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| ID | Type | Description | Link |
|---|---|---|---|
| I8X-MC-JECD | Other Identifier | Eli Lilly and Company | |
| 2019-001156-18 | EudraCT Number | ||
| KEYNOTE-961 | Other Identifier | Merck |
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The withdrawal is due to a strategic realignment and is not related to any particular safety or efficacy concern.
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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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The main purpose of this study is to see if the drug LY3200882 which is an inhibitor of transforming growth factor-β (TGFβ) receptor 1 in combination with pembrolizumab is safe and effective in participants with cancer that has spread to other parts of the body.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY3200882 and Pembrolizumab (Dose Level 1) | Experimental | Participants with urothelial carcinoma: LY3200882 administered orally with pembrolizumab administered intravenously (IV). |
|
| LY3200882 and Pembrolizumab (Dose Level 2) | Experimental | Participants with urothelial carcinoma: LY3200882 administered orally with pembrolizumab administered IV. |
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| LY3200882 and Pembrolizumab Expansion | Experimental | Participants with urothelial carcinoma, non-small cell lung cancer, or hepatocellular carcinoma: LY3200882 administered orally twice in combination with pembrolizumab administered IV. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY3200882 | Drug | LY3200882 administered orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Dose Limiting Toxicity (DLT) | Number of Participants with DLT | Up to 6 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR): Percentage of Participants with Complete Response (CR) or Partial Response (PR) | ORR: Percentage of Participants with CR or PR | Baseline through Disease Progression or Death (Estimated at up to 12 Months) |
| Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3200882 in Combination With Pembrolizumab |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dana Farber Cancer Institute | Boston | Massachusetts | 02215 | United States | ||
| CHU de Besancon Hopital Jean Minjoz |
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| Label | URL |
|---|---|
| A Study of LY3200882 and Pembrolizumab in Participants With Advanced Cancer | View source |
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Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
| ID | Term |
|---|---|
| D003966 | Camurati-Engelmann Syndrome |
| D002295 | Carcinoma, Transitional Cell |
| D006528 | Carcinoma, Hepatocellular |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D010009 | Osteochondrodysplasias |
| D001848 | Bone Diseases, Developmental |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| C582435 | pembrolizumab |
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| Pembrolizumab | Drug | Pembrolizumab administered IV |
|
PK: Cmax of LY3200882 in Combination With Pembrolizumab |
| Baseline through Week 13 |
| Duration of Response (DoR) | DoR | Date of CR or PR to Date of Disease Progression or Death Due to Any Cause (Estimated at up to 12 Months) |
| Besançon |
| 25030 |
| France |
| Gustave Roussy | Villejuif | 94805 | France |
| Institut Catala d'Oncologia | L'Hospitalet de Llobregat | Barcelona | 08907 | Spain |
| Hospital Clinic I Provincial | Barcelona | 08036 | Spain |
| Hospital Madrid Norte Sanchinarro | Madrid | 28050 | Spain |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D000230 | Adenocarcinoma |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |