Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2026-01-02 @ 6:09 AM
Study NCT ID:
NCT06305767
Status:
RECRUITING
Last Update Posted:
2025-12-24
First Post:
2024-03-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Clinical Study of Intismeran Autogene (V940) Treatment and Pembrolizumab in People With Bladder Cancer (V940-005/INTerpath-005)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001749', 'term': 'Urinary Bladder Neoplasms'}, {'id': 'C565324', 'term': 'Parkinson Disease 4, Autosomal Dominant Lewy Body'}], 'ancestors': [{'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D001745', 'term': 'Urinary Bladder Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C582435', 'term': 'pembrolizumab'}, {'id': 'C000632577', 'term': 'enfortumab vedotin'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'The Phase 2 Adjuvant Cohort of study will be conducted as a double-blind study under in-house blinding procedures. Intismeran autogene and placebo will be prepared and dispensed by unblinded pharmacists and administered in a blinded fashion by blinded personnel. The participants and the investigators who are involved in the study intervention administration will be unaware of the intervention assignments.\n\nThe Phase 1 Perioperative Cohort will be conducted as an open-label study. Participants and investigators will be aware of the intervention assignments.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The Phase 2 Adjuvant Cohort is a placebo- and active-controlled, parallel-group, multicenter, double-blind safety and efficacy study of adjuvant intismeran autogene plus pembrolizumab versus adjuvant placebo plus pembrolizumab in participants with pathologic high-risk MIUC after radical resection. Eligible participants will be randomly assigned in a 1:1 ratio to receive treatment with either intismeran autogene plus pembrolizumab or placebo plus pembrolizumab.\n\nThe Phase 1 Perioperative Cohort of this study has a single arm into which eligible participants are allocated. It will evaluate safety and preliminary efficacy of perioperative (neoadjuvant and adjuvant) intismeran autogene in combination with pembrolizumab plus EV for participants with muscle-invasive bladder cancer (MIBC).'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 230}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-03-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2031-10-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-23', 'studyFirstSubmitDate': '2024-03-05', 'studyFirstSubmitQcDate': '2024-03-05', 'lastUpdatePostDateStruct': {'date': '2025-12-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-04-23', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adjuvant Cohort: Disease Free Survival (DFS)', 'timeFrame': 'Up to approximately 28 months', 'description': 'DFS is defined as the time from randomization until death from any cause, or presence of disease per investigator assessment with muscle-invasive (≥pT2) disease or any high-grade non-muscle invasive disease in the urothelial tract (upper tract or lower tract) on imaging and biopsy, and/or disease recurrence outside the urothelial tract on imaging with or without confirmation by biopsy. DFS will be reported for the Adjuvant Cohort.'}, {'measure': 'Perioperative Cohort: Number of Participants Who Experience an Adverse Event (AE)', 'timeFrame': 'Up to approximately 19 months', 'description': 'An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment. The number of participants who experience AEs will be reported for the Perioperative Cohort.'}, {'measure': 'Perioperative Cohort: Number of Participants Who Discontinue Study Treatment Due to AE', 'timeFrame': 'Up to approximately 16 months', 'description': 'An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment. The number of participants who discontinue study treatment due to an AE will be reported for the Perioperative Cohort.'}], 'secondaryOutcomes': [{'measure': 'Adjuvant Cohort: Overall Survival (OS)', 'timeFrame': 'Up to approximately 28 months', 'description': 'Overall survival is defined as the time from randomization to death due to any cause. OS will be reported for the Adjuvant Cohort.'}, {'measure': 'Adjuvant Cohort: Distant Metastasis-Free Survival (DMFS)', 'timeFrame': 'Up to approximately 28 months', 'description': 'DMFS is defined as the time from randomization until death from any cause, or disease recurrence outside the urothelial tract on imaging with or without confirmation by biopsy, per investigator assessment. DMFS will be reported for the Adjuvant Cohort.'}, {'measure': 'Adjuvant Cohort: Number of Participants Who Experience an AE', 'timeFrame': 'Up to approximately 16 months', 'description': 'An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment. The number of participants who experience an AE will be reported for the Adjuvant Cohort.'}, {'measure': 'Adjuvant Cohort: Number of Participants Who Discontinue Study Treatment Due to an AE', 'timeFrame': 'Up to approximately 13 months', 'description': 'An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment. The number of participants who discontinue study treatment due to an AE will be presented for the Adjuvant Cohort.'}, {'measure': 'Perioperative Cohort: Pathologic Complete Response (pCR) Rate', 'timeFrame': 'Up to approximately 18 weeks', 'description': 'pCR is defined as the absence of viable tumor (pT0N0) in examined tissue from RC plus PLND as assessed by the investigator. pCR rate will be reported as the percentage of participants in the Perioperative Cohort having pCR.'}, {'measure': 'Perioperative Cohort: Pathologic Downstaging (pDS) Rate', 'timeFrame': 'Up to approximately 18 weeks', 'description': 'pDS is defined as participants with \\<pT2 (includes pT0, pTis, pTa, pT1) and N0 in examined tissue from RC plus PLND as assessed by the investigator. pDS rate will be reported as the percentage of participants in the Perioperative Cohort having pDS.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Programmed Cell Death-1 (PD1, PD-1)', 'Programmed Cell Death 1 Ligand 1 (PDL1, PD-L1)', 'Programmed Cell Death 1 Ligand 2 (PDL2, PD-L2)'], 'conditions': ['Bladder Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.merckclinicaltrials.com/', 'label': 'Merck Clinical Trials Information'}, {'url': 'https://msd.trialsummaries.com/Study/StudyDetails?id=26155&tenant=MT_MSD_9011', 'label': 'Plain Language Summary'}]}, 'descriptionModule': {'briefSummary': "Researchers are looking for new ways to treat people with high-risk muscle-invasive urothelial carcinoma (MIUC). Urothelial carcinoma is a type of bladder cancer that begins in cells that line the inside of the bladder and other parts of the urinary tract, such as part of the kidneys, ureters, and urethra. People with MIUC usually have chemotherapy before surgery, then surgery to remove the cancer. Chemotherapy is a type of medicine to destroy cancer cells or stop them from growing. After surgery, some people receive more treatment to prevent cancer from returning. Pembrolizumab is an immunotherapy, which is a treatment that helps the immune system fight cancer. Enfortumab vedotin (EV) is an antibody drug conjugate (ADC). An ADC attaches to a protein on cancer cells and delivers treatment to destroy those cells. Researchers want to learn if giving intismeran autogene (the study treatment) with pembrolizumab can prevent MIUC from returning after surgery. Intismeran autogene (also called mRNA-4157) is designed to treat each person's cancer by helping the person's immune system identify and kill cancer cells based on certain proteins found on those cancer cells.\n\nThe goals of this study are to learn if people who receive intismeran autogene and pembrolizumab are alive and cancer free longer than those who receive placebo and pembrolizumab, and to learn about the safety of intismeran autogene, pembrolizumab, and EV, and if people tolerate them.", 'detailedDescription': 'Enrollment of participants into the Phase 1 Perioperative Cohort of this study is planned to start in approximately April of 2025.