AzTrials
AzTrials

NeoplasmsPhase 3RUBYNCT03981796

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 study testing Dostarlimab, Carboplatin and Paclitaxel in people with Neoplasms, run by Tesaro, Inc. at 169 sites in 20 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Neoplasms
What is being tested?
Dostarlimab, Carboplatin and Paclitaxel
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
785 participants
Where
169 sitesin 20 countries
Study dates
18 Jul 2019to 26 Nov 2026
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;
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  • 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).

Who cannot join

  • Part 1 and Part 2:
  • 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 had >1 recurrence of endometrial cancer.
  • 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.
Show all 20Show fewer
  • 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 known uncontrolled central nervous system metastases, carcinomatosis meningitis, or both.
  • 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.
  • 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 is considered a poor medical risk due to a serious, uncontrolled medical disorder, nonmalignant systemic disease, or active infection requiring systemic therapy.
  • 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 has clinically significant cardiovascular disease.
  • Participant has any known history or current diagnosis of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML).
  • Participant is at increased bleeding risk due to concurrent conditions.
  • Participant has participated in Part 1 of this study

Trial locations and contacts

169 sites in 20 countries.

169 sites in 20 countries

United States59 sites

  • GSK Investigational Site

    Albany, New York, 12208

  • GSK Investigational Site

    Albuquerque, New Mexico, 87131

  • GSK Investigational Site

    Atlanta, Georgia, 30342

  • GSK Investigational Site

    Augusta, Georgia, 30912

  • GSK Investigational Site

    Austin, Texas, 78731

  • GSK Investigational Site

    Austin, Texas, 78758

  • GSK Investigational Site

    Boston, Massachusetts, 02114

  • GSK Investigational Site

    Charlotte, North Carolina, 28204

  • GSK Investigational Site

    Charlottesville, Virginia, 22903

  • GSK Investigational Site

    Cincinnati, Ohio, 45219

  • GSK Investigational Site

    Cincinnati, Ohio, 45220

  • GSK Investigational Site

    Cleveland, Ohio, 44106

  • GSK Investigational Site

    Columbus, Ohio, 43210

  • GSK Investigational Site

    Covington, Louisiana, 70433

  • GSK Investigational Site

    Dallas, Texas, 75246

  • GSK Investigational Site

    Dallas, Texas, 76104

  • GSK Investigational Site

    Deerfield Beach, Florida, 33442

  • GSK Investigational Site

    Detroit, Michigan, 48201

  • GSK Investigational Site

    Durham, North Carolina, 27710

  • GSK Investigational Site

    Fort Wayne, Indiana, 46845

  • GSK Investigational Site

    Hilliard, Ohio, 43026

  • GSK Investigational Site

    Hilliard, Ohio, 43210

  • GSK Investigational Site

    Hinsdale, Illinois, 60521

  • GSK Investigational Site

    Indianapolis, Indiana, 46202

  • GSK Investigational Site

    Indianapolis, Indiana, 46260

  • GSK Investigational Site

    Iowa City, Iowa, 52242

  • GSK Investigational Site

    Jacksonville, Florida, 32207

  • GSK Investigational Site

    Kernersville, North Carolina, 27284

  • GSK Investigational Site

    Knoxville, Tennessee, 37920

  • GSK Investigational Site

    Lebanon, New Hampshire, 03756

  • GSK Investigational Site

    Lexington, Kentucky, 40536

  • GSK Investigational Site

    Miami, Florida, 33136

  • GSK Investigational Site

    Miami, Florida, 33176

  • GSK Investigational Site

    Mineola, New York, 10016

  • GSK Investigational Site

    Mount Airy, North Carolina, 27030

  • GSK Investigational Site

    New Orleans, Louisiana, 70121

  • GSK Investigational Site

    New York, New York, 10016

  • GSK Investigational Site

    Newport Beach, California, 92663

  • GSK Investigational Site

    Orlando, Florida, 32804

  • GSK Investigational Site

    Palo Alto, California, 94304

  • GSK Investigational Site

    Philadelphia, Pennsylvania, 19111

  • GSK Investigational Site

    Phoenix, Arizona, 85016

  • GSK Investigational Site

    Pittsburgh, Pennsylvania, 15224

  • GSK Investigational Site

    Providence, Rhode Island, 02905

  • GSK Investigational Site

    Rio Rancho, New Mexico, 87124

  • GSK Investigational Site

    Roanoke, Virginia, 24016

  • GSK Investigational Site

    Savannah, Georgia, 31405

  • GSK Investigational Site

    Scottsdale, Arizona, 85016

  • GSK Investigational Site

    Seattle, Washington, 98109

  • GSK Investigational Site

    Shreveport, Louisiana, 71103

  • GSK Investigational Site

    Springfield, Massachusetts, 01199

  • GSK Investigational Site

    St Louis, Missouri, 63108

  • GSK Investigational Site

    The Bronx, New York, 10461

  • GSK Investigational Site

    Tucson, Arizona, 85704

  • GSK Investigational Site

    Tucson, Arizona, 85710

  • GSK Investigational Site

    Tulsa, Oklahoma, 74146

  • GSK Investigational Site

    Willow Grove, Pennsylvania, 19090

  • GSK Investigational Site

    Winston-Salem, North Carolina, 27103

  • GSK Investigational Site

    Zion, Illinois, 60099

Other trials in United States

Germany23 sites

  • GSK Investigational Site

    Amberg, 92224

  • GSK Investigational Site

    Bad Homburg, 61352

  • GSK Investigational Site

    Cologne, 50935

  • GSK Investigational Site

    Dessau, 06847

  • GSK Investigational Site

    Dresden, 01307

  • GSK Investigational Site

    Essen, 45136

  • GSK Investigational Site

    Essen, 45147

  • GSK Investigational Site

    Frankfurt, 20259

  • GSK Investigational Site

    Giessen, 35392

  • GSK Investigational Site

    Hamburg, 20246

  • GSK Investigational Site

    Hanover, 30177

  • GSK Investigational Site

    Jena, 07747

  • GSK Investigational Site

    Karlsruhe, 76135

  • GSK Investigational Site

    Kiel, 24105

  • GSK Investigational Site

    Lübeck, 23538

  • GSK Investigational Site

    Mainz, 55131

  • GSK Investigational Site

    München, 81675

  • GSK Investigational Site

    Offenbach, 63069

  • GSK Investigational Site

    Ravensburg, 88212

  • GSK Investigational Site

    Rosenheim, 83022

  • GSK Investigational Site

    Tübingen, 72076

  • GSK Investigational Site

    Ulm, 89075

  • GSK Investigational Site

    Wiesbaden, 65189

Other trials in Germany

Italy10 sites

  • GSK Investigational Site

    Candiolo, 10060

  • GSK Investigational Site

    Carpi MO, 41012

  • GSK Investigational Site

    Lecce, 73100

  • GSK Investigational Site

    Milan, 20133

