Last updated: 12/19/2025 09:50:44
A study of dostarlimab in combination with carboplatin-paclitaxel in Chinese participants with primary advanced or recurrent endometrial cancer (EC)
GSK study ID
222258
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Recruiting
Recruiting
Trial overview
Official title: A Phase 2, multicenter, open-label, single arm study of dostarlimab plus carboplatin-paclitaxel followed by dostarlimab monotherapy in participants with dMMR/MSI-H primary advanced or recurrent endometrial cancer in China (China RUBY)
Trial description: The goal of this clinical trial is to see how well dostarlimab works when administered with the chemotherapy drugs carboplatin and paclitaxelin in treating EC in Chinese participants. The study aims to understand the treatments effectiveness, safety, how the drugs behave in the body, and whether it causes any immune reactions.
Primary purpose:
Treatment
Trial design:
Single Group
Masking:
None (Open Label)
Allocation:
Not applicable
Primary outcomes:
Durable Response Rate for 12 months (DRR12) assessed by Blinded Independent Central Review (BICR)
Timeframe: Up to approximately 148 weeks
Secondary outcomes:
DRR12 assessed by Investigator
Timeframe: Up to approximately 148 weeks
Progression-free survival (PFS) per RECIST 1.1, assessed by BICR
Timeframe: Up to 226 weeks
Progression-free survival (PFS) per RECIST 1.1, assessed by investigator
Timeframe: Up to 226 weeks
Overall survival (OS)
Timeframe: Up to 226 weeks
Overall response rate (ORR) per RECIST 1.1 assessed by BICR
Timeframe: Up to 226 weeks
ORR per RECIST 1.1 assessed by Investigator
Timeframe: Up to 226 weeks
Duration of response (DOR) per RECIST 1.1 assessed by BICR
Timeframe: Up to 226 weeks
DOR per RECIST 1.1 assessed by Investigator
Timeframe: Up to 226 weeks
Serum concentration of dostarlimab
Timeframe: Up to 67 weeks
Concentration at the end of infusion (C-EOI) for dostarlimab
Timeframe: Up to 67 weeks
Trough concentration (Ctrough) for dostarlimab
Timeframe: Up to 67 weeks
Number of participants with Anti-drug antibody (ADA) against dostarlimab
Timeframe: Up to 226 weeks
Number of participants with adverse events (AEs), Immune-mediated adverse events (imAEs), and serious adverse events (SAEs) by severity
Timeframe: Up to 226 weeks
Number of participants with AEs, imAEs, and SAEs leading to dose modifications or study intervention discontinuation
Timeframe: Up to 226 weeks
Number of participants with AEs leading to death
Timeframe: Up to 226 weeks
Interventions:
Enrollment:
30
Primary completion date:
2030-31-03
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Neoplasms, Endometrial
Product
Dostarlimab
Collaborators
Not applicable
Study date(s)
November 2025 to March 2030
Type
Interventional
Phase
2
Participation criteria
Sex
Female
Age
18+ years
Accepts healthy volunteers
No
- 1. Participant has histologically or cytologically proven EC with recurrent or advanced disease.
- 2. Participant has molecular subtype of defective mismatch repair (dMMR) or microsatellite instability high (MSI-H) determined by the central reference laboratory before study intervention.
- 1. Participant has a concomitant malignancy, or participant 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. Non-melanoma skin cancer is allowed.
- 2. Participant has any medical history of interstitial lung disease or pneumonitis.
Inclusion and exclusion criteria
Inclusion criteria:
- 1. Participant has histologically or cytologically proven EC with recurrent or advanced disease. 2. Participant has molecular subtype of defective mismatch repair (dMMR) or microsatellite instability high (MSI-H) determined by the central reference laboratory before study intervention. 3. Participant must have primary Stage III or Stage IV disease or first recurrent EC with a low potential for cure by radiation therapy or surgery alone or in combination, and presence of at least one target lesion per RECIST 1.1 based on Investigator’s assessment and meet at least 1 of the following criteria: a. Has primary Stage III to IV disease and is naive to systemic anticancer therapy for EC; b. Has first recurrent disease and is naïve to systemic anticancer therapy for EC; c. Had received prior neo-adjuvant/adjuvant anticancer therapy and had a recurrence or PD ≥6 months after completing treatment (first recurrence only). 4. Participant has adequate archive tumor tissue sample for MMR/MSI status testing. If no archival tissue is available, tissue sample must be obtained before study intervention. 5. Participant is not pregnant or breastfeeding and agrees to use a highly effective contraceptive method during the study period if a woman of childbearing potential (WOCBP). 6. Participant has an Eastern Cooperative Oncology Group Performance status (ECOG PS) of 0 or 1. 7. Participant has adequate organ function, as assessed by hematologic, renal, hepatic and coagulation parameters.
Exclusion criteria:
- 1. Participant has a concomitant malignancy, or participant 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. Non-melanoma skin cancer is allowed. 2. Participant has any medical history of interstitial lung disease or pneumonitis. 3. Participant has cirrhosis or current unstable liver or biliary disease. 4. Participant has known uncontrolled central nervous system metastases, carcinomatosis meningitis, or both. 5. Participant has a diagnosis of immunodeficiency. 6. Participant has received prior therapy with an anti- Programmed death protein 1 (PD-1), anti- Programmed death ligand 1 (PD-L1), anti- Programmed death ligand 2 (PD-L2), or anti- Cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) agent. 7. Participant has not recovered adequately from AEs. 8. Participant has received prior anticancer therapy (chemotherapy, targeted therapies, hormonal therapy, radiotherapy, or immunotherapy) within 21 days prior to the first dose of study intervention. 9. Participant has received any live vaccine within 30 days of the first dose of study intervention. Vaccination against coronavirus disease 2019 (COVID-19) using vaccines that are authorized via the appropriate regulatory mechanisms are not exclusionary. 10. Participant has Hepatitis B surface antigen (HBsAg) positive, or Hepatitis C virus (HCV) Ribonucleic acid (RNA) positive at screening or within 3 months prior to the first dose of study intervention. 11. Participant is known human immunodeficiency virus (HIV) infection. 12. Participant is currently participating and receiving study intervention or has participated in a study of an investigational agent and received study intervention or used an investigational device within 4 weeks of the first dose of treatment. 13. Participant with contraindication to carboplatin and paclitaxel.
Trial location(s)
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Recruiting
Actual primary completion date
Not applicable
Actual study completion date
Not applicable
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
Participate in clinical trial
Access to clinical trial data by researchers
Visit website