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{
"total": 10,
"trials": [{
"nci_id": "NCI-2016-00290",
"nct_id": "NCT02689284",
"protocol_id": "CP-MGAH22-05",
"ccr_id": null,
"ctep_id": null,
"dcp_id": null,
"other_ids": null,
"associated_studies": null,
"amendment_date": null,
"current_trial_status": "Active",
"current_trial_status_date": "2016-02-23",
"start_date": "2016-01-01",
"start_date_type_code": "ACTUAL",
"completion_date": "2020-03-01",
"completion_date_type_code": "ANTICIPATED",
"record_verification_date": "2016-05-01",
"brief_title": "Combination Margetuximab and Pembrolizumab for Advanced, Metastatic HER2(+) Gastric or Gastroesophageal Junction Cancer",
"official_title": "A Phase 1b/2, Open Label, Dose Escalation Study of Margetuximab in Combination With Pembrolizumab in Patients With Relapsed/Refractory Advanced HER2+ Gastroesophageal Junction or Gastric Cancer",
"acronym": null,
"keywords": [
"Stomach Cancer",
"Gastroesophageal Junction",
"Gastric Cancer",
"Cancer of the Stomach",
"Cancer of Stomach",
"Stomach",
"Pembrolizumab",
"Keytruda",
"HER2+",
"GEJ",
"HER2 positive",
"Metastatic",
"Margetuximab",
"Immunotherapy",
"Trastuzumab",
"Human epidermal growth factor receptor 2",
"Human epidermal growth factor receptor 2-positive",
"gastroesophageal junction cancer",
"Pembro",
"PD-L1",
"PD-1",
"PD",
"Tumor",
"Cancer"
],
"brief_summary": "This main purpose of this clinical study is to learn about the safety and activity of\n margetuximab and pembrolizumab combination treatment in patients with HER2+ gastric and\n gastroesophageal junction cancer.",
"detail_description": "Detailed Description: Both margetuximab and pembrolizumab are monoclonal antibodies used in\n combination to treat HER2+ gastric and gastroesophageal junction cancer. This study has two\n parts: Dose Escalation and Dose Expansion. The Dose Escalation phase of the study will\n evaluate safety of escalating doses of the combination treatment. The Dose Expansion phase\n will evaluate safety and activity of the combination once the final dose and schedule are\n defined.",
"classification_code": "Safety/Efficacy",
"interventional_model": "Parallel",
"accepts_healthy_volunteers_indicator": "NO",
"study_protocol_type": "Interventional",
"study_subtype_code": null,
"study_population_description": null,
"study_model_code": null,
"study_model_other_text": null,
"sampling_method_code": null,
"bio_specimen": {
"f1": "bio_specimen_description",
"f2": null,
"f3": "bio_specimen_retention_code",
"f4": null
},
"primary_purpose": {
"primary_purpose_code": "TREATMENT",
"primary_purpose_other_text": null,
"primary_purpose_additional_qualifier_code": null
},
"phase": {
"phase": "I_II",
"phase_other_text": null,
"phase_additional_qualifier_code": null
},
"masking": {
"masking": "OPEN",
"masking_allocation_code": "Non-Randomized Trial",
"masking_role_investigator": null,
"masking_role_outcome_assessor": null,
"masking_role_subject": null,
"masking_role_caregiver": null
},
"principal_investigator": null,
"central_contact": {
"central_contact_email": null,
"central_contact_name": null,
"central_contact_phone": null,
"central_contact_type": null
},
"lead_org": "MacroGenics Inc",
"collaborators": [{
"name": "Merck and Company Inc",
"functional_role": "LABORATORY"
}],
"sites": [{
"contact_email": null,
"contact_name": null,
"contact_phone": null,
"generic_contact": null,
"recruitment_status": "APPROVED",
"recruitment_status_date": "2016-06-03",
"local_site_identifier": "2015-161",
"org_address_line_1": "4100 John R Street",
"org_address_line_2": null,
"org_city": "Detroit",
"org_country": "United States",
"org_email": null,
"org_family": "The Barbara Ann Karmanos Cancer Institute",
"org_fax": null,
"org_name": "Wayne State University / Karmanos Cancer Institute",
"org_to_family_relationship": "ORGANIZATIONAL",
"org_phone": "800-527-6266",
"org_postal_code": "48201",
"org_state_or_province": "MI",
"org_status": "ACTIVE",
"org_status_date": "2014-03-25",
"org_tty": null,
"org_coordinates": {
"lat": 42.3465,
"lon": -83.0598
}
}, {
"contact_email": null,
"contact_name": "Daniel Virgil Thomas Catenacci",
"contact_phone": "773-834-7424",
