RUBY
Research type
Research Study
Full 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)
IRAS ID
272039
Contact name
Rebecca Kristeleit
Contact email
Sponsor organisation
TESARO, Inc.
Eudract number
2019-001576-11
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
126472, IND Number
Duration of Study in the UK
3 years, 1 months, 4 days
Research summary
Endometrial cancer accounts for over 90% of all womb cancer. The majority of patients with endometrial cancer are diagnosed in early stages (Stage I or II) and receive surgery with curative intent; however about 20% are diagnosed with advanced disease (Stage III or IV) for which a surgical cure is not possible. For these patients, there is no approved anticancer therapy. Although radiotherapy, chemoradiation, or adjuvant systemic platinum-based chemotherapy is recommended, an unmet medical need in this patient population remains high.
The purpose of this study is to see if an investigational medication called Dostarlimab in combination with chemotherapy (carboplatin and paclitaxel) is safe and effective and whether it can help delay worsening of endometrial cancer among female patients. Dostarlimab is designed to stop cancer from growing by helping your immune system recognise and fight the cancer. Eligible participants will receive either the dostarlimab infusion or placebo (dummy treatment) infusion in combination with carboplatin-paclitaxel every 3 weeks for the first 6 cycles.
Approximately 470 female participants are planned to be enrolled in this study globally. Participants will be asked to visit the study centre around 13 times. At each visit, some of the following procedures will be performed: physical examination, vital signs (Blood pressure, Heart rate, Temperature), height and weight, Echocardiogram (ECG), blood and urine sampling, Computed Tomography (CT scan) or Magnetic Resonance Imaging (MRI scan) for assessing the tumour response, questionnaires etc
It is not known how long patients will participate in this study for. Dostarlimab or placebo treatment may continue for up to 3 years or until a patients’ disease worsens, have unacceptable side effects, withdraw from the study, study doctor’s decision, or the Sponsor decides to stop the study. Continued treatment with dostarlimab or placebo beyond 3 years may be considered following discussion between the Sponsor and the Investigator.
REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
20/NW/0035
Date of REC Opinion
17 Mar 2020
REC opinion
Further Information Favourable Opinion