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New hope for recurrent endometrial cancer: Rina-S faces off against standard chemo

NCT ID NCT07166094

Disease control Sponsor: Genmab 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 10, 2026 · Updated 8 times

Summary

This study compares a new drug called Rina-S to standard chemotherapy (paclitaxel or doxorubicin) in people with endometrial cancer that has returned or worsened after platinum-based chemo and immunotherapy. About 660 participants will be randomly assigned to receive either Rina-S or standard chemo. The goal is to see which treatment better delays cancer growth and extends survival.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 660 people

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

Started

Nov 2025

Expected to finish

Nov 2029

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 * Participants must have histologically or cytologically confirmed recurrent or progressive endometrial cancer (EC; any subtype excluding neuroendocrine tumors, carcinosarcoma, or endometrial sarcoma) following prior therapy. * Participants must have received at least 1, but not more than 3, prior lines of therapy: * Participants must have received prior platinum-based chemotherapy and a programmed death (ligand)-1 (PD(L)-1) inhibitor, either separately or in combination * If the tumor recurred more than 12 months after completion of platinum-based chemotherapy, additional platinum-based chemotherapy must be administered for recurrent disease unless the participant is ineligible for further platinum-based chemotherapy, in which case the reason for ineligibility must be documented. * Note: If Immunotherapy-based treatment is administered in the advanced/recurrent setting, then platinum rechallenge is not required, regardless of the duration of the platinum-free interval from prior platinum-based chemotherapy. In such cases, the reason for ineligibility for platinum-based chemotherapy must be documented. * Prior induction plus maintenance is considered 1 line of therapy * Hormonal therapy alone (i.e., without chemotherapy) will not be counted as a separate line of therapy. * Therapy changed due to toxicity in the absence of progression will be considered part of the same line of therapy (i.e., will not be counted independently as a separate line of therapy) * Participants must have progressed radiographically on or after their most recent line of therapy Key Exclusion Criteria * Prior therapy with an antibody-drug conjugate containing a topoisomerase 1 inhibitor. * Has a past or current malignancy other than the inclusion diagnosis before the planned first dose of study drug, or any evidence of residual disease from a previously diagnosed malignancy. Exceptions are malignancies with a negligible risk of metastasis or death (e.g., 5-year OS ≥90%), including, but not limited to, adequately treated cervical carcinoma of Stage 1B or less, noninvasive basal cell or squamous cell skin carcinoma, noninvasive superficial bladder cancer, ductal carcinoma in situ, or any past malignancy considered cured for ≥3 years (i.e., eligible participants must have complete response of ≥3 years duration). * Known active central nervous system metastases or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are clinically stable for at least 4 weeks prior to study entry after completion of brain metastasis treatment, they have no new or enlarging brain metastases, and are off corticosteroids and anticonvulsants prescribed for symptoms associated with brain metastases for at least 7 days prior to the planned first dose of study drug. Participants with suspected brain metastases at screening should undergo a computed tomography (CT)/magnetic resonance imaging (MRI) of the brain prior to study entry. * Hospitalization or clinical symptoms due to gastrointestinal obstruction within the past or radiographic evidence of gastrointestinal obstruction at the time of screening. Enrollment of participants who currently require parenteral nutrition must be discussed with the study medical monitor to determine eligibility. Note: Other protocol-defined Inclusion and Exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

