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At Bolder Science, we want your clinical trial search experience to be the best it can be. Complete the following prompts to easily find the trials you are interested in and see trials recruiting near you. You can adjust these selections in your dashboard after creating your account.

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

  • Clinicaltrials.gov identifier

    NCT04132817

  • Recruitment Status

    Recruiting

  • First Posted

    October 21, 2019

  • Last update posted

    May 14, 2021

Study Description

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:Breast Cancer
  • Intervention/Treatment: Biological: Nivolumab
    Biological: Ipilimumab
    Drug: Nab-paclitaxel
  • Phase: Phase 1

Detailed Description

N/A

Study Design

  • Study Type: Interventional
  • Estimated Enrollment: 135 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 2020
  • Estimated Primary Completion Date: June 2024
  • Estimated Study Completion Date: August 2025

Arms and interventions

Arm Intervention/treatment
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
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

Outcome Measures

  • 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

  • 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

Contacts

Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com

Contact: First line of the email MUST contain NCT # and Site #.

Locations

United States, California
Hoag Memorial Hospital Presbyterian
Los Angeles

United States, California
Usc Norris Cancer Center And Hospital
Los Angeles

United States, California
University of California Davis Medical Center
Sacramento

United States, California
Local Institution
San Francisco

United States, Colorado
University Of Colorado
Aurora

United States, Connecticut
Local Institution
New Haven

United States, Illinois
Local Institution
Chicago

United States, Missouri
Washington University School Of Medicine
Saint Louis

United States, New York
Laura And Isaac Perlmutter Cancer Center
New York

United States, New York
Local Institution
Uniondale

United States, Ohio
Local Institution
Cleveland

United States, Pennsylvania
University Of Pittsburgh Medical Center
Pittsburgh

United States, Texas
UT Southwestern Medical Center
Dallas

United States, Texas
South Texas Accelerated Research Therapeutics
San Antonio

United States, Utah
Local Institution
Salt Lake City

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

More Information

  • Responsible Party: Bristol-Myers Squibb
  • ClinicalTrials.gov Identifier: NCT04132817 History of Changes
  • Other Study ID Numbers: CA048-001
  • First Posted: October 21, 2019 Key Record Dates
  • Last Update Posted: May 14, 2021
  • Last Verified: April 2021
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Breast Neoplasms