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nThe main inclusion criteria include but are not limited to the following:\n\n* Has a histological diagnosis of urothelial carcinoma (UC)\n* Must provide blood samples per protocol, to enable intismeran autogene production, and circulating tumor deoxyribonucleic acid testing\n* Has an Eastern Cooperative Oncology Group performance status of 0 to 2 assessed within 7 days before randomization\n* Must provide a formalin-fixed paraffin-embedded tumor tissue sample for next generation sequencing\n\nAdjuvant Cohort:\n\n* Has MIUC\n* Has high-risk pathologic disease after radical resection\n* For participants who have not received cisplatin-based neoadjuvant chemotherapy, are ineligible to receive cisplatin according to protocol pre-defined criteria\n\nPerioperative Cohort:\n\n* Has MIBC\n* Is deemed eligible for RC and PLND and agrees to undergo curative intent standard RC and PLND and neoadjuvant and adjuvant treatment per protocol\n* Is ineligible to receive cisplatin according to protocol pre-defined criteria\n\nExclusion Criteria:\n\nThe main exclusion criteria include but are not limited to the following:\n\n* Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention\n* Has known additional malignancy that is progressing or has required active treatment ≤3 years prior to study randomization\n* Has current pneumonitis/interstitial lung disease\n* Has active infection requiring systemic therapy\n* Has active hepatitis B and hepatitis C virus infection\n\nAdjuvant Cohort:\n\n* Has received prior systemic anticancer therapy\n* Has received prior neoadjuvant therapy, with the exception of neoadjuvant cisplatin-based chemotherapy for MIUC\n* Has severe hypersensitivity to either intismeran autogene or pembrolizumab (MK-3475) and/or any of their excipients\n\nPerioperative Cohort:\n\n* Has received any prior systemic treatment, cancer vaccine treatment, chemoradiation, and/or radiation therapy treatment for MIBC\n* Has severe hypersensitivity to either intismeran autogene, pembrolizumab, or EV and/or any of their excipients\n* Has ongoing sensory or motor neuropathy\n* Has active keratitis or corneal ulcerations'}, 'identificationModule': {'nctId': 'NCT06305767', 'briefTitle': 'A Clinical Study of Intismeran Autogene (V940) Treatment and Pembrolizumab in People With Bladder Cancer (V940-005/INTerpath-005)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Phase 1/2 Study of V940 Plus Pembrolizumab With or Without Enfortumab Vedotin in Muscle-Invasive Urothelial Carcinoma (MIUC) (INTerpath-005)', 'orgStudyIdInfo': {'id': 'V940-005'}, 'secondaryIdInfos': [{'id': 'V940-005', 'type': 'OTHER', 'domain': 'MSD'}, {'id': 'U1111-1292-1952', 'type': 'REGISTRY', 'domain': 'UTN'}, {'id': '2023-505658-17-00', 'type': 'REGISTRY', 'domain': 'EU CT'}, {'id': 'INTerpath-005', 'type': 'OTHER', 'domain': 'MSD'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Adjuvant Cohort: Pembrolizumab + Intismeran autogene', 'description': 'Adjuvant Cohort participants receive adjuvant treatment with up to 9 cycles of pembrolizumab plus up to a total of 9 doses of intismeran autogene. Intismeran autogene doses may begin as soon as Day 22 of Cycle 1. The total duration of treatment is up to approximately 13 months.', 'interventionNames': ['Biological: Pembrolizumab', 'Biological: Intismeran autogene']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Adjuvant Cohort: Pembrolizumab + Placebo', 'description': 'Adjuvant Cohort participants receive adjuvant treatment with up to 9 cycles of pembrolizumab plus up to a total of 9 doses of placebo. Placebo doses may begin as soon as Day 22 of Cycle 1. The total duration of treatment is up to approximately 13 months.', 'interventionNames': ['Biological: Pembrolizumab', 'Other: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Perioperative Cohort: Pembrolizumab + Intismeran autogene + EV and Surgery', 'description': 'Participants will receive neoadjuvant treatment with up to 4 cycles of pembrolizumab plus EV and 1 to 4 doses of intismeran autogene, followed by radical cystectomy \\[RC\\] plus pelvic lymph node dissection \\[PLND\\], and then adjuvant treatment with up