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Tesaro 4010-03-001 (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

Description

This is a phase 3, randomized, double-blind, multicenter study to evaluate the efficacy and safety of dostarlimab plus carboplatin-paclitaxel versus placebo plus carboplatin-paclitaxel in patients with recurrent or primary advanced (atage III or IV) endometrial cancer.

Status

Accepting new patients

Primary Study Objective(s)

To compare the progression-free survival (PFS) of treatment with dostarlimab plus carboplatin-paclitaxel to treatment with placebo plus carboplatin-paclitaxel

Core eligibility

Note: This is only a partial list of eligibility criteria.

Including patients who:

  • Are female and at least 18 years old
  • Have histologically or cytologically proven endometrial cancer with recurrent or advanced disease
  • 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
  • Have an ECOG performance status of 0 or 1
  • Have adequate organ function

Excluding patients who:

  • Have received neo-adjuvant/adjuvant systemic chemotherapy for primary Stage III or IV disease and have not had a recurrence or PD prior to entering the study, or had a recurrence or PD within six months of completing chemotherapy treatment prior to entering the study
  • Had one or more recurrence of endometrial cancer
  • Have received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent
  • Have 1received prior anticancer therapy within 21 days or less than five times the half-life of the most recent therapy prior to day one of the study, whichever is shorter
  • Have a concomitant malignancy, or subject has a prior non-endometrial invasive malignancy who has been disease-free for less than three years or who received any active treatment in the last three years for that malignancy
  • Have known uncontrolled central nervous system metastases, carcinomatosis meningitis, or both
  • Have a known history of human immunodeficiency virus
  • Have known active hepatitis B or hepatitis C
  • Have an active autoimmune disease that has required systemic treatment in the past two years
  • Have a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of systemic immuno-suppressive therapy within seven days prior to the first dose of study treatment
  • Have not recovered from cytotoxic therapy-induced AEs
  • Have not recovered adequately from AEs or complications from any major surgery prior to starting therapy
     

Accepting new patients

 

Learn more at

clinicaltrials.gov

 

Principal Investigator(s)

Julian Schink