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)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Neoplasms
• Intervention / Treatment: Biological: Dostarlimab; Drug: Carboplatin; Drug: Paclitaxel; Drug: Placebo matching dostarlimab; Drug: Niraparib; Drug: Placebo matching Niraparib

• Study Type: Interventional
• Enrollment (Actual): 787
• Phase: Phase 3

Contacts and Locations

Study Locations

• Belarus
  • Grodno, Belarus, 230030
    • GSK Investigational Site
  • Minsk, Belarus, 223040
    • GSK Investigational Site
• Belgium
  • Aalst, Belgium, 9300
    • GSK Investigational Site
  • Leuven, Belgium, 3000
    • GSK Investigational Site
  • Liège, Belgium, 4000
    • GSK Investigational Site
• Canada
  • Quebec, Canada, G1R 2J6
    • GSK Investigational Site
  • Alberta
    • Calgary, Alberta, Canada, T2N 4N2
      • GSK Investigational Site
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3E 0V9
      • GSK Investigational Site
  • Ontario
    • Ottawa, Ontario, Canada, K1H 8L6
      • GSK Investigational Site
    • Sault Ste. Marie, Ontario, Canada, P6B 0A8
      • GSK Investigational Site
    • Toronto, Ontario, Canada, M5G 2M9
      • GSK Investigational Site
  • Quebec
    • Montreal, Quebec, Canada, H4A 3J1
      • GSK Investigational Site
    • Montréal, Quebec, Canada, H2X 3E4
      • GSK Investigational Site
• Czechia
  • Brno, Czechia, 625 00
    • GSK Investigational Site
  • Prague, Czechia, 128 00
    • GSK Investigational Site
• Denmark
  • Aalborg, Denmark, 9100
    • GSK Investigational Site
  • Copenhagen, Denmark, DK-2100
    • GSK Investigational Site
  • Dk-2730 Herlev, Denmark, 2730
    • GSK Investigational Site
  • Odense, Denmark, 5000
    • GSK Investigational Site
• Finland
  • Kuopio, Finland, 70210
    • GSK Investigational Site
  • Tampere, Finland, 33520
    • GSK Investigational Site
  • Turku, Finland, 20520
    • GSK Investigational Site
• Germany
  • Hamburg, Germany, 20246
    • GSK Investigational Site
  • Hamburg, Germany, 20259
    • GSK Investigational Site
  • Baden-Wuerttemberg
    • Karlsruhe, Baden-Wuerttemberg, Germany, 76135
      • GSK Investigational Site
    • Ravensburg, Baden-Wuerttemberg, Germany, 88212
      • GSK Investigational Site
    • Tuebingen, Baden-Wuerttemberg, Germany, 72076
      • GSK Investigational Site
    • Ulm, Baden-Wuerttemberg, Germany, 89075
      • GSK Investigational Site
  • Bayern
    • Amberg, Bayern, Germany, 92224
      • GSK Investigational Site
    • Muenchen, Bayern, Germany, 81675
      • GSK Investigational Site
    • Rosenheim, Bayern, Germany, 83022
      • GSK Investigational Site
  • Hessen
    • Bad Homburg, Hessen, Germany, 61352
      • GSK Investigational Site
    • Giessen, Hessen, Germany, 35385
      • GSK Investigational Site
    • Offenbach, Hessen, Germany, 63069
      • GSK Investigational Site
    • Wiesbaden, Hessen, Germany, 65189
      • GSK Investigational Site
  • Niedersachsen
    • Hannover, Niedersachsen, Germany, 30177
      • GSK Investigational Site
  • Nordrhein-Westfalen
    • Essen, Nordrhein-Westfalen, Germany, 45136
      • GSK Investigational Site
    • Essen, Nordrhein-Westfalen, Germany, 45147
      • GSK Investigational Site
    • Koeln, Nordrhein-Westfalen, Germany, 50935
      • GSK Investigational Site
  • Rheinland-Pfalz
    • Mainz, Rheinland-Pfalz, Germany, 55131
      • GSK Investigational Site
  • Sachsen
    • Dresden, Sachsen, Germany, 01307
      • GSK Investigational Site
  • Sachsen-Anhalt
    • Dessau, Sachsen-Anhalt, Germany, 06847
      • GSK Investigational Site
  • Schleswig-Holstein
    • Kiel, Schleswig-Holstein, Germany, 24105
      • GSK Investigational Site
    • Luebeck, Schleswig-Holstein, Germany, 23538
      • GSK Investigational Site
  • Thueringen
    • Jena, Thueringen, Germany, 07747
      • GSK Investigational Site
• Greece
  • Athens, Greece, 115 22
    • GSK Investigational Site
  • Thessaloniki, Greece, 54645
    • GSK Investigational Site
• Hungary
  • Budapest, Hungary, 1122
    • GSK Investigational Site
  • Debrecen, Hungary, 4032
    • GSK Investigational Site
• Israel
  • Ashkelon, Israel, 78278
    • GSK Investigational Site
  • Beer Sheva, Israel, 84101
    • GSK Investigational Site
  • Haifa, Israel, 3436212
    • GSK Investigational Site
  • Jerusalem, Israel, 91120
    • GSK Investigational Site
  • Petach Tikva, Israel, 4941492
    • GSK Investigational Site
  • Rehovot, Israel, 76100
    • GSK Investigational Site
  • Tel Aviv, Israel, 64239
    • GSK Investigational Site
• Italy
  • Ponderano, Italy, 13875
    • GSK Investigational Site
  • Emilia-Romagna
    • Carpi (MO), Emilia-Romagna, Italy, 41012
      • GSK Investigational Site
    • Sassuolo, Emilia-Romagna, Italy, 41049
      • GSK Investigational Site
  • Friuli-Venezia-Giulia
    • Udine, Friuli-Venezia-Giulia, Italy, 33100
      • GSK Investigational Site
  • Lazio
    • Roma, Lazio, Italy, 00128
      • GSK Investigational Site
    • Roma, Lazio, Italy, 00144
      • GSK Investigational Site
  • Lombardia
    • Milano, Lombardia, Italy, 20133
      • GSK Investigational Site
  • Piemonte
    • Candiolo, Piemonte, Italy, 10060
      • GSK Investigational Site
  • Puglia
    • Lecce, Puglia, Italy, 73100
      • GSK Investigational Site
  • Trentino-Alto Adige
    • Trento, Trentino-Alto Adige, Italy, 38122
      • GSK Investigational Site
• Netherlands
  • Amsterdam, Netherlands, 1105 AZ
    • GSK Investigational Site
  • Eindhoven, Netherlands, 5623 EJ
    • GSK Investigational Site
  • Enschede, Netherlands, 7512 KZ
    • GSK Investigational Site
  • Groningen, Netherlands, 9713 GZ
    • GSK Investigational Site
  • Maastricht, Netherlands, 6229 HX
    • GSK Investigational Site
  • Rotterdam, Netherlands, 3015 GD
    • GSK Investigational Site
• Norway
  • Bergen, Norway, 5021
    • GSK Investigational Site
  • Oslo, Norway, 0310
    • GSK Investigational Site
  • Stavanger, Norway, 4011
    • GSK Investigational Site
  • Tromso, Norway, 9019
    • GSK Investigational Site
  • Trondheim, Norway, 7006
    • GSK Investigational Site
• Poland
  • Bialystok, Poland, 15-207
    • GSK Investigational Site
  • Gdynia, Poland, 81-519
    • GSK Investigational Site
  • Lodz, Poland, 93-513
    • GSK Investigational Site
  • Olsztyn, Poland, 10-228
    • GSK Investigational Site
  • Poznan, Poland, 60-569
    • GSK Investigational Site
  • Szczecin, Poland, 70-111
    • GSK Investigational Site
  • Warszawa, Poland, 00-909
    • GSK Investigational Site
• Spain
  • Barcelona, Spain, 08036
    • GSK Investigational Site
  • Barcelona, Spain, 8035
    • GSK Investigational Site
  • Cordoba, Spain, 14004
    • GSK Investigational Site
  • Madrid, Spain, 28041
    • GSK Investigational Site
  • Málaga, Spain, 29010
    • GSK Investigational Site
  • San Sebastián, Spain, 20014
    • GSK Investigational Site
  • Sevilla, Spain, 41014
    • GSK Investigational Site
  • Valencia, Spain, 46010
    • GSK Investigational Site
  • Navarra
    • Madrid, Navarra, Spain, 28027
      • GSK Investigational Site
• Sweden
  • Linköping, Sweden, SE-581 85
    • GSK Investigational Site
  • Lund, Sweden, 222 42
    • GSK Investigational Site
  • Stockholm, Sweden, SE-171 76
    • GSK Investigational Site
  • Uppsala, Sweden, SE-751 85
    • GSK Investigational Site
• Turkey
  • Adapazari, Turkey, 54290
    • GSK Investigational Site
  • Ankara, Turkey, 06230
    • GSK Investigational Site
  • Istanbul, Turkey, 34093
    • GSK Investigational Site
  • Istanbul, Turkey, 34098
    • GSK Investigational Site
  • Istanbul, Turkey, 34147
    • GSK Investigational Site
• Ukraine
  • Chernihiv, Ukraine, 14029
    • GSK Investigational Site
  • Kharkiv, Ukraine, 61024
    • GSK Investigational Site
• United Kingdom
  • Brighton, United Kingdom, BN2 5BE
    • GSK Investigational Site
  • Cambridge, United Kingdom, CB2 0QQ
    • GSK Investigational Site
  • London, United Kingdom, SE1 9RT
    • GSK Investigational Site
  • London, United Kingdom, NW1 2PG
    • GSK Investigational Site
  • Cornwall
    • Truro, Cornwall, United Kingdom, TR1 3LJ
      • GSK Investigational Site
• United States
  • Arizona
    • Mesa, Arizona, United States, 85284
      • GSK Investigational Site
    • Phoenix, Arizona, United States, 85016
      • GSK Investigational Site
    • Tucson, Arizona, United States, 85704
      • GSK Investigational Site
    • Tucson, Arizona, United States, 85710
      • GSK Investigational Site
  • California
    • Newport Beach, California, United States, 92663
      • GSK Investigational Site
