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

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ClinicalTrials.gov Identifier: NCT04132817
Recruitment Status : Not yet recruiting
First Posted : October 21, 2019
Last Update Posted : October 21, 2019
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

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 Drug: nivolumab Drug: ipilimumab Drug: nab-paclitaxel Phase 1

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Study Type : Interventional  (Clinical Trial)
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
Estimated Study Start Date : November 6, 2019
Estimated Primary Completion Date : October 14, 2024
Estimated Study Completion Date : October 15, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Group A Target class A-1: nivolumab + nab-paclitaxel
The CA048001 clinical study will utilize a master protocol and sub-protocols representing distinct mechanisms of actions. Each sub-protocol 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.
Drug: 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 CA048001 clinical study will utilize a master protocol and sub-protocols representing distinct mechanisms of actions. Each sub-protocol 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.
Drug: nivolumab
specified dose on specified days

Drug: 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 CA048001 clinical study will utilize a master protocol and sub-protocols representing distinct mechanisms of actions. Each sub-protocol 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.
Drug: nivolumab
specified dose on specified days

Drug: ipilimumab
specified dose on specified days

Drug: nab-paclitaxel
specified dose on specified days




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. Adverse Events (AEs) leading to dose and asset limiting toxicity (DALT) [ Time Frame: 8 weeks following initial dose ]
  4. Adverse Events (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 in PD-L1 measure by PET scans [ 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
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 positive status
  • ER negativity defined as < 1% of tumor cells expressing hormonal receptors via IHC analysis
  • Metastatic disease or locoregionally recurrent disease in participants that have had 1 - 3 prior regimens for the treatment of metastatic disease, including endocrine therapy or chemotherapy
  • At least one measureable lesion, as per Response Evaluation Criteria in Solid Tumors version 1.1 (Recist 1.1)
  • Sufficient tumor tissue (>_ 20mm^3) obtained from metastatic or locoregionally recurrent tumor lesions during the screening period prior to first study dose
  • ECOG performance of 0 or 1
  • Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test and not be breastfeeding

Exclusion Criteria:

  • Any significant acute or chronic medical disease including autoimmune diseases, type I diabetes mellitus, hyperthyroidism, chronic hepatitis, or skin disorders
  • HER2-positive status or a negative/unknown ER status
  • Allergy or hypersensitivity to any study drugs or their excipients
  • Any major surgery within 4 weeks of study drug administration
  • History of unstable or deteriorating cardiac disease, myocardial infarction or stroke
  • Any other sound medical, psychiatric and/or social reason as determined by the investigator
  • Prior therapy with anit-PD-1, anti-PD-L1 or anti-CTLA-4 antibody
  • Participants with a condition requiring systemic treatment or other immunosuppressive medications
  • Evidence of organ dysfunction or any clinically significant deviation from normal
  • Positive urine screen for drugs of abuse
  • Positive blood screen for HIV-1 and -2 antibody

Other protocol defined inclusion/exclusion criteria could apply


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 Not yet recruiting
Sacramento, California, United States, 95817
Contact: Site 0003         
Local Institution Not yet recruiting
San Francisco, California, United States, 94115
Contact: Site 0006         
United States, Connecticut
Local Institution Not yet recruiting
New Haven, Connecticut, United States, 06520
Contact: Site 0001         
United States, Missouri
Local Institution Not yet recruiting
Saint Louis, Missouri, United States, 63110
Contact: Site 0002         
United States, New York
Local Institution Not yet recruiting
Uniondale, New York, United States, 11553
Contact: Site 0004         
United States, Pennsylvania
Local Institution Not yet recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Site 0005         
Sponsors and Collaborators
Bristol-Myers Squibb

Additional Information:
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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: October 21, 2019
Last Verified: October 2019

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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
Albumin-Bound Paclitaxel
Nivolumab
Ipilimumab
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological