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The goal of this study is to evaluate the safety profile of dostarlimab in Indian adults with recurrent or advanced endometrial cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dostarlimab | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dostarlimab | Drug | Dostarlimab will be administered. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Grade 3 or greater Treatment Emergent Adverse Events (TEAEs) | Up to 25 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with any TEAEs | Up to 25 weeks | |
| Number of Participants with Serious Adverse Events (SAEs), treatment related Adverse Events (AEs), treatment related SAEs, treatment related fatal AEs, non-fatal SAEs | Up to 25 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| US GSK Clinical Trials Call Center | Contact | 877-379-3718 | GSKClinicalSupportHD@gsk.com | |
| EU GSK Clinical Trials Call Center | Contact | +44 (0) 20 89904466 | GSKClinicalSupportHD@gsk.com |
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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 |
|---|---|
| D016889 | Endometrial Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| C000719628 | dostarlimab |
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| Number of Participants with AEs leading to discontinuation of treatment, AEs leading to death, AEs leading to study withdrawal and AEs leading to dose modification | Up to 25 weeks |
| Change from baseline in hematology parameters: neutrophils, lymphocytes, monocytes, eosinophils, basophils and platelet count (Giga cells per Liter) | Baseline (Day 1) up to 25 weeks |
| Change from baseline in hematology parameter: Red Blood Cell (RBC) count (Trillion cells per Liter) | Baseline (Day 1) up to 25 weeks |
| Change from baseline in hematology parameter: Hemoglobin (Hb) (Grams per Liter) | Baseline (Day 1) up to 25 weeks |
| Change from baseline in hematology parameter: Reticulocytes (Percentage of reticulocytes) | Baseline (Day 1) up to 25 weeks |
| Change from baseline in hematology parameter: Mean Corpuscular Volume (MCV) (Femtoliters) | Baseline (Day 1) up to 25 weeks |
| Change from baseline in hematology parameter: Mean Corpuscular Hemoglobin (MCH) (Picograms) | Baseline (Day 1) up to 25 weeks |
| Change from baseline in clinical chemistry parameters: Blood urea nitrogen [BUN], glucose, calcium, sodium, and potassium levels (Millimoles per Liter) | Baseline (Day 1) up to 25 weeks |
| Change from baseline in clinical chemistry parameters: Total bilirubin, direct bilirubin and creatinine levels (Micromoles per Liter) | Baseline (Day 1) up to 25 weeks |
| Change from baseline in clinical chemistry parameters: Total protein levels (Gram per liter) | Baseline (Day 1) up to 25 weeks |
| Change from baseline in clinical chemistry parameters: Aspartate aminotransferase (AST), alanine aminotransferase (ALT) and alkaline phosphatase (ALP) levels (International units per liter) | Baseline (Day 1) up to 25 weeks |
| Change from Baseline in Vital signs: systolic blood pressure (SBP) and diastolic blood pressure (DBP) (Millimeters of mercury [mmHg]) | Baseline (Day 1) up to 25 weeks |
| Change from Baseline in Vital signs: pulse rate (Beats per minute) | Baseline (Day 1) up to 25 weeks |
| Change from Baseline in Vital signs: body temperature (Degrees Celsius) | Baseline (Day 1) up to 25 weeks |
| Change from Baseline in Vital signs: respiratory rate (breaths per minute) | Baseline (Day 1) up to 25 weeks |
| Change from Baseline in electrocardiogram (ECG) values: Heart rate (Beats per minute) | Baseline (Day 1) up to 25 weeks |
| D009369 |
| Neoplasms |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |