Ignite Creation Date:
2025-12-24 @ 5:38 PM
Ignite Modification Date:
2025-12-31 @ 1:34 AM
Study NCT ID:
NCT06246968
Status:
RECRUITING
Last Update Posted:
2025-05-21
First Post:
2024-01-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Pembrolizumab and Cryoablation in People With Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D064726', 'term': 'Triple Negative Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C582435', 'term': 'pembrolizumab'}, {'id': 'D003452', 'term': 'Cryosurgery'}], 'ancestors': [{'id': 'D055011', 'term': 'Ablation Techniques'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-01-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2027-01-29', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-16', 'studyFirstSubmitDate': '2024-01-30', 'studyFirstSubmitQcDate': '2024-01-30', 'lastUpdatePostDateStruct': {'date': '2025-05-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-01-29', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in CD4-PD1 from baseline to post-cryoablation', 'timeFrame': '6 weeks after cryoablation', 'description': 'Assess changes in CD4-PD1 in the blood after cryoablation in patients with metastatic or locally advanced triple negative breast cancer (TNBC).'}]}, 'oversightModule': {'isUsExport': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['metastatic TNBC', 'metastatic triple negative breast carcinoma', 'metastatic breast cancer', 'breast cancer', 'breast cancer stage IV', 'triple negative breast cancer', 'pembrolizumab', 'cryoablation', 'Memorial Sloan Kettering Cancer Center', '23-390', 'locally advanced breast cancer', 'locally advanced triple negative breast carcinoma', 'locally advanced triple negative breast cancer'], 'conditions': ['Metastatic Breast Cancer', 'Breast Cancer', 'Breast Cancer Stage IV', 'Triple Negative Breast Cancer', 'Triple Negative Breast Neoplasms', 'Metastatic Triple-Negative Breast Carcinoma', 'Locally Advanced Breast Cancer', 'Locally Advanced Triple-Negative Breast Carcinoma']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mskcc.org', 'label': 'Memorial Sloan Kettering Cancer Center'}]}, 'descriptionModule': {'briefSummary': 'Participants will have a confirmed diagnosis of metastatic breast cancer and will receive pembrolizumab in combination with cryoablation OR pembrolizumab alone. Participants will be randomly assigned.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients ≥ 18 years of age\n* Confirmed histologic diagnosis of metastatic TNBC\n* 1 site amenable cryoablation of at least 1.5 cm in size as determined by an Interventional Radiologist. Eligible cryoablation sites include (but not limited to) soft tissue, liver, lung, and bone as determined by an Interventional Radiologist to be safest and most feasible.\n* Physically fit (clinically eligible) to undergo cryoablation as per usual clinical practice\n* Per clinical guidelines, women of childbearing age should use effective contraception during treatment with pembrolizumab and for at least 4 months after the last dose of the drug, which will be assessed and monitored by, and the responsibility of, the patient\'s medical oncologist (not study investigators or research team) as pembrolizumab is standard of care. Memorial Sloan Kettering Cancer Center Pregnancy Standards will be followed prior to cryoablation. That is, female patients that are 11-50 years of age and of childbearing potential will undergo a pregnancy test within 2 weeks (15 days) before cryoablation. Pregnancy test will not be required in patients with bilateral oophorectomy, bilateral salpingectomy, bilateral salpingectomy-oophorectomy, hysterectomy, menopause (no menses ≥ 1 year prior to treatment or after completion of all treatment), or surgical sterilization (i.e. tubal ligation or blockage), with documentation of permanent exemptions in CIS ("Pregnancy Testing Exemption").\n* Pembrolizumab therapy (200 mg every 3 weeks) planned as part of standard of care as first, second, or third line of therapy\n\n * Eligible for PD-1 inhibitor per the patient\'s medical oncologist, with planned treatment with PD-1 inhibitor per the patient\'s medical oncologist. Additional systemic therapy is per the patient\'s medical oncologist. The following systemic therapy will be accepted (the timing of the systemic therapy relative to pembrolizumab and cryoablation is not restricted):\n\n * Capecitabine (Xeloda, available as a generic drug)\n * Carboplatin (Paraplatin, available as a generic drug)\n * Cisplatin (Platinol, available as a generic drug)\n * Cyclophosphamide (Cytoxan, available as a generic drug)\n * Docetaxel (Taxotere)\n * Doxorubicin (Adriamycin, available as a generic drug)\n * Pegylated liposomal doxorubicin (Doxil)\n * Epirubicin (Ellence, available as a generic