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Breast CancerPhase 1NCT04132817

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

A Phase 1 study testing Nivolumab, Ipilimumab and Nab-paclitaxel in people with Breast Cancer, run by Bristol-Myers Squibb at 8 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Breast Cancer
What is being tested?
Nivolumab, Ipilimumab and Nab-paclitaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
8 sitesUnited States
Study dates
22 Sep 2020to 15 Aug 2022
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

United States8 sites

  • Local Institution - 0009

    Aurora, Colorado, 80045

  • Local Institution

    Dallas, Texas, 75390

  • Local Institution

    Los Angeles, California, 90033

  • Local Institution - 0008

    New York, New York, 10016

  • Local Institution

    Pittsburgh, Pennsylvania, 15213

  • Local Institution - 0003

    Sacramento, California, 95817

  • South Texas Accelerated Research Therapeutics

    San Antonio, Texas, 78229

  • Local Institution - 0002

    St Louis, Missouri, 63110

Other trials in United States

About this study

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

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.

Conditions
Breast Cancer
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04132817
Study groupRoleWhat they receive
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.
Receives: Biological: Nivolumab; Drug: 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.
Receives: Biological: Nivolumab; Biological: Ipilimumab; Drug: 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.
Receives: Biological: Nivolumab; Biological: Ipilimumab; Drug: Nab-paclitaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of Adverse Events (AEs)

    Measured: Up to 3 years

  2. Incidence of Serious Adverse Events (SAEs)

    Measured: Up to 3 years

  3. Incidence of AEs leading to dose and asset limiting toxicity (DALT)

    Measured: 8 weeks following initial dose

  4. Incidence of AEs leading to discontinuation

    Measured: Up to 3 years

  5. Incidence of laboratory abnormalities

    Measured: Up to 3 years

Secondary outcomes (4)

  1. Change from baseline in programmed cell death receptor-ligand 1 (PD-L1) by immunohistochemistry (IHC)

    Measured: Day 0, Day 22, Day 50

  2. Objective Response Rate (ORR)

    Measured: 24 weeks

  3. Median duration of response (mDOR)

    Measured: 24 weeks

  4. Progression-free survival rate (PFSR)

    Measured: 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Oct 2019
  2. Study start22 Sep 2020
  3. Primary completion15 Aug 2022
  4. Study completion15 Aug 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04132817
Sponsor's protocol ID
CA048-001
Status last verified
Dec 2022
First submitted
2 Oct 2019
Last updated
2 Dec 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Nivolumab, Ipilimumab and Nab-paclitaxel in people with Breast Cancer, run by Bristol-Myers Squibb at 8 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Adverse Events (AEs) (time frame: Up to 3 years). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04132817.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2022.

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