Procedures
Tumour, tumour
ADVERSE EVENT, TUMOUR, ADVERSE EVENTS, TUMOUR, HEREDITARY CANCER
In part A of the study, patients were enrolled sequentially to one of three schedules in which a single priming dose of No dose reductions of Gender and ethnicity data were obtained by patient self-report. Clinical and laboratory assessments in phase 1b of the study were done on days 1, 8, and 15 of cycle 1, and on day 1 of every cycle thereafter. Clinical assessment included assessment of adverse events, graded using Common Terminology Criteria for Adverse Events (CTCAE; version 4.03), assessment of vital signs, and a focused physical exam. Laboratory assessments included complete blood count with differential, electrolytes, liver, and thyroid function tests.Tumour response and progression monitoring was performed using whole-body technetium-99m bone scintography and cross-sectional imaging (CT or MRI) of the chest, abdomen, and pelvis at baseline and every 9 weeks until confirmed progression by RECIST (version 1.1) and PCWG3 criteria. Percentage change in tumour size from baseline was calculated as the sum of longest diameter of target lesions as per RECIST 1.1 criteria. Scans were assessed by investigators and were not centrally reviewed. Patients who discontinued study treatment for reasons other than progression continued to have restaging scans performed per protocol. A repeat Somatic and germline mutation status was ascertained for all patients using a Clinical Laboratory Improvement Amendments-approved assays (Invitae Common Hereditary Cancers Panel [Invitae Laboratories, San Francisco, CA, USA]; FoundationOne CDx and FoundationOneLiquid CDx [Foundation Medicine, Cambridge, MA, USA]; UCSF500 [University of California, San Francisco]).Whole blood was collected at baseline before the initiation of study treatment (cycle 1, day 1) and serially on study treatment (cycle 2, day 1; cycle 3, day 1; cycle 6, day 1; cycle 9, day 1). Changes in the blood immune response was assessed using mass cytometry by time-of-flight (CyTOF). Processing instructions for CyTOF are described in the 