NCT03981796Active, not recruitingPhase 3
A Study to Evaluate Dostarlimab Plus Carboplatin-paclitaxel Versus Placebo Plus Carboplatin-paclitaxel in Participants With Recurrent or Primary Advanced Endometrial Cancer
A Phase 3, Randomized, Double-blind, Multicenter Study of Dostarlimab (TSR-042) Plus Carboplatin-paclitaxel Versus Placebo Plus Carboplatin-paclitaxel in Patients With Recurrent or Primary Advanced Endometrial Cancer (RUBY)
Source: ClinicalTrials.gov · Last updated 3 Sept 2025
Brief summary (registry, in English)
This is a 2 part study. Part 1 is to evaluate the efficacy and safety of dostarlimab plus carboplatin-paclitaxel followed by dostarlimab versus placebo plus carboplatin-paclitaxel followed by placebo; and Part 2 is to evaluate the efficacy and safety of dostarlimab plus carboplatin-paclitaxel followed by dostarlimab plus niraparib versus placebo plus carboplatin-paclitaxel followed by placebo in participants with recurrent or primary advanced (Stage III or IV) endometrial cancer.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 785 (actual)
- First submitted
- 31 May 2019
- Start date
- 18 Jul 2019
- Primary completion date
- 26 Nov 2026
- Lead sponsor
- Tesaro, Inc.
- Diseases
- Endometrial cancer
- NCT number
- NCT03981796
- EU CT number
- 2023-506551-23-00
- EudraCT number
- 2019-001576-11
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 785
- From 18 Jul 2019 to the primary completion date, 26 Nov 2026
- 125 sites in 20 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participant has received neo-adjuvant/adjuvant systemic anticancer therapy for primary Stage III or IV disease and:
- has not had a recurrence or PD prior to first dose on the study OR
- has had a recurrence or PD within 6 months of completing systemic anticancer therapy treatment prior to first dose on the study.
- Participant has received prior therapy with an anti-programmed cell death protein 1 (anti-PD-1), anti-PD-ligand 1 (anti-PD-L1), or anti-PD-ligand 2 (anti-PD-L2) agent.
- Participant has received prior anticancer therapy (chemotherapy, targeted therapies, hormonal therapy, radiotherapy, or immunotherapy) within 21 days or \<5 times the half-life of the most recent therapy prior to Study Day 1, whichever is shorter.
- Participant has a concomitant malignancy, or participant has a prior non-endometrial invasive malignancy who has been disease-free for \<3 years or who received any active treatment in the last 3 years for that malignancy. Non-melanoma skin cancer is allowed.
- Participant has not recovered adequately from AEs or complications from any major surgery prior to starting therapy.
- Participant is currently participating and receiving study treatment or has participated in a study of an investigational agent and received study treatment or used an investigational device within 4 weeks of the first dose of treatment.
- Participant has received, or is scheduled to receive, a live vaccine within 30 days before first dose of study treatment, during study treatment, and for up to 180 days after receiving the last dose of study treatment.
- Part 2 only:
- Participant has received prior therapy with a poly (adenosine diphosphate \[ADP\]-ribose) polymerase (PARP) inhibitor.
- Participant is at increased bleeding risk due to concurrent conditions.
Other illness
- Participant has had \>1 recurrence of endometrial cancer.
- Participant is considered a poor medical risk due to a serious, uncontrolled medical disorder, nonmalignant systemic disease, or active infection requiring systemic therapy.
- Participant has clinically significant cardiovascular disease.
- Participant has any known history or current diagnosis of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML).
Lab values
- Participant has not recovered (that is \[i.e.\], to Grade \<=1 or to Baseline) from cytotoxic therapy induced AEs or has received transfusion of blood products (including platelets or red blood cells) or administration of colony-stimulating factors (including granulocyte colony-stimulating factor \[G-CSF\], granulocyte macrophage colony-stimulating factor \[GM-CSF\], or recombinant erythropoietin) within 21 days prior to the first dose of study drug.
Other
- Part 1 and Part 2:
- Participant has known uncontrolled central nervous system metastases, carcinomatosis meningitis, or both.
- Participant has participated in Part 1 of this study
Who the study is looking for
- Part 1 and Part 2:
- Female participant is at least 18 years of age.
- Participant has histologically or cytologically proven endometrial cancer with recurrent or advanced disease.
- Participant must have primary Stage III or Stage IV disease or first recurrent endometrial cancer with a low potential for cure by radiation therapy or surgery alone or in combination and meet at least one of the following criteria;
- Participant has primary Stage IIIA to IIIC1 disease with presence of evaluable or measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version (v).1.1 based on Investigator's assessment. Lesions that are equivocal or can be representative of post-operative change should be biopsied and confirmed for the presence of tumor;
- Participant has primary Stage IIIC1 disease with carcinosarcoma, clear cell, serous, or mixed histology (containing greater than or equal to \[\>=\] 10 percent carcinosarcoma, clear cell, or serous histology) regardless of presence of evaluable or measurable disease on imaging;
- Participant has primary Stage IIIC2 or Stage IV disease regardless of the presence of evaluable or measurable disease;
- Participant has first recurrent disease and is naïve to systemic anticancer therapy;
- Participant has received prior neo-adjuvant/adjuvant systemic anticancer therapy and had a recurrence or progression of disease (PD) \>=6 months after completing treatment (first recurrence only).
