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The hypothesis of the CA048-001 Phase 1 clinical trial is targeting multiple mechanisms involved in generating and maintaining antitumor immune response will lead to a tolerable and robust anti-tumor response. This study utilizes an innovative clinical trial design to determine the safety, tolerability, pharmacodynamic activity and efficacy of targeting multiple, distinct combination regimens that modulate several immune and non-immune mechanisms by escalating the number of therapies administered.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A Target class A-1: Nivolumab+nab-paclitaxel | Experimental | The CA048-001 clinical study will utilize a master protocol and subprotocols representing distinct mechanisms of actions. Each subprotocol will contain 1 Group, representing a particular mechanism of action, and will consist of 3 treatment arms that will be simultaneously evaluated. One treatment within a group will be selected to move forward to the next sub-protocol based on safety and tolerability, pharmacodynamic and efficacy data. Thus, the number of treatments within each group is increased by one for each subsequent group, with the intent to simultaneously impact a wide range of mechanisms thought to be important for generating anti-tumor immune responses. |
|
| Group A Target Class A-2: Nivolumab+nab-paclitaxel+ipilimumab | Experimental | The CA048-001 clinical study will utilize a master protocol and subprotocols representing distinct mechanisms of actions. Each subprotocol will contain 1 Group, representing a particular mechanism of action, and will consist of 3 treatment arms that will be simultaneously evaluated. One treatment within a group will be selected to move forward to the next sub-protocol based on safety and tolerability, pharmacodynamic and efficacy data. Thus, the number of treatments within each group is increased by one for each subsequent group, with the intent to simultaneously impact a wide range of mechanisms thought to be important for generating anti-tumor immune responses. |
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| Group A Target Class A-3: Nivolumab+nab-paclitaxel+ipilimumab | Experimental | The CA048-001 clinical study will utilize a master protocol and subprotocols representing distinct mechanisms of actions. Each subprotocol will contain 1 Group, representing a particular mechanism of action, and will consist of 3 treatment arms that will be simultaneously evaluated. One treatment within a group will be selected to move forward to the next sub-protocol based on safety and tolerability, pharmacodynamic and efficacy data. Thus, the number of treatments within each group is increased by one for each subsequent group, with the intent to simultaneously impact a wide range of mechanisms thought to be important for generating anti-tumor immune responses. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nivolumab | Biological | specified dose on specified days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Events (AEs) | Up to 3 years | |
| Incidence of Serious Adverse Events (SAEs) | Up to 3 years | |
| Incidence of AEs leading to dose and asset limiting toxicity (DALT) | 8 weeks following initial dose | |
| Incidence of AEs leading to discontinuation | Up to 3 years | |
| Incidence of laboratory abnormalities | Up to 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in programmed cell death receptor-ligand 1 (PD-L1) by immunohistochemistry (IHC) | Day 0, Day 22, Day 50 | |
| Objective Response Rate (ORR) | 24 weeks | |
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For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
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 | Los Angeles | California | 90033 | United States | ||
| Local Institution - 0003 |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| BMS Clinical Trial Patient Recruiting | View source |
| FDA Safety Alerts and Recalls |
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|
| Ipilimumab | Biological | specified dose on specified days |
|
| Nab-paclitaxel | Drug | specified dose on specified days |
|
| Median duration of response (mDOR) |
| 24 weeks |
| Progression-free survival rate (PFSR) | 24 weeks |
| Sacramento |
| California |
| 95817 |
| United States |
| Local Institution - 0009 | Aurora | Colorado | 80045 | United States |
| Local Institution - 0002 | St Louis | Missouri | 63110 | United States |
| Local Institution - 0008 | New York | New York | 10016 | United States |
| Local Institution | Pittsburgh | Pennsylvania | 15213 | United States |
| Local Institution | Dallas | Texas | 75390 | United States |
| South Texas Accelerated Research Therapeutics | San Antonio | Texas | 78229 | United States |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D000077594 | Nivolumab |
| D000074324 | Ipilimumab |
| C520255 | 130-nm albumin-bound paclitaxel |
| 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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