Ignite Creation Date:
2025-12-25 @ 4:16 AM
Ignite Modification Date:
2026-02-02 @ 3:41 AM
Study NCT ID:
NCT02261220
Status:
COMPLETED
Last Update Posted:
2020-03-06
First Post:
2014-10-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase 1 Study of MEDI4736 in Combination With Tremelimumab in Subjects With Advanced Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000613593', 'term': 'durvalumab'}, {'id': 'C520704', 'term': 'tremelimumab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 380}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-10-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2020-01-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-05', 'studyFirstSubmitDate': '2014-10-02', 'studyFirstSubmitQcDate': '2014-10-06', 'lastUpdatePostDateStruct': {'date': '2020-03-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-10-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-01-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in Biomarkers', 'timeFrame': 'Screening through 3 months following the last dose of study medication'}], 'primaryOutcomes': [{'measure': 'Number of subjects reporting adverse events', 'timeFrame': 'Screening through 15 months after the last subject enters re-treatment'}, {'measure': 'Number of subjects reporting serious adverse events', 'timeFrame': 'Screening through 15 months after the last subject enters re-treatment'}, {'measure': 'Number of subjects experiencing a dose-limiting toxicity', 'timeFrame': 'First dose of study medication through 4 weeks after the first dose of study medication'}, {'measure': 'Change from Baseline in laboratory evaluations', 'timeFrame': 'Screening through 3 months after the last dose of study medication'}, {'measure': 'Change from Baseline in vital signs', 'timeFrame': 'Screening through 3 months after the last dose of study medication'}, {'measure': 'Change from Baseline in electrocardiogram evaluations', 'timeFrame': 'Screening through 3 months after the last dose of study medication'}, {'measure': 'Overall Response Rate in Select Tumor Types', 'timeFrame': 'First dose of study medication through 15 months after the last subject enters re-treatment'}], 'secondaryOutcomes': [{'measure': 'Overall Response Rate', 'timeFrame': 'First dose of study medication through 15 months after the last subject enters re-treatment'}, {'measure': 'Disease Control Rate', 'timeFrame': 'First dose of study medication through 15 months after the last subject enters re-treatment'}, {'measure': 'Duration of Response', 'timeFrame': 'First dose of study medication through 15 months after the last subject enters re-treatment'}, {'measure': 'Progression-Free Survival', 'timeFrame': 'First dose of study medication through 15 months after the last subject enters re-treatment'}, {'measure': 'Overall Survival', 'timeFrame': 'First dose of study medication through 15 months after the last subject enters re-treatment'}, {'measure': 'Individual MEDI4736 concentrations', 'timeFrame': 'First dose of MEDI4736 through 3 months after the last dose of study medication'}, {'measure': 'Individual tremelimumab concentrations', 'timeFrame': 'First dose of tremelimumab through 3 months after the last dose of study medication'}, {'measure': 'MEDI4736 area under the concentration-curve', 'timeFrame': 'First dose of MEDI4736 through 3 months after the last dose of study medication'}, {'measure': 'Tremelimumab area under the concentration-curve', 'timeFrame': 'First dose of tremelimumab through 3 months after the last dose of study medication'}, {'measure': 'Number of subjects that develop detectable antidrug antibodies to MEDI4736', 'timeFrame': 'First dose of MEDI4736 through 3 months after the last dose of study medication'}, {'measure': 'Number of subjects that develop antidrug antibodies to tremelimumab', 'timeFrame': 'First dose of tremelimumab through 3 months after the last dose of study medication'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['advanced solid tumors', 'durvalumab', 'tremelimumab'], 'conditions': ['Advanced Solid Tumors']}, 'referencesModule': {'references': [{'pmid': '32816849', 'type': 'DERIVED', 'citation': 'Zhang Q, Luo J, Wu S, Si H, Gao C, Xu W, Abdullah SE, Higgs BW, Dennis PA, van der Heijden MS, Segal NH, Chaft JE, Hembrough T, Barrett JC, Hellmann MD. Prognostic and Predictive Impact of Circulating Tumor DNA in Patients with Advanced Cancers Treated with Immune Checkpoint Blockade. Cancer Discov. 2020 Dec;10(12):1842-1853. doi: 10.1158/2159-8290.CD-20-0047. Epub 2020 Aug 14.'}]}, 'descriptionModule': {'briefSummary': 'This is a multicenter, open-label, dose-exploration and dose-expansion study to evaluate the safety, tolerability, antitumor activity, PK and immunogenicity of MEDI4736 in combination with tremelimumab in subjects with select advanced solid tumors.