Study Summary
This trial is testing whether two cancer treatments, cryoablation and immune therapy, are safe to use together in women with early stage breast cancer.
Eligible Conditions
- Breast Cancer
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 0 Secondary · Reporting Duration: 12 weeks after ipilimumab/nivolumab administration.
Week 12
Number of adverse events
Trial Safety
Safety Progress
Side Effects for
3/Arm B - Tremelimumab + TACE
100%Hyponatremia
92%Hypoalbuminemia
92%Lymphocyte count decreased
92%Anemia
83%Alkaline phosphatase increased
83%Alanine aminotransferase increased
83%Aspartate aminotransferase increased
75%Activated partial thromboplastin time prolonged
75%Hypophosphatemia
67%Nausea
67%Fatigue
67%Constipation
67%Pain
67%Blood bilirubin increased
58%Fever
58%Insomnia
50%Abdominal pain
50%Diarrhea
50%Creatinine increased
50%Serum amylase increased
42%Hypokalemia
42%Hyperkalemia
42%Anorexia
42%Cough
42%Rash maculo-papular
42%Hypercalcemia
42%Platelet count decreased
25%Dehydration
25%Vomiting
25%Hypocalcemia
25%Ascites
25%Back pain
25%Hypomagnesemia
17%Edema limbs
17%Colitis
17%Hypermagnesemia
17%Weight loss
17%Neutrophil count decreased
17%Confusion
17%Bloating
17%Hypotension
17%Hypernatremia
17%Blurred vision
17%Gastrointestinal disorders - Other, gastrointestinal disorders - Other, cramping
17%Lipase increased
17%Headache
17%Dizziness
17%Dyspnea
17%Hyperhidrosis
8%Papulopustular rash
8%Peripheral motor neuropathy
8%Bronchial infection
8%Edema trunk
8%Flushing
8%Ileus
8%Myalgia
8%Pneumothorax
8%Skin and subcutaneous tissue disorders - Other, skin discoloration
8%Gastroesophageal reflux disease
8%Palpitations
8%Skin and subcutaneous tissue disorders - Other, skin peeling - bil. Hands
8%Malaise
8%Hypoxia
8%Hiccups
8%Skin infection
8%Atrial fibrillation
8%Intra-abdominal hemorrhage
8%Gastrointestinal disorders - Other, Inguinal hernia
8%Muscle weakness left-sided
8%Abdominal distension
8%Hypertension
8%Alopecia
8%Adrenal insufficiency
8%Anxiety
8%Allergic rhinitis
8%Dysgeusia
8%Erectile dysfunction
8%Hypothyroidism
8%Flu like symptoms
8%Skin hyperpigmentation
8%Urinary frequency
8%Hoarseness: voice changes
8%Lung infection
8%Depression
8%Dry mouth
8%Gastric ulcer
8%Palmar-plantar erythrodysesthesia syndrome
8%Vertigo
8%Hyperthyroidism
8%Dry skin
8%Infections and infestations - Other, C. Diff infection
8%Generalized muscle weakness
8%Seizure
8%CPK increased
8%Dry eye
8%Atrial flutter
8%Hypersomnia
8%Respiratory, thoracic and mediastinal disorders - Other, Pneumonia
8%Epistaxis
8%Sore throat
8%Rash acneiform
Trial Design
1 Treatment Group
Cryoablation and Immune Therapy
1 of 1
Experimental Treatment
5 Total Participants · 1 Treatment Group
Primary Treatment: Cryoablation · No Placebo Group · N/A
Cryoablation and Immune TherapyExperimental Group · 3 Interventions: Ipilimumab, Cryoablation, Nivolumab · Intervention Types: Drug, Procedure, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ipilimumab
FDA approved
Cryoablation
2016
Completed Phase 2
~930
Nivolumab
FDA approved
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 12 weeks after ipilimumab/nivolumab administration.
Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,832 Previous Clinical Trials
584,533 Total Patients Enrolled
192 Trials studying Breast Cancer
93,764 Patients Enrolled for Breast Cancer
Bristol-Myers SquibbIndustry Sponsor
2,500 Previous Clinical Trials
3,927,997 Total Patients Enrolled
49 Trials studying Breast Cancer
8,288 Patients Enrolled for Breast Cancer
Elizabeth Comen, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
Eligibility Criteria
Age 18+ · Female Participants · 10 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You have HER2-positive breast cancer.
The ER, PR and HER2 testing in progress (i.e.
You have a tumor measuring 1.5 cm or more in maximal diameter.
Who else is applying?
What state do they live in?
| Florida | 50.0% |
| New York | 50.0% |
How old are they?
| 18 - 65 | 100.0% |
What site did they apply to?
| Memorial Sloan Kettering Cancer Center | 100.0% |
What portion of applicants met pre-screening criteria?
| Met criteria | 100.0% |
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Conditions
Cancer Related
Treatments