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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-524090-16 | Other Identifier | EU CT Number |
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The purpose of this study is to assess the safety and tolerability of BMS-986525 alone and in combination with Nivolumab in participants with Relapsed/Refractory Small Cell Lung Cancer
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1A: BMS-986525 Monotherapy Dose Escalation | Experimental |
| |
| Part 1B: BMS-986525 Combination with Nivolumab Dose Escalation | Experimental |
| |
| Part 2A: BMS-986525 Monotherapy Dose Expansion | Experimental |
| |
| Part 2B: BMS-986525 Combination with Nivolumab Dose Expansion | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-986525 | Drug | Specified dose on specified days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events (AEs) | Up to approximately 2 years | |
| Number of participants with serious adverse events (SAEs) | Up to approximately 2 years | |
| Number of participants with AEs meeting dose-limiting toxicity (DLT) criteria | Up to 21 days | |
| Number of participants with AEs leading to discontinuation | Up to approximately 2 years | |
| Number of participants with AEs leading to death | Up to approximately 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumor Version 1.1 (RECIST v1.1) by investigator assessment | Up to approximately 3 years | |
| Maximum observed concentration within a dosing interval (Cmax) | Up to approximately 2 years |
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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 |
|---|---|---|---|---|---|---|
| Local Institution - 0011 | Not yet recruiting | Detroit | Michigan | 48201 | 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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| Nivolumab | Drug | Specified dose on specified days |
|
|
| Time of maximum observed plasma concentration within a dosing interval (Tmax) | Up to approximately 2 years |
| Area under the concentration-time curve within a dosing interval (AUC(TAU)) | Up to approximately 2 years |
| Local Institution - 0026 | Not yet recruiting | Buffalo | New York | 14263 | United States |
|
| Duke Cancer Institute | Recruiting | Durham | North Carolina | 27710 | United States |
|
| University Hospitals Cleveland Medical Center | Recruiting | Cleveland | Ohio | 44106 | United States |
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| SCRI Oncology Partners | Recruiting | Nashville | Tennessee | 37203 | United States |
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| Local Institution - 0001 | Not yet recruiting | Rozzano | Milano | 20089 | Italy |
|
| Local Institution - 0020 | Not yet recruiting | Hirakata | Osaka | 573-1191 | Japan |
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| Local Institution - 0018 | Not yet recruiting | Chuo-ku | Tokyo | 104-0045 | Japan |
|
| Local Institution - 0023 | Not yet recruiting | Timișoara | Timiș County | 300239 | Romania |
|
| Local Institution - 0003 | Not yet recruiting | Craiova | 200347 | Romania |
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| Local Institution - 0009 | Not yet recruiting | Madrid | 28041 | Spain |
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| ID | Term |
|---|---|
| D055752 | Small Cell Lung Carcinoma |
| 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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| ID | Term |
|---|---|
| D000077594 | Nivolumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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