A Study of Multiple Immune and Disease Treatment Combinations in Participants With ER+HER2- Breast Cancer That Has Spread
A Phase 1 Multi-Targeted Study to Promote Anti-Tumor Immunity in ER Positive, HER2 Negative Advanced Breast Cancer
1 other identifier
interventional
12
1 country
8
Brief Summary
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 breast-cancer
Started Sep 2020
Shorter than P25 for phase_1 breast-cancer
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 2, 2019
CompletedFirst Posted
Study publicly available on registry
October 21, 2019
CompletedStudy Start
First participant enrolled
September 22, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 15, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
August 15, 2022
CompletedDecember 2, 2022
December 1, 2022
1.9 years
October 2, 2019
December 1, 2022
Conditions
Outcome Measures
Primary Outcomes (5)
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
Secondary Outcomes (4)
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
Median duration of response (mDOR)
24 weeks
Progression-free survival rate (PFSR)
24 weeks
Study Arms (3)
Group A Target class A-1: Nivolumab+nab-paclitaxel
EXPERIMENTALThe 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
EXPERIMENTALThe 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-3: Nivolumab+nab-paclitaxel+ipilimumab
EXPERIMENTALThe 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.
Interventions
specified dose on specified days
specified dose on specified days
specified dose on specified days
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
Local Institution
Los Angeles, California, 90033, United States
Local Institution - 0003
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
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 2, 2019
First Posted
October 21, 2019
Study Start
September 22, 2020
Primary Completion
August 15, 2022
Study Completion
August 15, 2022
Last Updated
December 2, 2022
Record last verified: 2022-12