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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

2026-11-03

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 (178)

USAH Mitchell Cancer Inst

Mobile, Alabama, United States

HonorHealth Research Inst

Phoenix, Arizona, United States

Kaiser Permanente SoCal

Irvine, California, United States

CPMC Research Institute

San Francisco, California, United States

Norwalk Hospital

Danbury, Connecticut, United States

Hartford Hospital

Hartford, Connecticut, United States

Norwalk Hospital

Norwalk, Connecticut, 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

Endeavor Health NorthShore

Evanston, Illinois, United States

OLOL Cancer Institute

Baton Rouge, Louisiana, United States

LSU Health New Orleans

New Orleans, Louisiana, United States

Trials365, LLC

Shreveport, Louisiana, United States

Sinai Hospital

Baltimore, Maryland, United States

William Kahlert Reg. Can. Ctr

Westminster, Maryland, United States

UMass Memorial Medical Ctr

Worcester, Massachusetts, 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

Morristown Medical Center

Morristown, New Jersey, United States

Atlantic Health - Overlook MC

Summit, New Jersey, United States

Holy Name Medical Center

Teaneck, New Jersey, United States

NYU Laura and Isaac Perlmutter Cancer Center - 34th Street

New York, New York, United States

Perlmutter CC NYU Langone LI

New York, New York, United States

Atrium Health LCI - Morehead

Charlotte, North Carolina, United States

Atrium Health LCI - Ballantyne

Charlotte, North Carolina, United States

Atrium Health LCI - Concord

Concord, North Carolina, United States

Duke Cancer Institute

Durham, North Carolina, United States

Atrium Health LCI - Gaston

Gastonia, North Carolina, United States

Wake Forest University

Winston-Salem, 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

University of Virginia

Charlottesville, Virginia, United States

USOR - NW Cancer Specs P.C.

Vancouver, Washington, United States

Austin Health

Heidelberg, Heidelberg, Australia

GenesisCare Campbelltown

Campbelltown, New South Wales, Australia

Chris O'Brien Lifehouse

Camperdown, New South Wales, Australia

Gosford Hospital

Gosford, New South Wales, Australia

Nepean Cancer & Wellness Ctr

Kingswood, New South Wales, Australia

Calvary Mater Newcastle

Waratah, New South Wales, Australia

Joondalup Health Campus

Joondalup, Western Australia, 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

VITAZ

Sint-Niklaas, Sint-Niklaas, Belgium

CHU UCL Namur/Ste Elisabeth

Namur, Wallonia, Belgium

Oncoclinicas RJ S.A.

Rio de Janeiro, Rio de Janeiro, Brazil

Futtura Oncologia - Hub Pesq

Porto Alegre, Rio Grande do Sul, Brazil

Hospital São Lucas da PUCRS

Porto Alegre, Rio Grande do Sul, Brazil

Hospital Nove de Julho

São Paulo, São Paulo, Brazil

Arthur J E Child Cancer Comp

Calgary, Alberta, Canada

BC Cancer - Vancouver

Vancouver, British Columbia, Canada

MUHC - Glen Site

Montreal, Quebec, Canada

Aalborg University Hospital

Aalborg, Denmark

Hus Ccc/Ctu

Helsinki, Helsinki, Finland

Oulu University Hospital

Oulu, North Ostrobothnia, Finland

Kuopio Univ. Hospital, PSHVA

Kuopio, Northern Savonia, Finland

Tampere University Hospital

Tampere, Pirkanmaa, Finland

Centre Jean Perrin

Clermont-Ferrand, Auvergne-Rhône-Alpes, France

GHM Grenoble

Grenoble, Auvergne-Rhône-Alpes, France

HUS Strasbourg

Strasbourg, Bas-Rhin, France

CGFL Dijon

Dijon, Bourgogne-Franche-Comté, France

CHU Brest - Cavale Blanche

Brest, Brittany Region, France

Clinique Tivoli Ducos

Bordeaux, Gironde, France

And 78 more locations on ClinicalTrials.gov

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 (178)