endometrial cancer endometrial carcinoma endometrium neoplasm Recurrence

As listed by the trial registrant

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

Endometrial cancer Recurrent or progressive endometrial cancer

How to take part

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

  1. The places running it

    171 sites in 19 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

  • AUSL IRCCS Reggio Emilia

    RECRUITING

    Reggio Emilia, RE, 42123, Italy

  • Aalborg University Hospital

    RECRUITING

    Aalborg, 9000, Denmark

  • Alexandra General Hospital

    RECRUITING

    Athens, 11528, Greece

  • Antwerp University Hospital

    RECRUITING

    Edegem, Antwerp, 2650, Belgium

  • Aretaieio Hospital

    RECRUITING

    Athens, 115 28, Greece

  • Arthur J E Child Cancer Comp

    RECRUITING

    Calgary, Alberta, T2N 5G2, Canada

  • Asklepios Hospital Barmbek

    RECRUITING

    Hamburg, Free and Hanseatic City of Hamburg, 22453, Germany

  • Assuta Ashdod Hospital

    RECRUITING

    Ashdod, Southern Israel, 7747629, Israel

  • Atlantic Health - Overlook MC

    RECRUITING

    Summit, New Jersey, 07901, United States

  • Atrium Health LCI - Ballantyne

    RECRUITING

    Charlotte, North Carolina, 28277, United States

  • Atrium Health LCI - Concord

    RECRUITING

    Concord, North Carolina, 28025, United States

  • Atrium Health LCI - Gaston

    RECRUITING

    Gastonia, North Carolina, 28054, United States

  • Atrium Health LCI - Morehead

    RECRUITING

    Charlotte, North Carolina, 28204, United States

  • Austin Health

    RECRUITING

    Heidelberg, Heidelberg, 3084, Australia

  • BC Cancer - Vancouver

    RECRUITING

    Vancouver, British Columbia, V5Z 4E6, Canada

  • Białystok Onc. Ctr. (MSC), GO

    RECRUITING

    Bialystok, Podlaskie Voivodeship, 15-027, Poland

  • CARMEL

    RECRUITING

    Haifa, Haifa District, 3436212, Israel

  • CGFL Dijon

    RECRUITING

    Dijon, Bourgogne-Franche-Comté, 21079, France

  • CH de la Côte Basque

    RECRUITING

    Bayonne, Pyrénées-Atlantiques, 64109, France

  • CHU A Coruña

    RECRUITING

    A Coruña, La Coruña, 15006, Spain

  • CHU Brest - Cavale Blanche

    RECRUITING

    Brest, Brittany Region, 29609, France

  • CHU Orléans - Pharmacie

    RECRUITING

    Orléans, Loiret, 45067, France

  • CHU UCL Namur/Ste Elisabeth

    RECRUITING

    Namur, Wallonia, 5000, Belgium

  • CPMC Research Institute

    RECRUITING

    San Francisco, California, 94109, United States

  • CUN Madrid

    RECRUITING

    Madrid, Madrid, 28027, Spain

  • CUN Pamplona

    RECRUITING

    Pamplona, Navarre, 31008, Spain

  • Calvary Mater Newcastle

    RECRUITING

    Waratah, New South Wales, 2298, Australia

  • Cancer Institute Hospital of JFCR

    RECRUITING

    Tokyo, 135-8550, Japan

  • Cancer Institute Jean Godinot

    RECRUITING

    Reims, Marne, 51092, France

  • Centre Jean Perrin

    RECRUITING

    Clermont-Ferrand, Auvergne-Rhône-Alpes, 63011, France

  • Centrum Onkologi Ziemi Lubelsk

    RECRUITING

    Lublin, Lublin Voivodeship, 20-090, Poland

  • Chiba University Hospital- Center for Outpatient

    RECRUITING

    Chiba, Chiba, 260-8677, Japan

  • Chris O'Brien Lifehouse

    RECRUITING

    Camperdown, New South Wales, 2050, Australia

  • Clinique Tivoli Ducos

    RECRUITING

    Bordeaux, Gironde, 33000, France

  • Corewell Health

    RECRUITING

    Grand Rapids, Michigan, 49503, United States

  • Curie Oncology (Farrer)

    RECRUITING

    Singapore, Singapore, 217562, Singapore

  • Dept., VUH Santaros Clinics

    RECRUITING

    Vilnius, Vilnius County, LT-08406, Lithuania

  • Duke Cancer Institute

    RECRUITING

    Durham, North Carolina, 27710, United States

  • Emory Winship Cancer Inst.

    RECRUITING

    Atlanta, Georgia, 30308, United States

  • Emory Winship Cancer Inst.

    RECRUITING

    Atlanta, Georgia, 30322, United States

  • Emory Winship Cancer Inst./Emory Decatur Hospital

    RECRUITING

    Decatur, Georgia, 30033, United States

  • Endeavor Health NorthShore

    RECRUITING

    Evanston, Illinois, 60201, United States

  • European Institute of Oncology

    RECRUITING

    Milan, MI, 20141, Italy

  • Fukushima Medical University Hospital

    RECRUITING

    Fukushima, 960-1247, Japan

  • Futtura Oncologia - Hub Pesq

    RECRUITING

    Porto Alegre, Rio Grande do Sul, 90470-340, Brazil

  • GHM Grenoble

    RECRUITING

    Grenoble, Auvergne-Rhône-Alpes, 38028, France

  • Galilee Medical Center

    RECRUITING

    Nahariya, Nahariya, 2210001, Israel

  • GenesisCare Campbelltown

    RECRUITING

    Campbelltown, New South Wales, 2560, Australia

  • Grand Hôpital de Charleroi

    RECRUITING

    Gilly, Hainaut, 6060, Belgium

  • Gunma Prefectural Cancer Center

    RECRUITING

    Ōta, Gunma, 373-8550, Japan

  • H.R.U. Málaga - Materno-Inf.