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female subjects\n* 18 years and older\n* Histologic confirmation of advanced solid tumors\n* Subjects must have recurrent/metastatic disease and may have been previously treated in the recurrent/metastatic setting.\n\nExclusion Criteria:\n\n* Any concurrent chemotherapy, immune-mediated therapy or biologic or hormonal therapy for cancer treatment\n* Active or prior documented autoimmune disease within the past 2 years\n* Current or prior use of immunosuppressive medication within 14 days with some exceptions.'}, 'identificationModule': {'nctId': 'NCT02261220', 'briefTitle': 'A Phase 1 Study of MEDI4736 in Combination With Tremelimumab in Subjects With Advanced Solid Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'MedImmune LLC'}, 'officialTitle': 'A Phase I Study of MEDI4736 (Anti-PD-L1 Antibody) in Combination With Tremelimumab (Anti-CTLA-4 Antibody) in Subjects With Advanced Solid Tumors', 'orgStudyIdInfo': {'id': 'D4190C00010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MEDI4736 + Tremelimumab', 'description': 'Subjects with multiple tumor types.', 'interventionNames': ['Biological: MEDI4736', 'Biological: tremelimumab']}], 'interventions': [{'name': 'MEDI4736', 'type': 'BIOLOGICAL', 'description': 'MEDI4736 is administered by IV infusion in combination with tremelimumab', 'armGroupLabels': ['MEDI4736 + Tremelimumab']}, {'name': 'tremelimumab', 'type': 'BIOLOGICAL', 'description': 'Tremelimumab is administered by IV infusion in combination with MEDI4736', 'armGroupLabels': ['MEDI4736 + Tremelimumab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85258', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '91010', 'city': 'Duarte', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 34.13945, 'lon': -117.97729}}, {'zip': '92093', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '90025', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90603', 'city': 'Whittier', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.97918, 'lon': -118.03284}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '06510', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '33140', 'city': 'Miami Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 25.79065, 'lon': -80.13005}}, {'zip': '33612', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '52242-1008', 'city': 'Iowa City', 'state': 'Iowa', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}, {'zip': '40202', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10116', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10461', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}, {'zip': '45219', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '97213', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '19111', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '15212', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '29605', 'city': 'Greenville', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 34.85262, 'lon': -82.39401}}, {'zip': '75230', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77521', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '22031', 'city': 'Fairfax', 'state': 'Virginia', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 38.84622, 'lon': -77.30637}}, {'zip': '98104', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': 'N6A 4L6', 'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Research Site', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}, {'zip': 'M4N 3M5', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Research Site', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'M5G 1X5', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Research Site', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'H3T 1E2', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Research Site', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'G1R 2J6', 'city': 'Québec', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Research Site', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}, {'zip': '49055', 'city': 'Angers', 'country': 'France', 'facility': 'Research Site', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'zip': '25030', 'city': 'Besançon', 'country': 'France', 'facility': 'Research Site', 'geoPoint': {'lat': 47.24878, 'lon': 6.01815}}, {'zip': '33075', 'city': 'Bordeaux', 'country': 'France', 'facility': 'Research Site', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '69008', 'city': 'Lyon', 'country': 'France', 'facility': 'Research Site', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '13005', 'city': 'Marseille', 'country': 'France', 'facility': 'Research Site', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '34298', 