  • GSK Investigational Site

    Naples, 00144

  • GSK Investigational Site

    Ponderano BI, 13875

  • GSK Investigational Site

    Rome, 00128

  • GSK Investigational Site

    Sassuolo, 41049

  • GSK Investigational Site

    Trento, 38122

  • GSK Investigational Site

    Udine, 33100

Other trials in Italy

Spain9 sites

  • GSK Investigational Site

    Barcelona, 08035

  • GSK Investigational Site

    Barcelona, 08036

  • GSK Investigational Site

    Donostia / San Sebastian, 20014

  • GSK Investigational Site

    Madrid, 28027

  • GSK Investigational Site

    Madrid, 28041

  • GSK Investigational Site

    Málaga, 29010

  • GSK Investigational Site

    Málaga, 41014

  • GSK Investigational Site

    Murcia, 14004

  • GSK Investigational Site

    Valencia, 46010

Other trials in Spain

Canada8 sites

  • GSK Investigational Site

    Calgary, Alberta, T2N 5G2

  • GSK Investigational Site

    Montreal, Quebec, H2X 3E4

  • GSK Investigational Site

    Montreal, Quebec, H4A 3J1

  • GSK Investigational Site

    Ottawa, Ontario, K1H 8L6

  • GSK Investigational Site

    Québec, Quebec, G1J 1Z4

  • GSK Investigational Site

    Sault Ste. Marie, Ontario, P6B 0A8

  • GSK Investigational Site

    Toronto, Ontario, M5G 2M9

  • GSK Investigational Site

    Winnipeg, Manitoba, R3E 0V9

Other trials in Canada

Israel7 sites

  • GSK Investigational Site

    Ashkelon, 78278

  • GSK Investigational Site

    Beersheba, 8410101

  • GSK Investigational Site

    Haifa, 3436212

  • GSK Investigational Site

    Jerusalem, 9112001

  • GSK Investigational Site

    Petah Tikva, 4941492

  • GSK Investigational Site

    Rehovot, 7661041

  • GSK Investigational Site

    Tel Aviv, 6423906

Other trials in Israel

Poland7 sites

  • GSK Investigational Site

    Bialystok, 15-027

  • GSK Investigational Site

    Gdynia, 81-519

  • GSK Investigational Site

    Lodz, 93-513

  • GSK Investigational Site

    Olsztyn, 10-228

  • GSK Investigational Site

    Poznan, 60-569

  • GSK Investigational Site

    Szczecin, 70-111

  • GSK Investigational Site

    Warsaw, 04-141

Other trials in Poland

Netherlands6 sites

  • GSK Investigational Site

    Amsterdam, 1105 AZ

  • GSK Investigational Site

    Eindhoven, 5623 EJ

  • GSK Investigational Site

    Enschede, 7512 KZ

  • GSK Investigational Site

    Groningen, 9713 GZ

  • GSK Investigational Site

    Maastricht, 6229 HX

  • GSK Investigational Site

    Rotterdam, 3015 GD

Other trials in Netherlands

Denmark5 sites

  • GSK Investigational Site

    Aalborg, 9000

  • GSK Investigational Site

    Copenhagen, DK-2100

  • GSK Investigational Site

    Herlev, 2730

  • GSK Investigational Site

    Odense C, 5000

  • GSK Investigational Site

    Roskilde, 4000

Other trials in Denmark

Norway5 sites

  • GSK Investigational Site

    Bergen, 5053

  • GSK Investigational Site

    Oslo, 0379

  • GSK Investigational Site

    Stavanger, 4011

  • GSK Investigational Site

    Troms, 9019

  • GSK Investigational Site

    Trondheim, 7006

Other trials in Norway

Turkey (Türkiye)5 sites

  • GSK Investigational Site

    Adapazarı, 54290

  • GSK Investigational Site

    Ankara, 06230

  • GSK Investigational Site

    Istanbul, 34093

  • GSK Investigational Site

    Istanbul, 34098

  • GSK Investigational Site

    Istanbul, 34147

Other trials in Turkey (Türkiye)

