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The main goal of this study is to evaluate the effect of dostarlimab monotherapy in Chinese participants with locally advanced Mismatch-repair deficient (dMMR)/ Microsatellite instability-high (MSI-H) rectal cancer who have received no prior treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dostarlimab monotherapy | Experimental | Participants will receive dostarlimab as monotherapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dostarlimab | Biological | Dostarlimab will be administered. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Sustained Complete Clinical Response for 12 Months (cCR12) as assessed by Independent Central Review (ICR) | cCR12 is achieved when a participant maintains complete clinical response (cCR) as assessed by Independent central review (ICR) for 12 months from the first disease assessment after last dose of study intervention. Timeframe calculation includes 6 months (9 cycles of dostarlimab, with each cycle lasting 21 days) plus an additional 12 months of assessment time, amounting to a total of 18 months. | 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Sustained Complete Clinical Response for 24 Months (cCR24) as assessed by ICR | cCR24 is achieved when a participant maintains cCR as assessed by ICR for 24 months following their first disease assessment after last dose of study intervention. Timeframe calculation includes 6 months (9 cycles of dostarlimab, with each cycle lasting 21 days) plus an additional 24 months of assessment time, amounting to a total of 30 months. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Chengdu | 610041 | China | |||
| 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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| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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| ID | Term |
|---|---|
| C000719628 | dostarlimab |
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| 30 months |
| Number of Participants with Sustained Complete Clinical Response for 36 Months (cCR36) as assessed by ICR | cCR36 is achieved when a participant maintains cCR as assessed by ICR for 36 months following first disease assessment after last dose of study intervention. Timeframe calculation includes 6 months (9 cycles of dostarlimab, with each cycle lasting 21 days) plus an additional 36 months of assessment time, amounting to a total of 42 months. | 42 months |
| Number of Participants with Event Free Survival at 3 years (EFS3) as assessed by Investigator | EFS3 is defined as participants who remained alive and free of disease progression precluding surgery, local recurrence, and distant recurrence at 3 years from the first dose of study intervention as assessed by Investigator. | 3 years |
| Event Free Survival (EFS) as assessed by Investigator | EFS is defined as time from the date of first dose of study intervention to any of the following events including progression of disease that precludes surgery, local recurrence, distant recurrence (all as assessed by the investigator), or death due to any cause. | Up to approximately 77 months |
| Number of Participants with cCR12 as assessed by Investigator | cCR12 is achieved when a participant maintains cCR as assessed by Investigator for 12 months from the first disease assessment after last dose of study intervention. Timeframe calculation includes 6 months (9 cycles of dostarlimab, with each cycle lasting 21 days) plus an additional 12 months of assessment time, amounting to a total of 18 months. | 18 Months |
| Number of Participants with cCR24 as assessed by Investigator | cCR24 is achieved when a participant maintains cCR as assessed by Investigator for 24 months from the first disease assessment after last dose of study intervention. Timeframe calculation includes includes 6 months (9 cycles of dostarlimab, with each cycle lasting 21 days) plus an additional 24 months of assessment time, amounting to a total of 30 months. | 30 Months |
| Number of Participants with cCR36 as assessed by Investigator | cCR36 is achieved when a participant maintains cCR as assessed by Investigator for 36 months from the first disease assessment after last dose of study intervention. Timeframe calculation includes 6 months (9 cycles of dostarlimab, with each cycle lasting 21 days) plus an additional 36 months of assessment time, amounting to a total of 42 months. | 42 Months |
| Objective Response Rate (ORR) assessed by ICR | ORR is defined as number of participants achieving a partial response (PR), near complete response (nCR) or cCR at post-intervention disease assessment (PIDA) or at least 4 weeks but no longer than 8 weeks after PIDA for participants with nCR or incomplete clinical response (iCR) (PIDA 2) as assessed by ICR. | Up to 37 Weeks |
| Objective Response Rate (ORR) as assessed by Investigator | ORR by Investigator is defined as number of participants achieving a PR, nCR, or cCR at PIDA. | Up to 37 Weeks |
| Organ Preservation Rate | Organ Preservation Rate is defined as number of participants who did not undergo any rectal cancer surgery either as primary management or for local recurrence, or who did not have a permanent colostomy created, at any time up to 3 years. | Up to 3 years |
| Disease-Specific Survival (DSS) | DSS is defined as time from the date of first dose of study intervention to death due to disease under study. | Up to approximately 77 months |
| Disease-Specific Response at 5 years (DSS5) | DSS5 is defined as the number of participants not dying due to disease under study at 5 years from the first dose of study intervention. | Up to 5 years |
| Overall Survival (OS) | OS is defined as time from first dose of study intervention to death from any cause. | Up to approximately 77 months |
| Overall Survival at 5 years (OS5) | OS5 is defined as number of participants being alive at 5 years from first dose of study intervention. | Up to 5 years |
| Number of Participants with Adverse Events (AEs), Serious Adverse Events (SAEs), Immune related Adverse Events (irAEs) and AEs leading to death or discontinuation of study intervention. | Up to approximately 77 months |
| Serum concentration of Dostarlimab | Up to approximately 77 months |
| Concentration at the end of infusion (C-EOI) of Dostarlimab | Up to approximately 77 months |
| Trough Concentration (C-trough) of Dostarlimab | Up to approximately 77 months |
| Number of Participants with Anti-Drug Antibodies (ADA) against Dostarlimab | Up to approximately 77 months |
| Chongqing |
| 400010 |
| China |
| GSK Investigational Site | Guangzhou | 510060 | China |
| GSK Investigational Site | Guangzhou | 510655 | China |
| GSK Investigational Site | Hangzhou | 310016 | China |
| GSK Investigational Site | Hangzhou | China |
| GSK Investigational Site | Jinan | 250117 | China |
| GSK Investigational Site | Kunming | 650106 | China |
| GSK Investigational Site | Shanghai | 200032 | China |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |