Ignite Creation Date:
2025-12-26 @ 11:09 AM
Ignite Modification Date:
2025-12-29 @ 7:37 AM
Study NCT ID:
NCT04660812
Status:
COMPLETED
Last Update Posted:
2025-10-20
First Post:
2020-12-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Open Label Study Evaluating the Efficacy and Safety of Etrumadenant (AB928) Based Treatment Combinations in Participants With Metastatic Colorectal Cancer.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Germany']}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000723779', 'term': 'quemliclustat'}, {'id': 'C000719848', 'term': 'zimberelimab'}, {'id': 'D000068258', 'term': 'Bevacizumab'}, {'id': 'C559147', 'term': 'regorafenib'}], 'ancestors': [{'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 227}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-05-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-09-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-10-17', 'studyFirstSubmitDate': '2020-12-03', 'studyFirstSubmitQcDate': '2020-12-03', 'lastUpdatePostDateStruct': {'date': '2025-10-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2020-12-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cohort A and B - Progression-free Survival (PFS)', 'timeFrame': 'From randomization until death from any cause (up to approximately 3-7 years)', 'description': 'PFS according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, as assessed by the Investigator'}, {'measure': 'Cohort C - Objective Response Rate (ORR)', 'timeFrame': 'From randomization until death from any cause (up to approximately 3-7 years)', 'description': 'ORR according to RECIST v1.1, as assessed by the Investigator'}, {'measure': 'Number of Participants With Treatment-emergent Adverse Events', 'timeFrame': 'Up to approximately 10 Months'}], 'secondaryOutcomes': [{'measure': 'Cohorts A and B - Objective Response Rate (ORR)', 'timeFrame': 'From randomization until death from any cause (up to approximately 3-7 years)', 'description': 'ORR according to RECIST v1.1 as assessed by the Investigator'}, {'measure': 'Cohorts A, B, and C- Duration of Disease Response (DoR)', 'timeFrame': 'From randomization until death from any cause (up to approximately 3-7 years)', 'description': 'DoR according to RECIST v1.1, as assessed by the Investigator'}, {'measure': 'Cohorts A, B, and C- Disease Control Rate (DCR)', 'timeFrame': 'From randomization until death from any cause (up to approximately 3-7 years)', 'description': 'DCR according to RECIST v1.1, as assessed by the Investigator'}, {'measure': 'Cohorts A and B - Overall Survival (OS)', 'timeFrame': 'From randomization until death from any cause (up to approximately 3-7 years)', 'description': 'OS according to RECIST v1.1, as assessed by the Investigator'}, {'measure': 'Observed Maximum Concentration (Cmax) of Etrumadenant and its Metabolites', 'timeFrame': 'From randomization until death from any cause (up to approximately 10 months)', 'description': 'Cycle 1 Day 1 and Cycle 2 Day 1'}, {'measure': 'Area Under the Plasma Concentration Versus Time Curve From Time Zero to 24 Hours [AUC(0-24)] of Etrumadenant and its Metabolites', 'timeFrame': 'Up to 24 hours following Day 1 Cycle 1 and Cycle 2 (each cycle is 28 days)'}, {'measure': 'Trough Concentrations of Etrumadenant and its Metabolites', 'timeFrame': 'Multiple timepoints up to approximately 16 months'}, {'measure': 'Cmax End of Infusion (EOI) of AB680', 'timeFrame': 'At the end of infusion on Day 1 Cycle 1 and Cycle 2 (each cycle is 28 days)'}, {'measure': 'Area Under the Plasma Concentration Versus Time Curve From Time Zero to 336 Hours [AUC(0-336)] of AB680', 'timeFrame': 'Up to 336 hours following Day 1 Cycle and Cycle 2 (each cycle is 28 days)]'}, {'measure': 'Trough Concentrations of AB680', 'timeFrame': 'Multiple timepoints up to approximately 16 months'}, {'measure': 'Cmax EOI of Zimberelimab', 'timeFrame': 'Multiple timepoints up to approximately 16 months'}, {'measure': 'AUV(0-336) of Zimberelimab', 'timeFrame': 'Cycle 1 Day 1 up to 336 hours'}, {'measure': 'Trough Concentrations of Zimberelimab', 'timeFrame': 'Multiple timepoints up to approximately 16 months'}, {'measure': 'Number of Participants With Anti-Drug Antibodies to the Biologic Component(s) of Combination Therapy', 'timeFrame': 'Up to approximately 10 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['mCRC'], 'conditions': ['Metastatic Colorectal Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trials.arcusbio.com/study/?id=ARC-9', 'label': 'ARC-9 - Public website'}]}, 'descriptionModule': {'briefSummary': 'This randomized phase 1b/2 open-label study will evaluate the antitumour activity and safety of etrumadenant (AB928) treatment combinations in participants with metastatic colorectal cancer.', 'detailedDescription': 'This is a multicenter, open-label Phase 1b/2 study in participants with metastatic colorectal cancer that will assess the antitumour activity and safety of etrumadenant.