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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04132817
Recruitment Status : Completed
First Posted : October 21, 2019
Last Update Posted : December 2, 2022
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Description
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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.

Condition or disease Intervention/treatment Phase
Breast Cancer Biological: Nivolumab Biological: Ipilimumab Drug: Nab-paclitaxel Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Multi-Targeted Study to Promote Anti-Tumor Immunity in ER Positive, HER2 Negative Advanced Breast Cancer
Actual Study Start Date : September 22, 2020
Actual Primary Completion Date : August 15, 2022
Actual Study Completion Date : August 15, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: Group A Target class A-1: Nivolumab+nab-paclitaxel
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.
 Biological: Nivolumab
specified dose on specified days

Drug: Nab-paclitaxel
specified dose on specified days
Experimental: Group A Target Class A-2: Nivolumab+nab-paclitaxel+ipilimumab
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.
 Biological: Nivolumab
specified dose on specified days

Biological: Ipilimumab
specified dose on specified days

Drug: Nab-paclitaxel
specified dose on specified days
Experimental: Group A Target Class A-3: Nivolumab+nab-paclitaxel+ipilimumab
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.
 Biological: Nivolumab
specified dose on specified days

Biological: Ipilimumab
specified dose on specified days

Drug: Nab-paclitaxel
specified dose on specified days


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of Adverse Events (AEs) [ Time Frame: Up to 3 years ]
  2. Incidence of Serious Adverse Events (SAEs) [ Time Frame: Up to 3 years ]
  3. Incidence of AEs leading to dose and asset limiting toxicity (DALT) [ Time Frame: 8 weeks following initial dose ]
  4. Incidence of AEs leading to discontinuation [ Time Frame: Up to 3 years ]
  5. Incidence of laboratory abnormalities [ Time Frame: Up to 3 years ]

Secondary Outcome Measures :
  1. Change from baseline in programmed cell death receptor-ligand 1 (PD-L1) by immunohistochemistry (IHC) [ Time Frame: Day 0, Day 22, Day 50 ]
  2. Objective Response Rate (ORR) [ Time Frame: 24 weeks ]
  3. Median duration of response (mDOR) [ Time Frame: 24 weeks ]
  4. Progression-free survival rate (PFSR) [ Time Frame: 24 weeks ]

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04132817


Locations
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United States, California
Local Institution
Los Angeles, California, United States, 90033
Local Institution - 0003
Sacramento, California, United States, 95817
United States, Colorado
Local Institution - 0009
Aurora, Colorado, United States, 80045
United States, Missouri
Local Institution - 0002
Saint Louis, Missouri, United States, 63110
United States, New York
Local Institution - 0008
New York, New York, United States, 10016
United States, Pennsylvania
Local Institution
Pittsburgh, Pennsylvania, United States, 15213
United States, Texas
Local Institution
Dallas, Texas, United States, 75390
South Texas Accelerated Research Therapeutics
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information
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Additional Information:

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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT04132817    
Other Study ID Numbers: CA048-001
First Posted: October 21, 2019    Key Record Dates
Last Update Posted: December 2, 2022
Last Verified: December 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Paclitaxel
Nivolumab
Ipilimumab
 Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological
Immune Checkpoint Inhibitors