Ignite Creation Date:
2025-12-24 @ 4:05 PM
Ignite Modification Date:
2025-12-26 @ 5:16 PM
Study NCT ID:
NCT05814666
Status:
RECRUITING
Last Update Posted:
2024-12-31
First Post:
2023-03-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Activity and Safety of Danvatirsen and Pembrolizumab in HNSCC
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-11-18', 'mcpReleaseN': 10, 'releaseDate': '2025-11-10'}, {'resetDate': '2025-12-05', 'mcpReleaseN': 11, 'releaseDate': '2025-11-21'}, {'releaseDate': '2025-12-16'}], 'estimatedResultsFirstSubmitDate': '2025-11-10'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D000077195', 'term': 'Squamous Cell Carcinoma of Head and Neck'}], 'ancestors': [{'id': 'D002294', 'term': 'Carcinoma, Squamous Cell'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000610954', 'term': 'danvatirsen'}, {'id': 'C582435', 'term': 'pembrolizumab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 81}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-05-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2026-05-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-27', 'studyFirstSubmitDate': '2023-03-10', 'studyFirstSubmitQcDate': '2023-04-03', 'lastUpdatePostDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Confirmed ORR', 'timeFrame': 'Up to 18 months', 'description': 'Determine the ORR (Partial response \\[PR\\] + CR defined according to RECIST v1.1) as determined by the Investigator for the combination of danvatirsen and pembrolizumab compared with pembrolizumab alone'}], 'secondaryOutcomes': [{'measure': 'Number of participants with treatment-related adverse events as assessed by CTCAE v5.0', 'timeFrame': 'Up to 18 months', 'description': 'Drug induced toxicities are assessed and graded according to Common Toxicity Criteria for Adverse Events (CTCAE) Version 5.0.'}, {'measure': 'DOR', 'timeFrame': 'Up to 18months', 'description': 'Duration of Response by RECIST v1.1'}, {'measure': 'DCR & CR Rate', 'timeFrame': 'Up to 18months', 'description': 'Disease control rate and complete response rate by RECIST v1.1'}, {'measure': 'ORR in tumors with CPS ≥50', 'timeFrame': 'Up to 18months', 'description': 'Overall response rate per RECIST v1.1 in tumors with CPS ≥ 20 and ≥ 50'}, {'measure': 'DOR in tumors with CPS ≥50', 'timeFrame': 'Up to 18months', 'description': 'Duration of response by RECIST v1.1 in tumors with CPS ≥50'}, {'measure': 'PFS', 'timeFrame': 'Up to 18months', 'description': 'Progression-free survival by RECIST v1.1, defined as the time from randomization to the first documentation of progressive disease (PD) or death from any cause, whichever comes first'}, {'measure': 'OS', 'timeFrame': 'Up to 30months', 'description': 'Overall survival, defined as time from randomization to death from any cause'}, {'measure': 'Maximum plasma concentration', 'timeFrame': 'Up to 18 months', 'description': 'Maximum concentration recorded \\[Cmax\\]of danvatirsen at defined timepoints in the combination regimen'}, {'measure': 'Trough concentration', 'timeFrame': 'Up to 18 months', 'description': 'Trough concentration \\[Ctrough\\] of danvatirsen at defined timepoints in the combination regimen'}, {'measure': 'Area under the plasma concentration-time curve', 'timeFrame': 'Up to 18 months', 'description': 'Area under the plasma concentration-time curve over the dosing interval \\[AUCtau\\] of danvatirsen at defined timepoints in the combination regimen'}, {'measure': 'Time to maximum plasma concentration', 'timeFrame': 'Up to 18 months', 'description': 'Time to maximum plasma concentration \\[Tmax\\]) after single and multiple doses at defined timepoints in the combination regimen'}, {'measure': 'Immunogenicity of danvatirsen', 'timeFrame': 'Up to 18 months', 'description': 'Anti-danvatirsen antibody titers at defined timepoints in the combination regimen'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['HNSCC']}, 'descriptionModule': {'briefSummary': 'Open-label, Phase II, randomized, controlled study evaluating the efficacy and safety of danvatirsen in combination with pembrolizumab compared with pembrolizumab alone as first-line treatment of patients with recurrent/metastatic (R/M) HNSCC. Two-thirds of patients will be randomized to receive danvatirsen and pembrolizumab and one-third will be randomized to receive pembrolizumab alone.', 'detailedDescription': 'This is a multicenter, open-label, Phase II, randomized, controlled study to determine the efficacy, safety, and other indicators of clinical and biological activity of the combination of danvatirsen and pembrolizumab as first-line treatment for R/M HNSCC.