\n\nApproximately 250 participants will be enrolled to 1 of 3 cohorts:\n\nCohort A) etrumadenant + zimberelimab +mFOLFOX-6 +/-bevacizumab vs mFOLFOX-6 +/-bevacizumab\n\nCohort B) etrumadenant + zimberelimab +mFOLFOX-6 +/-bevacizumab vs regorafenib\n\nCohort C) chemotherapy-free combinations of etrumadenant + zimberelimab + other agents\n\nThe primary objective of this clinical study is to evaluate the safety of etrumadenant-based combination therapy in participants with metastatic colorectal cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female participants ≥ 18 years of age\n* Histologically confirmed metastatic colorectal adenocarcinoma\n* Must have at least 1 measurable lesion per RECIST v1.1\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n* Life expectancy at least 3 months\n* Adequate hematologic and end-organ function\n* Negative HIV, Hep B and Hep C antibody testing\n* Agreement to remain abstinent or use contraceptive measures with female partners of reproductive potential, and agreement to refrain from donating sperm, for 30 days after the last dose of etrumadenant, 90 days after the last dose of zim, 180 days after mFOLFOX-6 and 180 days after bev, whichever is longer.\n\n * Inclusion Criteria for Cohort A:\n* Disease progression following not more than one prior line of treatment for mCRC that consisted of oxaliplatin or irinotecan containing chemotherapy in combination with a biologic agent\n\n * Inclusion Criteria for Cohort B:\n* Disease progression during or following not more than two separate lines of treatment for mCRC that consisted of oxaliplatin, and irinotecan containing chemotherapy in combination with a biologic agent\n\nExclusion Criteria:\n\n* Previous anticancer treatment within 4 weeks prior to initiation of study treatment\n* Prior allogeneic stem cell or solid organ transplant\n* Treatment with systemic immunostimulatory agents within 4 weeks prior to initiation of study treatment\n* Use of any live vaccines against infectious diseases within 28 days of first dose.\n* Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases\n* Current treatment with anti-viral therapy for HBV\n* Structurally unstable bone lesions suggesting impending fracture\n* History or leptomeningeal disease\n* History of idiopathic pulmonary fibrosis, organizing pneumonia, drug induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan\n* History of malignancy other than colorectal cancer within 2 years prior to screening, except for malignancies such as non-melanoma skin carcinoma or ductal carcinoma in situ\n* Active tuberculosis\n* Treatment with therapeutic oral or intravenous (IV) antibiotics within 2 weeks prior to initiating study treatment\n* Severe infection within 4 weeks (28 days) prior to initiation of study treatment\n* Significant cardiovascular disease, unstable or new onset of angina within 3 months prior to initiation of treatment, or myocardial infarction within 6 months prior to study treatment or unstable arrhythmia\n* Major surgical procedures, other than for diagnosis, within 4 weeks prior to initiation of study treatment, or anticipation of need for major surgical procedure during the study\n* Known allergy or hypersensitivity to any of the study drugs or their excipients\n* Inability to swallow medications\n* Malabsorption condition that would alter the absorption of orally administered medications\n* Evidence of inherited bleeding diathesis or significant coagulopathy at risk of bleeding (i.e., in the absence of therapeutic anticoagulation)\n* Prior treatment with an agent targeting the adenosine pathway\n* Active or history of autoimmune disease or immune deficiency, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjögren syndrome, Guillain Barré syndrome, or multiple sclerosis\n\n * Exclusion Criteria for Cohorts A and B:\n* Prior treatment with immune checkpoint blockade therapies including anti-cytotoxic T lymphocyte-associated protein-4, anti PD-1, and anti-PD-L1 therapeutic antibodies\n* Mutation in the BRAF oncogene. Patients with unknown BRAF status will be required to undergo testing at a local laboratory and provide results at screening'}, 'identificationModule': {'nctId': 'NCT04660812', 'acronym': 'ARC-9', 'briefTitle': 'An Open Label Study Evaluating the Efficacy and Safety of Etrumadenant (AB928) Based Treatment Combinations in Participants With Metastatic Colorectal Cancer.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Arcus Biosciences, Inc.'