to 13 cycles of pembrolizumab plus up to 5 cycles of EV and 5 to 8 doses of intismeran autogene (for a total of 9 neoadjuvant plus adjuvant Intismeran autogene doses), or until any of the protocol-specified criteria for discontinuation of study intervention are met. The total duration of treatment is up to approximately 16 months.', 'interventionNames': ['Biological: Pembrolizumab', 'Biological: Intismeran autogene', 'Biological: Enfortumab Vedotin', 'Procedure: Surgery (RC plus PLND)']}], 'interventions': [{'name': 'Pembrolizumab', 'type': 'BIOLOGICAL', 'otherNames': ['MK-3475', 'Keytruda®'], 'description': 'Administered via intravenous (IV) infusion at a dose of 400 mg on Day 1 of every 6-week cycle for up to 9 adjuvant cycles for Adjuvant Cohort participants, or at a dose of 200 mg on Day 1 of every cycle for up to four 3-week neoadjuvant cycles and up to thirteen 3-week adjuvant cycles for Perioperative Cohort participants.', 'armGroupLabels': ['Adjuvant Cohort: Pembrolizumab + Intismeran autogene', 'Adjuvant Cohort: Pembrolizumab + Placebo', 'Perioperative Cohort: Pembrolizumab + Intismeran autogene + EV and Surgery']}, {'name': 'Intismeran autogene', 'type': 'BIOLOGICAL', 'otherNames': ['V940'], 'description': 'Administered via intramuscular (IM) injection at a dose of 1 mg every 3 weeks for a total of up to 9 adjuvant doses for Adjuvant Cohort participants, or at a dose of 1 mg every 3 weeks for a total of up to 9 doses in the neoadjuvant and adjuvant periods for Perioperative Cohort participants.', 'armGroupLabels': ['Adjuvant Cohort: Pembrolizumab + Intismeran autogene', 'Perioperative Cohort: Pembrolizumab + Intismeran autogene + EV and Surgery']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Intismeran autogene diluent only (saline and/or dextrose) administered via IM injection Q3W for up to 9 doses.', 'armGroupLabels': ['Adjuvant Cohort: Pembrolizumab + Placebo']}, {'name': 'Enfortumab Vedotin', 'type': 'BIOLOGICAL', 'otherNames': ['PADCEV®'], 'description': 'Administered via IV infusion at a dose of 1.25 mg/kg on Day 1 and Day 8 of every cycle for up to four 3-week neoadjuvant cycles and up to five 3-week adjuvant cycles for Perioperative Cohort participants.', 'armGroupLabels': ['Perioperative Cohort: Pembrolizumab + Intismeran autogene + EV and Surgery']}, {'name': 'Surgery (RC plus PLND)', 'type': 'PROCEDURE', 'description': 'Curative intent surgery (RC plus PLND) will be administered to all participants in the Perioperative Cohort and will be done in accordance with the American Urological Association/American Society for Radiation Oncology/American Society of Clinical Oncology/Society of Urologic Oncology guidelines. RC plus PLND will be performed within 6 weeks of the last dose of neoadjuvant intismeran autogene plus pembrolizumab plus EV treatment. Adjuvant intismeran autogene plus pembrolizumab plus EV treatment will begin within 8 weeks of completing RC plus PLND.', 'armGroupLabels': ['Perioperative Cohort: Pembrolizumab + Intismeran autogene + EV and Surgery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '888-577-8839'}], 'facility': 'UCLA Hematology/Oncology - Westwood (Building 200 Suite 140)-Department of Urology/Institute of Uro ( Site 0104)', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '32804', 'city': 'Orlando', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '407-303-5600'}], 'facility': 'AdventHealth Orlando-AdventHealth Medical Group Hematology & Oncology at Orlandoc ( Site 0102)', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '888-577-8839'}], 'facility': 'University of Chicago Medical Center ( Site 0109)', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '52242', 'city': 'Iowa City', 'state': 'Iowa', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'United States', 'facility': 'University of Iowa ( Site 0110)', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}, {'zip': '10029', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '888-577-8839'}], 'facility': 'Icahn School of Medicine at Mount Sinai ( Site 0101)', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '888-577-8839'}], 