A Study to Evaluate Dostarlimab Plus Carboplatin-paclitaxel Versus Placebo Plus Carboplatin-paclitaxel in Participants With Recurrent or Primary Advanced Endometrial Cancer

Official Title

A Phase 3, Randomized, Double-blind, Multicentre Study of Dostarlimab (TSR-042) Plus Carboplatin-paclitaxel Versus Placebo Plus Carboplatin-paclitaxel in Patients With Recurrent or Primary Advanced Endometrial Cancer (RUBY)

Summary:

Endometrial cancer accounts for greater than 90 percent (%) of all uterine cancer. The majority of participants with endometrial cancer are diagnosed in early stages (Stage I or II) and receive surgery with curative intent; however, approximately 20% are diagnosed with advanced or metastatic disease (Stage III or IV) for which a surgical cure is not possible. Paclitaxel in combination with carboplatin has been shown to be efficacious against a variety of different tumour types, including non-small-cell-lung-carcinoma (NSCLC), ovarian cancer, endometrial cancer, and head and neck cancer. This study will evaluate the efficacy and safety of dostarlimab in combination with carboplatin-paclitaxel, the standard of care for participants with recurrent or primary advanced endometrial cancer. This study consists of a Screening Period, Treatment Period, an End of Treatment (EOT) Visit, a Safety Follow-up Visit, and a Survival Assessment Period. Participants will be randomized in a 1:1 ratio to receive either dostarlimab plus carboplatin paclitaxel or placebo plus carboplatin-paclitaxel.

Trial Description

Primary Outcome:

• Progression-Free Survival (PFS) - Investigator assessment

• Progression free survival (PFS) - Blinded Independent Central Review (BICR)
• Overall survival (OS)
• Objective response rate (ORR)
• Duration of response (DOR)
• Disease control rate (DCR)
• Patient-reported outcomes (PROs) in the European Quality of Life scale, 5-Dimensions, 5-Levels (EQ-5D-5L)
• Patient-reported outcomes (PROs) in the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30 [Core])
• Patient-reported outcomes (PROs) in the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-EN24 [Endometrial Cancer Module])
• Number of participants with adverse events (AEs) and Serious adverse events (SAEs)
• Number of participants experiencing treatment-emergent adverse events (TEAEs)
• Change from Baseline in hematology parameter: Hemoglobin (Hb) (Grams per Liter)
• Change from Baseline in Hematology Parameters: Basophils Count, Eosinophils Count, Lymphocytes Count, Monocytes Count, Neutrophils Count, white blood cell count (WBC), and Platelet Count (Giga cells per Liter)
• Change from Baseline in hematology parameter: Mean corpuscle volume (MCV) (Femtoliters)
• Change From Baseline in hematology parameter: activated partial thromboplastin time (aPTT) (Seconds)
• Change FromBaseline in hematology parameter: International Normalized Ratio (INR) (Ratio)
• Change from Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Blood urea nitrogen (Millimoles per liter)
• Change from Baseline in Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) (International units per liter)
• Change from Baseline in Chemistry Parameters: Albumin, Total Protein (Grams per liter)
• Change from Baseline in Chemistry Parameters: Creatinine, Total Bilirubin (Micromoles per liter)
• Change From Baseline in Chemistry Parameters: Amylase, Lipase (Units per liter)
• Change from Baseline in Chemistry parameter: Magnesium, Phosphate (Millimoles per liter)
• Change from Baseline in Urinalysis Parameter: Specific Gravity (Ratio)
• Change from Baseline in Urinalysis parameter: Glucose (Millimoles per liter)
• Change from Baseline in Urinalysis parameter: Nitrite (Milligrams per deciliter)
• Change from Baseline in Urinalysis parameter: Leukocyte esterase (White blood cells per high power field)
• Change from Baseline in Urinalysis parameter: Occult blood (10^9 cells per liter)
• Change from Baseline in Urinalysis parameter: Protein (Grams per liter)
• Change from Baseline in Urinalysis parameter: Bilirubin (Milligrams per deciliter)
• Change from Baseline in Urinalysis parameter: Ketones (Millimoles per liter)
• Change from Baseline in Thyroid Stimulating Harmone (TSH) (milliunits per liter)
• Change from Baseline in Free T3 (Triiodothyronine) (picomoles per liter)
• Change from Baseline in Thyroxine (T4) (Picomole per Liter)
• Number of participants with abnormal Vital Signs
• Number of participants with abnormality in physical examinations
• Number of participants with abnormal Electrocardiogram (ECG)
• Number of participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores
• Number of participants Reporting the Intake of Concomitant Medication

View this trial on ClinicalTrials.gov