}, 'officialTitle': 'A Phase 1b/2, Open-Label, Randomized Platform Study Evaluating The Efficacy and Safety of AB928 Based Treatment Combinations in Patients With Metastatic Colorectal Cancer', 'orgStudyIdInfo': {'id': 'ARC-9'}, 'secondaryIdInfos': [{'id': '2020-005386-13', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Etrumadenant + Zimberelimab + mFOLFOX-6 +/- Bevacizumab', 'description': 'Participants will receive oral etrumadenant in combination with zimberelimab +mFOLFOX-6 +/-bevacizumab by IV infusion.', 'interventionNames': ['Drug: Etrumadenant', 'Drug: Zimberelimab', 'Drug: Bevacizumab', 'Drug: m-FOLFOX-6 regimen']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'mFOLFOX-6 +/- Bevacizumab', 'description': 'Participants will receive mFOLFOX-6 +/- bevacizumab by IV infusion.', 'interventionNames': ['Drug: Bevacizumab', 'Drug: m-FOLFOX-6 regimen']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Regorafenib', 'description': 'Participants will receive oral regorafenib', 'interventionNames': ['Drug: Regorafenib']}, {'type': 'EXPERIMENTAL', 'label': 'AB680 + Etrumadenant + Zimberelimab', 'description': 'Participants will receive oral etrumadenant in combination with AB680 + zimberelimab by IV infusion.', 'interventionNames': ['Drug: AB680', 'Drug: Etrumadenant', 'Drug: Zimberelimab']}], 'interventions': [{'name': 'AB680', 'type': 'DRUG', 'description': 'AB680 is a cluster of differentiated CD73 Inhibitor', 'armGroupLabels': ['AB680 + Etrumadenant + Zimberelimab']}, {'name': 'Etrumadenant', 'type': 'DRUG', 'otherNames': ['AB928'], 'description': 'Etrumadenant is a dual adenosine receptor (A2aR and A2bR) antagonist', 'armGroupLabels': ['AB680 + Etrumadenant + Zimberelimab', 'Etrumadenant + Zimberelimab + mFOLFOX-6 +/- Bevacizumab']}, {'name': 'Zimberelimab', 'type': 'DRUG', 'otherNames': ['AB122'], 'description': 'Zimberelimab is a fully human anti-PD-1 monoclonal antibody', 'armGroupLabels': ['AB680 + Etrumadenant + Zimberelimab', 'Etrumadenant + Zimberelimab + mFOLFOX-6 +/- Bevacizumab']}, {'name': 'Bevacizumab', 'type': 'DRUG', 'description': 'Bevacizumab is administered as part of standard chemotherapy regimen', 'armGroupLabels': ['Etrumadenant + Zimberelimab + mFOLFOX-6 +/- Bevacizumab', 'mFOLFOX-6 +/- Bevacizumab']}, {'name': 'm-FOLFOX-6 regimen', 'type': 'DRUG', 'description': 'mFOLFOX-6 regimen is administered as part of standard chemotherapy regimen', 'armGroupLabels': ['Etrumadenant + Zimberelimab + mFOLFOX-6 +/- Bevacizumab', 'mFOLFOX-6 +/- Bevacizumab']}, {'name': 'Regorafenib', 'type': 'DRUG', 'description': 'Regorafenib is administered as part of standard chemotherapy regimen', 'armGroupLabels': ['Regorafenib']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85715', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arizona Clinical Research Center Inc', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '91010', 'city': 'Duarte', 'state': 'California', 'country': 'United States', 'facility': 'City of Hope Comprehensive Cancer Center', 'geoPoint': {'lat': 34.13945, 'lon': -117.97729}}, {'zip': '90404', 'city': 'Santa Monica', 'state': 'California', 'country': 'United States', 'facility': 'UCLA Hematology Oncology', 'geoPoint': {'lat': 34.01949, 'lon': -118.49138}}, {'zip': '06510', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale Cancer Center', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '20016-2633', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Sibley Memorial Hospital', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Winship Cancer Institute at Emory University', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '70121', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Ochsner Medical Center (OMC)', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '20817', 'city': 'Bethesda', 'state': 'Maryland', 'country': 'United States', 'facility': 'American Oncology Partners of Maryland PA', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University School of Medicine', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '89169', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Comprehensive Cancer Centers Of Nevada', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'NYU Langone Medical Center - NYU Medical Oncology Associates', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York-Presbyterian Hospital-Columbia University Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '29605', 'city': 'Greenville', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Prisma Health-Upstate', 'geoPoint': {'lat': 34.85262, 'lon': -82.39401}}, {'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt-Ingram Cancer Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Sarah Cannon Research Institute', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'The University of Texas MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '53792', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'University of Wisconsin School of Medicine', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}, {'zip': '33076', 'city': 'Bordeaux', 