Last updated: 07/24/2025 04:50:08
A study of dostarlimab in combination with carboplatin-paclitaxel in Japanese participants with primary advanced or recurrent endometrial cancerRUBY-J
GSK study ID
221968
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Active, not recruiting
Active, not recruiting
Trial overview
Official title: 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)
Trial description: 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
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Not applicable
Primary outcomes:
Durable response rate for 12 months (DRR12) assessed by Blinded independent central review (BICR)
Timeframe: Approximately 18 months
Secondary outcomes:
DRR12 per RECIST 1.1, assessed by investigator
Timeframe: Approximately 18 months
Progression-free survival (PFS) per RECIST 1.1, assessed by BICR and investigator
Timeframe: Up to approximately 3 years
Overall survival (OS)
Timeframe: Up to approximately 3 years
Overall response rate (ORR) per RECIST 1.1 assessed by BICR
Timeframe: Up to approximately 3 years
ORR per RECIST 1.1 assessed by investigator
Timeframe: Up to approximately 3 years
Disease control rate (DCR) per RECIST 1.1 assessed by BICR
Timeframe: Up to approximately 3 years
DCR per RECIST 1.1 assessed by investigator
Timeframe: Up to approximately 3 years
Duration of response (DOR) per RECIST 1.1 assessed by BICR
Timeframe: Up to approximately 3 years
DOR per RECIST 1.1 assessed by investigator
Timeframe: Up to approximately 3 years
Maximum concentration (Cmax) for dostarlimab
Timeframe: Up to 67 weeks
Minimum concentration (Cmin) for dostarlimab
Timeframe: Up to 67 weeks
Number of participants with adverse events (AEs), Immune-related adverse events (irAEs), and serious adverse events (SAEs) by severity
Timeframe: Up to approximately 3 years
Number of participants AEs, irAEs, and SAEs leading to dose modifications such as dose delay or study intervention discontinuation
Timeframe: Up to approximately 3 years
Number of participants with AEs leading to death
Timeframe: Up to approximately 3 years
Interventions:
Biological/vaccine: Dostarlimab
Drug: Carboplatin
Drug: Paclitaxel
Enrollment:
41
Observational study model:
Not applicable
Primary completion date:
2026-15-07
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Carcinoma
Product
Dostarlimab
Collaborators
Not applicable
Study date(s)
May 2024 to August 2027
Type
Interventional
Phase
2
Participation criteria
Sex
Female
Age
18+ years
Accepts healthy volunteers
No
- 1. Participant has histologically or cytologically proven endometrial cancer with recurrent or advanced disease.
- 2. Participant has molecular subtype of defective mismatch repair/microsatellite instability high (dMMR/MSI-H) or mismatch repair proficient/microsatellite stable (MMRp/MSS) determined.
- 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 endometrial cancer with recurrent or advanced disease. 2. Participant has molecular subtype of defective mismatch repair/microsatellite instability high (dMMR/MSI-H) or mismatch repair proficient/microsatellite stable (MMRp/MSS) determined. 3. Participant 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, and presence of at least one measurable lesion per RECIST 1.1 based on Investigator’s assessment. 4. 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). 5. Participant has an Eastern Cooperative Oncology Group Performance status (ECOG PS) of 0 or 1. 6. 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 or <5 times the half-life of the most recent therapy prior to the first dose of study intervention, whichever is shorter. 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 HBsAg positive, or HCV RNA positive. 11. Participant is known 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
Active, not 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
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