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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dostarlimab- Carboplatin-Paclitaxel followed by Dostarlimab Monotherapy | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dostarlimab | Biological | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Durable response rate for 12 months (DRR12) assessed by Blinded independent central review (BICR) | 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) | Approximately 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| DRR12 per RECIST 1.1, assessed by investigator | Approximately 18 months | |
| Progression-free survival (PFS) per RECIST 1.1, assessed by BICR and investigator | 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 |
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Inclusion Criteria:
Exclusion Criteria:
Female
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Aichi | 464-8681 | Japan | |||
| GSK Investigational Site |
Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/
Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.
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| Carboplatin | Drug | 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 | Drug | 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) |
|
| Up to approximately 3 years |
| Overall survival (OS) | OS is defined as time from first dose of study intervention to death from any cause | Up to approximately 3 years |
| Overall response rate (ORR) per RECIST 1.1 assessed by BICR | 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 | Up to approximately 3 years |
| ORR per RECIST 1.1 assessed by investigator | Up to approximately 3 years |
| Disease control rate (DCR) per RECIST 1.1 assessed by BICR | 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 | Up to approximately 3 years |
| DCR per RECIST 1.1 assessed by investigator | Up to approximately 3 years |
| Duration of response (DOR) per RECIST 1.1 assessed by BICR | 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 | Up to approximately 3 years |
| 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 |
| Chiba |
| 260-8717 |
| Japan |
| GSK Investigational Site | Ehime | 791-0280 | Japan |
| GSK Investigational Site | Fukuoka | 811-1395 | Japan |
| GSK Investigational Site | Fukuoka | 830-0011 | Japan |
| GSK Investigational Site | Gunma | 373-8550 | Japan |
| GSK Investigational Site | Hokkaido | 060-8648 | Japan |
| GSK Investigational Site | Hyōgo | 673-8558 | Japan |
| GSK Investigational Site | Ibaraki | 305-8576 | Japan |
| GSK Investigational Site | Kanagawa | 259-1193 | Japan |
| GSK Investigational Site | Numakunai | 028-3695 | Japan |
| GSK Investigational Site | Okayama | 700-8558 | Japan |
| GSK Investigational Site | Osaka | 541-8567 | Japan |
| GSK Investigational Site | Osaka | 569-8686 | Japan |
| GSK Investigational Site | Saitama | 350-1298 | Japan |
| GSK Investigational Site | Shizuoka | 411-8777 | Japan |
| GSK Investigational Site | Tochigi | 329-0498 | Japan |
| GSK Investigational Site | Tokyo | 104-0045 | Japan |
| GSK Investigational Site | Tokyo | 135-8550 | Japan |
| GSK Investigational Site | Tokyo | 160-8582 | Japan |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D016889 | Endometrial Neoplasms |
| ID | Term |
|---|---|
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
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| ID | Term |
|---|---|
| C000719628 | dostarlimab |
| D016190 | Carboplatin |
| D017239 | Paclitaxel |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004224 | Diterpenes |
| D013729 | Terpenes |
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