    • Palo Alto, California, United States, 94304
      • GSK Investigational Site
  • Florida
    • Deerfield Beach, Florida, United States, 33442
      • GSK Investigational Site
    • Jacksonville, Florida, United States, 32207
      • GSK Investigational Site
    • Miami, Florida, United States, 33136
      • GSK Investigational Site
    • Miami, Florida, United States, 33176
      • GSK Investigational Site
    • Orlando, Florida, United States, 32804
      • GSK Investigational Site
  • Georgia
    • Augusta, Georgia, United States, 30912
      • GSK Investigational Site
    • Savannah, Georgia, United States, 31405
      • GSK Investigational Site
  • Illinois
    • Hinsdale, Illinois, United States, 60521
      • GSK Investigational Site
    • Zion, Illinois, United States, 60099
      • GSK Investigational Site
  • Indiana
    • Fort Wayne, Indiana, United States, 46845
      • GSK Investigational Site
    • Indianapolis, Indiana, United States, 46260
      • GSK Investigational Site
  • Iowa
    • Iowa City, Iowa, United States, 52242-1009
      • GSK Investigational Site
  • Kentucky
    • Lexington, Kentucky, United States, 40536
      • GSK Investigational Site
  • Louisiana
    • Covington, Louisiana, United States, 70433
      • GSK Investigational Site
    • New Orleans, Louisiana, United States, 70121
      • GSK Investigational Site
    • Shreveport, Louisiana, United States, 71103
      • GSK Investigational Site
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • GSK Investigational Site
    • Springfield, Massachusetts, United States, 01199
      • GSK Investigational Site
  • Michigan
    • Detroit, Michigan, United States, 48201
      • GSK Investigational Site
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • GSK Investigational Site
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • GSK Investigational Site
  • New Mexico
    • Albuquerque, New Mexico, United States, 87131
      • GSK Investigational Site
    • Rio Rancho, New Mexico, United States, 87124
      • GSK Investigational Site
  • New York
    • Albany, New York, United States, 12208
      • GSK Investigational Site
    • Bronx, New York, United States, 10461
      • GSK Investigational Site
    • New York, New York, United States, 10016
      • GSK Investigational Site
  • North Carolina
    • Charlotte, North Carolina, United States, 28204
      • GSK Investigational Site
    • Durham, North Carolina, United States, 27710
      • GSK Investigational Site
    • Kernersville, North Carolina, United States, 27284
      • GSK Investigational Site
    • Mount Airy, North Carolina, United States, 27030
      • GSK Investigational Site
    • Winston-Salem, North Carolina, United States, 27103
      • GSK Investigational Site
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • GSK Investigational Site
    • Cincinnati, Ohio, United States, 45220
      • GSK Investigational Site
    • Cleveland, Ohio, United States, 44106
      • GSK Investigational Site
    • Columbus, Ohio, United States, 43210
      • GSK Investigational Site
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • GSK Investigational Site
    • Tulsa, Oklahoma, United States, 74146
      • GSK Investigational Site
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19111
      • GSK Investigational Site
    • Pittsburgh, Pennsylvania, United States, 15224
      • GSK Investigational Site
    • Willow Grove, Pennsylvania, United States, 19090
      • GSK Investigational Site
  • Rhode Island
    • Providence, Rhode Island, United States, 02905
      • GSK Investigational Site
  • Tennessee
    • Knoxville, Tennessee, United States, 37920
      • GSK Investigational Site
  • Texas
    • Austin, Texas, United States, 78731
      • GSK Investigational Site
    • Dallas, Texas, United States, 75246
      • GSK Investigational Site
    • Fort Worth, Texas, United States, 76104
      • GSK Investigational Site
  • Virginia
    • Charlottesville, Virginia, United States, 22903
      • GSK Investigational Site
    • Roanoke, Virginia, United States, 24016
      • GSK Investigational Site
  • Washington
    • Seattle, Washington, United States, 98109
      • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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;

  1. 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;
  2. 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;
  3. Participant has primary Stage IIIC2 or Stage IV disease regardless of the presence of evaluable or measurable disease;
  4. Participant has first recurrent disease and is naïve to systemic anticancer therapy;
  5. 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).

Exclusion Criteria:

Part 1 and Part 2:

• Participant has received neo-adjuvant/adjuvant systemic anticancer therapy for primary Stage III or IV disease and:

  1. has not had a recurrence or PD prior to first dose on the study OR
  2. 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:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Arm 1: Participants receiving dostarlimab + Carboplatin-paclitaxel followed by dostarlimab	Biological: Dostarlimab; Participants will be administered dostarlimab; Other Names: TSR-042; Drug: Carboplatin; Participants will be administered carboplatin; Drug: Paclitaxel; Participants will be administered paclitaxel
Placebo Comparator: Arm 2: Participants receiving placebo + carboplatin-paclitaxel followed by placebo	Drug: Carboplatin; Participants will be administered carboplatin; Drug: Paclitaxel; Participants will be administered paclitaxel; Drug: Placebo matching dostarlimab; Participants will be administered placebo matching dostarlimab
Active Comparator: Arm 3: Participants receiving dostarlimab + carboplatin-paclitaxel followed by dostarlimab+niraparib	Biological: Dostarlimab; Participants will be administered dostarlimab; Other Names: TSR-042; Drug: Carboplatin; Participants will be administered carboplatin; Drug: Paclitaxel; Participants will be administered paclitaxel; Drug: Niraparib; Participants will be administered niraparib
Placebo Comparator: Arm 4: Participants receiving placebo + carboplatin-paclitaxel followed by placebo	Drug: Carboplatin; Participants will be administered carboplatin; Drug: Paclitaxel; Participants will be administered paclitaxel; Drug: Placebo matching dostarlimab; Participants will be administered placebo matching dostarlimab; Drug: Placebo matching Niraparib; Participants will be administered placebo matching Niraparib

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Parts 1 and 2: Progression-Free Survival (PFS) - investigator assessment	Up to 6 years
Part 1: Overall survival	Up to 6 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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.	Up to 6 years
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.	Up to 6 years
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.	Up to 6 years
Parts 1 and 2: Progression-free survival 2 (PFS2)		Up to 6 years
Parts 1 and 2: Number of participants with adverse events (AEs), Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs)		Up to 6 years
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		Up to 6 years
Parts 1 and 2: Change from Baseline in vital sign: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) (Millimeters of mercury)		Baseline and up to 6 Years
Parts 1 and 2: Change from Baseline in vital sign: Heart Rate		Baseline and up to 6 Years
Parts 1 and 2: Change from Baseline in vital sign: Respiratory rate		Baseline and up to 6 Years
Parts 1 and 2: Change from Baseline in vital sign: Body temperature		Baseline and up to 6 Years
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.	Up to 6 years
Parts 1 and 2: Minimum observed concentration (Cmin) and maximum observed concentration (Cmax) of dostarlimab (micrograms per milliliter)		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)
Parts 1 and 2: Cmin and Cmax at steady state of dostarlimab (micrograms per milliliter)		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)
Part 2: Cmin and Cmax of niraparib (nanograms per milliliter)		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)
Part 2: Cmin and Cmax at steady state of niraparib (nanograms per milliliter)		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)
Parts 1 and 2: Number of participants with anti-drug antibodies (ADA) against dostarlimab		Predose (Day 1)

Collaborators and Investigators

• Sponsor: Tesaro, Inc.
• Collaborators: GOG Foundation; European Network of Gynaecological Oncological Trial Groups (ENGOT)
• Investigators: Study Director: GSK Clinical Trials, GlaxoSmithKline

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 18, 2019
• Primary Completion (Estimated): November 26, 2026
• Study Completion (Estimated): November 26, 2026

Study Registration Dates

• First Submitted: May 31, 2019
• First Submitted That Met QC Criteria: June 7, 2019
• First Posted (Actual): June 11, 2019

Study Record Updates

• Last Update Posted (Actual): August 14, 2023
• Last Update Submitted That Met QC Criteria: August 8, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Niraparib; Carboplatin; Paclitaxel; TSR-042; Dostarlimab; Recurrent or primary advanced endometrial cancer
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Endometrial Neoplasms; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Poly(ADP-ribose) Polymerase Inhibitors; Carboplatin; Paclitaxel; Niraparib; Dostarlimab
• Other Study ID Numbers: 213361; ENGOT-EN6 (Other Identifier: ENGOT); GOG-3031 (Other Identifier: GOG); 4010-03-001 (Other Identifier: Tesaro)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No