A Study to Evaluate Dostarlimab Plus Carboplatin-paclitaxel Versus Placebo Plus Carboplatin-paclitaxel in Participants With Recurrent or Primary Advanced Endometrial Cancer
RUBY
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)
5 other identifiers
interventional
785
19 countries
166
Brief 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 plus niraparib versus placebo plus carboplatin-paclitaxel followed by placebo in participants with recurrent or primary advanced (Stage III or IV) endometrial cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jul 2019
Longer than P75 for phase_3
166 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 31, 2019
CompletedFirst Posted
Study publicly available on registry
June 11, 2019
CompletedStudy Start
First participant enrolled
July 18, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 26, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 26, 2026
September 3, 2025
September 1, 2025
7.4 years
May 31, 2019
September 2, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Parts 1 and 2: Progression-Free Survival (PFS) - investigator assessment
Up to 6 years
Part 1: Overall survival
Up to 6 years
Secondary Outcomes (21)
Part 2: Overall survival
Up to 6 years
Parts 1 and 2: Progression free survival (PFS) blinded independent central review (BICR)
Up to 6 years
Parts 1 and 2: Objective response rate (ORR) - BICR and Investigator assessment
Up to 6 years
Parts 1 and 2: Duration of response (DOR) - BICR and Investigator assessment
Up to 6 years
Parts 1 and 2: Disease control rate (DCR) - BICR and Investigator assessment
Up to 6 years
- +16 more secondary outcomes
Study Arms (4)
Arm 1: Participants receiving dostarlimab + Carboplatin-paclitaxel followed by dostarlimab
ACTIVE COMPARATORArm 2: Participants receiving placebo + carboplatin-paclitaxel followed by placebo
PLACEBO COMPARATORArm 3: Participants receiving dostarlimab + carboplatin-paclitaxel followed by dostarlimab+niraparib
ACTIVE COMPARATORArm 4: Participants receiving placebo + carboplatin-paclitaxel followed by placebo
PLACEBO COMPARATORInterventions
Participants will be administered dostarlimab
Participants will be administered placebo matching dostarlimab
Participants will be administered carboplatin
Participants will be administered paclitaxel
Participants will be administered niraparib
Participants will be administered placebo matching Niraparib
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
- 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:
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tesaro, Inc.lead
- European Network of Gynaecological Oncological Trial Groups (ENGOT)collaborator
- GOG Foundationcollaborator
Study Sites (169)
GSK Investigational Site
Phoenix, Arizona, 85016, United States
GSK Investigational Site
Scottsdale, Arizona, 85016, United States
GSK Investigational Site
Tucson, Arizona, 85704, United States
GSK Investigational Site
Tucson, Arizona, 85710, United States
GSK Investigational Site
Newport Beach, California, 92663, United States
GSK Investigational Site
Palo Alto, California, 94304, United States
GSK Investigational Site
Deerfield Beach, Florida, 33442, United States
GSK Investigational Site
Jacksonville, Florida, 32207, United States
GSK Investigational Site
Miami, Florida, 33136, United States
GSK Investigational Site
Miami, Florida, 33176, United States
GSK Investigational Site
Orlando, Florida, 32804, United States
GSK Investigational Site
Atlanta, Georgia, 30342, United States
GSK Investigational Site
Augusta, Georgia, 30912, United States
GSK Investigational Site
Savannah, Georgia, 31405, United States
GSK Investigational Site
Hinsdale, Illinois, 60521, United States
GSK Investigational Site
Zion, Illinois, 60099, United States
GSK Investigational Site
Fort Wayne, Indiana, 46845, United States
GSK Investigational Site
Indianapolis, Indiana, 46202, United States
GSK Investigational Site
Indianapolis, Indiana, 46260, United States
GSK Investigational Site
Iowa City, Iowa, 52242, United States
GSK Investigational Site
Lexington, Kentucky, 40536, United States
GSK Investigational Site
Covington, Louisiana, 70433, United States
GSK Investigational Site
New Orleans, Louisiana, 70121, United States
GSK Investigational Site
Shreveport, Louisiana, 71103, United States
GSK Investigational Site
Boston, Massachusetts, 02114, United States
GSK Investigational Site
Springfield, Massachusetts, 01199, United States
GSK Investigational Site
Detroit, Michigan, 48201, United States
