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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-522543-18 | Other Identifier | EU CTR | |
| U1111-1323-5879 | Other Identifier | WHO |
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This is a first-in-human study of BMS-986506 in participants with advanced Clear Cell Renal Cell Carcinoma (ccRCC). The primary objective of this study is to find out if BMS-986506 is safe and can be tolerated when taken alone by participants with ccRCC.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BMS-986506: Part 1A | Experimental |
| |
| BMS-986506: Part 2A | Experimental |
| |
| BMS-986506: Part 2B | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-986506 | Drug | Specified dose on specified days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events (AEs) | Up to approximately 2 years from first dose of BMS-986506 | |
| Number of Participants With Serious Adverse Events (SAEs) | Up to approximately 2 years from first dose of BMS-986506 | |
| Number of Participants With AEs Meeting Protocol Defined Dose-limiting Toxicity (DLT) Criteria | Up to approximately Day 28 | |
| Number of Participants With AEs Leading to Discontinuation | Up to approximately 2 years from first dose of BMS-986506 | |
| Number of Participants With AEs Leading to Deaths as Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v 5.0 | Up to approximately 2 years from first dose of BMS-986506 |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) of BMS-986506 | Up to approximately Day 85 | |
| Time of Maximum Observed Plasma Concentration (Tmax) of BMS-986506 | Up to approximately Day 112 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| BMS Clinical Trials Contact Center www.BMSClinicalTrials.com | Contact | 855-907-3286 | Clinical.Trials@bms.com | |
| First line of the email MUST contain NCT # and Site #. | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dana-Farber Cancer Institute | Recruiting | Boston | Massachusetts | 02215 | United States |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| BMS Clinical Trial Patient Recruiting | View source |
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BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
See Plan Description
See Plan Description
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| Area Under the Concentration-time Curve Within a Dosing Interval (AUC-TAU) of BMS-986506 |
| Up to approximately Day 112 |
| Objective Response Rate (ORR) as Assessed by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) | Up to approximately 3 years from first dose of BMS-986506 |
| Disease Control Rate (DCR) as Assessed by RECIST v1.1 | Up to approximately 3 years from first dose of BMS-986506 |
| Duration of Response (DOR) as Assessed by RECIST v1.1 | Up to approximately 3 years from first dose of BMS-986506 |
| Time to Response (TTR) as Assessed by RECIST v1.1 | Up to approximately 3 years from first dose of BMS-986506 |
| Memorial Sloan Kettering Cancer Center | Recruiting | New York | New York | 10065 | United States |
|
| Fox Chase Cancer Center | Recruiting | Philadelphia | Pennsylvania | 19111 | United States |
|
| SCRI Oncology Partners | Recruiting | Nashville | Tennessee | 37203 | United States |
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| START San Antonio | Recruiting | San Antonio | Texas | 78229 | United States |
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| Arthur J.E. Child Comprehensive Cancer Centre | Recruiting | Calgary | Alberta | T2N 5G2 | Canada |
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| Gustave Roussy | Recruiting | Villejuif | Val-de-Marne | 94800 | France |
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| Hospital Universitario Reina Sofia | Recruiting | Córdoba | Andalusia | 14004 | Spain |
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| Hospital Universitari Vall d'Hebron | Recruiting | Barcelona | Barcelona [Barcelona] | 08035 | Spain |
|
| ID | Term |
|---|---|
| D002292 | Carcinoma, Renal Cell |
| C538445 | Clear-cell metastatic renal cell carcinoma |
| D007680 | Kidney Neoplasms |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
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