A Study of Dostarlimab in Combination With Carboplatin-paclitaxel in Japanese Participants With Primary Advanced or Recurrent Endometrial Cancer
- Conditions
- Carcinoma
- Interventions
- Registration Number
- NCT06317311
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 41
- Participant has histologically or cytologically proven endometrial cancer with recurrent or advanced disease.
- Participant has molecular subtype of defective mismatch repair/microsatellite instability high (dMMR/MSI-H) or mismatch repair proficient/microsatellite stable (MMRp/MSS) determined.
- 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.
- 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).
- Participant has an Eastern Cooperative Oncology Group Performance status (ECOG PS) of 0 or 1.
- Participant has adequate organ function, as assessed by hematologic, renal, hepatic and coagulation parameters.
- 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.
- Participant has any medical history of interstitial lung disease or pneumonitis.
- Participant has cirrhosis or current unstable liver or biliary disease.
- Participant has known uncontrolled central nervous system metastases, carcinomatosis meningitis, or both.
- Participant has a diagnosis of immunodeficiency.
- 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.
- Participant has not recovered adequately from AEs.
- 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.
- 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.
- Participant has HBsAg positive, or HCV RNA positive.
- Participant is known HIV infection.
- 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.
- Participant with contraindication to carboplatin and paclitaxel.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Dostarlimab- Carboplatin-Paclitaxel followed by Dostarlimab Monotherapy Dostarlimab - Dostarlimab- Carboplatin-Paclitaxel followed by Dostarlimab Monotherapy Carboplatin - Dostarlimab- Carboplatin-Paclitaxel followed by Dostarlimab Monotherapy Paclitaxel -
- Primary Outcome Measures
Name Time Method Durable response rate for 12 months (DRR12) assessed by Blinded independent central review (BICR) 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)
- Secondary Outcome Measures
Name Time Method DRR12 per RECIST 1.1, assessed by investigator Approximately 18 months Progression-free survival (PFS) per RECIST 1.1, assessed by BICR and investigator 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
DCR per RECIST 1.1 assessed by investigator Up to approximately 3 years Disease control rate (DCR) per RECIST 1.1 assessed by BICR 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
Overall survival (OS) Up to approximately 3 years OS is defined as time from first dose of study intervention to death from any cause
Overall response rate (ORR) per RECIST 1.1 assessed by BICR 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
ORR per RECIST 1.1 assessed by investigator Up to approximately 3 years Duration of response (DOR) per RECIST 1.1 assessed by BICR 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
DOR per RECIST 1.1 assessed by investigator Up to approximately 3 years Maximum concentration (Cmax) for dostarlimab Up to 67 weeks Minimum concentration (Cmin) for dostarlimab Up to 67 weeks Number of participants with adverse events (AEs), Immune-related adverse events (irAEs), and serious adverse events (SAEs) by severity Up to approximately 3 years Number of participants AEs, irAEs, and SAEs leading to dose modifications such as dose delay or study intervention discontinuation Up to approximately 3 years Number of participants with AEs leading to death Up to approximately 3 years
Trial Locations
- Locations (1)
GSK Investigational Site
🇯🇵Tokyo, Japan