May 31, 2019
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June 11, 2019
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May 20, 2024
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July 18, 2019
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September 28, 2022 (Final data collection date for primary outcome measure)
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- Parts 1 and 2: Progression-Free Survival (PFS) - investigator assessment [ Time Frame: Up to 6 years ]
- Part 1: Overall survival [ Time Frame: Up to 6 years ]
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To compare the progression-free survival (PFS) of treatment with dostarlimab plus carboplatin-paclitaxel to treatment with placebo plus carboplatin-paclitaxel, as assessed by the Investigator per RECIST v.1.1, in the following: [ Time Frame: Up to 5 years ]
- All subjects with recurrent or primary advanced endometrial cancer
- Subjects with microsatellite instability-high (MSI-H) recurrent or primary advanced endometrial cancer
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- Part 2: Overall survival [ Time Frame: Up to 6 years ]
- Parts 1 and 2: Progression free survival (PFS) blinded independent central review (BICR) [ Time Frame: Up to 6 years ]
- Parts 1 and 2: Objective response rate (ORR) - BICR and Investigator assessment [ Time Frame: Up to 6 years ]
- Parts 1 and 2: Duration of response (DOR) - BICR and Investigator assessment [ Time Frame: Up to 6 years ]
- Parts 1 and 2: Disease control rate (DCR) - BICR and Investigator assessment [ Time Frame: 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) [ Time Frame: Up to 6 years ]
EQ-5D-5L is a validated questionnaire to assess the overall health-related quality of life in participants across diseases.
- Parts 1 and 2: PROs in the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30 [Core]) [ Time Frame: Up to 6 years ]
EORTC QLQ-C30 is validated questionnaire to assess overall health-related quality of life in participants with cancer.
- Parts 1 and 2: PROs in the EORTC Quality of Life Questionnaire (Endometrial Cancer Module [QLQ-EN24]) [ Time Frame: Up to 6 years ]
EORTC QLQ-EN24 is a validated questionnaire to assess the overall health-related quality of life in participants with all stages of endometrial cancer.
- Parts 1 and 2: Progression-free survival 2 (PFS2) [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: Baseline and up to 6 Years ]
- Parts 1 and 2: Change from Baseline in vital sign: Heart Rate [ Time Frame: Baseline and up to 6 Years ]
- Parts 1 and 2: Change from Baseline in vital sign: Respiratory rate [ Time Frame: Baseline and up to 6 Years ]
- Parts 1 and 2: Change from Baseline in vital sign: Body temperature [ Time Frame: Baseline and up to 6 Years ]
- Parts 1 and 2: Number of participants with Eastern Cooperative Oncology Group (ECOG) Performance Status Scores [ Time Frame: Up to 6 years ]
Performance status will be assessed using the ECOG scale, with status score ranging from 0 to 5.
- Parts 1 and 2: Minimum observed concentration (Cmin) and maximum observed concentration (Cmax) of dostarlimab (micrograms per milliliter) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: Predose (Day 1) ]
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- PFS based on blinded independent central review (BICR) [ Time Frame: Up to 5 years ]
- Overall survival (OS) [ Time Frame: Up to 5 years ]
- Objective response rate (ORR) [ Time Frame: Up to 5 years ]
- Duration of response (DOR) [ Time Frame: Up to 5 years ]
- Disease control rate (DCR) [ Time Frame: Up to 5 years ]
- Patient-reported outcomes (PROs) in the European Quality of Life scale, 5-Dimensions, 5-Levels (EQ-5D-5L) [ Time Frame: Up to 5 years ]
EQ-5D-5L is a validated questionnaire to assess the overall health-related quality of life in patients across diseases. EQ-5D-5L consists of a descriptive section of 5 questions, one related to each of: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Questions use a 5-point scale ("no problems", "slight problems", "moderate problems", "severe problems", "unable/extreme problems"). Scores are converted to an index value based on country-specific value sets, with a value of 0 representing "death" and 1 representing "perfect health"). The EQ-5D-5L also includes a visual-analogue scale of overall health on a 100-point scale (from "Worst imaginable health state" to "Best imaginable health state").
- Patient-reported outcomes (PROs) in the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30 [Core]) [ Time Frame: Up to 5 years ]
EORTC QLQ-C30 is a validated questionnaire to assess the overall health-related quality of life in patients with cancer and is composed of 30 questions including multi-item scales and single item measures. These include five functional scales (physical, role, emotional, cognitive and social), three symptom scales (fatigue, nausea/vomiting, and pain), a global health status/quality of life scale (GHS/QOL), and six single items (dyspnoea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The QLQ-C30 employs a week recall period for all items and a 4-point scale for the functional and symptom scales/items with response categories "Not at all", "A little", "Quite a bit" and "Very much". The two items assessing GHS/QOL utilize a 7-point scale ranging from 1 ("Very Poor") to 7 ("Excellent"). Scores are averaged, and transformed to a 0-100 scale. A higher score on functional scales represents better function, and on symptom scales represents more severe symptoms.