United Kingdom5 sites

  • GSK Investigational Site

    Brighton, BN2 5BE

  • GSK Investigational Site

    Cambridge, CB2 0QQ

  • GSK Investigational Site

    London, NW1 2PG

  • GSK Investigational Site

    London, SE1 9RT

  • GSK Investigational Site

    Truro, TR1 3LJ

Other trials in United Kingdom

Sweden4 sites

  • GSK Investigational Site

    Linköping, SE-581 85

  • GSK Investigational Site

    Lund, 222 42

  • GSK Investigational Site

    Stockholm, SE-171 76

  • GSK Investigational Site

    Uppsala, 751 85

Other trials in Sweden

Belgium3 sites

  • GSK Investigational Site

    Aalst, 9300

  • GSK Investigational Site

    Leuven, 3000

  • GSK Investigational Site

    Liège, 4000

Other trials in Belgium

Finland3 sites

  • GSK Investigational Site

    Kuopio, 70210

  • GSK Investigational Site

    Tampere, 33520

  • GSK Investigational Site

    Turku, 20520

Other trials in Finland

Belarus2 sites

  • GSK Investigational Site

    Grodno, 230030

  • GSK Investigational Site

    Minsk, 223040

Other trials in Belarus

Czechia2 sites

  • GSK Investigational Site

    Brno, 625 00

  • GSK Investigational Site

    Prague, 128 51

Other trials in Czechia

Greece2 sites

  • GSK Investigational Site

    Marousi, 151 23

  • GSK Investigational Site

    Thessaloniki, 54645

Other trials in Greece

Hungary2 sites

  • GSK Investigational Site

    Budapest, 1122

  • GSK Investigational Site

    Debrecen, 4032

Other trials in Hungary

Ukraine2 sites

  • GSK Investigational Site

    Chernihiv, 14029

  • GSK Investigational Site

    Kharkiv, 61024

Other trials in Ukraine

About this study

Official title: 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)

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.

Conditions
Neoplasms
Being tested
Dostarlimab, Placebo matching dostarlimab, Carboplatin, Paclitaxel, Niraparib
Keywords
Dostarlimab, Carboplatin, Paclitaxel, Niraparib, Recurrent or primary advanced endometrial cancer, TSR-042
Medical subject headings
Neoplasms, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DostarlimabBiological

    Also called TSR-042

    Participants will be administered dostarlimab

  • Placebo matching dostarlimabDrug

    Participants will be administered placebo matching dostarlimab

  • CarboplatinDrug

    Participants will be administered carboplatin

  • PaclitaxelDrug

    Participants will be administered paclitaxel

  • NiraparibDrug

    Participants will be administered niraparib

  • Placebo matching NiraparibDrug

    Participants will be administered placebo matching Niraparib

Study groups in NCT03981796
Study groupRoleWhat they receive
Arm 1: Participants receiving dostarlimab + Carboplatin-paclitaxel followed by dostarlimabActive comparatorNot described
Receives: Biological: Dostarlimab; Drug: Carboplatin; Drug: Paclitaxel
Arm 2: Participants receiving placebo + carboplatin-paclitaxel followed by placeboPlacebo comparatorNot described
Receives: Drug: Placebo matching dostarlimab; Drug: Carboplatin; Drug: Paclitaxel
Arm 3: Participants receiving dostarlimab + carboplatin-paclitaxel followed by dostarlimab+niraparibActive comparatorNot described
Receives: Biological: Dostarlimab; Drug: Carboplatin; Drug: Paclitaxel; Drug: Niraparib
Arm 4: Participants receiving placebo + carboplatin-paclitaxel followed by placeboPlacebo comparatorNot described
Receives: Drug: Placebo matching dostarlimab; Drug: Carboplatin; Drug: Paclitaxel; Drug: Placebo matching Niraparib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Parts 1 and 2: Progression-Free Survival (PFS) - investigator assessment

    Measured: Up to 6 years

  2. Part 1: Overall survival

    Measured: Up to 6 years

Secondary outcomes (21)

  1. Part 2: Overall survival

    Measured: Up to 6 years

  2. Parts 1 and 2: Progression free survival (PFS) blinded independent central review (BICR)

    Measured: Up to 6 years

  3. Parts 1 and 2: Objective response rate (ORR) - BICR and Investigator assessment

    Measured: Up to 6 years

  4. Parts 1 and 2: Duration of response (DOR) - BICR and Investigator assessment

    Measured: Up to 6 years

  5. Parts 1 and 2: Disease control rate (DCR) - BICR and Investigator assessment

    Measured: Up to 6 years

  6. Parts 1 and 2: Patient-reported outcomes (PROs) in the European Quality of Life scale, 5-Dimensions, 5-Levels (EQ-5D-5L)

    EQ-5D-5L is a validated questionnaire to assess the overall health-related quality of life in participants across diseases.

