Breast Cancer
Conditions
Keywords
Early stage, Resectable, Ipilimumab, Nivolumab, Cryoablation, 16-495
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.
Interventions
PROCEDURECryoablation
DRUGIpilimumab
DRUGNivolumab
Sponsors
Bristol-Myers Squibb
Memorial Sloan Kettering Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Evaluated for Adverse Events | 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 5 |
| Total | 5 |
Baseline characteristics
| Characteristic | Cryoablation and Immune Therapy |
|---|---|
| Age, Continuous | 54 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 3 Participants |
| Region of Enrollment United States | 5 Participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 5 |
| other Total, other adverse events | 5 / 5 |
| serious Total, serious adverse events | 1 / 5 |
Outcome results
Primary
Number of Participants Evaluated for Adverse Events
Safety will be evaluated for all treated subjects using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events v4.0 (CTCAE).
Time frame: 12 weeks after ipilimumab/nivolumab administration.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cryoablation and Immune Therapy | Number of Participants Evaluated for Adverse Events | 5 Participants |