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Completed

NCT Number: NCT04132817

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Local Institution, Los Angeles, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nivolumab

Biological

specified dose on specified days

Ipilimumab

Biological

specified dose on specified days

Nab-paclitaxel

Drug

specified dose on specified days

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

A Phase 1 Multi-Targeted Study to Promote Anti-Tumor Immunity in ER Positive, HER2 Negative Advanced Breast Cancer

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Oct 21, 2019
Registry last updated
Dec 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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