    RECRUITING

    Málaga, 7120, Spain

  • HM Sanchinarro

    RECRUITING

    Madrid, Madrid, 28050, Spain

  • HU Miguel Servet

    RECRUITING

    Zaragoza, Zaragoza, 50009, Spain

  • HU Virgen de Valme

    RECRUITING

    Seville, 41014, Spain

  • HU Virgen de la Victoria

    RECRUITING

    Málaga, Málaga, 29010, Spain

  • HU Virgen del Rocío

    RECRUITING

    Seville, 41013, Spain

  • HUS Strasbourg

    RECRUITING

    Strasbourg, Bas-Rhin, 67200, France

  • Hartford Hospital

    RECRUITING

    Hartford, Connecticut, 06102, United States

  • Haukeland University Hospital

    RECRUITING

    Bergen, Vestland, NO-5021, Norway

  • Helios Hospital Berlin-Buch

    RECRUITING

    Berlin, State of Berlin, 13125, Germany

  • Holy Name Medical Center

    RECRUITING

    Teaneck, New Jersey, 07666, United States

  • HonorHealth Research Inst

    RECRUITING

    Phoenix, Arizona, 85016, United States

  • Hosp. Univ. Son Espases

    RECRUITING

    Palma de Mallorca, Balearic Islands, 07120, Spain

  • Hospital 12 de Octubre

    RECRUITING

    Madrid, Madrid, 28041, Spain

  • Hospital Clínic BCN

    RECRUITING

    Barcelona, Catalonia, 08036, Spain

  • Hospital La Paz

    RECRUITING

    Madrid, 28046, Spain

  • Hospital Nove de Julho

    RECRUITING

    São Paulo, São Paulo, 01308-070, Brazil

  • Hospital São Lucas da PUCRS

    RECRUITING

    Porto Alegre, Rio Grande do Sul, 90610-000, Brazil

  • Hospital Universitari de Girona Doctor Josep Trueta

    RECRUITING

    Girona, GI, 17007, Spain

  • Humanitas San Pio X

    RECRUITING

    Milan, MI, 20159, Italy

  • Hus Ccc/Ctu

    RECRUITING

    Helsinki, Helsinki, 00250, Finland

  • Hyogo Cancer Center

    RECRUITING

    Hyōgo, 673-0021, Japan

  • Hôpital Foch

    RECRUITING

    Suresnes, Île-de-France Region, 92150, France

  • ICM Montpellier

    RECRUITING

    Montpellier, Occitanie, 34298, France

  • ICO Angers

    RECRUITING

    Angers, Pays de la Loire Region, 49055, France

  • ICZMP

    RECRUITING

    Lodz, Łódź Voivodeship, 93-338, Poland

  • IRCCS San Gerardo Tintori

    RECRUITING

    Monza, MB, 20900, Italy

  • IVO Valencia

    RECRUITING

    Valencia, Valenciana, Comunidad, 46009, Spain

  • Irst Meldola

    RECRUITING

    Meldola, FC, 47014, Italy

  • Iwate Medical University Hosp

    RECRUITING

    Shiwa-gun, Iwate, 028-3695, Japan

  • Joondalup Health Campus

    RECRUITING

    Joondalup, Western Australia, 6027, Australia

  • Kaiser Permanente SoCal

    RECRUITING

    Irvine, California, 92618, United States

  • Kanagawa Cancer Center

    RECRUITING

    Yokohama, Kanagawa, 241-8515, Japan

  • Keio University Hospital

    RECRUITING

    Tokyo, Tokyo, 160-8582, Japan

  • Kitasato University Hospital

    RECRUITING

    Sagamihara-shi, Kanagawa, 252-0373, Japan

  • Klinikum Lippe GmbH Pharmacy

    RECRUITING

    Lemgo, North Rhine-Westphalia, 32657, Germany

  • Kuopio Univ. Hospital, PSHVA

    RECRUITING

    Kuopio, Northern Savonia, 70210, Finland

  • L'Hôpital Privé Nancy Lorraine

    RECRUITING

    Nancy, Meurthe-Et-Moselle, 54000, France

  • LSMU Hospital Kauno klinikos

    RECRUITING

    Kaunas, Central Lithuania, LT-45434, Lithuania

  • MUHC - Glen Site

    RECRUITING

    Montreal, Quebec, H4A 3J1, Canada

  • MedStar Washington Hospital

    RECRUITING

    Washington D.C., District of Columbia, 20010, United States

  • Mie University Hospital

    RECRUITING

    Tsu, Kansai, 514-8507, Japan

  • Morristown Medical Center

    RECRUITING

    Morristown, New Jersey, 07960, United States

  • NEXT San Antonio

    RECRUITING

    San Antonio, Texas, 78240, United States

  • NUC Tohoku Univ. Hospital

    RECRUITING

    Sendai, Miyagi, 980-8574, Japan

  • NUH Singapore

    RECRUITING

    Singapore, Singapore, 119082, Singapore

  • NW Cancer Specs. P.C.

