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A Study of Pre-Operative Treatment With Cryoablation and Immune Therapy in Early Stage Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02833233
Recruitment Status : Active, not recruiting
First Posted : July 14, 2016
Last Update Posted : September 17, 2020
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Tracking Information
First Submitted Date  ICMJE July 12, 2016
First Posted Date  ICMJE July 14, 2016
Last Update Posted Date September 17, 2020
Actual Study Start Date  ICMJE June 2016
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 13, 2016)
Number of adverse events [ Time Frame: 12 weeks after ipilimumab/nivolumab administration. ]
Safety will be evaluated for all treated subjects using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events v4.0 (CTCAE).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Pre-Operative Treatment With Cryoablation and Immune Therapy in Early Stage Breast Cancer
Official Title  ICMJE A Pilot Study of Pre-Operative, Single-Dose Ipilimumab, Nivolumab and Cryoablation in Early Stage/Resectable Breast Cancer
Brief Summary This study is being done to evaluate the safety of combining two strategies called "cryoablation" and "immune therapy" in women with curable early stage breast cancer.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Breast Cancer
Intervention  ICMJE
  • Procedure: Cryoablation
  • Drug: Ipilimumab
  • Drug: Nivolumab
Study Arms  ICMJE Experimental: Cryoablation and Immune Therapy
Patients will undergo breast biopsy with cryoablation 7-10 days prior to the planned surgery, and ipilimumab with nivolumab administration 1-5 days before cryoablation. All patients will undergo surgery at the pre-determined day defined at the initial surgical consultation. Women will receive ipilimumab and nivolumab 1-5 days prior to US or MRI-guided core biopsy and cryoablation date. Intravenous ipilimumab will be administered as a single 1 mg/kg dose to be infused intravenously over 90 minutes. Intravenous nivolumab will be administered as a single 3 mg/kg dose to be infused intravenously over 60 minutes.
Interventions:
  • Procedure: Cryoablation
  • Drug: Ipilimumab
  • Drug: Nivolumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: November 1, 2017)
5
Original Estimated Enrollment  ICMJE
 (submitted: July 13, 2016)
6
Estimated Study Completion Date  ICMJE June 2021
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Women age 18 years or older
  • Confirmed histologic diagnosis of invasive adenocarcinoma of the breast, including MSKCC pathology confirmation
  • ER, PR and HER2 testing in progress (i.e. on outside or MSKCC biopsy report)

    • HER2-positive pathology is permitted
  • Operable tumor measuring ≥1.5 cm in maximal diameter

    • Any nodal status
    • Multifocal and multicentric disease is permitted
    • Synchronous bilateral invasive breast cancer is permitted
    • The tumor should be more than 5 mm from the skin
  • No indication of distant metastases
  • Breast surgery planned
  • Tumor amenable to cryoablation as determined by radiologist
  • ECOG performance status score of 0 or 1
  • Screening laboratory values must meet the following criteria:

    • White blood cells (WBCs) ≥ 2000/μL
    • Absolute neutrophil count (ANC) ≥ 1500/μL
    • Platelets ≥ 100 x 10^3/μL
    • Hemoglobin ≥ 11.0 g/dL
    • Serum creatinine ≤ 2 mg/dL (or glomerular filtration rate ≥ 40 ml/min)
    • AST ≤ 2.5 x upper limit of normal (ULN)
    • ALT ≤ 2.5 x ULN
    • Bilirubin within normal limits (except subjects with Gilbert's syndrome, who must have total bilirubin < 3.0 mg/dL)
    • Negative HIV screening test
    • Negative screening tests for Hepatitis B and Hepatitis C. Patients with positive results that do not indicate true active or chronic infection may enroll after discussion and consensus agreement by the treating physician and principal investigator.
  • Women of childbearing potential (WOCBP) must be using an acceptable method of contraception to avoid pregnancy throughout the study and for at least 3 months after the last dose of ipilimumab in such a manner that the risk of pregnancy is minimized. See below for the definition of WOCBP.
  • WOCBP must have a negative serum pregnancy test within 14 days prior to the first dose of ipilimumab/nivolumab
  • Women must not be breastfeeding
  • Willing to adhere to the study visit schedule and the prohibitions and restrictions specified in this protocol.

Exclusion Criteria:

  • Inflammatory breast cancer
  • Medical history and concurrent diseases

    • Subjects with active, known or suspected autoimmune disease. Subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
    • Any serious or uncontrolled medical disorder that, in the opinion of the investigator, may increase the risk associated with study participation or study drug administration, impair the ability of the subject to receive protocol therapy, or interfere with the interpretation of study results.
  • Prohibited Treatments and/or Therapies

    • Chronic use of immunosuppressants and/or systemic corticosteroids (used in the management of cancer or non-cancer-related illnesses). However, use of corticosteroids is allowed for the treatment of immune related Adverse Events (irAEs), or adrenal insufficiency.
    • Any non-oncology vaccine therapy used for prevention of infectious diseases within 4 weeks prior to first dose of ipilimumab.
    • Prior treatment with a CD137 agonist, ipilimumab or other CTLA4 inhibitor;
    • Prior investigational agents within 2 weeks prior to first dose of ipilimumab;
    • Prior therapy with any anti-cancer agents including chemotherapy, adjuvant chemotherapy, immunosuppressive agents, surgery or radiotherapy within 2 weeks prior to first dose of ipilimumab.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02833233
Other Study ID Numbers  ICMJE 16-495
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Memorial Sloan Kettering Cancer Center
Study Sponsor  ICMJE Memorial Sloan Kettering Cancer Center
Collaborators  ICMJE Bristol-Myers Squibb
Investigators  ICMJE
Principal Investigator: Elizabeth Comen, MD Memorial Sloan Kettering Cancer Center
PRS Account Memorial Sloan Kettering Cancer Center
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP