A Study of Dostarlimab (TSR-042) Plus Carboplatin-paclitaxel Versus Placebo Plus Carboplatin-paclitaxel in Patients With Recurrent or Primary Advanced Endometrial Cancer

Status: In Review

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 (Stage III or IV) endometrial cancer.

Eligibility Criteria

Inclusion Criteria

  • Female subject is at least 18 years of age.
  • Subject has histologically or cytologically proven endometrial cancer with recurrent or advanced disease.
  • Subject 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.
  • Subject has an ECOG performance status of 0 or 1.
  • Subject has adequate organ function.

Exclusion Criteria

  • Subject has received neo-adjuvant/adjuvant systemic chemotherapy for primary Stage III or IV disease and:
  • has not had a recurrence or PD prior to entering the study OR
  • has had a recurrence or PD within 6 months of completing chemotherapy treatment prior to entering the study
  • Subject has had > 1 recurrence of endometrial cancer.
  • Subject has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent.
  • Subject has received prior anticancer therapy within 21 days or < 5 times the half-life of the most recent therapy prior to Study Day 1, whichever is shorter.
  • Subject has a concomitant malignancy, or subject 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.
  • Subject has known uncontrolled central nervous system metastases, carcinomatosis meningitis, or both.
  • Subject has a known history of human immunodeficiency virus.
  • Subject has known active hepatitis B or hepatitis C.
  • Subject has an active autoimmune disease that has required systemic treatment in the past 2 years.
  • Subject has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of systemic immunosuppressive therapy within 7 days prior to the first dose of study treatment.
  • Subject has not recovered from cytotoxic therapy-induced AEs.
  • Subject has not recovered adequately from AEs or complications from any major surgery prior to starting therapy.

Locations & Contacts

Iowa

Iowa City
University of Iowa / Holden Comprehensive Cancer Center
Status: In review
Name Not Available

New Hampshire

Lebanon
Dartmouth Hitchcock Medical Center
Status: In review
Name Not Available

Pennsylvania

Willow Grove
Abington Memorial Hospital-Asplundh Cancer Pavilion
Status: Approved
Name Not Available

Washington

Seattle
Fred Hutch / University of Washington Cancer Consortium
Status: In review
Name Not Available

Trial Phase & Type

Trial Phase

Phase III

Trial Type

Treatment

Lead Organization

Lead Organization
Tesaro Inc

Trial IDs

Primary ID 4010-03-001
Secondary IDs NCI-2019-04891, ENGOT-EN6, GOG-3031
Clinicaltrials.gov ID NCT03981796