'facility': 'Duke Cancer Institute ( Site 0107)', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'United States', 'facility': 'Cleveland Clinic Main ( Site 0100)', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '19111', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '888-577-8839'}], 'facility': 'Fox Chase Cancer Center ( Site 0106)', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '75390', 'city': 'Dallas', 'state': 'Texas', 'status': 'COMPLETED', 'country': 'United States', 'facility': 'UT Southwestern Medical Center ( Site 0103)', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'United States', 'facility': 'Houston Methodist Hospital-Department of Urology ( Site 0111)', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '2109', 'city': 'Macquarie University', 'state': 'New South Wales', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '+61 2 9812 2956'}], 'facility': 'Macquarie University-MQ Health Clinical Trials Unit ( Site 1803)'}, {'zip': '2145', 'city': 'Westmead', 'state': 'New South Wales', 'status': 'COMPLETED', 'country': 'Australia', 'facility': 'Westmead Hospital ( Site 1802)', 'geoPoint': {'lat': -33.80383, 'lon': 150.98768}}, {'zip': '4101', 'city': 'South Brisbane', 'state': 'Queensland', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '+61 7 3163 6166'}], 'facility': 'Mater Misericordiae Limited ( Site 1808)', 'geoPoint': {'lat': -27.48034, 'lon': 153.02049}}, {'zip': '6009', 'city': 'Nedlands', 'state': 'Western Australia', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Australia', 'facility': 'One Clinical Research ( Site 1807)', 'geoPoint': {'lat': -31.98184, 'lon': 115.8073}}, {'zip': 'V5Z 4E6', 'city': 'Vancouver', 'state': 'British Columbia', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Canada', 'facility': 'BC Cancer Vancouver ( Site 0004)', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'M5G 2M9', 'city': 'Toronto', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '416-946-2246'}], 'facility': 'Princess Margaret Cancer Centre ( Site 0003)', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'H2X 3E4', 'city': 'Montreal', 'state': 'Quebec', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '514-890-8000'}], 'facility': "Centre Hospitalier de l'Université de Montréal ( Site 0005)", 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'G1J 1Z4', 'city': 'Québec', 'state': 'Quebec', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '418-525-4444 x67512'}], 'facility': "Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0001)", 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}, {'zip': 'J1H 5H4', 'city': 'Sherbrooke', 'state': 'Quebec', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '819-346-1110x13446'}], 'facility': "Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Univer ( Site 0002)", 'geoPoint': {'lat': 45.40008, 'lon': -71.89908}}, {'zip': '8420383', 'city': 'Recoleta, Santiago', 'state': 'Region M. de Santiago', 'status': 'RECRUITING', 'country': 'Chile', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '56998744662'}], 'facility': 'Bradfordhill-Clinical Area ( Site 1501)'}, {'zip': '7500921', 'city': 'Santiago', 'state': 'Region M. de Santiago', 'status': 'RECRUITING', 'country': 'Chile', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '56956075934'}], 'facility': 'FALP ( Site 1500)', 'geoPoint': {'lat': -33.45694, 'lon': -70.64827}}, {'zip': '8330024', 'city': 'Santiago', 'state': 'Region M. de Santiago', 'status': 'RECRUITING', 'country': 'Chile', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '+56934331806'}], 'facility': 'Pontificia Universidad Catolica de Chile ( Site 1503)', 'geoPoint': {'lat': -33.45694, 'lon': -70.64827}}, {'zip': '4810148', 'city': 'Temuco', 'state': 'Región de la Araucanía', 'status': 'RECRUITING', 'country': 'Chile', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '+56452657374'}], 'facility': 'CIDO SpA ( Site 1509)', 'geoPoint': {'lat': -38.73628, 'lon': -72.59738}}, {'zip': '2520598', 'city': 'Viña del 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