    Measured: Up to 6 years

  7. Parts 1 and 2: PROs in the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30 [Core])

    EORTC QLQ-C30 is validated questionnaire to assess overall health-related quality of life in participants with cancer.

    Measured: Up to 6 years

  8. Parts 1 and 2: PROs in the EORTC Quality of Life Questionnaire (Endometrial Cancer Module [QLQ-EN24])

    EORTC QLQ-EN24 is a validated questionnaire to assess the overall health-related quality of life in participants with all stages of endometrial cancer.

    Measured: Up to 6 years

  9. Parts 1 and 2: Progression-free survival 2 (PFS2)

    Measured: Up to 6 years

  10. Parts 1 and 2: Number of participants with adverse events (AEs), Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs)

    Measured: Up to 6 years

  11. Parts 1 and 2: Number of participants with clinically significant changes in clinical laboratory parameters, physical examination, electrocardiogram (ECG) and participants reporting the intake of concomitant medication

    Measured: Up to 6 years

  12. Parts 1 and 2: Change from Baseline in vital sign: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) (Millimeters of mercury)

    Measured: Baseline and up to 6 Years

  13. Parts 1 and 2: Change from Baseline in vital sign: Heart Rate

    Measured: Baseline and up to 6 Years

  14. Parts 1 and 2: Change from Baseline in vital sign: Respiratory rate

    Measured: Baseline and up to 6 Years

  15. Parts 1 and 2: Change from Baseline in vital sign: Body temperature

    Measured: Baseline and up to 6 Years

  16. Parts 1 and 2: Number of participants with Eastern Cooperative Oncology Group (ECOG) Performance Status Scores

    Performance status will be assessed using the ECOG scale, with status score ranging from 0 to 5.

    Measured: Up to 6 years

  17. Parts 1 and 2: Minimum observed concentration (Cmin) and maximum observed concentration (Cmax) of dostarlimab (micrograms per milliliter)

    Measured: Predose (Day 1) and postdose (Day 1) of Cycles 1, 2, 6, 7, 10, 15, and 20 (Cycle 1, 2, 6 is 21 days and Cycle 7, 10, 15, 20 is 42 days)

  18. Parts 1 and 2: Cmin and Cmax at steady state of dostarlimab (micrograms per milliliter)

    Measured: Predose (Day 1) and postdose (Day 1) of Cycles 1, 2, 6, 7, 10, 15, and 20 (Cycle 1, 2, 6 is 21 days and Cycle 7, 10, 15, 20 is 42 days)

  19. Part 2: Cmin and Cmax of niraparib (nanograms per milliliter)

    Measured: Predose (Day 1) and 3 hours postdose (Day 1) of Cycles 7 and 8 and Predose (Day 1) of Cycles 10 and 14 (each cycle is 42 days)

  20. Part 2: Cmin and Cmax at steady state of niraparib (nanograms per milliliter)

    Measured: Predose (Day 1) and 3 hours postdose (Day 1) of Cycles 7 and 8 and Predose (Day 1) of Cycles 10 and 14 (each cycle is 42 days)

  21. Parts 1 and 2: Number of participants with anti-drug antibodies (ADA) against dostarlimab

    Measured: Predose (Day 1)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jun 2019
  2. Study start18 Jul 2019
  3. Primary completion26 Nov 2026 (estimated)
  4. Study completion26 Nov 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
785 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03981796
Sponsor's protocol ID
213361
Other IDs
ENGOT-EN6, GOG-3031, 4010-03-001, 2023-506551-23-00, 2023
Acronym
RUBY
Status last verified
Sep 2025
First submitted
31 May 2019
Last updated
3 Sep 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/

