Last updated: 09/02/2025 12:30:14
A study to evaluate Dostarlimab plus carboplatin-paclitaxel versus placebo plus carboplatin-paclitaxel in participants with recurrent or primary advanced endometrial cancerRUBY
GSK study ID
213361
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Trial status
Recruitment complete
Recruitment complete
Trial overview
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)
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
Parts 1 and 2: Progression-Free Survival (PFS) – investigator assessment
Timeframe: Up to 6 years
Part 1: Overall survival
Timeframe: Up to 6 years
Secondary outcomes:
Part 2: Overall survival
Timeframe: Up to 6 years
Parts 1 and 2: Progression free survival (PFS) blinded independent central review (BICR)
Timeframe: Up to 6 years
Parts 1 and 2: Objective response rate (ORR) – BICR and Investigator assessment
Timeframe: Up to 6 years
Parts 1 and 2: Duration of response (DOR) - BICR and Investigator assessment
Timeframe: Up to 6 years
Parts 1 and 2: Disease control rate (DCR) - BICR and Investigator assessment
Timeframe: 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)
Timeframe: 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])
Timeframe: Up to 6 years
Parts 1 and 2: PROs in the EORTC Quality of Life Questionnaire (Endometrial Cancer Module [QLQ-EN24])
Timeframe: Up to 6 years
Parts 1 and 2: Progression-free survival 2 (PFS2)
Timeframe: 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)
Timeframe: 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
Timeframe: 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)
Timeframe: Baseline and up to 6 Years
Parts 1 and 2: Change from Baseline in vital sign: Heart Rate
Timeframe: Baseline and up to 6 Years
Parts 1 and 2: Change from Baseline in vital sign: Respiratory rate
Timeframe: Baseline and up to 6 Years
Parts 1 and 2: Change from Baseline in vital sign: Body temperature
Timeframe: Baseline and up to 6 Years
Parts 1 and 2: Number of participants with Eastern Cooperative Oncology Group (ECOG) Performance Status Scores
Timeframe: Up to 6 years
Parts 1 and 2: Minimum observed concentration (Cmin) and maximum observed concentration (Cmax) of dostarlimab (micrograms per milliliter)
Timeframe: 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)
Timeframe: 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)
Timeframe: 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)
Timeframe: 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
Timeframe: Predose (Day 1)
Interventions:
Enrollment:
785
Primary completion date:
2026-26-11
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical 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
Medical condition
Neoplasms
Product
Dostarlimab
Collaborators
European Network of Gynaecological Oncological Trial Groups (ENGOT), Gynecologic Oncology Group (GOG)
Study date(s)
July 2019 to November 2026
Type
Interventional
Phase
3
Participation criteria
Sex
Female
Age
18+ years
Accepts healthy volunteers
No
- Part 1 and Part 2:
- Female participant is at least 18 years of age.
- Part 1 and Part 2:
- Participant has received neo-adjuvant/adjuvant systemic anticancer therapy for primary Stage III or IV disease and:
Inclusion and exclusion criteria
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; a) 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; b) 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; c) Participant has primary Stage IIIC2 or Stage IV disease regardless of the presence of evaluable or measurable disease; d) Participant has first recurrent disease and is naïve to systemic anticancer therapy; e) 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: a) has not had a recurrence or PD prior to first dose on the study OR b) 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
Trial location(s)
Location
GSK Investigational Site
Dallas, TX, United States, 75246
Status
Recruitment Complete
Location
GSK Investigational Site
Indianapolis, IN, United States, 46202
Status
Recruitment Complete
Location
GSK Investigational Site
Indianapolis, IN, United States, 46260
Status
Recruitment Complete
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Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Recruitment complete
Actual primary completion date
Not applicable
Actual study completion date
Not applicable
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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