- Participant has an ECOG performance status of 0 or 1.
- Participant has adequate organ function.
- Part 2 only:
- Participants must have normal blood pressure (BP) or adequately treated and controlled hypertension (systolic BP lesser than or equal to \[\<=\] 140 millimeter of mercury \[mmHg\] and diastolic BP \<=90 mmHg).
- Participants must be able to take medication orally, by mouth (PO).
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (125)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Onze-Lieve-Vrouwziekenhuis Coordinator of this site? Confirm its status | Aalst | Belgium | Active, not recruiting |
| UZ Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Active, not recruiting |
| Centre Hospitalier Universitaire de Liège Coordinator of this site? Confirm its status | Liège | Belgium | Active, not recruiting |
| - Coordinator of this site? Confirm its status | Grodno | Belarus | Unknown status |
| - Coordinator of this site? Confirm its status | Minsk | Belarus | Unknown status |
| - Coordinator of this site? Confirm its status | Calgary | Canada | Unknown status |
| - Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| - Coordinator of this site? Confirm its status | Ottawa | Canada | Unknown status |
| - Coordinator of this site? Confirm its status | Québec | Canada | Unknown status |
| - Coordinator of this site? Confirm its status | Sault Ste. Marie | Canada | Unknown status |
| - Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| - Coordinator of this site? Confirm its status | Winnipeg | Canada | Unknown status |
| Fakultni Nemocnice Brno Coordinator of this site? Confirm its status | Brno-Stred | Czechia | Active, not recruiting |
| Vseobecna fakultni nemocnice v Praze Coordinator of this site? Confirm its status | Prague | Czechia | Active, not recruiting |
| Hochtaunus-Kliniken gGmbH Coordinator of this site? Confirm its status | Bad Homburg | Germany | Active, not recruiting |
| Universitaetsklinikum Schleswig-Holstein AöR Coordinator of this site? Confirm its status | Kiel | Germany | Active, not recruiting |
| MVZ fuer Haematologie und Onkologie Ravensburg GmbH Coordinator of this site? Confirm its status | Ravensburg | Germany | Active, not recruiting |
| Aalborg University Hospital Coordinator of this site? Confirm its status | Aalborg | Denmark | Active, not recruiting |
| Rigshospitalet Coordinator of this site? Confirm its status | Copenhagen Oe | Denmark | Active, not recruiting |
| Region Hovedstaden Coordinator of this site? Confirm its status | Herlev | Denmark | Active, not recruiting |
| Odense University Hospital Coordinator of this site? Confirm its status | Odense C | Denmark | Active, not recruiting |
| Region Sjaelland Coordinator of this site? Confirm its status | Roskilde | Denmark | Active, not recruiting |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Completed |
| Hospital Clinic de Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Completed |
| Hospital Universitario Reina Sofia Coordinator of this site? Confirm its status | Córdoba | Spain | Completed |
| Hospital Universitario Donostia Coordinator of this site? Confirm its status | Donostia | Spain | Completed |
| Hospital Universitario 12 de Octubre Coordinator of this site? Confirm its status | Madrid | Spain | Completed |
| Hospital Universitario Virgen de la Victoria Coordinator of this site? Confirm its status | Málaga | Spain | Completed |
| Hospital Universitario Virgen De Valme Coordinator of this site? Confirm its status | Sevilla | Spain | Completed |
| Hospital Clinico Universitario de Valencia Coordinator of this site? Confirm its status | Valencia | Spain | Completed |
| Pohjois-Savon hyvinvointialue Coordinator of this site? Confirm its status | Kuopio | Finland | Active, not recruiting |
| Tampere University Hospital Coordinator of this site? Confirm its status | Tampere | Finland | Active, not recruiting |
| Turku University Hospital Coordinator of this site? Confirm its status | Turku | Finland | Active, not recruiting |
| - Coordinator of this site? Confirm its status | Brighton | United Kingdom | Unknown status |
| - Coordinator of this site? Confirm its status | Cambridge | United Kingdom | Unknown status |
| - Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| - Coordinator of this site? Confirm its status | Truro | United Kingdom | Unknown status |
| Diagnostic & Therapeutic Center Of Athens Hygeia Single Member S.A. Coordinator of this site? Confirm its status | Maroussi | Greece | Completed |
| Euromedica General Clinic of Thessaloniki Coordinator of this site? Confirm its status | Thessaloniki | Greece | Completed |
| Orszagos Onkologiai Intezet Coordinator of this site? Confirm its status | Budapest XII | Hungary | Active, not recruiting |
| University of Debrecen Coordinator of this site? Confirm its status | Debrecen | Hungary | Active, not recruiting |
| - Coordinator of this site? Confirm its status | Ashkelon | Israel | Unknown status |
| - Coordinator of this site? Confirm its status | Beersheba | Israel | Unknown status |
| - Coordinator of this site? Confirm its status | Haifa | Israel | Unknown status |
| - Coordinator of this site? Confirm its status | Jerusalem | Israel | Unknown status |
| - Coordinator of this site? Confirm its status | Petah Tikva | Israel | Unknown status |
| - Coordinator of this site? Confirm its status | Rehovot | Israel | Unknown status |
| - Coordinator of this site? Confirm its status | Tel Aviv | Israel | Unknown status |
| Istituto Di Candiolo Fondazione Del Piemonte Per Loncologia IRCCS Coordinator of this site? Confirm its status | Candiolo | Italy | Active, not recruiting |
| Fondazione IRCCS - Istituto Nazionale dei Tumori Coordinator of this site? Confirm its status | Milan | Italy | Active, not recruiting |
| Azienda Sanitaria Locale Della Provincia Di Biella Coordinator of this site? Confirm its status | Ponderano | Italy | Active, not recruiting |
| I.F.O. Istituti Fisioterapici Ospitalieri Coordinator of this site? Confirm its status | Rome | Italy | Active, not recruiting |
| Fondazione Policlinico Universitario Campus Bio-medico In Forma A Bbreviata Fon Coordinator of this site? Confirm its status | Rome | Italy | Active, not recruiting |
| Ospedale Di Sassuolo S.p.A. Coordinator of this site? Confirm its status | Sassuolo | Italy | Active, not recruiting |
| Azienda Provinciale Per I Servizi Sanitari Coordinator of this site? Confirm its status | Trento | Italy | Active, not recruiting |
| Azienda Sanitaria Universitaria Friuli Centrale Coordinator of this site? Confirm its status | Udine | Italy | Active, not recruiting |
| Amsterdam UMC Stichting Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Active, not recruiting |
| Catharina Ziekenhuis Stichting Coordinator of this site? Confirm its status | Eindhoven | Netherlands | Active, not recruiting |
| Academisch Ziekenhuis Maastricht Coordinator of this site? Confirm its status | Maastricht | Netherlands | Active, not recruiting |
| Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC) Coordinator of this site? Confirm its status | Rotterdam | Netherlands | Active, not recruiting |
| Helse Bergen HF Coordinator of this site? Confirm its status | Bergen | Norway | Active, not recruiting |
| Oslo University Hospital HF Coordinator of this site? Confirm its status | Oslo | Norway | Active, not recruiting |
| Universitetssykehuset Nord-Norge HF Coordinator of this site? Confirm its status | Tromsoe | Norway | Active, not recruiting |
| St. Olavs hospital HF Coordinator of this site? Confirm its status | Trondheim | Norway | Active, not recruiting |
| Bialostockie Centrum Onkologii im Marii Sklodowskiej Curie w Bialymstoku Coordinator of this site? Confirm its status | Bialystok | Poland | Completed |
| Uniwersytecki Szpital Kliniczny Nr 2 PUM w Szczecinie Coordinator of this site? Confirm its status | Szczecin | Poland | Completed |
| Karolinska University Hospital Coordinator of this site? Confirm its status | Solna | Sweden | Active, not recruiting |
| Uppsala University Hospital Coordinator of this site? Confirm its status | Uppsala | Sweden | Active, not recruiting |
| - Coordinator of this site? Confirm its status | Chernihiv | Ukraine | Unknown status |
| - Coordinator of this site? Confirm its status | Kharkiv | Ukraine | Unknown status |
| - Coordinator of this site? Confirm its status | Albany | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Albuquerque | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Augusta | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Austin | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Charlotte | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Charlottesville | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Cincinnati | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Cleveland | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Columbus | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Covington | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Deerfield Beach | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Detroit | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Durham | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Fort Wayne | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Hilliard | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Hinsdale | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Indianapolis | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Iowa City | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Jacksonville | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Kernersville | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Knoxville | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Lebanon | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Lexington | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Mineola | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Mount Airy | United States | Unknown status |
| - Coordinator of this site? Confirm its status | New Orleans | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Newport Beach | United States | Unknown status |
| - Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Orlando | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Palo Alto | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Phoenix | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Pittsburgh | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Providence | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Rio Rancho | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Roanoke | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Savannah | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Scottsdale | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Seattle | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Shreveport | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Springfield | United States | Unknown status |
| - Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
| - Coordinator of this site? Confirm its status | The Bronx | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Tucson | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Tulsa | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Willow Grove | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Winston-Salem | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Zion | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Adapazarı | Turkey (Türkiye) | Unknown status |
| - Coordinator of this site? Confirm its status | Ankara | Turkey (Türkiye) | Unknown status |
| - Coordinator of this site? Confirm its status | Istanbul | Turkey (Türkiye) | Unknown status |
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This page is information, not medical advice. Discuss any trial with your doctor.