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NCT07166094PHASE3Recruiting

Study to Assess the Efficacy and Safety of Rina-S Compared to Treatment of Investigator's Choice in Participants With Endometrial Cancer

Genmab

Start Date

11/28/2025

Completion Date

11/1/2029

Summary

The purpose of this study is to compare how well Rina-S (GEN1184) works compared to treatment of physician's choice (paclitaxel or doxorubicin) that are considered standard medical care for the treatment of recurrent or progressive endometrial cancer (EC) following prior therapy. There is an equal (50:50) chance of getting either Rina-S or a chemotherapy agent as treatment in this study. The study duration will be approximately 3 years. The treatment duration will be different for every participant, but an average of 4 to 6 months is expected. All participants will receive active drug; no one will be given placebo. Participation in the study will require visits to the study site(s).

Detailed Description

This is a global, open-label, randomized Phase 3 study in approximately 660 participants with recurrent or progressive EC following prior therapy. Participants will be randomized in a 1:1 ratio to receive treatment with Rina-S vs investigator's choice (IC) (paclitaxel or doxorubicin). Investigators must select one of the IC treatment options for each participant prior to randomization so that this may be used for treatment assignment if the participant is randomized to the IC arm.

Eligibility Criteria

Age Range: 18 years to No maximum

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.

Interventions

DRUG

Rina-S

DRUG

IC

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Conditions

Endometrial CancerRecurrent or Progressive Endometrial Cancer

Locations

HonorHealth Research Inst

Phoenix, Arizona 85016

United States

Kaiser Permanente SoCal

Irvine, California 92618

United States

MedStar Washington Hospital

Washington D.C., District of Columbia 20010

United States

SMH - Sarasota - Main Campus

Sarasota, Florida 34239

United States

Women's Care - 9th Ave

St. Petersburg, Florida 33713

United States

Women's Care - Armenia Ave

Tampa, Florida 33603

United States

Emory Winship Cancer Inst.

Atlanta, Georgia 30308

United States

Emory Winship Cancer Inst.

Atlanta, Georgia 30322

United States

Northside Hospital Atlanta

Atlanta, Georgia 30342

United States

Emory Winship Cancer Inst./Emory Decatur Hospital

Decatur, Georgia 30033

United States

Trials365, LLC

Shreveport, Louisiana 71103

United States

Sinai Hospital

Baltimore, Maryland 21215

United States

William Kahlert Reg. Can. Ctr

Westminster, Maryland 21157

United States

Corewell Health

Grand Rapids, Michigan 49503

United States

USOR - Minnesota Oncology-Coon Rapids Clinic

Coon Rapids, Minnesota 55433

United States

USOR - Minnesota Oncology/ Coon Rapids Clinic

Coon Rapids, Minnesota 55433

United States

USOR - Minnesota Oncology - Edina Clinic

Edina, Minnesota 55435

United States

USOR - Minnesota Oncology/Edina Clinic

Edina, Minnesota 55435

United States

USOR - Minnesota Oncology/ Maple Grove Clinic

Maple Grove, Minnesota 55369

United States

USOR - Minnesota Oncology-Maplewood Clinic

Maplewood, Minnesota 55109

United States

USOR - Minnesota Oncology/ Maplewood Clinic

Maplewood, Minnesota 55109

United States

USOR - Minnesota Oncology/ Minneapolis Clinic

Minneapolis, Minnesota 55404

United States

USOR - Minnesota Oncology

Minneapolis, Minnesota 55404

United States

USOR - Minnesota Oncology/ Woodbury Clinic

Woodbury, Minnesota 55125

United States

Washington University School of Medicine

St Louis, Missouri 63110

United States

Holy Name Medical Center

Teaneck, New Jersey 07666

United States

Duke Cancer Institute

Durham, North Carolina 27710

United States

University of Cincinnati Medical Center

Cincinnati, Ohio 45219

United States

Willamette Valley Cancer Institute and Research Center - Eugene

Eugene, Oregon 97401

United States

NW Cancer Specs. P.C.

Happy Valley, Oregon 97015

United States

USOR - NW Cancer Specs P.C.

Portland, Oregon 97227

United States

USOR - NW Cancer Specs. P.C.

Tigard, Oregon 97223

United States

TX Onc - Arlington North

Arlington, Texas 76012

United States

USOR - Texas Oncology

Austin, Texas 78731

United States

USOR - Texas Oncology

Austin, Texas 78745

United States

USOR - Texas Oncology- Austin North

Austin, Texas 78758

United States

TX Onc - Bedford

Bedford, Texas 76022

United States

TX Onc - Methodist Dallas

Dallas, Texas 75203

United States

TX Onc - Presbyterian Dallas

Dallas, Texas 75231

United States

TX Onc - Methodist Charlton

Dallas, Texas 75237

United States

TX Onc - Sammons

Dallas, Texas 75246

United States

USOR - Texas Oncology - Dallas Fort Worth (DFW)

Fort Worth, Texas 76104

United States

USOR - Texas Oncology

Harlingen, Texas 78550

United States

USOR - Texas Oncology

McAllen, Texas 78503

United States

USOR - TX Oncology - SA NE

San Antonio, Texas 78217

United States

NEXT San Antonio

San Antonio, Texas 78240

United States

USOR - Texas Oncology- Horizon Circle

Waco, Texas 76712

United States

USOR - Texas Oncology- Waco

Waco, Texas 76712

United States

USOR - Texas Oncology

Weslaco, Texas 78596

United States

USOR - NW Cancer Specs P.C.

Vancouver, Washington 98684

United States

GenesisCare Campbelltown

Campbelltown, New South Wales 2560

Australia

Chris O'Brien Lifehouse

Camperdown, New South Wales 2050

Australia

Calvary Mater Newcastle

Waratah, New South Wales 2298

Australia

Antwerp University Hospital

Edegem, Antwerp 2650

Belgium

Saint-Luc University Clinics

Brussels, Brussels Capital 1200

Belgium

Universitair Ziekenhuis Leuven

Leuven, Flanders 3000

Belgium

Grand Hôpital de Charleroi

Gilly, Hainaut 6060

Belgium

CHU UCL Namur/Ste Elisabeth

Namur, Wallonia 5000

Belgium

VITAZ

Sint-Niklaas, 9100

Belgium

Arthur J E Child Cancer Comp

Calgary, Alberta T2N 5G2

Canada

MUHC - Glen Site

Montreal, Quebec H4A 3J1

Canada

Aalborg University Hospital

Aalborg, 9000

Denmark

Oulu University Hospital

Oulu, North Ostrobothnia 90220

Finland

Kuopio Univ. Hospital, PSHVA

Kuopio, Northern Savonia 70210

Finland

Hus Ccc/Ctu

Helsinki, 00250

Finland

Tampere University Hospital

Tampere, 33520

Finland

GHM Grenoble

Grenoble, Auvergne-Rhône-Alpes 38028

France

HUS Strasbourg

Strasbourg, Bas-Rhin 67200

France

CHU Brest - Cavale Blanche

Brest, Brittany Region 29609

France

Clinique Tivoli Ducos

Bordeaux, Gironde 33000

France

CHU Orléans - Pharmacie

Orléans, Loiret 45067

France

L'Hôpital Privé Nancy Lorraine

Nancy, Meurthe-Et-Moselle 54000

France

ICM Montpellier

Montpellier, Occitanie 34298

France

ICO Angers

Angers, Pays de la Loire Region 49055

France

CH de la Côte Basque

Bayonne, Pyrénées-Atlantiques 64109

France

Hôpital Foch

Suresnes, Île-de-France Region 92150

France

Klinikum Lippe GmbH Pharmacy

Lemgo, North Rhine-Westphalia 32657

Germany

Asklepios Hospital Barmbek

Hamburg, 22453

Germany

Chiba University Hospital- Center for Outpatient

Chiba, Chiba 260-8677

Japan

Gunma Prefectural Cancer Center

Ōta, Gunma 373-8550

Japan

Iwate Medical University Hosp

Shiwa-gun, Iwate 028-3695

Japan

Kitasato University Hospital

Sagamihara-shi, Kanagawa 252-0373

Japan

Kanagawa Cancer Center

Yokohama, Kanagawa 241-8515

Japan

Mie University Hospital

Tsu, Kansai 514-8507

Japan

NUC Tohoku Univ. Hospital

Sendai, Miyagi 980-8574

Japan

Osaka International Cancer Institute - Osaka - Otemae Acti

Osaka, Osaka 541-8567

Japan

Shizuoka Cancer Center

Nagaizumi-cho, Shizuoka 411-8777

Japan

Keio University Hospital

Tokyo, Tokyo 160-8582

Japan

National Cancer Center Hospital East

Chiba, 277-8577

Japan

National Hospital Organization Kyushu Cancer Center

Fukuoka, 811-1347

Japan

Fukushima Medical University Hospital

Fukushima, 960-1247

Japan

Hyogo Cancer Center

Hyōgo, 673-0021

Japan

Niigata Cancer Center Hospital

Niigata,

Japan

Saitama Medical University - International Medical Center

Saitama, 350-1298

Japan

Sapporo Medical University Hospital

Sapporo, 060-8543

Japan

Osaka Medical and Pharmaceutical University Hospital

Takatsuki, 569-8686

Japan

Cancer Institute Hospital of JFCR

Tokyo, 135-8550

Japan

Yamagata University Hospital

Yamagata, 990-9585

Japan

LSMU Hospital Kauno klinikos

Kaunas, Central Lithuania LT-45434

Lithuania

OUH Radium Hospital

Oslo, Oslofjord 0379

Norway

Haukeland University Hospital

Bergen, Vestland NO-5021

Norway

Siedleckie Centrum Onkologii

Siedlce, Masovian Voivodeship 08-110

Poland

Białystok Onc. Ctr. (MSC), GO

Bialystok, Podlaskie Voivodeship 15-027

Poland

ICZMP

Lodz, 93-338

Poland

PR Cancer Specialists

San Juan, 00917

Puerto Rico

NUH Singapore

Singapore, 119082

Singapore

Curie Oncology (Farrer)

Singapore, 217562

Singapore

Hosp. Univ. Son Espases

Palma de Mallorca, Balearic Islands 07120

Spain

Hospital Clínic BCN

Barcelona, Catalonia 08036

Spain

CHU A Coruña

A Coruña, La Coruña 15006

Spain

CUN Pamplona

Pamplona, Navarre 31008

Spain

IVO Valencia

Valencia, Valenciana, Comunidad 46009

Spain

CUN Madrid

Madrid, 28027

Spain

Hospital La Paz

Madrid, 28046

Spain

HM Sanchinarro

Madrid, 28050

Spain

HU Virgen de la Victoria

Málaga, 29010

Spain

H.R.U. Málaga - Materno-Inf.

Málaga, 7120

Spain

HU Virgen del Rocío

Seville, 41013

Spain

HU Virgen de Valme

Seville, 41014

Spain

HU Miguel Servet

Zaragoza, 50009

Spain