Ignite Creation Date:
2025-12-24 @ 7:36 PM
Ignite Modification Date:
2025-12-29 @ 8:17 AM
Study NCT ID:
NCT04620603
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-11-06
First Post:
2020-11-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Low-Dose-Rate Brachytherapy Combined With Immune Checkpoint Inhibition in Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000096142', 'term': 'Melanoma, Cutaneous Malignant'}, {'id': 'D002292', 'term': 'Carcinoma, Renal Cell'}], 'ancestors': [{'id': 'D008545', 'term': 'Melanoma'}, {'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D018326', 'term': 'Nevi and Melanomas'}, {'id': 'D012878', 'term': 'Skin Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D007680', 'term': 'Kidney Neoplasms'}, {'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-05-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-02-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-05', 'studyFirstSubmitDate': '2020-11-04', 'studyFirstSubmitQcDate': '2020-11-04', 'lastUpdatePostDateStruct': {'date': '2025-11-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2020-11-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with tumor response assessed by Immunotherapy Response Evaluation Criteria in Solid Tumors (iRECIST)', 'timeFrame': '3 months after brachytherapy', 'description': 'iRECIST was developed by the RECIST working group for the use of RECIST version 1.1 in cancer immunotherapy trials, to ensure consistent design and data collection.\n\nORR is defined as the number of patients achieving a complete response (CR) or partial response (PR) based on iRECIST or RECIST v1.1 at any time during the study. CR = disappearance of all target lesions, PR is =\\>30% decrease in sum of diameters of target lesions, progressive disease (PD) is \\>20% increase in sum of diameters of target lesions, stable disease (SD) is \\<30% decrease or \\<20% increase in sum of diameters of target lesions. Estimation based on CT or MRI scans'}, {'measure': 'Number of participants with tumor response assessed by Immunotherapy Response Evaluation Criteria in Solid Tumors (iRECIST)', 'timeFrame': '6 months after brachytherapy', 'description': 'iRECIST was developed by the RECIST working group for the use of RECIST version 1.1 in cancer immunotherapy trials, to ensure consistent design and data collection.\n\nORR is defined as the number of patients achieving a complete response (CR) or partial response (PR) based on iRECIST or RECIST v1.1 at any time during the study. CR = disappearance of all target lesions, PR is =\\>30% decrease in sum of diameters of target lesions, progressive disease (PD) is \\>20% increase in sum of diameters of target lesions, stable disease (SD) is \\<30% decrease or \\<20% increase in sum of diameters of target lesions. Estimation based on CT or MRI scans'}, {'measure': 'Number of participants with tumor response assessed by Immunotherapy Response Evaluation Criteria in Solid Tumors (iRECIST)', 'timeFrame': '9 months after brachytherapy', 'description': 'iRECIST was developed by the RECIST working group for the use of RECIST version 1.1 in cancer immunotherapy trials, to ensure consistent design and data collection.\n\nORR is defined as the number of patients achieving a complete response (CR) or partial response (PR) based on iRECIST or RECIST v1.1 at any time during the study. CR = disappearance of all target lesions, PR is =\\>30% decrease in sum of diameters of target lesions, progressive disease (PD) is \\>20% increase in sum of diameters of target lesions, stable disease (SD) is \\<30% decrease or \\<20% increase in sum of diameters of target lesions. Estimation based on CT or MRI scans'}, {'measure': 'Number of participants with tumor response assessed by Immunotherapy Response Evaluation Criteria in Solid Tumors (iRECIST)', 'timeFrame': '12 months after brachytherapy', 'description': 'iRECIST was developed by the RECIST working group for the use of RECIST version 1.1 in cancer immunotherapy trials, to ensure consistent design and data collection.