GSK Investigational Site
St Louis, Missouri, 63108, United States
GSK Investigational Site
Lebanon, New Hampshire, 03756, United States
GSK Investigational Site
Albuquerque, New Mexico, 87131, United States
GSK Investigational Site
Rio Rancho, New Mexico, 87124, United States
GSK Investigational Site
Albany, New York, 12208, United States
GSK Investigational Site
Mineola, New York, 10016, United States
GSK Investigational Site
New York, New York, 10016, United States
GSK Investigational Site
The Bronx, New York, 10461, United States
GSK Investigational Site
Charlotte, North Carolina, 28204, United States
GSK Investigational Site
Durham, North Carolina, 27710, United States
GSK Investigational Site
Kernersville, North Carolina, 27284, United States
GSK Investigational Site
Mount Airy, North Carolina, 27030, United States
GSK Investigational Site
Winston-Salem, North Carolina, 27103, United States
GSK Investigational Site
Cincinnati, Ohio, 45219, United States
GSK Investigational Site
Cincinnati, Ohio, 45220, United States
GSK Investigational Site
Cleveland, Ohio, 44106, United States
GSK Investigational Site
Columbus, Ohio, 43210, United States
GSK Investigational Site
Hilliard, Ohio, 43026, United States
GSK Investigational Site
Hilliard, Ohio, 43210, United States
GSK Investigational Site
Tulsa, Oklahoma, 74146, United States
GSK Investigational Site
Philadelphia, Pennsylvania, 19111, United States
GSK Investigational Site
Pittsburgh, Pennsylvania, 15224, United States
GSK Investigational Site
Willow Grove, Pennsylvania, 19090, United States
GSK Investigational Site
Providence, Rhode Island, 02905, United States
GSK Investigational Site
Knoxville, Tennessee, 37920, United States
GSK Investigational Site
Austin, Texas, 78731, United States
GSK Investigational Site
Austin, Texas, 78758, United States
GSK Investigational Site
Dallas, Texas, 75246, United States
GSK Investigational Site
Dallas, Texas, 76104, United States
GSK Investigational Site
Charlottesville, Virginia, 22903, United States
GSK Investigational Site
Roanoke, Virginia, 24016, United States
GSK Investigational Site
Seattle, Washington, 98109, United States
GSK Investigational Site
Grodno, 230030, Belarus
GSK Investigational Site
Minsk, 223040, Belarus
GSK Investigational Site
Aalst, 9300, Belgium
GSK Investigational Site
Leuven, 3000, Belgium
GSK Investigational Site
Liège, 4000, Belgium
GSK Investigational Site
Calgary, Alberta, T2N 5G2, Canada
GSK Investigational Site
Winnipeg, Manitoba, R3E 0V9, Canada
GSK Investigational Site
Ottawa, Ontario, K1H 8L6, Canada
GSK Investigational Site
Sault Ste. Marie, Ontario, P6B 0A8, Canada
GSK Investigational Site
Toronto, Ontario, M5G 2M9, Canada
GSK Investigational Site
Montreal, Quebec, H2X 3E4, Canada
GSK Investigational Site
Montreal, Quebec, H4A 3J1, Canada
GSK Investigational Site
Québec, Quebec, G1J 1Z4, Canada
GSK Investigational Site
Brno, 625 00, Czechia
GSK Investigational Site
Prague, 128 51, Czechia
GSK Investigational Site
Aalborg, 9000, Denmark
GSK Investigational Site
Copenhagen, DK-2100, Denmark
GSK Investigational Site
Herlev, 2730, Denmark
GSK Investigational Site
Odense C, 5000, Denmark
GSK Investigational Site
Roskilde, 4000, Denmark
GSK Investigational Site
Kuopio, 70210, Finland
GSK Investigational Site
Tampere, 33520, Finland
GSK Investigational Site
Turku, 20520, Finland
GSK Investigational Site
Amberg, 92224, Germany
GSK Investigational Site
Bad Homburg, 61352, Germany
GSK Investigational Site
Cologne, 50935, Germany
GSK Investigational Site
Dessau, 06847, Germany
GSK Investigational Site
Dresden, 01307, Germany
GSK Investigational Site
Essen, 45136, Germany
GSK Investigational Site
Essen, 45147, Germany
GSK Investigational Site
Frankfurt, 20259, Germany
GSK Investigational Site
Giessen, 35392, Germany
GSK Investigational Site
Hamburg, 20246, Germany
GSK Investigational Site
Hanover, 30177, Germany
GSK Investigational Site
Jena, 07747, Germany
GSK Investigational Site
Karlsruhe, 76135, Germany
GSK Investigational Site
Kiel, 24105, Germany
GSK Investigational Site
Lübeck, 23538, Germany
GSK Investigational Site
Mainz, 55131, Germany
GSK Investigational Site
München, 81675, Germany
GSK Investigational Site
Offenbach, 63069, Germany
GSK Investigational Site
Ravensburg, 88212, Germany
GSK Investigational Site
Rosenheim, 83022, Germany
GSK Investigational Site
Tübingen, 72076, Germany
GSK Investigational Site
Ulm, 89075, Germany
GSK Investigational Site
Wiesbaden, 65189, Germany
GSK Investigational Site
