Breast CancerNCT02833233
A Study of Pre-Operative Treatment With Cryoablation and Immune Therapy in Early Stage Breast Cancer
A study testing Cryoablation, Ipilimumab and Nivolumab in people with Breast Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Cryoablation, Ipilimumab and Nivolumab
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2016to 7 Jun 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
Official title: A Pilot Study of Pre-Operative, Single-Dose Ipilimumab, Nivolumab and Cryoablation in Early Stage/Resectable Breast Cancer
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.
- Conditions
- Breast Cancer
- Being tested
- Cryoablation, Ipilimumab, Nivolumab
- Keywords
- Early stage, Resectable, Ipilimumab, Nivolumab, Cryoablation, 16-495
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CryoablationProcedure or surgery
IpilimumabDrug
NivolumabDrug
| Study group | Role | What they receive |
|---|---|---|
| Cryoablation and Immune Therapy | Experimental | 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. Receives: Procedure: Cryoablation; Drug: Ipilimumab; Drug: Nivolumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 12 weeks after ipilimumab/nivolumab administration.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2016 (estimated)
- Study startJun 2016
- Primary completion7 Jun 2024
- Study completion7 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Responsible party
- Sponsor
- Investigators
- Elizabeth Comen, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02833233
- Sponsor's protocol ID
- 16-495
- Status last verified
- Oct 2024
- First submitted
- 12 Jul 2016
- Last updated
- 23 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Pre-Operative, Single-Dose Ipilimumab, Nivolumab and Cryoablation in Early Stage/Resectable Breast Cancer
- ClinicalTrials.gov ID
- NCT02833233
- Acronym / sponsor ID
- 16-495
- Conditions
- Breast Cancer
- Keywords
- Early stage, Resectable, Ipilimumab, Nivolumab, Cryoablation, 16-495
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Study start
- Jun 2016 (actual)
- Primary completion
- 7 Jun 2024 (actual)
- Study completion
- 7 Jun 2024 (actual)
- First posted
- 14 Jul 2016 (estimated)
- Results
- Posted 23 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cryoablation and Immune Therapy | Experimental | Procedure: Cryoablation, Drug: Ipilimumab, Drug: NivolumabPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (28 listed)
- 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)
- Operable tumor measuring ≥1.5 cm in maximal diameter
- No indication of distant metastases
Key exclusion criteria (10 listed)
- Inflammatory breast cancer
- Medical history and concurrent diseases
- Prohibited Treatments and/or Therapies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cryoablation | Procedure or surgery | Cryoablation and Immune Therapy |
| Ipilimumab | Drug | Cryoablation and Immune Therapy |
| Nivolumab | Drug | Cryoablation and Immune Therapy |
Primary outcome
Number of Participants Evaluated for 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).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabeth Comen, MD principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cryoablation, Ipilimumab and Nivolumab in people with Breast Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site 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 28 inclusion and 10 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 23 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants Evaluated for Adverse Events (time frame: 12 weeks after ipilimumab/nivolumab administration.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Oct 2024.