Publications

  • Mansoor R Mirza, Dana M Chase, Brian M Slomovitz, René dePont Christensen, Zoltán Novák, Destin Black, Lucy Gilbert, Sudarshan Sharma, Giorgio Valabrega, Lisa M Landrum, Lars C Hanker, Ashley Stuckey, Ingrid Boere, Michael A Gold, Annika Auranen, Bhavana Pothuri, David Cibula, Carolyn McCourt, Francesco Raspagliesi, Mark S Shahin, Sarah E Gill, Bradley J Monk, Joseph Buscema, Thomas J Herzog, Larry J Copeland, Min Tian, Zangdong He, Shadi Stevens, Eleftherios Zografos, Robert L Coleman, Matthew A Powell, . Dostarlimab for Primary Advanced or Recurrent Endometrial Cancer. The New England journal of medicine. 2023-Jun-08;388(23): 2145-2158. DOI : 10.1056/NEJMoa2216334 PMID: 36972026

  • Chen Y, Lubinga SJ, Ramsey S, Hurteau J, Reynolds J, Carlson JJ. Molecular Testing in Primary Advanced or Recurrent Endometrial Cancer: A Cost-Effectiveness Analysis. JCO Precis Oncol. 2026 Jul;10(7):e2501110. doi: 10.1200/PO-25-01110. Epub 2026 Jul 6.

    PubMed 42407008

  • Chase DM, Herrstedt J, Miller EM, Gilbert L, Zub O, Mathews C, Angioli R, Teneriello M, Gropp-Meier M, Powell MA, Reyners AKL, Cloven NG, Eminowicz G, Gill SE, Mackowiak-Matejczyk B, Pothuri B, Samouelian V, Jain A, Boone J, Bouberhan S, Trinidad J, Braly P, Buttin B, Backes FJ, Sawyer B, Antony G, Garside J, Allonby O, McCourt CK, Mirza MR. Quality-adjusted time without symptoms of disease progression or toxicity of treatment in patients with primary advanced or recurrent endometrial cancer treated with dostarlimab plus carboplatin-paclitaxel versus carboplatin-paclitaxel. Int J Gynecol Cancer. 2025 Aug;35(8):101935. doi: 10.1016/j.ijgc.2025.101935. Epub 2025 May 21.

    PubMed 40616865

  • Banerjee S, Ingles Russo Garces A, Garside J, Rahman T, Pearson C, Heffernan K. Real-world patient characteristics and survival outcomes in patients with advanced or recurrent endometrial cancer in England: a retrospective, population-based study. BMJ Open. 2024 Nov 24;14(11):e083540. doi: 10.1136/bmjopen-2023-083540.

    PubMed 39581729

  • Auranen A, Powell MA, Sukhin V, Landrum LM, Ronzino G, Buscema J, Bauerschlag D, Lalisang R, Bender D, Gilbert L, Armstrong A, Safra T, Nevadunsky N, Sebastianelli A, Slomovitz B, Ring K, Coleman R, Podzielinski I, Stuckey A, Teneriello M, Gill S, Pothuri B, Willmott L, Sharma S, Dabrowski C, Antony G, Stevens S, Mirza MR, Fleming E. Safety of dostarlimab in combination with chemotherapy in patients with primary advanced or recurrent endometrial cancer in a phase III, randomized, placebo-controlled trial (ENGOT-EN6-NSGO/GOG-3031/RUBY). Ther Adv Med Oncol. 2024 Sep 28;16:17588359241277656. doi: 10.1177/17588359241277656. eCollection 2024.

