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

Part of paid clinical trials in Los Angeles, California.

Sponsor
Bristol-Myers Squibb
Study ID
NCT04132817
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Nivolumab — BIOLOGICAL
    specified dose on specified days
  • Ipilimumab — BIOLOGICAL
    specified dose on specified days
  • Nab-paclitaxel — DRUG
    specified dose on specified days

Study Details

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.

Key Dates

Start date
Sep 22, 2020
Status verified
Dec 2022
Primary completion
Aug 15, 2022
Completion
Aug 15, 2022

Study Design

Enrollment
12 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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.
  • 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.
  • 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.

Primary Outcome Measure

Incidence of Adverse Events (AEs) [ Time Frame: Up to 3 years ]

Locations (8)

FacilityCityStateZIPSite coordinators
Local InstitutionLos AngelesCalifornia90033-
Local Institution - 0003SacramentoCalifornia95817-
Local Institution - 0009AuroraColorado80045-
Local Institution - 0002St LouisMissouri63110-
Local Institution - 0008New YorkNew York10016-
Local InstitutionPittsburghPennsylvania15213-
Local InstitutionDallasTexas75390-
South Texas Accelerated Research TherapeuticsSan AntonioTexas78229-

Find similar trials in Los Angeles, CA

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Local Institution· Los Angeles, CALocal Institution - 0003· Sacramento, CALocal Institution - 0009· Aurora, COLocal Institution - 0002· St Louis, MOLocal Institution - 0008· New York, NYLocal Institution· Pittsburgh, PA

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