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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-523067-38 | Other Identifier | EU CTR |
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The purpose of this study is to evaluate the safety, tolerability, and efficacy of escalating doses of BMS-986463 in participants with select advanced malignant tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: Dose Escalation | Experimental |
| |
| Arm 2: Dose Expansion | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-986463 | Drug | Specified dose on specified days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events (AEs) | Up to 108 weeks | |
| Number of participants with serious adverse events (SAEs) | Up to 108 weeks | |
| Number of participants with AEs meeting protocol defined dose-limiting toxicity (DLT) criteria | Up to 108 weeks | |
| Number of participants with AEs leading to discontinuation | Up to 108 weeks | |
| Number of participants with AEs leading to death | Up to 108 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed concentration (Cmax) | Up to 104 weeks | |
| Area under the concentration-time curve (AUC) | Up to 104 weeks | |
| Time of maximum observed concentration (Tmax) |
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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 |
|---|---|---|---|---|---|---|
| USC/Norris Comprehensive Cancer Center | Recruiting | Los Angeles | California | 90033 | 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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| Up to 104 weeks |
| Objective response rate (ORR) | Up to 104 weeks |
| Disease control rate (DCR) | Up to 104 weeks |
| Duration of response (DOR) | Up to 104 weeks |
| Valkyrie Clinical Trials | Recruiting | Los Angeles | California | 90067 | United States |
|
| John Theurer Cancer Center at Hackensack University Medical Center | Recruiting | Hackensack | New Jersey | 07601 | United States |
|
| Local Institution - 0045 | Not yet recruiting | Columbus | Ohio | 43210 | United States |
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| Local Institution - 0046 | Not yet recruiting | Dallas | Texas | 75390 | United States |
|
| Local Institution - 0049 | Not yet recruiting | Houston | Texas | 77054 | United States |
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| BC Cancer Vancouver | Recruiting | Vancouver | British Columbia | V5Z 4E6 | Canada |
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| Princess Margaret Cancer Centre | Recruiting | Toronto | Ontario | M5G 2M9 | Canada |
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| Centre Hospitalier de l'Université de Montréal | Recruiting | Montreal | Quebec | H2X 3E4 | Canada |
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| Jewish General Hospital | Recruiting | Montreal | Quebec | H3T 1E2 | Canada |
|
| Local Institution - 0036 | Not yet recruiting | Bordeaux | Aquitaine | 33076 | France |
|
| Local Institution - 0031 | Not yet recruiting | Villejuif | Val-de-Marne | 94800 | France |
|
| Local Institution - 0035 | Not yet recruiting | Lyon | 69373 | France |
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| Local Institution - 0033 | Not yet recruiting | Milan | 20141 | Italy |
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| Local Institution - 0032 | Not yet recruiting | Milan | 20159 | Italy |
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| Local Institution - 0042 | Not yet recruiting | Barcelona | Barcelona [Barcelona] | 08035 | Spain |
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| Local Institution - 0041 | Not yet recruiting | Avda.Pio XII 36, | 31008 | Spain |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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