{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"0"}],"units":"Participants"}],"description":"Dose limiting toxicity is assessed using CTCAE v5.0 and defined as any one of: neutropenia with fever grade\\>=3; neutropenia grade\\>=4; thrombocytopenia with bleeding grade \\>=3; thrombocytopenia grade \\>=4; any non-haematological toxicity grade \\>=3 which is definitely, probably or possibly related to the combination of pembrolizumab and SBRT","groups":[{"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":"OG000","title":"Initial Safety Cohort"},{"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":"OG001","title":"Expansion Cohort"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"Patients who remained on trial for the duration of the DLT time frame","reportingStatus":"POSTED","timeFrame":"Worst grade as assessed 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, up to 12 weeks from last dose of SBRT (i.e. cycle 6 day 1)","title":"Percentage of Patients With Dose Limiting Toxicity (DLT)","type":"PRIMARY","unitOfMeasure":"Participants"}