"generic_contact": null,
"recruitment_status": "APPROVED",
"recruitment_status_date": "2016-02-02",
"local_site_identifier": "IRB15-1372",
"org_address_line_1": "5841 South Maryland Avenue",
"org_address_line_2": null,
"org_city": "Chicago",
"org_country": "United States",
"org_email": null,
"org_family": "University of Chicago Comprehensive Cancer Center",
"org_fax": "773-702-9311",
"org_name": "University of Chicago Comprehensive Cancer Center",
"org_to_family_relationship": "ORGANIZATIONAL",
"org_phone": "773-834-7424\r773-702-6180",
"org_postal_code": "60637",
"org_state_or_province": "IL",
"org_status": "ACTIVE",
"org_status_date": "2015-01-12",
"org_tty": null,
"org_coordinates": {
"lat": 41.781,
"lon": -87.6021
}
}, {
"contact_email": null,
"contact_name": null,
"contact_phone": null,
"generic_contact": null,
"recruitment_status": "ACTIVE",
"recruitment_status_date": "2016-03-09",
"local_site_identifier": "201510084",
"org_address_line_1": "4921 Parkview Place",
"org_address_line_2": null,
"org_city": "Saint Louis",
"org_country": "United States",
"org_email": null,
"org_family": "Siteman Cancer Center",
"org_fax": null,
"org_name": "Siteman Cancer Center at Washington University",
"org_to_family_relationship": "ORGANIZATIONAL",
"org_phone": "314-747-7236",
"org_postal_code": "63110",
"org_state_or_province": "MO",
"org_status": "ACTIVE",
"org_status_date": "2012-03-29",
"org_tty": null,
"org_coordinates": {
"lat": 38.6267,
"lon": -90.267
}
}, {
"contact_email": null,
"contact_name": null,
"contact_phone": null,
"generic_contact": null,
"recruitment_status": "ACTIVE",
"recruitment_status_date": "2016-04-29",
"local_site_identifier": "Pro00068590",
"org_address_line_1": "2301 Erwin Road",
"org_address_line_2": null,
"org_city": "Durham",
"org_country": "United States",
"org_email": null,
"org_family": "Duke Cancer Institute",
"org_fax": "919-684-5653",
"org_name": "Duke University Medical Center",
"org_to_family_relationship": "ORGANIZATIONAL",
"org_phone": "888-275-3853",
"org_postal_code": "27710",
"org_state_or_province": "NC",
"org_status": "ACTIVE",
"org_status_date": "2010-06-04",
"org_tty": null,
"org_coordinates": {
"lat": 35.9995,
"lon": -78.94
}
}, {
"contact_email": null,
"contact_name": null,
"contact_phone": null,
"generic_contact": null,
"recruitment_status": "ACTIVE",
"recruitment_status_date": "2016-06-13",
"local_site_identifier": "J15204",
"org_address_line_1": "600 North Wolfe Street",
"org_address_line_2": null,
"org_city": "Baltimore",
"org_country": "United States",
"org_email": "[email protected]",
"org_family": "Sidney Kimmel Comprehensive Cancer Center",
"org_fax": null,
"org_name": "Johns Hopkins University / Sidney Kimmel Cancer Center",
"org_to_family_relationship": "ORGANIZATIONAL",
"org_phone": "410-955-8804",
"org_postal_code": "21287",
"org_state_or_province": "MD",
"org_status": "ACTIVE",
"org_status_date": "2015-05-05",
"org_tty": null,
"org_coordinates": {
"lat": 39.3021,
"lon": -76.5621
}
}, {
"contact_email": null,
"contact_name": null,
"contact_phone": null,
"generic_contact": null,
"recruitment_status": "ACTIVE",
"recruitment_status_date": "2016-03-28",
"local_site_identifier": "1510016618",
"org_address_line_1": "333 Cedar Street",
"org_address_line_2": null,
"org_city": "New Haven",
"org_country": "United States",
"org_email": null,
"org_family": "Yale Cancer Center",
"org_fax": null,
"org_name": "Yale University",
"org_to_family_relationship": "ORGANIZATIONAL",
"org_phone": "203-785-5702",
"org_postal_code": "06520",
"org_state_or_province": "CT",
"org_status": "ACTIVE",
"org_status_date": "2010-05-26",
"org_tty": null,
"org_coordinates": {
"lat": 41.31,
"lon": -72.9291
}
}],
"anatomic_sites": [
"Stomach",
"Esophagus"
],
"diseases": [{
"disease_code": "CDR0000040814",
"inclusion_indicator": "TRIAL",
"lead_disease_indicator": null,
"nci_thesaurus_concept_id": "C9237",
"preferred_name": "Recurrent Gastric Carcinoma",
"display_name": "Recurrent Gastric Cancer",
"parents": [
"C9354",
"C7622",
"C4911"
],
"synonyms": [
"Recurrent Gastric Carcinoma",
"Gastric Carcinoma, Recurrent",
"Recurrent Cancer of Stomach",
"Recurrent Cancer of the Stomach",
"Recurrent Carcinoma of Stomach",