\n\nORR is defined as the number of patients achieving a complete response (CR) or partial response (PR) based on iRECIST or RECIST v1.1 at any time during the study. CR = disappearance of all target lesions, PR is =\\>30% decrease in sum of diameters of target lesions, progressive disease (PD) is \\>20% increase in sum of diameters of target lesions, stable disease (SD) is \\<30% decrease or \\<20% increase in sum of diameters of target lesions. Estimation based on CT or MRI scans'}, {'measure': 'Number of participants with tumor response assessed by RECIST v1.1', 'timeFrame': '3 months after brachytherapy', 'description': 'ORR is defined as the number of patients achieving a complete response (CR) or partial response (PR) based on the Response Evaluation Criteria in Solid Tumors (iRECIST or RECIST v1.1) at any time during the study. CR = disappearance of all target lesions, PR is =\\>30% decrease in sum of diameters of target lesions, progressive disease (PD) is \\>20% increase in sum of diameters of target lesions, stable disease (SD) is \\<30% decrease or \\<20% increase in sum of diameters of target lesions. Estimation based on CT or MRI scans'}, {'measure': 'Number of participants with tumor response assessed by RECIST v1.1', 'timeFrame': '6 months after brachytherapy', 'description': 'ORR is defined as the number of patients achieving a complete response (CR) or partial response (PR) based on iRECIST or RECIST v1.1 at any time during the study. CR = disappearance of all target lesions, PR is =\\>30% decrease in sum of diameters of target lesions, progressive disease (PD) is \\>20% increase in sum of diameters of target lesions, stable disease (SD) is \\<30% decrease or \\<20% increase in sum of diameters of target lesions. Estimation based on CT or MRI scans'}, {'measure': 'Number of participants with tumor response assessed by RECIST v1.1', 'timeFrame': '9 months after brachytherapy', 'description': 'ORR is defined as the number of patients achieving a complete response (CR) or partial response (PR) based on iRECIST or RECIST v1.1 at any time during the study. CR = disappearance of all target lesions, PR is =\\>30% decrease in sum of diameters of target lesions, progressive disease (PD) is \\>20% increase in sum of diameters of target lesions, stable disease (SD) is \\<30% decrease or \\<20% increase in sum of diameters of target lesions. Estimation based on CT or MRI scans'}, {'measure': 'Number of participants with tumor response assessed by RECIST v1.1', 'timeFrame': '12 months after brachytherapy', 'description': 'ORR is defined as the number of patients achieving a complete response (CR) or partial response (PR) based on iRECIST or RECIST v1.1 at any time during the study. CR = disappearance of all target lesions, PR is =\\>30% decrease in sum of diameters of target lesions, progressive disease (PD) is \\>20% increase in sum of diameters of target lesions, stable disease (SD) is \\<30% decrease or \\<20% increase in sum of diameters of target lesions. Estimation based on CT or MRI scans'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Brachytherapy'], 'conditions': ['Cutaneous Malignant Melanoma', 'Renal Cell Cancer', 'Urothelial Cancer of Renal Pelvis']}, 'descriptionModule': {'briefSummary': 'This is a pilot study of combination low dose rate brachytherapy (LDR) added to standard of care (SOC) immunotherapy in stage III and IV melanoma, stage IV renal call cancer, and stage IV urothelial cancer.', 'detailedDescription': 'The purpose of this study is to evaluate the effect of combining LDR with immune checkpoint inhibition in stage III and IV melanoma, stage IV renal call cancer, and stage IV urothelial cancer. This involves the addition of a treatment called brachytherapy to SOC immunotherapy. Brachytherapy is a form of radiation therapy where radioactive pellets are placed within a tumor to temporarily irradiate the tumor at a low level. This is the first time that this combination (immunotherapy and brachytherapy) has been used in humans.\n\nThe objectives of this study are to evaluate the effect of combining LDR with immunotherapy, determine safety and feasibility, generate a toxicity profile, evaluate response, and overall survival.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Participants must have histologically confirmed unresectable stage III or stage IV cutaneous melanoma, stage IV renal cell cancer, and stage IV urothelial cancer.\n* ECOG performance status 0-2.\n* Have measurable disease per RECIST v1.1 or iRECIST. Refer to Appendix B\n* Have the following clinical laboratory values:\n\n * Absolute neutrophil count (ANC) ≥ 1500/ μL\n * Hgb ≥ 9 g/dL\n * Platelet count ≥ 75, 000/ μL\n * Total bilirubin ≤ 1.5 x ULN (upper limit of normal)\n * AST and ALT ≤ 2x ULN\n * Serum Creatinine \\< 2x ULN\n* Female participants who:\n\n * Are postmenopausal for at least 1 year before entering the screening visit, OR\n * Are surgically sterile, OR\n * Agree to practice true abstinence from heterosexual contact or agree to use effective contraception without interruption during the study therapy and 90 days after the last dose.\n* Male participants who:\n\n * Are surgically sterile, OR\n * Agree to practice true abstinence from heterosexual contact or agree to use effective contraception without interruption during the study therapy and 90 days after the last dose.\n\nExclusion Criteria:\n\n* Participants diagnosed with uveal melanoma\n* Participants who have been treated with whole head radiation for brain metastases\n* Invasive cancers not being treated on this trial (i.e. lymphoma that received systemic therapy) diagnosed \\< 3 years prior that required systemic treatment. This is intended to include a patient with melanoma who was diagnosed \\< 3 years prior to screening for this trial that has received antecedent systemic therapy.\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.\n* Prior anti-cancer therapy for melanoma, renal cell cancer, or urothelial cancer less than 14 days prior to first dose of study treatment.\n* Pregnant or nursing females\n* Unwilling or unable to follow protocol requirements.\n* Any condition which in the Investigator's opinion deems the participant an unsuitable candidate to receive study treatment.\n* Other active non-melanoma, non-renal cell, or non-urothelial metastatic cancers requiring systemic treatment.\n* Participants currently receiving systemic corticosteroids doses over 15mg prednisone or equivalent.\n* Participants with uncontrolled HIV or hepatitis."}, 'identificationModule': {'nctId': 'NCT04620603', 'briefTitle': 'Low-Dose-Rate Brachytherapy Combined With Immune Checkpoint Inhibition in Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Case Comprehensive Cancer Center'}, 'officialTitle': 'Low-Dose-Rate Brachytherapy Combined With Immune Checkpoint Inhibition in Cancer', 'orgStudyIdInfo': {'id': 'CASE6620'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LDR + SOC Immunotherapy', 'description': 'Participants will receive one treatment of brachytherapy on treatment day 1 (LDRD1). After a minimum of 7 days but no more than 30 days to allow antigenic release, participants will then begin immunotherapy treatment with SOC immunotherapy at the standard FDA-approved dose. Standard immunotherapy will be administered on D1 of every standard of care cycle (either 14, 21, 28, or 42 day cycle) at the standard dose. Participants can receive up to 1 year of SOC immunotherapy.', 'interventionNames': ['Radiation: Low Dose Rate Brachytherapy (LDR)', 'Drug: Standard-of-Care Immunotherapy']}], 'interventions': [{'name': 'Low Dose Rate Brachytherapy (LDR)', 'type': 'RADIATION', 'description': 'LDR on treatment day 1', 'armGroupLabels': ['LDR + SOC Immunotherapy']}, {'name': 'Standard-of-Care Immunotherapy', 'type': 'DRUG', 'description': 'Standard or care immunotherapy will be administered at the FDA approved dose via IV infusion.', 'armGroupLabels': ['LDR + SOC Immunotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44122', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic, Case Comprehensive Cancer Center', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}], 'overallOfficials': [{'name': 'Jay Ciezki, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cleveland Clinic, Case Comprehensive Cancer Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data will not be shared but the study team is expecting to publish the data'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Case Comprehensive Cancer Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}