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Carboplatin, Nab-Paclitaxel and Pembrolizumab for Metastatic Triple-Negative Breast Cancer

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ClinicalTrials.gov Identifier: NCT03121352
Recruitment Status : Recruiting
First Posted : April 20, 2017
Last Update Posted : August 29, 2018
Sponsor:
Information provided by (Responsible Party):
Joseph Baar, MD, PhD, Case Comprehensive Cancer Center

Brief Summary:

The purpose of this study is to see how effective the combination of the two chemotherapy drugs (carboplatin and nab-paclitaxel) are when added to a third drug, pembrolizumab.

Pembrolizumab is an investigational (experimental) drug that works by reinvigorating the immune system, allowing it to target and destroy cancer cells. Pembrolizumab is experimental because it is not approved by the Food and Drug Administration (FDA) for this type of breast cancer treatment.


Condition or disease Intervention/treatment Phase
Metastatic Triple Negative Breast Cancer Drug: Carboplatin Drug: Nab-paclitaxel Drug: Pembrolizumab Phase 2

Detailed Description:

Primary Objective - Determine overall response rate (ORR) in patients treated with CNP

Secondary Objective(s)

  • Determine progression-free survival (PFS), and disease control rate (DCR) in patients treated with CNP.
  • Determine duration of response in patients treated with CNP.
  • Determine safety/tolerability of CNP.

Correlative Endpoints

- Identify pathologic and genomic correlates of response to CNP.

Study design including dose escalation / cohorts This is prospective pilot clinical trial of CNP in up to 30 patients with mTNBC


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study of Carboplatin, Nab-Paclitaxel and Pembrolizumab for Metastatic Triple-Negative Breast Cancer
Actual Study Start Date : May 19, 2017
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Carboplatin + Nab-paclitaxel + Pembrolizumab
Combination therapy of Carboplatin, Nab-paclitaxel, and Pembrolizumab
Drug: Carboplatin
AUC 4.5 IV day 1 of 21-day cycle

Drug: Nab-paclitaxel
75mg/m2 IV days 1, 8 and 15 of 21-day cycle
Other Name: Abraxane

Drug: Pembrolizumab
200 mg IV every 21 days
Other Name: MK-3475




Primary Outcome Measures :
  1. Determine overall response rate (ORR) in patients treated with CNP [ Time Frame: Up to 24 months ]
    The number of people with tumor responses according to RECIST (V1.1). These responses include Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study


Secondary Outcome Measures :
  1. Determine progression-free survival (PFS) in patients treated with CNP [ Time Frame: Up to 24 months ]
    Average time (in months) patient's tumors did not progress according to the RECIST criteria (V1.1). Progressive disease is defined as Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm

  2. Determine disease control rate (DCR) in patients treated with CNP [ Time Frame: Up to 24 months ]
    the percentage of patients with advanced or metastatic cancer who have achieved complete response, partial response and stable disease to a therapeutic intervention. Responses are defined as Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm or Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study

  3. Determine duration of response in patients treated with CNP [ Time Frame: Up to 24 months ]
    Average time patients have a response, as defined by the RECIST criteria (V1.1). Response includes: Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm or Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects must have histologically or cytologically confirmed metastatic triple negative breast cancer
  • Subjects must have received no more than 2 prior therapies for this disease
  • ECOG Performance Status 0-1
  • Subjects must have normal organ and marrow function as defined below:

    • Hemoglobin ≥ 10.0 g/dl
    • Absolute neutrophil count ≥ 1,000/μL
    • Platelet count ≥ 100,000/μL
    • Total bilirubin within normal institutional limits
    • AST (SGOT) ≤ 2.5 X institutional upper limit of normal
    • ALT (SGPT) ≤ 2.5 X institutional upper limit of normal
    • Serum creatinine ≤ 1.5 normal institutional limits
  • Life expectancy of 12 weeks or more
  • Subjects must have the ability to understand and the willingness to sign a written informed consent document
  • Subjects must have measurable disease per RECIST v1.1
  • Subjects must be willing to undergo a preliminary biopsy of a metastatic focus for research purposes. A second post-treatment biopsy will be offered but will not be mandated

Exclusion Criteria:

  • Prior treatment toxicities have not resolved to ≤ Grade 1 according to NCI CTCAE Version 4.0 (except for alopecia and neuropathy)
  • Subjects receiving any other investigational agents
  • Subjects with radiographically stable treated brain metastases are eligible but must not have been on steroid therapy for at least 4 weeks
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to nab-paclitaxel, carboplatin, pembrolizumab, or other agents used in this study
  • Subjects with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Pregnant or breastfeeding women are excluded from this study
  • Patients with conditions requiring immunosuppressive medications or chronic infections (including HIV infection, hepatitis B and C)
  • Patients with chronic autoimmune disease
  • Patients with prior therapy with antibodies that modulate T-cell function (e.g., anti-PD-1, anti-PD-L1)
  • Patients with evidence of active, non-infectious pneumonia
  • Patients active infection requiring intravenous systemic therapy
  • Patients with known psychiatric or substance abuse disorders that would interfere with cooperation with requirements of the trial
  • Patients who have received a live vaccine within 30 days prior to the first dose of pembrolizumab
  • Patients with a known additional malignancy that is progressing or requires active treatment (within the last 5 years). Exceptions: basal cell carcinoma of the skin, squamous cell carcinoma of the skin or in situ cervical cancer that has undergone potentially curative therapy
  • Patients who have received monoclonal anti-cancer antibody within 4 weeks of first dose of study drugs
  • Patients who have received chemotherapy, small molecule targeted therapy or radiation within the 2 weeks of first dose of study drugs
  • Patients who have participated in MK-3475 Merck studies
  • Patients with carcinomatous meningitis

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): NCT03121352


Contacts
Contact: Joseph Baar, MD 216-844-8683 joseph.baar@uhhospitals.org
Contact: Jame Abraham, MD 216-444-6833 abrahaj5@ccf.org

Locations
United States, Ohio
University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center Recruiting
Cleveland, Ohio, United States, 44106
Contact: Joseph Baar, MD, PhD    216-844-8683    joseph.baar@uhhospitals.org   
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center Suspended
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
Case Comprehensive Cancer Center
Investigators
Principal Investigator: Joseph Baar, MD University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center

Responsible Party: Joseph Baar, MD, PhD, Associate Professor of Medicine, Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT03121352     History of Changes
Other Study ID Numbers: CASE6115
First Posted: April 20, 2017    Key Record Dates
Last Update Posted: August 29, 2018
Last Verified: August 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Joseph Baar, MD, PhD, Case Comprehensive Cancer Center:
Carboplatin
Nab-Paclitaxel
Pembrolizumab

Additional relevant MeSH terms:
Breast Neoplasms
Triple Negative Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Paclitaxel
Pembrolizumab
Albumin-Bound Paclitaxel
Carboplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action