'country': 'France', 'facility': 'Institut Bergonie - Centre Regional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '21000', 'city': 'Dijon', 'country': 'France', 'facility': 'Centre Georges Francois Leclerc', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}, {'zip': '44093', 'city': 'Nantes', 'country': 'France', 'facility': 'Hopital Hotel Dieu', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'zip': '75012', 'city': 'Paris', 'country': 'France', 'facility': 'Hopital Saint Antoine', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75651', 'city': 'Paris', 'country': 'France', 'facility': "Groupe Hospitalier Pitie-Salpetriere-Centre De Recherche et de Medecine de l'Obesite", 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '86000', 'city': 'Poitiers', 'country': 'France', 'facility': 'CHU la Miletrie', 'geoPoint': {'lat': 46.58261, 'lon': 0.34348}}, {'zip': '70013', 'city': 'Castellana Grotte', 'country': 'Italy', 'facility': 'IRCCS - Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis', 'geoPoint': {'lat': 40.88643, 'lon': 17.16549}}, {'zip': '50134', 'city': 'Florence', 'country': 'Italy', 'facility': 'Azienda Ospedaliero Universitaria Careggi-S.O.D. Patologia Medica', 'geoPoint': {'lat': 43.77925, 'lon': 11.24626}}, {'zip': '20141', 'city': 'Milan', 'country': 'Italy', 'facility': "Azienda Ospedaliera Niguarda Ca' Granda", 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'zip': '20162', 'city': 'Milan', 'country': 'Italy', 'facility': 'Instituto Europeo di Oncologia', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'zip': '20089', 'city': 'Rozzano', 'country': 'Italy', 'facility': 'Istituto Clinico Humanitas IRCCS', 'geoPoint': {'lat': 45.38193, 'lon': 9.1559}}, {'zip': '53100', 'city': 'Siena', 'country': 'Italy', 'facility': 'Universita di Siena - Azienda Ospedaliera Universitaria Senese-Policlincio Santa Maria Alle Scotte', 'geoPoint': {'lat': 43.31822, 'lon': 11.33064}}, {'zip': '58128', 'city': 'Hwasun', 'country': 'South Korea', 'facility': 'Chonnam National University Hwasun Hospital', 'geoPoint': {'lat': 35.06125, 'lon': 126.98746}}, {'zip': '13620', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Bundang Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '3080', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital (SNUH)', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '3722', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Severance Hospital | Yonsei University Health System', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '5538', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Asan Medical Center | University of Ulsan College of Medicine', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '6351', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '8241', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Korea University Anam Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Kyungpook National University Chilgok Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '28007', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario La Paz', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28046', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital General Universitario Gregorio Maranon', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '32005', 'city': 'Ourense', 'country': 'Spain', 'facility': 'Complejo Hospitalario de Orense', 'geoPoint': {'lat': 42.33669, 'lon': -7.86407}}, {'zip': '31008', 'city': 'Pamplona', 'country': 'Spain', 'facility': 'Clinica Universidad Navarra-Sede Madrid', 'geoPoint': {'lat': 42.81687, 'lon': -1.64323}}, {'zip': '8208', 'city': 'Sabadell', 'country': 'Spain', 'facility': 'Corporacio Sanitaria Parc Tauli', 'geoPoint': {'lat': 41.54329, 'lon': 2.10942}}, {'zip': 'BT9 7AB', 'city': 'Belfast', 'state': 'Northern Ireland', 'country': 'United Kingdom', 'facility': 'Belfast City Hospital', 'geoPoint': {'lat': 54.59682, 'lon': -5.92541}}, {'zip': 'AB25 2ZN', 'city': 'Aberdeen', 'state': 'Scotland', 'country': 'United Kingdom', 'facility': 'Aberdeen Royal Infirmary', 'geoPoint': {'lat': 57.14369, 'lon': -2.09814}}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Arcus Biosciences'}]}, 'ipdSharingStatementModule': {'url': 'https://trials.arcusbio.com/our-transparency-policy', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'ipdSharing': 'YES', 'description': 'Arcus will provide access to individual de-identified participant data and related study documents (e.g., protocol, Statistical Analysis Plan \\[SAP\\], Clinical Study Report \\[CSR\\]) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions.\n\nFor more information, please visit our website.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Arcus Biosciences, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Gilead Sciences', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}