    RECRUITING

    Happy Valley, Oregon, 97015, United States

  • NYU Laura and Isaac Perlmutter Cancer Center - 34th Street

    RECRUITING

    New York, New York, 10016, United States

  • National Cancer Center Hospital East

    RECRUITING

    Chiba, 277-8577, Japan

  • National Hospital Organization Kyushu Cancer Center

    RECRUITING

    Fukuoka, 811-1347, Japan

  • Niigata Cancer Center Hospital

    RECRUITING

    Niigata, Japan

  • Northside Hospital Atlanta

    RECRUITING

    Atlanta, Georgia, 30342, United States

  • Norwalk Hospital

    RECRUITING

    Danbury, Connecticut, 06810, United States

  • Norwalk Hospital

    RECRUITING

    Norwalk, Connecticut, 06856, United States

  • OLOL Cancer Institute

    RECRUITING

    Baton Rouge, Louisiana, 70808, United States

  • OUH Radium Hospital

    RECRUITING

    Oslo, Oslofjord, 0379, Norway

  • Oncoclinicas RJ S.A.

    RECRUITING

    Rio de Janeiro, Rio de Janeiro, 2250-905, Brazil

  • Osaka International Cancer Institute - Osaka - Otemae Acti

    RECRUITING

    Osaka, Osaka, 541-8567, Japan

  • Osaka Medical and Pharmaceutical University Hospital

    RECRUITING

    Takatsuki, 569-8686, Japan

  • Ospedale S Stefano

    RECRUITING

    Prato, PO, 59100, Italy

  • Oulu University Hospital

    RECRUITING

    Oulu, North Ostrobothnia, 90220, Finland

  • PR Cancer Specialists

    RECRUITING

    San Juan, 00917, Puerto Rico

  • Perlmutter CC NYU Langone LI

    RECRUITING

    New York, New York, 11501, United States

  • Rambam Medical Center

    RECRUITING

    Haifa, Haifa District, 3109601, Israel

  • SMH - Sarasota - Main Campus

    RECRUITING

    Sarasota, Florida, 34239, United States

  • Saint-Luc University Clinics

    RECRUITING

    Brussels, Brussels Capital, 1200, Belgium

  • Saitama Medical University - International Medical Center

    RECRUITING

    Saitama, 350-1298, Japan

  • Sapporo Medical University Hospital

    RECRUITING

    Sapporo, 060-8543, Japan

  • Shaare Zedek Medical Center

    RECRUITING

    Jerusalem, Jerusalem, 9103102, Israel

  • Shizuoka Cancer Center

    RECRUITING

    Nagaizumi-cho, Shizuoka, 411-8777, Japan

  • Siedleckie Centrum Onkologii

    RECRUITING

    Siedlce, Masovian Voivodeship, 08-110, Poland

  • Sinai Hospital

    RECRUITING

    Baltimore, Maryland, 21215, United States

  • TX Onc - Arlington North

    RECRUITING

    Arlington, Texas, 76012, United States

  • TX Onc - Bedford

    RECRUITING

    Bedford, Texas, 76022, United States

  • TX Onc - Methodist Charlton

    RECRUITING

    Dallas, Texas, 75237, United States

  • TX Onc - Methodist Dallas

    RECRUITING

    Dallas, Texas, 75203, United States

  • TX Onc - Presbyterian Dallas

    RECRUITING

    Dallas, Texas, 75231, United States

  • TX Onc - Sammons

    RECRUITING

    Dallas, Texas, 75246, United States

  • Tampere University Hospital

    RECRUITING

    Tampere, Pirkanmaa, 33520, Finland

  • Trials365, LLC

    RECRUITING

    Shreveport, Louisiana, 71103, United States

  • UCH No. 2, PMU Szczecin

    RECRUITING

    Szczecin, West Pomeranian Voivodeship, 70-111, Poland

  • UGH Patras

    RECRUITING

    Pátrai, RIO, 265 04, Greece

  • UMass Memorial Medical Ctr

    RECRUITING

    Worcester, Massachusetts, 01605, United States

  • USAH Mitchell Cancer Inst

    RECRUITING

    Mobile, Alabama, 36604, United States

  • USOR - Minnesota Oncology

    RECRUITING

    Minneapolis, Minnesota, 55404, United States

