Breast Cancer
Conditions
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.
Interventions
BIOLOGICALNivolumab
specified dose on specified days
BIOLOGICALIpilimumab
specified dose on specified days
DRUGNab-paclitaxel
specified dose on specified days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of laboratory abnormalities | 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 Adverse Events (AEs) | Up to 3 years |
| Incidence of Serious Adverse Events (SAEs) | Up to 3 years |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival rate (PFSR) | 24 weeks |
| Median duration of response (mDOR) | 24 weeks |
| 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 |
Countries
United States
Outcome results
None listed