Clinical Trials /

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

NCT04132817

Description:

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.

Related Conditions:
  • Breast Adenocarcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: 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

Clinical Trial IDs

  • ORG STUDY ID: CA048-001
  • NCT ID: NCT04132817

Conditions

  • Breast Cancer

Interventions

DrugSynonymsArms
NivolumabGroup A Target Class A-2: Nivolumab+nab-paclitaxel+ipilimumab
IpilimumabGroup A Target Class A-2: Nivolumab+nab-paclitaxel+ipilimumab
Nab-paclitaxelGroup A Target Class A-2: Nivolumab+nab-paclitaxel+ipilimumab

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
Group A Target class A-1: Nivolumab+nab-paclitaxelExperimentalThe 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.
  • Nivolumab
  • Nab-paclitaxel
Group A Target Class A-2: Nivolumab+nab-paclitaxel+ipilimumabExperimentalThe 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.
  • Nivolumab
  • Ipilimumab
  • Nab-paclitaxel
Group A Target Class A-3: Nivolumab+nab-paclitaxel+ipilimumabExperimentalThe 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.
  • Nivolumab
  • Ipilimumab
  • Nab-paclitaxel

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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Incidence of Adverse Events (AEs)
Time Frame:Up to 3 years
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Change from baseline in programmed cell death receptor-ligand 1 (PD-L1) by immunohistochemistry (IHC)
Time Frame:Day 0, Day 22, Day 50
Safety Issue:
Description:
Measure:Objective Response Rate (ORR)
Time Frame:24 weeks
Safety Issue:
Description:
Measure:Median duration of response (mDOR)
Time Frame:24 weeks
Safety Issue:
Description:
Measure:Progression-free survival rate (PFSR)
Time Frame:24 weeks
Safety Issue:
Description:

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Bristol-Myers Squibb

Last Updated

September 10, 2020