  • USOR - Minnesota Oncology - Edina Clinic

    RECRUITING

    Edina, Minnesota, 55435, United States

  • USOR - Minnesota Oncology-Coon Rapids Clinic

    RECRUITING

    Coon Rapids, Minnesota, 55433, United States

  • USOR - Minnesota Oncology-Maplewood Clinic

    RECRUITING

    Maplewood, Minnesota, 55109, United States

  • USOR - Minnesota Oncology/ Coon Rapids Clinic

    RECRUITING

    Coon Rapids, Minnesota, 55433, United States

  • USOR - Minnesota Oncology/ Maple Grove Clinic

    RECRUITING

    Maple Grove, Minnesota, 55369, United States

  • USOR - Minnesota Oncology/ Maplewood Clinic

    RECRUITING

    Maplewood, Minnesota, 55109, United States

  • USOR - Minnesota Oncology/ Minneapolis Clinic

    RECRUITING

    Minneapolis, Minnesota, 55404, United States

  • USOR - Minnesota Oncology/ Woodbury Clinic

    RECRUITING

    Woodbury, Minnesota, 55125, United States

  • USOR - Minnesota Oncology/Edina Clinic

    RECRUITING

    Edina, Minnesota, 55435, United States

  • USOR - NW Cancer Specs P.C.

    RECRUITING

    Portland, Oregon, 97227, United States

  • USOR - NW Cancer Specs P.C.

    RECRUITING

    Vancouver, Washington, 98684, United States

  • USOR - NW Cancer Specs. P.C.

    RECRUITING

    Tigard, Oregon, 97223, United States

  • USOR - TX Oncology - SA NE

    RECRUITING

    San Antonio, Texas, 78217, United States

  • USOR - Texas Oncology

    RECRUITING

    Austin, Texas, 78731, United States

  • USOR - Texas Oncology

    RECRUITING

    Austin, Texas, 78745, United States

  • USOR - Texas Oncology

    RECRUITING

    Harlingen, Texas, 78550, United States

  • USOR - Texas Oncology

    RECRUITING

    McAllen, Texas, 78503, United States

  • USOR - Texas Oncology

    RECRUITING

    Weslaco, Texas, 78596, United States

  • USOR - Texas Oncology - Dallas Fort Worth (DFW)

    RECRUITING

    Fort Worth, Texas, 76104, United States

  • USOR - Texas Oncology- Austin North

    RECRUITING

    Austin, Texas, 78758, United States

  • USOR - Texas Oncology- Horizon Circle

    RECRUITING

    Waco, Texas, 76712, United States

  • USOR - Texas Oncology- Waco

    RECRUITING

    Waco, Texas, 76712, United States

  • Universitair Ziekenhuis Leuven

    RECRUITING

    Leuven, Flanders, 3000, Belgium

  • University of Cincinnati Medical Center

    RECRUITING

    Cincinnati, Ohio, 45219, United States

  • University of Virginia

    RECRUITING

    Charlottesville, Virginia, 22908, United States

  • VITAZ

    RECRUITING

    Sint-Niklaas, Sint-Niklaas, 9100, Belgium

  • Vall d'Hebron

    RECRUITING

    Barcelona, Catalonia, 08035, Spain

  • Wake Forest University

    RECRUITING

    Winston-Salem, North Carolina, 27517, United States

  • Washington University School of Medicine

    RECRUITING

    St Louis, Missouri, 63110, United States

  • Willamette Valley Cancer Institute and Research Center - Eugene

    RECRUITING

    Eugene, Oregon, 97401, United States

  • William Kahlert Reg. Can. Ctr

    RECRUITING

    Westminster, Maryland, 21157, United States

  • Wolfson Medical Center

    RECRUITING

    Holon, Holon, 58110, Israel

  • Women's Care - 9th Ave

    RECRUITING

    St. Petersburg, Florida, 33713, United States

  • Women's Care - Armenia Ave

    RECRUITING

    Tampa, Florida, 33603, United States

  • Yamagata University Hospital

    RECRUITING

    Yamagata, 990-9585, Japan

  • ŚCO SPZOZ Kielce

    RECRUITING

    Kielce, 25-734, Poland

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