'city': 'Montpellier', 'country': 'France', 'facility': 'Research Site', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '69495', 'city': 'Pierre-Bénite', 'country': 'France', 'facility': 'Research Site', 'geoPoint': {'lat': 45.70359, 'lon': 4.82424}}, {'zip': '54519', 'city': 'Vandœuvre-lès-Nancy', 'country': 'France', 'facility': 'Research Site', 'geoPoint': {'lat': 48.66115, 'lon': 6.17114}}, {'zip': '94805', 'city': 'Villejuif', 'country': 'France', 'facility': 'Research Site', 'geoPoint': {'lat': 48.7939, 'lon': 2.35992}}, {'zip': '07747', 'city': 'Jena', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 50.92878, 'lon': 11.5899}}, {'zip': '48149', 'city': 'Münster', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 51.96236, 'lon': 7.62571}}, {'zip': '72076', 'city': 'Tübingen', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 48.52266, 'lon': 9.05222}}, {'zip': '31096', 'city': 'Haifa', 'country': 'Israel', 'facility': 'Research Site', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}, {'zip': '91031', 'city': 'Jerusalem', 'country': 'Israel', 'facility': 'Research Site', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}, {'zip': '44410', 'city': 'Kfar Saba', 'country': 'Israel', 'facility': 'Research Site', 'geoPoint': {'lat': 32.175, 'lon': 34.90694}}, {'zip': '64239', 'city': 'Tel Aviv', 'country': 'Israel', 'facility': 'Research Site', 'geoPoint': {'lat': 32.08088, 'lon': 34.78057}}, {'zip': '1066 CX', 'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'Research Site', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'zip': '1081 HV', 'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'Research Site', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'zip': '5042AD', 'city': 'Tilburg', 'country': 'Netherlands', 'facility': 'Research Site', 'geoPoint': {'lat': 51.55551, 'lon': 5.0913}}, {'zip': '49241', 'city': 'Busan', 'country': 'South Korea', 'facility': 'Research Site', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'zip': '41404', 'city': 'Daegu', 'country': 'South Korea', 'facility': 'Research Site', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'zip': '42601', 'city': 'Daegu', 'country': 'South Korea', 'facility': 'Research Site', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'zip': '61469', 'city': 'Gwangju', 'country': 'South Korea', 'facility': 'Research Site', 'geoPoint': {'lat': 35.15472, 'lon': 126.91556}}, {'zip': '13620', 'city': 'Seongnam-si', 'country': 'South Korea', 'facility': 'Research Site', 'geoPoint': {'lat': 37.43861, 'lon': 127.13778}}, {'zip': '03722', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Research Site', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '06591', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Research Site', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '135-710', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Research Site', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '08026', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Research Site', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08035', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Research Site', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08036', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Research Site', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '28034', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Research Site', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28041', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Research Site', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '31008', 'city': 'Pamplona', 'country': 'Spain', 'facility': 'Research Site', 'geoPoint': {'lat': 42.81687, 'lon': -1.64323}}, {'zip': '46010', 'city': 'Valencia', 'country': 'Spain', 'facility': 'Research Site', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'zip': 'G12 0YN', 'city': 'Glasgow', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 55.86515, 'lon': -4.25763}}, {'zip': 'EC1M 6BQ', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'NW1 2BU', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'CH63 4JY', 'city': 'Metropolitan Borough of Wirral', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 53.37616, 'lon': -3.10501}}, {'zip': 'TS4 3BW', 'city': 'Middlesbrough', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 54.57623, 'lon': -1.23483}}, {'zip': 'OX3 7LE', 'city': 'Oxford', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 51.75222, 'lon': -1.25596}}], 'overallOfficials': [{'name': 'MedImmune LLC', 'role': 'STUDY_DIRECTOR', 'affiliation': 'MedImmune LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'MedImmune LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}