\n\nAfter providing informed consent, patients will be assessed for eligibility during the screening phase of the study. All patients must be willing and able to provide a formalin fixed paraffin-embedded (FFPE) archival or fresh tumor sample collected during the screening period; a fresh biopsy is preferred if safe and feasible to obtain and consented to by the patient. Following the screening period, eligible patients will be randomized in a 2:1 ratio to danvatirsen + pembrolizumab or pembrolizumab monotherapy, respectively. Patients will receive treatment in 21-day cycles. Patients assigned to the pembrolizumab monotherapy arm will receive treatment until a criterion for discontinuation is met or a maximum of 24 months of treatment. Patients assigned to combination therapy will receive both treatments until a criterion for discontinuation is met or the patient has received a maximum of 24 months of treatment, after which they may remain on danvatirsen monotherapy.\n\nPatients in both treatment arms will have radiologic tumor assessments every 6 weeks (±1 week), regardless of treatment delays, until objective disease progression, initiation of new anticancer treatment, death, withdrawal of consent, or end of study, whichever occurs first.\n\nAll patients who discontinue study treatment for any reason will have a safety follow-up visit 30 days (+7 days) after the last dose of study treatment and a follow-up for AEs 90 days (+7 days) after the last dose of pembrolizumab. Patients will be followed for survival at 12 week (±7 days) intervals until death or withdrawal of consent, whichever occurs first. Survival follow-up will continue until at least 15 months after the last patient is randomized in the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Must have given written informed consent (signed and dated).\n2. Aged ≥18 years at the time of informed consent.\n3. Recurrent/metastatic histologically or cytologically proven squamous cell carcinoma of the head and neck that is considered incurable by local therapy. Eligible primary tumor locations are oropharynx, oral cavity, hypopharynx, and larynx.\n4. Presence of measurable tumor per RECIST v1.1 criteria.\n5. Detectable PD-L1 expression in tumor, defined as CPS ≥1 determined by a FDA or national regulatory agency of the country in which the patient resides.-approved test.\n6. Baseline fresh tumor biopsy or archival specimen.\n7. ECOG performance status of 0 or 1.\n8. Adequate organ function within 10 days of study treatment,\n9. Oxygen saturation on room air ≥92% by pulse oximetry.\n10. Females must be non-pregnant and non-lactating and either be postmenopausal or agree to adequate birth control.\n11. Males must be surgically sterile or agree to adequate birth control.\n12. Has an estimated life expectancy of at least 3 months.\n13. Has recovered from all complications or surgery and all toxicities of prior therapy\n\nExclusion Criteria:\n\n1. Prior therapy for metastatic HNSCC.\n2. Has disease suitable for local therapy with curative intent.\n3. Primary tumor of the nasopharynx.\n4. Has received prior therapy with an anti-programmed death 1 (PD-1), anti PD L1, or anti-programmed death-ligand-2 (PD-L2).\n5. Radiation therapy (or other non-systemic therapy) within 2 weeks of Day 1 of study treatment.\n6. Known autoimmune disease that has required systemic treatment\n7. Known immunodeficiency or receiving systemic steroid therapy that would be the equivalent of \\>10 mg prednisone daily\n8. Prior allogeneic tissue/solid organ transplant.\n9. Has significant cardiovascular disease\n10. Has received a live vaccine within 30 days\n11. Active infection requiring systemic antiviral or antimicrobial therapy\n12. History of (non-infectious) pneumonitis that required steroids or current pneumonitis.\n13. History of other malignancies\n14. Active HIV infection except patients who are currently stable on antiretroviral therapy for at least 4 weeks\n15. Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.\n16. Treated or untreated parenchymal brain metastases or leptomeningeal disease.\n17. Treatment with another investigational drug, biological agent, or device within 1 month of screening, or 5 half-lives of investigational agent (if known), whichever is longer.\n18. Hypersensitivity to any component of danvatirsen or pembrolizumab.'}, 'identificationModule': {'nctId': 'NCT05814666', 'acronym': 'PEMDA-HN', 'briefTitle': 'Activity and Safety of Danvatirsen and Pembrolizumab in HNSCC', 'organization': {'class': 'INDUSTRY', 'fullName': 'Flamingo Therapeutics NV'}, 'officialTitle': 'An Open-Label, Phase II, Randomized, Controlled Study of Danvatirsen Plus Pembrolizumab Compared to Pembrolizumab Alone in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC)', 'orgStudyIdInfo': {'id': 'FLM-6774-201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Danvatirsen plus pembrolizumab', 'description': 'Danvatirsen dosing:\n\nWeek 1: Danvatirsen intravenously (IV) on Days 1, 3, and 5\n\nWeek 2 and subsequent weeks: Danvatirsen IV weekly\n\nPembrolizumab dosing:\n\nPembrolizumab every 3 weeks after the Danvatirsen dose.', 'interventionNames': ['Drug: Danvatirsen', 'Drug: Pembrolizumab']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Pembrolizumab', 'description': 'Pembrolizumab IV every 3 weeks after the Danvatirsen dose.', 'interventionNames': ['Drug: Pembrolizumab']}], 'interventions': [{'name': 'Danvatirsen', 'type': 'DRUG', 'otherNames': ['ISIS 481464', 'AZD9150'], 'description': 'Danvatirsen is a STAT3 targeting drug.', 'armGroupLabels': ['Danvatirsen plus pembrolizumab']}, {'name': 'Pembrolizumab', 'type': 'DRUG', 'otherNames': ['Keytruda'], 'description': 'Pembrolizumab is a monoclonal antibody that binds to the PD-1 receptor and blocks its interaction with PD-L1 and PD-L2', 'armGroupLabels': ['Danvatirsen plus pembrolizumab', 'Pembrolizumab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85719', 'city': 'Tucson', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '520-621-2999'}], 'facility': 'The University of Arizona Cancer Center', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '92617', 'city': 'Irvine', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Clinical Research Manager', 'role': 'CONTACT', 'phone': '714-509-2643'}], 'facility': 'University of California Irvine (UCI)', 'geoPoint': {'lat': 33.66946, 'lon': -117.82311}}, {'zip': '90505', 'city': 'Torrance', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '310-750-3376'}], 'facility': 'TMPN Hunt Cancer Care', 'geoPoint': {'lat': 33.83585, 'lon': -118.34063}}, {'zip': '90024', 'city': 'Westwood, Los Angeles', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '310-794-2464'}], 'facility': 'University of California Los Angeles', 'geoPoint': {'lat': 34.05612, 'lon': -118.43063}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '303-724-9695'}], 'facility': 'University of Colorado Hospital (UCH) Anschutz Cancer Pavilion', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '33176', 'city': 'Miami', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '786-527-8546'}], 'facility': 'Miami Cancer Institute', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '30308', 'city': 'Atlanta', 'state': 'Georgia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'email': 'allyson.anderson@emory.edu', 'phone': '404-686-0239'}], 'facility': 'Emory University Hospital Midtown', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT'}], 'facility': 'University of Illinois Cancer Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '66204', 'city': 'Merriam', 'state': 'Kansas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site Manager', 'role': 'CONTACT', 'phone': '913-386-7557'}], 'facility': 'AMR Kansas City Oncology', 'geoPoint': {'lat': 39.02362, 'lon': -94.69357}}, {'zip': '66205', 'city': 'Westwood', 'state': 'Kansas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Project Manager', 'role': 'CONTACT', 'phone': '913-574-2854'}], 'facility': 'University of Kansas Medical Center', 'geoPoint': {'lat': 39.04056, 'lon': -94.6169}}, {'zip': '70809', 'city': 'Baton Rouge', 'state': 'Louisiana', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '225-215-1204'}], 'facility': 'Mary Bird Perkins Cancer Center', 'geoPoint': {'lat': 30.44332, 'lon': -91.18747}}, {'zip': '21201', 'city': 'Baltimore', 'state': 'Maryland', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'email': 'Rehan.khan@umm.edu', 'phone': '410-328-7496'}], 'facility': 'University of Maryland Baltimore, Greenebaum Comprehensive Cancer Center', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '89169', 'city': 'Las Vegas', 'state': 'Nevada', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site Manager', 'role': 'CONTACT', 'phone': '702-862-1100'}], 'facility': 'Comprehensive Cancer Centers of Nevada', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '07960', 