A Study of Multiple Immune and Disease Treatment Combinations in Participants With ER+HER2- Breast Cancer That Has Spread

Breast Cancer Clinical Trial

Official title:

A Phase 1 Multi-Targeted Study to Promote Anti-Tumor Immunity in ER Positive, HER2 Negative Advanced Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04132817
• Other study ID #: CA048-001
• Status: Completed
• Phase: Phase 1
• Start date: September 22, 2020
• Est. completion date: August 15, 2022

Study information

• Verified date: December 2022
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: August 15, 2022
• Est. primary completion date: August 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Biological:
• Nivolumab
specified dose on specified days
• Ipilimumab
specified dose on specified days

Drug:
• Nab-paclitaxel
specified dose on specified days

Locations

Country	Name	City	State
United States	Local Institution - 0009	Aurora	Colorado
United States	Local Institution	Dallas	Texas
United States	Local Institution	Los Angeles	California
United States	Local Institution - 0008	New York	New York
United States	Local Institution	Pittsburgh	Pennsylvania
United States	Local Institution - 0003	Sacramento	California
United States	Local Institution - 0002	Saint Louis	Missouri
United States	South Texas Accelerated Research Therapeutics	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Adverse Events (AEs)		Up to 3 years
Primary	Incidence of Serious Adverse Events (SAEs)		Up to 3 years
Primary	Incidence of AEs leading to dose and asset limiting toxicity (DALT)		8 weeks following initial dose
Primary	Incidence of AEs leading to discontinuation		Up to 3 years
Primary	Incidence of laboratory abnormalities		Up to 3 years
Secondary	Change from baseline in programmed cell death receptor-ligand 1 (PD-L1) by immunohistochemistry (IHC)		Day 0, Day 22, Day 50
Secondary	Objective Response Rate (ORR)		24 weeks
Secondary	Median duration of response (mDOR)		24 weeks
Secondary	Progression-free survival rate (PFSR)		24 weeks

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting
•   FDA Safety Alerts and Recalls