Dostarlimab
BiologicalDostarlimab is administered via intravenous (IV) infusion at a dose of 500 milligram (mg) for first 6 cycles (each cycle is of 21 days) followed by 1,000 mg from cycle 7 (each cycle is of 42 days)
NCT Number: NCT06317311
The goal of this clinical trial is to understand the effectiveness of dostarlimab and carboplatin-paclitaxel followed by dostarlimab monotherapy in participants with endometrial cancer
This study is active but is not currently recruiting participants.
18 year and older
Female
Interventional
Phase 2
GSK Investigational Site, Aichi, Japan
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Dostarlimab is administered via intravenous (IV) infusion at a dose of 500 milligram (mg) for first 6 cycles (each cycle is of 21 days) followed by 1,000 mg from cycle 7 (each cycle is of 42 days)
Carboplatin is administered IV at a dose of Area under the concentration time curve (AUC) 5 milligram*millilitre/ minute (mg•mL/min) for cycles 1 to 6 (each cycle is of 21 days)
Paclitaxel is administered IV at a dose of 175 milligram per meter square (mg/m2) for cycles 1 to 6 (each cycle is of 21 days)
Time frame: Approximately 18 months
DRR12 is defined as the proportion of participants with Complete Response (CR) or Partial Response (PR) lasting greater than or equal to (≥) 12 months, per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1)
Time frame: Approximately 18 months
Time frame: Up to approximately 3 years
PFS is defined as the time from the date of first dose to the earlier date of assessment of progression or death by any cause
Time frame: Up to approximately 3 years
OS is defined as time from first dose of study intervention to death from any cause
Time frame: Up to approximately 3 years
ORR is achieving a best overall response (BOR) of CR or PR. BOR is defined as the best confirmed response [CR > PR > Stable disease (SD) > Progressive Disease (PD) > Not evaluable (NE)] from treatment start date until disease progression, death or initiation of next line of therapy, whichever is earlier
Time frame: Up to approximately 3 years
Time frame: Up to approximately 3 years
Achieving a BOR of CR, PR, or SD, defined as the best confirmed response (CR > PR > SD) from treatment start date until disease progression, death or initiation of next line of therapy, whichever is earlier
Time frame: Up to approximately 3 years
Time frame: Up to approximately 3 years
DOR is defined as the time from the date of first documented objective response to the date of first documented PD or death, whichever comes first
Time frame: Up to approximately 3 years
Time frame: Up to 67 weeks
Time frame: Up to 67 weeks
Time frame: Up to approximately 3 years
Time frame: Up to approximately 3 years
Time frame: Up to approximately 3 years
GlaxoSmithKline
Industry
A Phase 2, Multicenter, Open-label, Single Arm Study of Dostarlimab Plus Carboplatin-paclitaxel Followed by Dostarlimab Monotherapy in Japanese Patients With Primary Advanced or Recurrent Endometrial Cancer (RUBY-J)
Acronym: RUBY-J
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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