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RECRUITING Phase 3 ClinicalTrials.gov

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

Sponsor: Genmab • ClinicalTrials.gov ID: NCT07166094

Registry updated: 2026-10-06
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Description

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).

Interventions

  • Rina-S (Drug)
    Intravenous (IV) infusion.
  • IC (Drug)
    * Paclitaxel: IV infusion * Doxorubicin: IV bolus injection/infusion

Eligibility criteria

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.

Conditions

Endometrial Cancer Recurrent or Progressive Endometrial Cancer

Locations

  • 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
  • CHU Orléans - Pharmacie — Orléans, Loiret, France
  • Cancer Institute Jean Godinot — Reims, Marne, 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
  • Asklepios Hospital Barmbek — Hamburg, Free and Hanseatic City of Hamburg, Germany
  • Central Whse (Zentrallager) — Wiesbaden, Hesse (Hessen), Germany
  • Bonn University Hospital — Bonn, North Rhine-Westphalia, Germany
  • Klinikum Lippe GmbH Pharmacy — Lemgo, North Rhine-Westphalia, Germany
  • Helios Hospital Berlin-Buch — Berlin, State of Berlin, Germany
  • UGH Patras — Pátrai, RIO, Greece
  • Aretaieio Hospital — Athens, Greece
  • Alexandra General Hospital — Athens, Greece
  • Rambam Medical Center — Haifa, Haifa District, Israel
  • CARMEL — Haifa, Haifa District, Israel
  • Wolfson Medical Center — Holon, Holon, Israel
  • Shaare Zedek Medical Center — Jerusalem, Jerusalem, Israel
  • Galilee Medical Center — Nahariya, Nahariya, Israel
  • Assuta Ashdod Hospital — Ashdod, Southern Israel, Israel
  • AOU Sant Orsola Malpighi — Bologna, BO, Italy
  • Irst Meldola — Meldola, FC, Italy
  • IRCCS San Gerardo Tintori — Monza, MB, Italy
  • European Institute of Oncology — Milan, MI, Italy
  • Humanitas San Pio X — Milan, MI, Italy
  • Ospedale S Stefano — Prato, PO, Italy
  • AUSL IRCCS Reggio Emilia — Reggio Emilia, RE, Italy
  • 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
  • Dept., VUH Santaros Clinics — Vilnius, Vilnius County, Lithuania
  • OUH Radium Hospital — Oslo, Oslofjord, Norway
  • Haukeland University Hospital — Bergen, Vestland, Norway
  • Centrum Onkologi Ziemi Lubelsk — Lublin, Lublin Voivodeship, Poland
  • Siedleckie Centrum Onkologii — Siedlce, Masovian Voivodeship, Poland
  • Białystok Onc. Ctr. (MSC), GO — Bialystok, Podlaskie Voivodeship, Poland
  • UCH No. 2, PMU Szczecin — Szczecin, West Pomeranian Voivodeship, Poland
  • ŚCO SPZOZ Kielce — Kielce, Poland
  • ICZMP — Lodz, Łódź Voivodeship, Poland
  • PR Cancer Specialists — San Juan, Puerto Rico
  • NUH Singapore — Singapore, Singapore, Singapore
  • Curie Oncology (Farrer) — Singapore, Singapore, Singapore
  • Hosp. Univ. Son Espases — Palma de Mallorca, Balearic Islands, Spain
  • Vall d'Hebron — Barcelona, Catalonia, Spain
  • Hospital Clínic BCN — Barcelona, Catalonia, Spain
  • Hospital Universitari de Girona Doctor Josep Trueta — Girona, GI, Spain
  • CHU A Coruña — A Coruña, La Coruña, Spain
  • CUN Madrid — Madrid, Madrid, Spain
  • Hospital 12 de Octubre — Madrid, Madrid, Spain
  • HM Sanchinarro — Madrid, Madrid, Spain
  • HU Virgen de la Victoria — Málaga, Málaga, Spain
  • CUN Pamplona — Pamplona, Navarre, Spain
  • IVO Valencia — Valencia, Valenciana, Comunidad, Spain
  • HU Miguel Servet — Zaragoza, Zaragoza, Spain
  • Hospital La Paz — Madrid, Spain
  • H.R.U. Málaga - Materno-Inf. — Málaga, Spain
  • HU Virgen del Rocío — Seville, Spain
  • HU Virgen de Valme — Seville, Spain
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record