Description:
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.
Title
- Brief Title: A Study of Multiple Immune and Disease Treatment Combinations in Participants With ER+HER2- Breast Cancer That Has Spread
- Official Title: A Phase 1 Multi-Targeted Study to Promote Anti-Tumor Immunity in ER Positive, HER2 Negative Advanced Breast Cancer
Clinical Trial IDs
- ORG STUDY ID:
CA048-001
- NCT ID:
NCT04132817
Conditions
Interventions
Drug | Synonyms | Arms |
---|
Nivolumab | | Group A Target Class A-2: Nivolumab+nab-paclitaxel+ipilimumab |
Ipilimumab | | Group A Target Class A-2: Nivolumab+nab-paclitaxel+ipilimumab |
Nab-paclitaxel | | Group A Target Class A-2: Nivolumab+nab-paclitaxel+ipilimumab |
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
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. | - Nivolumab
- Ipilimumab
- Nab-paclitaxel
|
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. | - Nivolumab
- Ipilimumab
- Nab-paclitaxel
|
Eligibility Criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
visit www.BMSStudyConnect.com
Inclusion Criteria:
- Histological and cytological confirmation of adenocarcinoma of the breast
- Documented HER2 negative and estrogen receptor (ER) positive status of primary or
metastatic tumor tissue using the most recently assessed tumor specimen, according to
the local laboratory parameters
- ER negativity is defined as < 1% of tumor cells expressing hormonal receptors via IHC
analysis
- At least one measurable lesion, as per Response Evaluation Criteria in Solid Tumors
version 1.1 [RECIST v1.1] that can be accurately assessed at baseline and is suitable
for repeated assessment by computed tomography (CT) or magnetic resonance imaging
(MRI)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Women and Men must agree to follow specific methods of contraception, if applicable,
while participating in the trial
Exclusion Criteria:
- Allergy or hypersensitivity to any study drugs or their excipients
- Any other sound medical, psychiatric and/or social reason as determined by the
investigator
- Active, known, or suspected autoimmune disease or immune-related diseases
- History of unstable or deteriorating cardiac disease within the previous 12 months
prior to screening
- Prior therapy with anti-programmed death 1 (PD-1), anti-programmed death-ligand 1
(PD-L1) or anti-Cytotoxic T Lymphocyte Antigen 4 (CTLA-4) class antibody
- Any major surgery within 4 weeks of the first dose of study treatment
Other protocol-defined inclusion/exclusion criteria apply
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Incidence of Adverse Events (AEs) |
Time Frame: | Up to 3 years |
Safety Issue: | |
Description: | |
Secondary Outcome Measures
Measure: | Change from baseline in programmed cell death receptor-ligand 1 (PD-L1) by immunohistochemistry (IHC) |
Time Frame: | Day 0, Day 22, Day 50 |
Safety Issue: | |
Description: | |
Measure: | Objective Response Rate (ORR) |
Time Frame: | 24 weeks |
Safety Issue: | |
Description: | |
Measure: | Median duration of response (mDOR) |
Time Frame: | 24 weeks |
Safety Issue: | |
Description: | |
Measure: | Progression-free survival rate (PFSR) |
Time Frame: | 24 weeks |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Bristol-Myers Squibb |
Last Updated
May 14, 2021