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RECRUITING

NCT07166094

PHASE3

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

Sponsor: Genmab

View on ClinicalTrials.gov

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).

Official title: A Phase 3 Randomized, Open-label Study of Rinatabart Sesutecan (Rina-S) Versus Treatment of Investigator's Choice (IC) in Patients With Endometrial Cancer After Platinum-Based Chemotherapy and PD(L)-1 Therapy

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

660

Start Date

2025-11-28

Completion Date

2029-11

Last Updated

2026-07-07

Healthy Volunteers

Conditions

Endometrial Cancer Recurrent or Progressive Endometrial Cancer

Interventions

DRUG

Rina-S

Intravenous (IV) infusion.

DRUG

* Paclitaxel: IV infusion * Doxorubicin: IV bolus injection/infusion

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.

Locations (120)

HonorHealth Research Inst

Phoenix, Arizona, United States

Kaiser Permanente SoCal

Irvine, California, United States

MedStar Washington Hospital

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

SMH - Sarasota - Main Campus

Sarasota, Florida, United States

Women's Care - 9th Ave

St. Petersburg, Florida, United States

Women's Care - Armenia Ave

Tampa, Florida, United States

Emory Winship Cancer Inst.

Atlanta, Georgia, United States

Emory Winship Cancer Inst.

Atlanta, Georgia, United States

Northside Hospital Atlanta

Atlanta, Georgia, United States

Emory Winship Cancer Inst./Emory Decatur Hospital

Decatur, Georgia, United States

Trials365, LLC

Shreveport, Louisiana, United States

Sinai Hospital

Baltimore, Maryland, United States

William Kahlert Reg. Can. Ctr

Westminster, Maryland, United States

Corewell Health

Grand Rapids, Michigan, United States

USOR - Minnesota Oncology-Coon Rapids Clinic

Coon Rapids, Minnesota, United States

USOR - Minnesota Oncology/ Coon Rapids Clinic

Coon Rapids, Minnesota, United States

USOR - Minnesota Oncology - Edina Clinic

Edina, Minnesota, United States

USOR - Minnesota Oncology/Edina Clinic

Edina, Minnesota, United States

USOR - Minnesota Oncology/ Maple Grove Clinic

Maple Grove, Minnesota, United States

USOR - Minnesota Oncology-Maplewood Clinic

Maplewood, Minnesota, United States

USOR - Minnesota Oncology/ Maplewood Clinic

Maplewood, Minnesota, United States

USOR - Minnesota Oncology/ Minneapolis Clinic

Minneapolis, Minnesota, United States

USOR - Minnesota Oncology

Minneapolis, Minnesota, United States

USOR - Minnesota Oncology/ Woodbury Clinic

Woodbury, Minnesota, United States

Washington University School of Medicine

St Louis, Missouri, United States

Holy Name Medical Center

Teaneck, New Jersey, United States

Duke Cancer Institute

Durham, North Carolina, United States

University of Cincinnati Medical Center

Cincinnati, Ohio, United States

Willamette Valley Cancer Institute and Research Center - Eugene

Eugene, Oregon, United States

NW Cancer Specs. P.C.

Happy Valley, Oregon, United States

USOR - NW Cancer Specs P.C.

Portland, Oregon, United States

USOR - NW Cancer Specs. P.C.

Tigard, Oregon, United States

TX Onc - Arlington North

Arlington, Texas, United States

USOR - Texas Oncology

Austin, Texas, United States

USOR - Texas Oncology

Austin, Texas, United States

USOR - Texas Oncology- Austin North

Austin, Texas, United States

TX Onc - Bedford

Bedford, Texas, United States

TX Onc - Methodist Dallas

Dallas, Texas, United States

TX Onc - Presbyterian Dallas

Dallas, Texas, United States

TX Onc - Methodist Charlton

Dallas, Texas, United States

TX Onc - Sammons

Dallas, Texas, United States

USOR - Texas Oncology - Dallas Fort Worth (DFW)

Fort Worth, Texas, United States

USOR - Texas Oncology

Harlingen, Texas, United States

USOR - Texas Oncology

McAllen, Texas, United States

USOR - TX Oncology - SA NE

San Antonio, Texas, United States

NEXT San Antonio

San Antonio, Texas, United States

USOR - Texas Oncology- Horizon Circle

Waco, Texas, United States

USOR - Texas Oncology- Waco

Waco, Texas, United States

USOR - Texas Oncology

Weslaco, Texas, United States

USOR - NW Cancer Specs P.C.

