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
Secondary Outcome:
  • 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

Interested in this trial?

Print this page and take it to your doctor to discuss your eligibilty and treatment options. Only your doctor can refer you to a clinical trial.

Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society