Clinical trial NCT04132817: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Breast Cancer
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2019-10-21
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Incidence of Adverse Events (AEs)
timeFrame: Up to 3 years
measure: Incidence of Serious Adverse Events (SAEs)
timeFrame: Up to 3 years
measure: Incidence of AEs leading to dose and asset limiting toxicity (DALT)
timeFrame: 8 weeks following initial dose
measure: Incidence of AEs leading to discontinuation
timeFrame: Up to 3 years
measure: Incidence of laboratory abnormalities
timeFrame: Up to 3 years
Secondary outcomes:
measure: Change from baseline in programmed cell death receptor-ligand 1 (PD-L1) by immunohistochemistry (IHC)
timeFrame: Day 0, Day 22, Day 50
measure: Objective Response Rate (ORR)
timeFrame: 24 weeks
measure: Median duration of response (mDOR)
timeFrame: 24 weeks
measure: Progression-free survival rate (PFSR)
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Local Institution
state: California
city: Sacramento
country: United States
facility: Local Institution - 0003
state: California
city: Aurora
country: United States
facility: Local Institution - 0009
state: Colorado
city: Saint Louis
country: United States
facility: Local Institution - 0002
state: Missouri
city: New York
country: United States
facility: Local Institution - 0008
state: New York
city: Pittsburgh
country: United States
facility: Local Institution
state: Pennsylvania
city: Dallas
country: United States
facility: Local Institution
state: Texas
city: San Antonio
country: United States
facility: South Texas Accelerated Research Therapeutics
state: Texas
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: