Ignite Creation Date:
2025-12-24 @ 7:58 PM
Ignite Modification Date:
2026-01-05 @ 5:54 PM
Study NCT ID:
NCT06589804
Status:
RECRUITING
Last Update Posted:
2025-12-24
First Post:
2024-09-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Testing the Addition of Anti-Cancer Drug, Cetuximab, to Standard of Care Treatment (Pembrolizumab) for Returning or Spreading Head and Neck Cancer After Previous Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000077195', 'term': 'Squamous Cell Carcinoma of Head and Neck'}, {'id': 'D007012', 'term': 'Hypopharyngeal Neoplasms'}, {'id': 'D007822', 'term': 'Laryngeal Neoplasms'}, {'id': 'D009062', 'term': 'Mouth Neoplasms'}, {'id': 'D002277', 'term': 'Carcinoma'}], 'ancestors': [{'id': 'D002294', 'term': 'Carcinoma, Squamous Cell'}, {'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'}, {'id': 'D010610', 'term': 'Pharyngeal Neoplasms'}, {'id': 'D010039', 'term': 'Otorhinolaryngologic Neoplasms'}, {'id': 'D010608', 'term': 'Pharyngeal Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D007818', 'term': 'Laryngeal Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D009059', 'term': 'Mouth Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D000068818', 'term': 'Cetuximab'}, {'id': 'C000612800', 'term': '(225)Ac-DOTA-c(RGDyK)'}, {'id': 'D009682', 'term': 'Magnetic Resonance Spectroscopy'}, {'id': 'C582435', 'term': 'pembrolizumab'}], 'ancestors': [{'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D013057', 'term': 'Spectrum Analysis'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 158}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-03-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2029-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-23', 'studyFirstSubmitDate': '2024-09-06', 'studyFirstSubmitQcDate': '2024-09-06', 'lastUpdatePostDateStruct': {'date': '2025-12-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Estimates of median OS by sex', 'timeFrame': 'Up to 5 years', 'description': 'Estimates of treatment effects (median OS) and the corresponding 95% confidence intervals will be provided by sex.'}, {'measure': 'Estimates of median OS by race', 'timeFrame': 'Up to 5 years', 'description': 'Estimates of treatment effects (median OS) and the corresponding 95% confidence intervals will be provided by race.'}, {'measure': 'Estimates of median OS by ethnicity', 'timeFrame': 'Up to 5 years', 'description': 'Estimates of treatment effects (median OS) and the corresponding 95% confidence intervals will be provided by ethnicity.'}], 'primaryOutcomes': [{'measure': 'Overall survival (OS)', 'timeFrame': 'Time from randomization to death from any cause, assessed up to 5 years', 'description': 'Will be estimated using the Kaplan-Meier method. Will be based on the stratified log-rank test that will compare the distributions across the treatment arms. Univariable and multivariable Cox models stratified by the stratification factors used in the randomization will be assessed as well, where the multivariable Cox model will also adjust for other key baseline factors of interest. Hazard ratios and 95% confidence intervals, along with likelihood ratio p-values will be reported from these Cox models.'}], 'secondaryOutcomes': [{'measure': 'Confirmed response rate', 'timeFrame': 'Up to 5 years', 'description': "Will be assessed per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria if patients have a partial or complete response for 2 consecutive evaluations at least 4 weeks apart, using local review only. The proportion of patients with a confirmed response will be calculated and compared between the 2 arms using a Chi-square or Fisher's Exact test."}, {'measure': 'Duration of response', 'timeFrame': "From the date at which the patient's earliest best objective status is first noted to be either a complete response or partial response to the earliest date progression is documented, assessed up to 5 years", 'description': 'Will be defined for all evaluable patients who have achieved an objective response. Will be assessed per RECIST 1.1 criteria. Will be compared between the 2 arms using the Kaplan-Meier method, where the log-rank test will be used to compare the 2 treatment arms.'}, {'measure': 'Progression free survival', 'timeFrame': 'Time from randomization to the first of either disease progression or death from any cause, assessed up to 5 years', 'description': 'Disease progression will be assessed per RECIST 1.1 criteria. Will be compared between the 2 arms using the Kaplan-Meier method, where the log-rank test will be used to calculate the p-value.'}, {'measure': 'Incidence of adverse events', 'timeFrame': 'Up to 5 years', 'description': "Will be summarized using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. The frequency and percentage of grade 3+ adverse events will be compared between the 2 treatment arms. Comparisons between arms will be made by using either the Chi-square or Fisher's Exact test."}, {'measure': 'Patient-reported toxicity', 'timeFrame': 'Up to 5 years', 'description': "Will be assessed using Patient-Reported Outcomes version of the CTCAE. The frequency and proportion of patients with a maximum post-baseline score greater than 0 will be compared across arms using a Chi-square or Fisher's exact test with a nominal significance level of alpha = 0.10. Similarly, the frequency and proportion of patients with a maximum post-baseline score greater than or equal to 3 will be compared across arms using a Chi-square or Fisher's exact test with a nominal significance level of alpha = 0.10. Patients' maximum baseline-adjusted scores will be calculated using the method described by Dueck et al."}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Metastatic Head and Neck Squamous Cell Carcinoma', 'Metastatic Hypopharyngeal Squamous Cell Carcinoma', 'Metastatic Laryngeal Squamous Cell Carcinoma', 'Metastatic Oral Cavity Squamous Cell Carcinoma', 'Metastatic Oropharyngeal Squamous Cell Carcinoma', 'Recurrent Head and Neck Squamous Cell Carcinoma', 'Recurrent Hypopharyngeal Squamous Cell Carcinoma', 'Recurrent Laryngeal Squamous Cell Carcinoma', 'Recurrent Neck Squamous Cell Carcinoma of Unknown Primary', 'Recurrent Oral Cavity Squamous Cell Carcinoma', 'Recurrent Oropharyngeal Squamous Cell Carcinoma', 'Refractory Head and Neck Squamous Cell Carcinoma', 'Refractory Hypopharyngeal Squamous Cell Carcinoma', 'Refractory Laryngeal Squamous Cell Carcinoma', 'Refractory Oral Cavity Squamous Cell Carcinoma', 'Refractory Oropharyngeal Squamous Cell Carcinoma', 'Stage IV Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8', 'Stage IV Hypopharyngeal Carcinoma AJCC v8', 'Stage IV Laryngeal Cancer AJCC v8', 'Stage IV Lip and Oral Cavity Cancer AJCC v8', 'Stage IV Oropharyngeal (p16-Negative) Carcinoma AJCC v8']}, 'descriptionModule': {'briefSummary': "This phase III trial compares the effect of adding cetuximab to pembrolizumab versus pembrolizumab alone in treating patients with head and neck squamous cell carcinoma (HNSCC) that has come back after a period of improvement (recurrent) and/or that has spread from where it first started (primary site) to other places in the body (metastatic). Cetuximab is in a class of medications called monoclonal antibodies. It binds to a protein called EGFR, which is found on some types of tumor cells. This may help keep tumor cells from growing. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Giving cetuximab and pembrolizumab together may be more effective at treating patients with recurrent and/or metastatic HNSCC than pembrolizumab alone.", 'detailedDescription': 'PRIMARY OBJECTIVE:\n\nI. To assess whether the combination of cetuximab and pembrolizumab (arm 2) compared to pembrolizumab alone (arm 1) results in improved overall survival (OS) in subjects with platinum refractory HNSCC.\n\nSECONDARY OBJECTIVES:\n\nI. To compare pembrolizumab + cetuximab (arm 2) versus (vs.) pembrolizumab alone (arm 1) with respect to objective response rate per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.\n\nII. To compare pembrolizumab + cetuximab (arm 2) vs. pembrolizumab alone (arm 1) with respect to progression free survival (PFS) per RECIST 1.1.\n\nIII. To evaluate pembrolizumab + cetuximab (arm 2) vs. pembrolizumab alone (arm 1) with respect to duration of response (DOR) per RECIST 1.1.\n\nIV. To assess the safety and tolerability of pembrolizumab + cetuximab (arm 2) vs. pembrolizumab alone (arm 1).\n\nV. To assess the patient-reported toxicity using Patient Reported Outcomes version of Common Terminology Criteria for Adverse Events (PRO-CTCAE) of pembrolizumab + cetuximab (arm 2) vs. pembrolizumab alone (arm 1).\n\nEXPLORATORY OBJECTIVES:\n\nI. To identify specific mutational changes that may be indicative of clinical response to pembrolizumab + cetuximab and pembrolizumab alone.\n\nII. To evaluate circulating tumor-derived deoxyribonucleic acid (ctDNA) kinetics over the course of treatment in response to pembrolizumab + cetuximab and pembrolizumab alone.\n\nOUTLINE: Patients are randomized to 1 of 2 arms.