Marousi, 151 23, Greece
GSK Investigational Site
Thessaloniki, 54645, Greece
GSK Investigational Site
Budapest, 1122, Hungary
GSK Investigational Site
Debrecen, 4032, Hungary
GSK Investigational Site
Ashkelon, 78278, Israel
GSK Investigational Site
Beersheba, 8410101, Israel
GSK Investigational Site
Haifa, 3436212, Israel
GSK Investigational Site
Jerusalem, 9112001, Israel
GSK Investigational Site
Petah Tikva, 4941492, Israel
GSK Investigational Site
Rehovot, 7661041, Israel
GSK Investigational Site
Tel Aviv, 6423906, Israel
GSK Investigational Site
Candiolo, 10060, Italy
GSK Investigational Site
Carpi MO, 41012, Italy
GSK Investigational Site
Lecce, 73100, Italy
GSK Investigational Site
Milan, 20133, Italy
GSK Investigational Site
Naples, 00144, Italy
GSK Investigational Site
Ponderano BI, 13875, Italy
GSK Investigational Site
Rome, 00128, Italy
GSK Investigational Site
Sassuolo, 41049, Italy
GSK Investigational Site
Trento, 38122, Italy
GSK Investigational Site
Udine, 33100, Italy
GSK Investigational Site
Amsterdam, 1105 AZ, Netherlands
GSK Investigational Site
Eindhoven, 5623 EJ, Netherlands
GSK Investigational Site
Enschede, 7512 KZ, Netherlands
GSK Investigational Site
Groningen, 9713 GZ, Netherlands
GSK Investigational Site
Maastricht, 6229 HX, Netherlands
GSK Investigational Site
Rotterdam, 3015 GD, Netherlands
GSK Investigational Site
Bergen, 5053, Norway
GSK Investigational Site
Oslo, 0379, Norway
GSK Investigational Site
Stavanger, 4011, Norway
GSK Investigational Site
Troms, 9019, Norway
GSK Investigational Site
Trondheim, 7006, Norway
GSK Investigational Site
Bialystok, 15-027, Poland
GSK Investigational Site
Gdynia, 81-519, Poland
GSK Investigational Site
Lodz, 93-513, Poland
GSK Investigational Site
Olsztyn, 10-228, Poland
GSK Investigational Site
Poznan, 60-569, Poland
GSK Investigational Site
Szczecin, 70-111, Poland
GSK Investigational Site
Warsaw, 04-141, Poland
GSK Investigational Site
Barcelona, 08035, Spain
GSK Investigational Site
Barcelona, 08036, Spain
GSK Investigational Site
Donostia / San Sebastian, 20014, Spain
GSK Investigational Site
Madrid, 28027, Spain
GSK Investigational Site
Madrid, 28041, Spain
GSK Investigational Site
Málaga, 29010, Spain
GSK Investigational Site
Málaga, 41014, Spain
GSK Investigational Site
Murcia, 14004, Spain
GSK Investigational Site
Valencia, 46010, Spain
GSK Investigational Site
Linköping, SE-581 85, Sweden
GSK Investigational Site
Lund, 222 42, Sweden
GSK Investigational Site
Stockholm, SE-171 76, Sweden
GSK Investigational Site
Uppsala, 751 85, Sweden
GSK Investigational Site
Adapazarı, 54290, Turkey (Türkiye)
GSK Investigational Site
Ankara, 06230, Turkey (Türkiye)
GSK Investigational Site
Istanbul, 34093, Turkey (Türkiye)
GSK Investigational Site
Istanbul, 34098, Turkey (Türkiye)
GSK Investigational Site
Istanbul, 34147, Turkey (Türkiye)
GSK Investigational Site
Chernihiv, 14029, Ukraine
GSK Investigational Site
Kharkiv, 61024, Ukraine
GSK Investigational Site
Brighton, BN2 5BE, United Kingdom
GSK Investigational Site
Cambridge, CB2 0QQ, United Kingdom
GSK Investigational Site
London, NW1 2PG, United Kingdom
GSK Investigational Site
London, SE1 9RT, United Kingdom
GSK Investigational Site
Truro, TR1 3LJ, United Kingdom
Related Publications (8)
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
BACKGROUNDBanerjee 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.
PMID: 39581729DERIVEDAuranen 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.
PMID: 39346117DERIVEDValabrega 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.
PMID: 39322611DERIVEDMirza 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.
PMID: 38990090DERIVEDYou 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.
PMID: 37731489DERIVEDMorton 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.
PMID: 37411031DERIVEDMirza 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.
PMID: 36972026DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- The participant, Investigator, study staff, and the Sponsor study team and its representatives will be blinded to the assigned treatment.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 31, 2019
First Posted
June 11, 2019
Study Start
July 18, 2019
Primary Completion (Estimated)
November 26, 2026
Study Completion (Estimated)
November 26, 2026
Last Updated
September 3, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
- Access Criteria
- Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.
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/