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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 : July 17, 2019
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Procedure: Cryoablation Drug: Ipilimumab Drug: Nivolumab Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 5 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study of Pre-Operative, Single-Dose Ipilimumab, Nivolumab and Cryoablation in Early Stage/Resectable Breast Cancer
Actual Study Start Date : June 2016
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
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.
Procedure: Cryoablation
Drug: Ipilimumab
Drug: Nivolumab



Primary Outcome Measures :
  1. 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).



Information from the National Library of Medicine

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

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.

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): NCT02833233


Locations
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United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Bristol-Myers Squibb
Investigators
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Principal Investigator: Elizabeth Comen, MD Memorial Sloan Kettering Cancer Center

Additional Information:
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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT02833233     History of Changes
Other Study ID Numbers: 16-495
First Posted: July 14, 2016    Key Record Dates
Last Update Posted: July 17, 2019
Last Verified: July 2018
Keywords provided by Memorial Sloan Kettering Cancer Center:
Early stage
Resectable
Ipilimumab
Nivolumab
Cryoablation
16-495
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Nivolumab
Ipilimumab
Antineoplastic Agents, Immunological
Antineoplastic Agents