"Recurrent Carcinoma of the Stomach",
"Recurrent Gastric Cancer",
"Recurrent Stomach Cancer",
"Recurrent Stomach Carcinoma"
]
}, {
"disease_code": null,
"inclusion_indicator": "TRIAL",
"lead_disease_indicator": null,
"nci_thesaurus_concept_id": "C8627",
"preferred_name": "Recurrent Esophageal Adenocarcinoma",
"display_name": "",
"parents": [
"C4025",
"C3999"
],
"synonyms": [
"Recurrent Esophageal Adenocarcinoma",
"Esophageal Adenocarcinoma, Recurrent",
"Oesophageal Adenocarcinoma Recurrent",
"Recurrent Adenocarcinoma of Esophagus",
"Recurrent Adenocarcinoma of the Esophagus",
"Recurrent Esophagus Adenocarcinoma",
"Relapsed Adenocarcinoma of Esophagus",
"Relapsed Adenocarcinoma of the Esophagus",
"Relapsed Esophageal Adenocarcinoma",
"Relapsed Esophagus Adenocarcinoma"
]
}, {
"disease_code": null,
"inclusion_indicator": "TRIAL",
"lead_disease_indicator": null,
"nci_thesaurus_concept_id": "C5693",
"preferred_name": "Stage IVB Esophageal Cancer",
"display_name": "",
"parents": [
"C87778"
],
"synonyms": [
"Stage IVB Esophageal Cancer",
"Esophageal Cancer Stage IVB",
"Stage IVB Carcinoma of Esophagus",
"Stage IVB Carcinoma of the Esophagus",
"Stage IVB Esophageal Carcinoma",
"Stage IVB Esophagus Carcinoma"
]
}, {
"disease_code": null,
"inclusion_indicator": "TRIAL",
"lead_disease_indicator": null,
"nci_thesaurus_concept_id": "C5694",
"preferred_name": "Stage IVA Esophageal Cancer",
"display_name": "",
"parents": [
"C87778"
],
"synonyms": [
"Stage IVA Esophageal Cancer",
"Esophageal Cancer Stage IVA",
"Stage IVA Carcinoma of Esophagus",
"Stage IVA Carcinoma of the Esophagus",
"Stage IVA Esophageal Carcinoma",
"Stage IVA Esophagus Carcinoma"
]
}, {
"disease_code": "CDR0000717463",
"inclusion_indicator": "TRIAL",
"lead_disease_indicator": null,
"nci_thesaurus_concept_id": "C115121",
"preferred_name": "Stage IIIC Esophageal Cancer",
"display_name": "Stage IIIC Esophageal Cancer",
"parents": [
"C89795"
],
"synonyms": [
"Stage IIIC Esophageal Cancer",
"Stage IIIC Esophageal Cancer AJCC v7"
]
}, {
"disease_code": "CDR0000717462",
"inclusion_indicator": "TRIAL",
"lead_disease_indicator": null,
"nci_thesaurus_concept_id": "C115120",
"preferred_name": "Stage IIIB Esophageal Cancer",
"display_name": "Stage IIIB Esophageal Cancer",
"parents": [
"C89795"
],
"synonyms": [
"Stage IIIB Esophageal Cancer",
"Stage IIIB Esophageal Cancer AJCC v7"
]
}, {
"disease_code": "CDR0000717461",
"inclusion_indicator": "TRIAL",
"lead_disease_indicator": null,
"nci_thesaurus_concept_id": "C115119",
"preferred_name": "Stage IIIA Esophageal Cancer",
"display_name": "Stage IIIA Esophageal Cancer",
"parents": [
"C89795"
],
"synonyms": [
"Stage IIIA Esophageal Cancer",
"Stage IIIA Esophageal Cancer AJCC v7"
]
}, {
"disease_code": null,
"inclusion_indicator": "TRIAL",
"lead_disease_indicator": null,
"nci_thesaurus_concept_id": "C8626",
"preferred_name": "Stage IV Gastric Cancer with Metastasis",
"display_name": "",
"parents": [
"C87778"
],
"synonyms": [
"Stage IV Gastric Cancer with Metastasis",
"Stage IV Gastric Carcinoma with Metastasis"
]
}, {
"disease_code": "CDR0000040504",
"inclusion_indicator": "TRIAL",
"lead_disease_indicator": null,
"nci_thesaurus_concept_id": "C89861",
"preferred_name": "Stage IV Gastric Cancer",
"display_name": "Stage IV Gastric Cancer",
"parents": [
"C91222"
],
"synonyms": [
"Stage IV Gastric Cancer",
"Stage IV Gastric Cancer AJCC v7"
]
}, {
"disease_code": "CDR0000714177",
"inclusion_indicator": "TRIAL",
"lead_disease_indicator": null,
"nci_thesaurus_concept_id": "C87777",
"preferred_name": "Stage IIIC Gastric Cancer",
"display_name": "Stage IIIC Gastric Cancer",
"parents": [
"C89860"
],
"synonyms": [
"Stage IIIC Gastric Cancer",
"Stage IIIC Gastric Cancer AJCC v7"
]
}, {
"disease_code": "CDR0000714175",
"inclusion_indicator": "TRIAL",
"lead_disease_indicator": null,
"nci_thesaurus_concept_id": "C5470",
"preferred_name": "Stage IIIB Gastric Cancer",
"display_name": "Stage IIIB Gastric Cancer",
"parents": [
"C89860"
],
"synonyms": [
"Stage IIIB Gastric Cancer",
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"Carcinoma of the Stomach Stage IIIB",
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