    PubMed 39346117

  • Valabrega G, Powell MA, Hietanen S, Miller EM, Novak Z, Holloway R, Denschlag D, Myers T, Thijs AM, Pennington KP, Gilbert L, Fleming E, Zub O, Landrum LM, Ataseven B, Gogoi R, Podzielinski I, Cloven N, Monk BJ, Sharma S, Herzog TJ, Stuckey A, Pothuri B, Secord AA, Chase D, Vincent V, Meyers O, Garside J, Mirza MR, Black D. Patient-reported outcomes in the subpopulation of patients with mismatch repair-deficient/microsatellite instability-high primary advanced or recurrent endometrial cancer treated with dostarlimab plus chemotherapy compared with chemotherapy alone in the ENGOT-EN6-NSGO/GOG3031/RUBY trial. Int J Gynecol Cancer. 2025 Jun;35(6):101852. doi: 10.1136/ijgc-2024-005484. Epub 2025 Apr 19.

    PubMed 39322611

  • Mirza MR, Chase DM, Slomovitz BM, Christensen RD, Novak Z, Black D, Gilbert L, Sharma S, Valabrega G, Landrum LM, Hanker LC, Stuckey A, Boere I, Gold MA, Auranen A, Pothuri B, Cibula D, McCourt C, Raspagliesi F, Shahin MS, Gill SE, Monk BJ, Buscema J, Herzog TJ, Copeland LJ, Tian M, He Z, Stevens S, Zografos E, Coleman RL, Powell MA. A Plain Language Summary of "Dostarlimab for primary advanced or recurrent endometrial cancer". Future Oncol. 2025 Jan;21(2):151-168. doi: 10.2217/fon-2023-0940. Epub 2024 Jul 11.

    PubMed 38990090

  • Bogani G, Monk BJ, Powell MA, Westin SN, Slomovitz B, Moore KN, Eskander RN, Raspagliesi F, Barretina-Ginesta MP, Colombo N, Mirza MR. Adding immunotherapy to first-line treatment of advanced and metastatic endometrial cancer. Ann Oncol. 2024 May;35(5):414-428. doi: 10.1016/j.annonc.2024.02.006. Epub 2024 Feb 29.

    PubMed 38431043

  • You M, Zeng X, Zhang J, Huang Y, Zhang Y, Cai Z, Hu Y. Cost-effectiveness analysis of dostarlimab plus carboplatin-paclitaxel as first-line treatment for advanced endometrial cancer. Front Immunol. 2023 Sep 4;14:1267322. doi: 10.3389/fimmu.2023.1267322. eCollection 2023.

    PubMed 37731489

  • Morton M, Marcu I, Levine M, Cosgrove C, Backes F, O'Malley D, Chambers L. Evaluation of Efficacy and Adverse Events After Second Immunotherapy Exposure in Endometrial and Cervical Carcinoma. Obstet Gynecol. 2023 Aug 1;142(2):360-363. doi: 10.1097/AOG.0000000000005243. Epub 2023 Jul 5.

    PubMed 37411031

  • Mirza MR, Chase DM, Slomovitz BM, dePont Christensen R, Novak Z, Black D, Gilbert L, Sharma S, Valabrega G, Landrum LM, Hanker LC, Stuckey A, Boere I, Gold MA, Auranen A, Pothuri B, Cibula D, McCourt C, Raspagliesi F, Shahin MS, Gill SE, Monk BJ, Buscema J, Herzog TJ, Copeland LJ, Tian M, He Z, Stevens S, Zografos E, Coleman RL, Powell MA; RUBY Investigators. Dostarlimab for Primary Advanced or Recurrent Endometrial Cancer. N Engl J Med. 2023 Jun 8;388(23):2145-2158. doi: 10.1056/NEJMoa2216334. Epub 2023 Mar 27.

    PubMed 36972026

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Dostarlimab, Carboplatin and Paclitaxel in people with Neoplasms, run by Tesaro, Inc. at 169 sites in 20 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 3 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 169 sites in United States, Germany, Italy, Spain, Canada and 15 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Parts 1 and 2: Progression-Free Survival (PFS) - investigator assessment (time frame: Up to 6 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03981796, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2025.

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