{"description":"Adverse events were assessed using CTCAE v5.0. Disease progression of the cancer under study is not considered an AE unless the investigator considers it to be IMP-related or it results in hospitalisation or prolongs existing in-patient hospitalisation or death.","eventGroups":[{"deathsNumAffected":2,"deathsNumAtRisk":5,"description":"Patients will receive an initial dose of pembrolizumab in week 1 dosed at 200 mg. They will then receive SBRT dosed at 30 Gy in 3 fractions (#) alternate days in week 3. Treatment with pembrolizumab will be continued dosed at 200 mg given every 3 weeks.\n\nPembrolizumab: Pembrolizumab will be continued dosed at 200 mg given every 3 weeks\n\nDrug: Pembrolizumab Pembrolizumab in week 1 dosed at 200 mg (prior to SBRT) and then treatment with pembrolizumab will be continued dosed at 200 mg given every 3 weeks.\n\nStereotactic Body Radiotherapy (SBRT): Stereotactic Body Radiotherapy (SBRT) 30 Gy 3 fractions (#)","id":"EG000","otherNumAffected":5,"otherNumAtRisk":5,"seriousNumAffected":3,"seriousNumAtRisk":5,"title":"Initial Safety Cohort"},{"deathsNumAffected":0,"deathsNumAtRisk":0,"description":"An additional 12 patients will be recruited for this cohort. Patients will receive an initial dose of pembrolizumab at 200 mg in week 1. This will be followed in by SBRT dosed at 30 Gy in 3 fractions (#) alternate days in week 3. Treatment with pembrolizumab will be continued dosed at 200 mg given every 3 weeks.\n\nPembrolizumab: Pembrolizumab will be continued dosed at 200 mg given every 3 weeks\n\nDrug: Pembrolizumab Pembrolizumab in week 1 dosed at 200 mg (prior to SBRT) and then treatment with pembrolizumab will be continued dosed at 200 mg given every 3 weeks.\n\nStereotactic Body Radiotherapy (SBRT): Stereotactic Body Radiotherapy (SBRT) 30 Gy 3 fractions (#)","id":"EG001","otherNumAffected":0,"otherNumAtRisk":0,"seriousNumAffected":0,"seriousNumAtRisk":0,"title":"Expansion Cohort"}],"frequencyThreshold":"0","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":5,"numEvents":4},{"groupId":"EG001","numAtRisk":0}],"term":"Dyspnea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":5,"numEvents":4},{"groupId":"EG001","numAtRisk":0}],"term":"Lethargy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":5,"numEvents":4},{"groupId":"EG001","numAtRisk":0}],"term":"Weight loss"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":5,"numEvents":4},{"groupId":"EG001","numAtRisk":0}],"term":"Alanine aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":5,"numEvents":2},{"groupId":"EG001","numAtRisk":0}],"term":"Anorexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":5,"numEvents":4},{"groupId":"EG001","numAtRisk":0}],"term":"Aspartate aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":5,"numEvents":2},{"groupId":"EG001","numAtRisk":0}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":5,"numEvents":4},{"groupId":"EG001","numAtRisk":0}],"term":"Cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":5,"numEvents":2},{"groupId":"EG001","numAtRisk":0}],"term":"Diarrhea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":5,"numEvents":3},{"groupId":"EG001","numAtRisk":0}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":5,"numEvents":2},{"groupId":"EG001","numAtRisk":0}],"term":"Fever"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG001","numAtRisk":0}],"term":"Alkaline phosphatase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG001","numAtRisk":0}],"term":"Anemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG001","numAtRisk":0}],"term":"Anxiety"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5,"numEvents":3},{"groupId":"EG001","numAtRisk":0}],"term":"Arthritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5,"numEvents":2},{"groupId":"EG001","numAtRisk":0}],"term":"Back pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG001","numAtRisk":0}],"term":"Blood lactate dehydrogenase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5,"numEvents":2},{"groupId":"EG001","numAtRisk":0}],"term":"Chest wall pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG001","numAtRisk":0}],"term":"Dry mouth"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG001","numAtRisk":0}],"term":"Dysphagia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG001","numAtRisk":0}],"term":"Erythroderma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG001","numAtRisk":0}],"term":"Flu like symptoms"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG001","numAtRisk":0}],"term":"Generalized muscle weakness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG001","numAtRisk":0}],"term":"Hyperhidrosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG001","numAtRisk":0}],"term":"Hyperphosphatemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5,"numEvents":4},{"groupId":"EG001","numAtRisk":0}],"term":"Hypertension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG001","numAtRisk":0}],"term":"Hyperuricemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG001","numAtRisk":0}],"term":"Hypoalbuminemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG001","numAtRisk":0}],"term":"Hypocalcemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG001","numAtRisk":0}],"term":"Investigations - other, increased C-reactive protein"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG001","numAtRisk":0}],"term":"Investigations - other, increased lactate"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG001","numAtRisk":0}],"term":"Insomnia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG001","numAtRisk":0}],"term":"Lung infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG001","numAtRisk":0}],"term":"Lymphocyte count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG001","numAtRisk":0}],"term":"Papilledema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5,"numEvents":3},{"groupId":"EG001","numAtRisk":0}],"term":"Pneumonitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5,"numEvents":2},{"groupId":"EG001","numAtRisk":0}],"term":"Rash maculo-papular"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG001","numAtRisk":0}],"term":"Rhinorrhea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG001","numAtRisk":0}],"term":"Skin atrophy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG001","numAtRisk":0}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG001","numAtRisk":0}],"term":"Investigations - other, raised urea"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG001","numAtRisk":0}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG001","numAtRisk":0}],"term":"Flank pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG001","numAtRisk":0}],"term":"Alanine aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG001","numAtRisk":0}],"term":"Aspartate aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG001","numAtRisk":0}],"term":"Lung infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG001","numAtRisk":0}],"term":"Pneumonitis"}],"timeFrame":"AEs will be graded and recorded from confirmation of entry into the trial, at cycle 1 day 1 of pembrolizumab, at each of three radiotherapy fractions (cycle 1 days 15, 17, 19) and then at day 1 of each 21 day cycle, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 10 months). All cause mortality is recorded until death or end of trial (24 months)."}