\n\nARM 1: Patients receive pembrolizumab intravenously (IV) over 30 minutes on day 1 of each cycle. Cycles repeat every 42 days for up to 18 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo computed tomography (CT), positron emission tomography (PET)/CT or magnetic resonance imaging (MRI) throughout the trial and optionally undergo blood sample collection on study and at disease progression or end of treatment.\n\nARM 2: Patients receive cetuximab IV over 120 minutes on day -14 prior to cycle 1 and then on days 1, 15 and 29 of each cycle and pembrolizumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 42 days for up to 18 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo CT, PET/CT or MRI throughout the trial and optionally undergo blood sample collection on study and at disease progression or end of treatment.\n\nAfter completion of study treatment, patients are followed up within 4 weeks and then every 3 and/or 6 months for up to 5 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically confirmed diagnosis head and neck squamous cell carcinomas (HNSCC).\n* Previously untreated for recurrent and/or metastatic disease incurable by local therapies.\n* Primary tumor location of oral cavity, oropharynx, larynx, or hypopharynx.\n\n * Note: Other primary tumor sites of HNSCC, including nasopharynx primary tumor are not eligible. Unknown primary tumors may be eligible and can be enrolled at the discretion of the treatment team with approval by the study chair.\n* Measurable disease.\n* Must have platinum-refractory disease defined as disease progression during or ≤ 29 weeks after completion of definitive therapy (chemoradiation therapy) or adjuvant (post-operative) therapy.\n* Patient must have a combined positive score PD-L1 positive (CPS \\>/= 1) tumor.\n* Any radiation therapy must be completed \\>= 10 days prior to registration.\n* Patients should not have received any prior treatment in the recurrent or metastatic setting.\n* Prior therapy with neoadjuvant or induction anti PD-1/PD-L1 monoclonal antibody or cetuximab in the curative setting is allowed if last treatment dose was \\>= 26 weeks prior to registration without evidence of disease progression during that treatment period.\n* Patient has not received a live vaccine within 30 days prior to registration.\n* Patient does not have a history of any contraindication or has a severe hypersensitivity to any component of pembrolizumab or cetuximab (≥ grade 3).\n* Patient has not received chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone or equivalent) or any other form of immunosuppressive therapy within 7 days prior to registration.\n* Patient with oropharyngeal cancer only must have negative results from testing of human papillomavirus (HPV) status defined as p16 immunohistochemistry (IHC) and/or HPV in situ hybridization (ISH).\n\n * Note: A Clinical Laboratory Improvement Act (CLIA) certified circulating tumor HPV deoxyribonucleic acid (ctHPVDNA) assay can be used if tissue sample is not available.\n* Age ≥ 18 years.\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.\n* Absolute neutrophil count (ANC) ≥ 1,500/mm\\^3.\n* Platelet count ≥ 100,000/mm\\^3.\n* Hemoglobin (Hgb) ≥ 9 g/dL (if \\< 9 g/dL, then transfusions are acceptable to increase hemoglobin above 9 g/dL).\n* Creatinine ≤ 1.5 x upper limit of normal (ULN) OR calculated (calc.) creatinine clearance ≥ 30 mL/min using the Cockcroft-Gault formula for participant with creatinine levels \\> 1.5 x institutional ULN.\n* Total bilirubin ≤ 1.5 x ULN OR direct bilirubin \\< ULN for participant with total bilirubin \\> 1.5 x institutional ULN.\n* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \\[SGOT\\])/alanine aminotransferase (ALT) (serum glutamic-pyruvic transaminase \\[SGPT\\]) ≤ 3.0 x ULN unless liver metastases are present in which case \\< 5.0 x ULN.\n* Not pregnant and not nursing, because this study involves an agent that has known genotoxic, mutagenic, and teratogenic effects.\n\n * Therefore, for women of childbearing potential only, a negative pregnancy test done ≤ 7 days prior to registration is required.\n* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen should be included.\n* For treated/stable brain metastases: Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression.\n\n * Patients with new or progressive brain metastases (active brain metastases) or leptomeningeal disease are eligible if the treating physician determines that immediate CNS specific treatment is not required and is unlikely to be required during the first cycle of therapy.\n* HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months prior to registration are eligible for this trial.\n* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.\n* Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.\n* Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better.\n* Patients does not have a history of active myocarditis.\n* Patients does not have a history of any form of pneumonitis or diffuse idiopathic or immune mediated interstitial pulmonary disease.\n* Patient does not have a history of solid organ transplantation.'}, 'identificationModule': {'nctId': 'NCT06589804', 'briefTitle': 'Testing the Addition of Anti-Cancer Drug, Cetuximab, to Standard of Care Treatment (Pembrolizumab) for Returning or Spreading Head and Neck Cancer After Previous Treatment', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'Randomized Phase III Trial of Pembrolizumab vs. Pembrolizumab/Cetuximab in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma With Platinum Refractory Disease', 'orgStudyIdInfo': {'id': 'NCI-2024-07339'}, 'secondaryIdInfos': [{'id': 'NCI-2024-07339', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': 'A092205', 'type': 'OTHER', 'domain': 'Alliance for Clinical Trials in Oncology'}, {'id': 'A092205', 'type': 'OTHER', 'domain': 'CTEP'}, {'id': 'U10CA180821', 'link': 'https://reporter.nih.gov/quickSearch/U10CA180821', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Arm 1 (pembrolizumab)', 'description': 'Patients receive pembrolizumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 42 days for up to 18 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo CT, PET/CT or MRI throughout the trial and optionally undergo blood sample collection on study and at disease progression or end of treatment.', 'interventionNames': ['Procedure: Biospecimen Collection', 'Procedure: Computed Tomography', 'Procedure: Magnetic Resonance Imaging', 'Biological: Pembrolizumab', 'Procedure: Positron Emission Tomography']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 2 (cetuximab, pembrolizumab)', 'description': 'Patients receive cetuximab IV over 120 minutes on day -14 prior to cycle 1 and then on days 1, 15 and 29 of each cycle and pembrolizumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 42 days for up to 18 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo CT, PET/CT or MRI throughout the trial and optionally undergo blood sample collection on study and at disease progression or end of treatment.', 'interventionNames': ['Procedure: Biospecimen Collection', 'Biological: Cetuximab', 'Procedure: Computed Tomography', 'Procedure: Magnetic Resonance Imaging', 'Biological: Pembrolizumab', 'Procedure: Positron Emission Tomography']}], 'interventions': [{'name': 'Biospecimen Collection', 'type': 'PROCEDURE', 'otherNames': ['Biological Sample Collection', 'Biospecimen Collected', 'Specimen Collection'], 'description': 'Undergo blood sample collection', 'armGroupLabels': ['Arm 1 (pembrolizumab)', 'Arm 2 (cetuximab, pembrolizumab)']}, {'name': 'Cetuximab', 'type': 'BIOLOGICAL', 'otherNames': ['C 225', 'C-225', 'C225', 'Cetuximab Biosimilar CDP-1', 'Cetuximab Biosimilar CMAB009', 'Cetuximab Biosimilar KL 140', 'Chimeric Anti-EGFR Monoclonal Antibody', 'Chimeric MoAb C225', 'Chimeric Monoclonal Antibody C225', 'Erbitux', 'IMC-C225'], 'description': 'Given IV', 'armGroupLabels': ['Arm 2 (cetuximab, pembrolizumab)']}, {'name': 'Computed Tomography', 'type': 'PROCEDURE', 'otherNames': ['CAT', 'CAT Scan', 'Computed Axial Tomography', 'Computerized Axial Tomography', 'Computerized axial tomography (procedure)', 'Computerized Tomography', 'Computerized Tomography (CT) scan', 'CT', 'CT Scan', 'Diagnostic CAT Scan', 'Diagnostic CAT Scan Service Type', 'tomography'], 'description': 'Undergo CT or PET/CT', 'armGroupLabels': ['Arm 1 (pembrolizumab)', 'Arm 2 (cetuximab, pembrolizumab)']}, {'name': 'Magnetic Resonance Imaging', 'type': 'PROCEDURE', 'otherNames': ['Magnetic Resonance', 'Magnetic Resonance Imaging (MRI)', 'Magnetic resonance imaging (procedure)', 'Magnetic Resonance Imaging Scan', 'Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance', 'MR', 'MR Imaging', 'MRI', 'MRI Scan', 'MRIs', 'NMR Imaging', 'NMRI', 'Nuclear Magnetic Resonance Imaging', 'sMRI', 'Structural MRI'], 'description': 'Undergo MRI', 'armGroupLabels': ['Arm 1 (pembrolizumab)', 'Arm 2 (cetuximab, pembrolizumab)']}, {'name': 'Pembrolizumab', 'type': 'BIOLOGICAL', 'otherNames': ['BCD-201', 'GME 751', 'GME751', 'Keytruda', 'Lambrolizumab', 'MK 3475', 'MK-3475', 'MK3475', 'Pembrolizumab Biosimilar BCD-201', 'Pembrolizumab Biosimilar GME751', 'Pembrolizumab Biosimilar QL2107', 'Pembrolizumab Biosimilar RPH-075', 'Pembrolizumab Biosimilar SB27', 'QL2107', 'RPH 075', 'RPH-075', 'RPH075', 'SB 27', 'SB-27', 'SB27', 'SCH 900475', 'SCH-900475', 'SCH900475'], 'description': 'Given IV', 'armGroupLabels': ['Arm 1 (pembrolizumab)', 'Arm 2 (cetuximab, pembrolizumab)']}, {'name': 'Positron Emission Tomography', 'type': 'PROCEDURE', 'otherNames': ['Medical Imaging, Positron Emission Tomography', 'PET', 'PET Scan', 'Positron emission tomography (procedure)', 'Positron Emission Tomography Scan', 'Positron-Emission Tomography', 'PT'], 'description': 'Undergo PET/CT', 'armGroupLabels': ['Arm 1 (pembrolizumab)', 'Arm 2 (cetuximab, pembrolizumab)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site Public Contact', 'role': 'CONTACT', 'phone': '501-686-8274'}, {'name': 'Omar T. Atiq', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Arkansas for Medical Sciences', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '95901', 'city': 'Marysville', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site Public Contact', 'role': 'CONTACT', 'phone': '530-749-4400'}, {'name': 'Edward J. Kim', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Fremont - Rideout Cancer Center', 'geoPoint': {'lat': 39.14573, 'lon': -121.59135}}, {'zip': '94304', 'city': 'Palo Alto', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site Public Contact', 'role': 'CONTACT', 'phone': '800-455-0057'}, {'name': 'Harlan A. Pinto', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'VA Palo Alto Health Care System', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': '80909', 'city': 'Colorado Springs', 'state': 'Colorado', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site Public Contact', 'role': 'CONTACT', 'phone': '719-365-2406'}, {'name': 'Steven R. Schuster', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'UCHealth Memorial Hospital Central', 'geoPoint': {'lat': 38.83388, 'lon': -104.82136}}, {'zip': '80920', 'city': 'Colorado Springs', 'state': 'Colorado', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site Public Contact', 'role': 'CONTACT', 'phone': '719-364-6700'}, {'name': 'Steven R. Schuster', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Memorial Hospital North', 'geoPoint': {'lat': 38.83388, 'lon': -104.82136}}, {'zip': '80524', 'city': 'Fort Collins', 'state': 'Colorado', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site Public Contact', 'role': 'CONTACT', 'phone': '970-297-6150'}, {'name': 'Steven R. Schuster', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Poudre Valley Hospital', 'geoPoint': {'lat': 40.58526, 'lon': -105.08442}}, {'zip': '80528', 'city': 'Fort Collins', 'state': 'Colorado', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site Public Contact', 'role': 'CONTACT', 'email': 'protocols@AllianceNCTN.org', 'phone': '773-702-9171'}, {'name': 'Steven R. Schuster', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Cancer Care and Hematology-Fort Collins', 'geoPoint': {'lat': 40.58526, 'lon': -105.08442}}, {'zip': '80401', 'city': 'Golden', 'state': 'Colorado', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site Public Contact', 'role': 'CONTACT', 'email': 'peaksresearch@imail.org'}, {'name': 'Karng S. Log', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Lutheran Hospital - Cancer Centers of Colorado', 'geoPoint': {'lat': 39.75554, 'lon': -105.2211}}, {'zip': '80631', 'city': 'Greeley', 'state': 'Colorado', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site Public Contact', 'role': 'CONTACT', 'email': 'protocols@AllianceNCTN.org', 'phone': '773-702-9171'}, {'name': 'Steven R. Schuster', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'UCHealth Greeley Hospital', 'geoPoint': {'lat': 40.42331, 'lon': -104.70913}}, {'zip': '80538', 'city': 'Loveland', 'state': 'Colorado', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site Public Contact', 'role': 'CONTACT', 'phone': '970-203-7083'}, {'name': 'Steven R. Schuster', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Medical Center of the Rockies', 'geoPoint': {'lat': 40.39776, 'lon': -105.07498}}, {'zip': '33140', 'city': 'Miami Beach', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site Public Contact', 'role': 'CONTACT', 'email': 'yenrique@msmc.com', 'phone': '305-674-2625'}, {'name': 'Mike Cusnir', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Mount Sinai Medical Center', 'geoPoint': {'lat': 25.79065, 'lon': -80.13005}}, {'zip': '83706', 'city': 'Boise', 'state': 'Idaho', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site Public Contact', 'role': 'CONTACT', 'email': 'stephanie.couch@stjoeshealth.org', 'phone': '734-712-3671'}, {'name': 'Christopher M. 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