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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-500930-27 | EudraCT Number |
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The aim of this study is to assess the safety and tolerability of BMS-986360 as monotherapy and in combination with chemotherapy or nivolumab in participants with advanced solid tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BMS-986360 | Experimental |
| |
| BMS-986360 + Docetaxel | Experimental |
| |
| BMS-986360 + Nivolumab | Experimental |
| |
| BMS-986360 + Capecitabine | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-986360 | 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 Dose-Limiting Toxicities (DLTs) | Up to approximately 2 years | |
| Number of participants with AEs leading to discontinuation | Up to approximately 2 years | |
| Number of deaths | Up to approximately 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed plasma concentration (Cmax) | Up to approximately 2 years | |
| Time of maximum observed plasma concentration (Tmax) | Up to approximately 2 years | |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria apply.
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution - 0029 | Los Angeles | California | 90025 | United States | ||
| Local Institution - 0051 |
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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 Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html
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|
| Docetaxel | Drug | Specified dose on specified days |
|
|
| Nivolumab | Drug | Specified dose on specified days |
|
|
| Capecitabine | Drug | Specified dose on specified days |
|
|
| Area under the plasma concentration-time curve (AUC) |
| Up to approximately 2 years |
| Part 1: Objective response rate (ORR) based on Response Evaluation Criteria in Solid Tumors (RECIST v1.1) by investigator | Up to approximately 2 years |
| Part 2: ORR based on RECIST v1.1 by blinded independent central review (BICR) assessment | Up to approximately 2 years |
| Part 1: Duration of Response (DOR) based on RECIST v1.1 by investigator | Up to approximately 2 years |
| Part 2: DOR based on RECIST v1.1 by BICR assessment | Up to approximately 2 years |
| Los Angeles |
| California |
| 90067 |
| United States |
| Local Institution - 0026 | New Orleans | Louisiana | 70121 | United States |
| Local Institution - 0001 | Hackensack | New Jersey | 07601 | United States |
| Local Institution - 0018 | Huntersville | North Carolina | 28078 | United States |
| Local Institution - 0028 | Nashville | Tennessee | 37203 | United States |
| Local Institution - 0027 | San Antonio | Texas | 78229 | United States |
| Local Institution - 0046 | West Valley City | Utah | 84119 | United States |
| Local Institution - 0033 | Ciudad Autónoma de Buenos Aires | Buenos Aires | 1280 | Argentina |
| Local Institution - 0030 | CABA | Buenos Aires F.D. | C1430EGF | Argentina |
| Local Institution - 0031 | Buenos Aires | 1426 | Argentina |
| Local Institution - 0010 | Darlinghurst | New South Wales | 2010 | Australia |
| Local Institution - 0061 | St Leonards | New South Wales | 2065 | Australia |
| Local Institution - 0008 | Brisbane | Queensland | 4120 | Australia |
| Local Institution - 0063 | Frankston | Victoria | 3199 | Australia |
| Local Institution - 0003 | Ottawa | Ontario | K1H 8L6 | Canada |
| Local Institution - 0005 | Toronto | Ontario | M5G 2M9 | Canada |
| Local Institution - 0047 | Santiago | Santiago Metropolitan | 7500921 | Chile |
| Local Institution - 0035 | Santiago | Santiago Metropolitan | 8330032 | Chile |
| Local Institution - 0034 | Santiago | Santiago Metropolitan | 8420383 | Chile |
| Local Institution - 0049 | Marseille | Provence-Alpes-Côte d'Azur Region | 13273 | France |
| Local Institution - 0052 | Villejuif | Val-de-Marne | 94800 | France |
| Local Institution - 0048 | Paris | 75248 | France |
| Local Institution - 0050 | Toulouse | 31059 | France |
| Local Institution - 0057 | Rozzano | Milano | 20089 | Italy |
| Local Institution - 0059 | Candiolo | Torino | 10060 | Italy |
| Local Institution - 0065 | Padova | 35128 | Italy |
| Local Institution - 0041 | Zapopan | Jalisco | 45070 | Mexico |
| Local Institution - 0038 | Mexico City | Mexico City | 03100 | Mexico |
| Local Institution - 0039 | Monterrey | Nuevo León | 66460 | Mexico |
| Local Institution - 0037 | Puebla City | 72424 | Mexico |
| Local Institution - 0053 | Barcelona | Catalunya [Cataluña] | 08036 | Spain |
| Local Institution - 0055 | Madrid | Madrid, Comunidad de | 28034 | Spain |
| Local Institution - 0056 | Madrid | Madrid, Comunidad de | 28041 | Spain |
| Local Institution - 0064 | Seville | 41013 | Spain |
| ID | Term |
|---|---|
| C000722276 | CC-90001 |
| D000077143 | Docetaxel |
| D000077594 | Nivolumab |
| D000069287 | Capecitabine |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| 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 |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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