- Patient-reported outcomes (PROs) in the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-EN24 [Endometrial Cancer Module]) [ Time Frame: Up to 5 years ]
EORTC QLQ-EN24 is a validated questionnaire to assess the overall health-related quality of life in patients with all stages of endometrial cancer, and consists of 24 questions including multi-item scales and single item measures. These include three functional scales (sexual interest, activity, and enjoyment), five symptom scales (lymphoedema, urological symptoms, GI symptoms, poor body image, and sexual/vaginal problems), and five single items (back/pelvis pain, tingling/numbness, muscular pain, hair loss, and taste change). Questions use a 4-point scale (from 1 'Not at All' to 4 'Very Much'). Scores are averaged, and transformed to a 0-100 scale; a higher score represents a more severe overall side effect of treatment.
- Number and percentage of participants experiencing treatment-emergent adverse events (TEAEs) [ Time Frame: Up to 5 years ]
- Number and percentage of participants with drug-related adverse events (AEs) [ Time Frame: Up to 5 years ]
- Number and percentage of participants discontinuing study drug due to an adverse event (AE) [ Time Frame: Up to 5 years ]
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Not Provided
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Not Provided
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A Study to Evaluate Dostarlimab Plus Carboplatin-paclitaxel Versus Placebo Plus Carboplatin-paclitaxel in Participants With Recurrent or Primary Advanced Endometrial Cancer
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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)
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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.
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Not Provided
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Interventional
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Phase 3
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Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Masking Description: The participant, Investigator, study staff, and the Sponsor study team and its representatives will be blinded to the assigned treatment. Primary Purpose: Treatment
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Neoplasms
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- Biological: Dostarlimab
Participants will be administered dostarlimab
Other Name: TSR-042
- Drug: Placebo matching dostarlimab
Participants will be administered placebo matching dostarlimab
- Drug: Carboplatin
Participants will be administered carboplatin
- Drug: Paclitaxel
Participants will be administered paclitaxel
- Drug: Niraparib
Participants will be administered niraparib
- Drug: Placebo matching Niraparib
Participants will be administered placebo matching Niraparib
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- Active Comparator: Arm 1: Participants receiving dostarlimab + Carboplatin-paclitaxel followed by dostarlimab
Interventions:
- Biological: Dostarlimab
- Drug: Carboplatin
- Drug: Paclitaxel
- Placebo Comparator: Arm 2: Participants receiving placebo + carboplatin-paclitaxel followed by placebo
Interventions:
- Drug: Placebo matching dostarlimab
- Drug: Carboplatin
- Drug: Paclitaxel
- Active Comparator: Arm 3: Participants receiving dostarlimab + carboplatin-paclitaxel followed by dostarlimab+niraparib
Interventions:
- Biological: Dostarlimab
- Drug: Carboplatin
- Drug: Paclitaxel
- Drug: Niraparib
- Placebo Comparator: Arm 4: Participants receiving placebo + carboplatin-paclitaxel followed by placebo
Interventions:
- Drug: Placebo matching dostarlimab
- Drug: Carboplatin
- Drug: Paclitaxel
- Drug: Placebo matching Niraparib
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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.
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Active, not recruiting
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785
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470
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November 26, 2026
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September 28, 2022 (Final data collection date for primary outcome measure)
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Inclusion Criteria:
Part 1 and Part 2:
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:
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
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Sexes Eligible for Study: |
Female |
Gender Based Eligibility: |
Yes |
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18 Years and older (Adult, Older Adult)
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No
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Contact information is only displayed when the study is recruiting subjects
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Belarus, Belgium, Canada, Czechia, Denmark, Finland, Germany, Greece, Hungary, Israel, Italy, Netherlands, Norway, Poland, Spain, Sweden, Turkey, Ukraine, United Kingdom, United States
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NCT03981796
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213361 ENGOT-EN6 ( Other Identifier: ENGOT ) GOG-3031 ( Other Identifier: GOG ) 4010-03-001 ( Other Identifier: Tesaro )
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Yes
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Studies a U.S. FDA-regulated Drug Product: |
Yes |
Studies a U.S. FDA-regulated Device Product: |
No |
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Plan to Share IPD: |
Yes |
Plan Description: |
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/ |
Supporting Materials: |
Study Protocol |
Supporting Materials: |
Statistical Analysis Plan (SAP) |
Supporting Materials: |
Informed Consent Form (ICF) |
Supporting Materials: |
Clinical Study Report (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. |
URL: |
https://www.gsk.com/en-gb/innovation/trials/data-transparency/ |
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Tesaro, Inc.
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Same as current
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Tesaro, Inc.
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Same as current
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- European Network of Gynaecological Oncological Trial Groups (ENGOT)
- GOG Foundation
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Study Director: |
GSK Clinical Trials |
GlaxoSmithKline |
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Tesaro, Inc.
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May 2024
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