drug)\n * Eribulin (Halaven)\n * Fluorouracil (5-FU, Adrucil, available as a generic drug)\n * Gemcitabine (Gemzar, available as a generic drug)\n * Ixabepilone (Ixempra)\n * Methotrexate (available as a general drug)\n * Nab-paclitaxel (Abraxane)\n * Paclitaxel (Taxol, available as a generic drug)\n * Vinorelbine (Navelbine, available as a generic drug)\n\nExclusion Criteria:\n\n* Patient not eligible for PD-1 inhibitor per the patient\'s medical oncologist\n* No disease amenable for cryoablation\n* Pembrolizumab therapy not planned as part of standard of care'}, 'identificationModule': {'nctId': 'NCT06246968', 'briefTitle': 'A Study of Pembrolizumab and Cryoablation in People With Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Memorial Sloan Kettering Cancer Center'}, 'officialTitle': 'Does Cryoablation Boost Immune Response Improving the Benefits of Pembrolizumab in Patients With Metastatic or Locally Advanced Triple Negative Breast Cancer?', 'orgStudyIdInfo': {'id': '23-390'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pembrolizumab + Cryoablation', 'description': 'Participants will have a diagnosis of metastatic triple negative breast cancer or locally advanced inoperable triple negative breast cancer. Participants will be randomized 2 (cryoablation arm): 1 (no cryoablation arm).', 'interventionNames': ['Drug: Pembrolizumab', 'Device: Cryoablation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Pembrolizumab', 'description': 'Participants will have a diagnosis of metastatic triple negative breast cancer or locally advanced inoperable triple negative breast cancer. Participants will be randomized 2 (cryoablation arm): 1 (no cryoablation arm).', 'interventionNames': ['Drug: Pembrolizumab']}], 'interventions': [{'name': 'Pembrolizumab', 'type': 'DRUG', 'description': 'Participants will receive Pembrolizumab as part of standard of care treatment.', 'armGroupLabels': ['Pembrolizumab', 'Pembrolizumab + Cryoablation']}, {'name': 'Cryoablation', 'type': 'DEVICE', 'description': 'Cryoablation is a type of thermal ablation that is a minimally invasive alternative technique to surgical resection.', 'armGroupLabels': ['Pembrolizumab + Cryoablation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '07920', 'city': 'Basking Ridge', 'state': 'New Jersey', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Yolanda Bryce, MD', 'role': 'CONTACT', 'phone': '212-639-6530'}], 'facility': 'Memorial Sloan Kettering Cancer Center at Basking Ridge (Limited Protocol Activities)', 'geoPoint': {'lat': 40.70621, 'lon': -74.54932}}, {'zip': '07748', 'city': 'Middletown', 'state': 'New Jersey', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Yolanda Bryce, MD', 'role': 'CONTACT', 'phone': '212-639-6530'}], 'facility': 'Memorial Sloan Kettering Monmouth (Limited protocol activities)', 'geoPoint': {'lat': 40.39428, 'lon': -74.11709}}, {'zip': '07645', 'city': 'Montvale', 'state': 'New Jersey', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Yolanda Bryce, MD', 'role': 'CONTACT', 'phone': '212-639-6530'}], 'facility': 'Memorial Sloan Kettering Bergen (Limited Protocol Activities)', 'geoPoint': {'lat': 41.04676, 'lon': -74.02292}}, {'zip': '11725', 'city': 'Commack', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Yolanda Bryce, MD', 'role': 'CONTACT', 'phone': '212-639-6530'}], 'facility': 'Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities )', 'geoPoint': {'lat': 40.84288, 'lon': -73.29289}}, {'zip': '10604', 'city': 'Harrison', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Yolanda Bryce, MD', 'role': 'CONTACT', 'phone': '212-639-6530'}], 'facility': 'Memorial Sloan Kettering Westchester (Limited Protocol Activities)', 'geoPoint': {'lat': 40.96899, 'lon': -73.71263}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Yolanda Bryce, MD', 'role': 'CONTACT', 'phone': '212-639-6530'}], 'facility': 'Memorial Sloan Kettering Cancer Center (All protocol activites)', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '11553', 'city': 'Rockville Centre', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Yolanda Bryce, MD', 'role': 'CONTACT', 'phone': '212-639-6530'}], 'facility': 'Memorial Sloan Kettering Nassau (Limited Protocol Activites)', 'geoPoint': {'lat': 40.65871, 'lon': -73.64124}}], 'centralContacts': [{'name': 'Yolanda Bryce, MD', 'role': 'CONTACT', 'email': 'brycey@mskcc.org', 'phone': '212-639-6530'}, {'name': 'Larry Norton, MD', 'role': 'CONTACT', 'email': 'nortonl@MSKCC.ORG', 'phone': '646-888-5319'}], 'overallOfficials': [{'name': 'Yolanda Bryce, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Memorial Sloan Kettering Cancer Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Memorial Sloan Kettering Cancer Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}