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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-523547-35 | Other Identifier | EU CTR |
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The purpose of this study is to evaluate the safety, tolerability, and efficacy of BMS-986523 alone and in combination with anti-cancer agents in participants with advanced solid malignancies
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | Experimental |
| |
| Arm B | Experimental |
| |
| Arm C | Experimental |
| |
| Arm D | Experimental |
| |
| Arm E | Experimental |
| |
| Arm F | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-986523 | Drug | Specified dose on specified days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events (AEs) | Up to 3 years | |
| Number of participants with serious adverse events (SAEs) | Up to 3 years | |
| Number of participants with AEs meeting protocol-defined dose limiting toxicity (DLT) criteria | Up to 3 years | |
| Number of participants with AEs leading to discontinuation | Up to 3 years | |
| Number of deaths | Up to 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as assessed by the investigator. | Up to 3 years | |
| Duration of response (DOR) per RECIST v1.1 as assessed by the investigator. | Up to 3 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 |
|---|---|---|---|---|---|---|
| Johns Hopkins Hospital | Recruiting | Baltimore | Maryland | 21287 | 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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| Gemcitabine | Drug | Specified dose on specified days |
|
| Nab-Paclitaxel | Drug | Specified dose on specified days |
|
| Cetuximab | Drug | Specified dose on specified days |
|
| Pembrolizumab | Drug | Specified dose on specified days |
|
| Maximum observed plasma concentration (Cmax) | Up to 3 years |
| Time of maximum observed plasma concentration (Tmax) | Up to 3 years |
| Area under the concentration-time curve in 1 dosing interval (AUC(TAU)) | Up to 3 years |
| NEXT Oncology | Recruiting | San Antonio | Texas | 78229 | United States |
|
| START Mountain Region | Recruiting | West Valley City | Utah | 84119 | United States |
|
| NEXT Virginia | Recruiting | Fairfax | Virginia | 22031 | United States |
|
| BC Cancer Vancouver | Recruiting | Vancouver | British Columbia | V5Z 4E6 | Canada |
|
| Princess Margaret Cancer Centre | Recruiting | Toronto | Ontario | M5G 2M9 | Canada |
|
| Local Institution - 0006 | Not yet recruiting | Badalona | Barcelona [Barcelona] | 08916 | Spain |
|
| Local Institution - 0008 | Not yet recruiting | Hortaleza | Madrid | 28050 | Spain |
|
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D015179 | Colorectal Neoplasms |
| D010190 | Pancreatic Neoplasms |
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000093542 | Gemcitabine |
| C520255 | 130-nm albumin-bound paclitaxel |
| D000068818 | Cetuximab |
| C582435 | pembrolizumab |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| 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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