Vancouver, Washington, United States

GenesisCare Campbelltown

Campbelltown, New South Wales, Australia

Chris O'Brien Lifehouse

Camperdown, New South Wales, Australia

Calvary Mater Newcastle

Waratah, New South Wales, Australia

Antwerp University Hospital

Edegem, Antwerp, Belgium

Saint-Luc University Clinics

Brussels, Brussels Capital, Belgium

Universitair Ziekenhuis Leuven

Leuven, Flanders, Belgium

Grand Hôpital de Charleroi

Gilly, Hainaut, Belgium

CHU UCL Namur/Ste Elisabeth

Namur, Wallonia, Belgium

VITAZ

Sint-Niklaas, Belgium

Arthur J E Child Cancer Comp

Calgary, Alberta, Canada

MUHC - Glen Site

Montreal, Quebec, Canada

Aalborg University Hospital

Aalborg, Denmark

Oulu University Hospital

Oulu, North Ostrobothnia, Finland

Kuopio Univ. Hospital, PSHVA

Kuopio, Northern Savonia, Finland

Hus Ccc/Ctu

Helsinki, Finland

Tampere University Hospital

Tampere, Finland

GHM Grenoble

Grenoble, Auvergne-Rhône-Alpes, France

HUS Strasbourg

Strasbourg, Bas-Rhin, France

CHU Brest - Cavale Blanche

Brest, Brittany Region, France

Clinique Tivoli Ducos

Bordeaux, Gironde, France

CHU Orléans - Pharmacie

Orléans, Loiret, France

L'Hôpital Privé Nancy Lorraine

Nancy, Meurthe-Et-Moselle, France

ICM Montpellier

Montpellier, Occitanie, France

ICO Angers

Angers, Pays de la Loire Region, France

CH de la Côte Basque

Bayonne, Pyrénées-Atlantiques, France

Hôpital Foch

Suresnes, Île-de-France Region, France

Klinikum Lippe GmbH Pharmacy

Lemgo, North Rhine-Westphalia, Germany

Asklepios Hospital Barmbek

Hamburg, Germany

Chiba University Hospital- Center for Outpatient

Chiba, Chiba, Japan

Gunma Prefectural Cancer Center

Ōta, Gunma, Japan

Iwate Medical University Hosp

Shiwa-gun, Iwate, Japan

Kitasato University Hospital

Sagamihara-shi, Kanagawa, Japan

Kanagawa Cancer Center

Yokohama, Kanagawa, Japan

Mie University Hospital

Tsu, Kansai, Japan

NUC Tohoku Univ. Hospital

Sendai, Miyagi, Japan

Osaka International Cancer Institute - Osaka - Otemae Acti

Osaka, Osaka, Japan

Shizuoka Cancer Center

Nagaizumi-cho, Shizuoka, Japan

Keio University Hospital

Tokyo, Tokyo, Japan

National Cancer Center Hospital East

Chiba, Japan

National Hospital Organization Kyushu Cancer Center

Fukuoka, Japan

Fukushima Medical University Hospital

Fukushima, Japan

Hyogo Cancer Center

Hyōgo, Japan

Niigata Cancer Center Hospital

Niigata, Japan

Saitama Medical University - International Medical Center

Saitama, Japan

Sapporo Medical University Hospital

Sapporo, Japan

Osaka Medical and Pharmaceutical University Hospital

Takatsuki, Japan

Cancer Institute Hospital of JFCR

Tokyo, Japan

Yamagata University Hospital

Yamagata, Japan

LSMU Hospital Kauno klinikos

Kaunas, Central Lithuania, Lithuania

OUH Radium Hospital

Oslo, Oslofjord, Norway

Haukeland University Hospital

Bergen, Vestland, Norway

Siedleckie Centrum Onkologii

Siedlce, Masovian Voivodeship, Poland

Białystok Onc. Ctr. (MSC), GO

Bialystok, Podlaskie Voivodeship, Poland

ICZMP

Lodz, Poland

PR Cancer Specialists

San Juan, Puerto Rico

NUH Singapore

Singapore, Singapore

Curie Oncology (Farrer)

Singapore, Singapore

Hosp. Univ. Son Espases

Palma de Mallorca, Balearic Islands, Spain

Hospital Clínic BCN

Barcelona, Catalonia, Spain

CHU A Coruña

A Coruña, La Coruña, Spain

CUN Pamplona

Pamplona, Navarre, Spain

IVO Valencia

Valencia, Valenciana, Comunidad, Spain

CUN Madrid

Madrid, Spain

Hospital La Paz

Madrid, Spain

HM Sanchinarro

Madrid, Spain

HU Virgen de la Victoria

Málaga, Spain

H.R.U. Málaga - Materno-Inf.

Málaga, Spain

HU Virgen del Rocío

Seville, Spain

HU Virgen de Valme

Seville, Spain

HU Miguel Servet

Zaragoza, Spain

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (120)