  • Centre Francois Baclesse (CFB)

    RECRUITING

    Caen, Normandy, 14076, France

  • Centre Georges Francois Leclerc

    RECRUITING

    Dijon, Bourgogne-Franche-Comté, 21000, France

  • Centro de Pesquisa em Oncologia PUCRS

    RECRUITING

    Porto Alegre, Rio Grande do Sul, 90619-900, Brazil

  • Chao Family Comprehensive Cancer Center

    RECRUITING

    Orange, California, 92868, United States

  • City of Hope Comprehensive Cancer Center

    RECRUITING

    Duarte, California, 91010, United States

  • Ciudad Universitaria

    RECRUITING

    Madrid, 28040, Spain

  • Dana Farber Cancer Institute Brookline Avenue

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • Fundacao Pio XII - Hospital de Cancer de Barretos

    RECRUITING

    Barretos, São Paulo, 14784-400, Brazil

  • H. Lee Moffitt Cancer Center

    COMPLETED

    Tampa, Florida, 33612, United States

  • Hopital Lyon Sud

    RECRUITING

    Pierre-Bénite, Auvergne-Rhône, 69310, France

  • Hospital Clinico Universitario Santiago de Compostela

    RECRUITING

    Santiago de Compostela, A Coruna, 15706, Spain

  • Hospital Universitario 12 de Octubre Universidad Complutense de Madrid UCM

    RECRUITING

    Madrid, 28041, Spain

  • Hospital Universitario Fundacion Jimenez

    RECRUITING

    Madrid, 28040, Spain

  • Institut Bergonie

    RECRUITING

    Bordeaux, New Aquitaine, 33076, France

  • Institut Catala dOncologia Girona

    RECRUITING

    Girona, 17007, Spain

  • Institut Gustave Roussy

    RECRUITING

    Villejuif, 94805, France

  • Karmanos Cancer Institute

    RECRUITING

    Detroit, Michigan, 48201, United States

  • Massachusetts General Hospital

    RECRUITING

    Boston, Massachusetts, 02114, United States

  • Memorial Sloan Kettering Cancer Center

    RECRUITING

    New York, New York, 10065, United States

  • Perelman School of Medicine at the University of Pennsylvania

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • Robert H. Lurie Comprehensive Cancer Center of Northwestern University

    RECRUITING

    Chicago, Illinois, 60611, United States

  • Seattle Cancer Care Alliance at South Lake Union - G3630

    RECRUITING

    Seattle, Washington, 98109, United States

  • The City of Hope Orange County Lennar Foundation Cancer Center

    RECRUITING

    Irvine, California, 92618, United States

  • The Ohio State University Wexner Medical Center

    RECRUITING

    Columbus, Ohio, 43210, United States

  • Unimed Sorocaba

    RECRUITING

    Sorocaba, São Paulo, 18065-100, Brazil

  • Universitair Ziekenhuis Leuven

    RECRUITING

    Leuven, Vlaams-Brabant, 3000, Belgium

  • University of Chicago Medical Center

    RECRUITING

    Chicago, Illinois, 60637, United States

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