'city': 'Morristown', 'state': 'New Jersey', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT'}], 'facility': 'Morristown Medical Center', 'geoPoint': {'lat': 40.79677, 'lon': -74.48154}}, {'zip': '10029', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Clinical Trials Manager', 'role': 'CONTACT', 'phone': '212-824-7860'}], 'facility': 'Mount Sinai', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '11794', 'city': 'Stony Brook', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Research Nurse', 'role': 'CONTACT', 'phone': '631-216-2990'}], 'facility': 'Stony Brook Cancer Center', 'geoPoint': {'lat': 40.92565, 'lon': -73.14094}}, {'zip': '45219', 'city': 'Cincinnati', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Operations Manager', 'role': 'CONTACT', 'phone': '513-585-1140'}], 'facility': 'The Christ Hospital Cancer Center', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '45229', 'city': 'Cincinnati', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '513-584-7703'}], 'facility': 'University of Cincinnati Medical Center', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '216-286-9469'}], 'facility': 'University Hospitals Cleveland', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '29605', 'city': 'Greenville', 'state': 'South Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site Manager', 'role': 'CONTACT', 'phone': '864-522-2066'}], 'facility': 'Prisma Health Cancer Institute', 'geoPoint': {'lat': 34.85262, 'lon': -82.39401}}, {'zip': '75390', 'city': 'Dallas', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'email': 'desiree.pierre@utsouthwestern.edu', 'phone': '214-648-3111'}], 'facility': 'UT Southwestern Medical Center/Simmons Comprehensive Cancer Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '49201', 'city': 'Busan', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Study Coordinator, 82-10-8843-0031', 'role': 'CONTACT'}], 'facility': 'Dong-A University Hospital', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'zip': '602-702', 'city': 'Busan', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '82-51-990-5820'}], 'facility': 'Kosin University College of Medicine - Kosin University Gospel Hospital (KUGH)', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'zip': '52727', 'city': 'Jinju', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '82-10-2858-4757'}], 'facility': 'Gyeongsang National University Hospital', 'geoPoint': {'lat': 35.19278, 'lon': 128.08472}}, {'zip': '02841', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '010-6227-6721'}], 'facility': 'Korea University Medical Center (KUMC)', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'email': 'soyeon0031@gmail.com', 'phone': '82-10-8843-0031'}], 'facility': "The Catholic University of Korea - Eunpyeong St. Mary's Hospital", 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Leeds', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'email': 'leedsth-tr.earlyphaseadmin@nhs.net', 'phone': '0113 2067935'}], 'facility': "Saint James's University Hospital (SJUH) - St James's Institute of Oncology", 'geoPoint': {'lat': 53.79648, 'lon': -1.54785}}, {'city': 'Liverpool', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Research Manager', 'role': 'CONTACT', 'email': 'ccf-tr.eoicc@nhs.net', 'phone': '01515565000'}], 'facility': 'The Clatterbridge Cancer Centre NHS Foundation Trust', 'geoPoint': {'lat': 53.41058, 'lon': -2.97794}}, {'zip': 'EC1A 7BE', 'city': 'London', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '44 02078828264'}], 'facility': "Barts Health MHS Trust (Barts and The London NHS Trust) - St Bartholomew's (Barts) Hospital", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'SW3 6JJ', 'city': 'London', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '02031865258'}], 'facility': 'The Royal Marsden NHS Foundation Trust', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'HA6 2RN', 'city': 'Northwood, Middlesex', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '0203 826 2153'}], 'facility': 'East and North Hertfordshire NHS Trust, Lister Hospital'}, {'zip': 'SM2 5PT', 'city': 'Surry', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '02031865258'}], 'facility': 'The Royal Marsden NHS Foundation Trust'}], 'centralContacts': [{'name': 'Flamingo Therapeutics', 'role': 'CONTACT', 'email': 'clinical@flamingotx.com', 'phone': '484 482 0007'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Flamingo Therapeutics NV', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}