{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"0"},{"groupId":"OG006","value":"0"}]}],"title":"Grade 3 CK increase"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"2"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"0"},{"groupId":"OG006","value":"0"}]}],"title":"Grade 3 AST increase"}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"10"},{"groupId":"OG002","value":"11"},{"groupId":"OG003","value":"4"},{"groupId":"OG004","value":"3"},{"groupId":"OG005","value":"3"},{"groupId":"OG006","value":"6"}],"units":"Participants"}],"description":"A DLT was defined as a study drug-related ≥ Grade 3 AE (using National Cancer Institute Common Terminology Criteria for Adverse Events v 4.03) occurring during the first 28-days, excluding Grade 3 tumor flare (defined as local pain, irritation, or rash localized at sites of known or suspected tumor), rash, immune-related adverse event (irAE) that resolved to ≤ Grade 1 by 14 days or a transient (resolving within 6 hours of onset) Grade 3 infusion-related AE. Any recurrence of Grade 3 rash, irAE or infusion-related AE was considered a DLT.\n\nThe protocol was amended such that in the absence of clinical symptoms and other accompanying changes in bilirubin or alanine aminotransferase (ALT), serum elevation of aspartate aminotransferase (AST)/ALT \\> 12 × upper limit of normal (ULN) and ≤ 20 × ULN that lasted for \\< 7 days and serum elevation of creatine kinase (CK) and/or lactate dehydrogenase (LDH) \\> 15 × ULN and ≤ 20 × ULN that lasted for \\< 7 days were not considered DLTs.","groups":[{"description":"Participants received 2 mg/kg cabiralizumab administered intravenously (IV) once every 2 weeks (Q2W).","id":"OG000","title":"Cabiralizumab 2 mg/kg Q2W"},{"description":"Participants received 4 mg/kg cabiralizumab IV Q2W","id":"OG001","title":"Cabiralizumab 4 mg/kg Q2W"},{"description":"Participants received 6 mg/kg cabiralizumab IV Q2W.","id":"OG002","title":"Cabiralizumab 6 mg/kg Q2W"},{"description":"Participants received 1 mg/kg cabiralizumab IV and 3 mg/kg nivolumab IV Q2W.","id":"OG003","title":"Cabiralizumab 1 mg/kg + Nivolumab 3 mg/kg Q2W"},{"description":"Participants received 2 mg/kg cabiralizumab IV and 3 mg/kg nivolumab IV Q2W.","id":"OG004","title":"Cabiralizumab 2 mg/kg + Nivolumab 3 mg/kg Q2W"},{"description":"Participants received 4 mg/kg cabiralizumab IV and 3 mg/kg nivolumab IV Q2W.","id":"OG005","title":"Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W"},{"description":"Participants received 6 mg/kg cabiralizumab IV and 3 mg/kg nivolumab IV Q2W.","id":"OG006","title":"Cabiralizumab 6 mg/kg + Nivolumab 3 mg/kg Q2W"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"Participants enrolled in the dose escalation phase who received at least 2 doses of study drug during the 28-day evaluation interval or who discontinued study treatment for drug-related adverse events before receiving 2 doses of study drug were considered evaluable for DLT determination.","reportingStatus":"POSTED","timeFrame":"28 days","title":"Safety: Number of Participants With Grade 3 or Grade 4 Adverse Events (AEs) and Laboratory Abnormalities Defined as Dose Limiting Toxicities (DLT) (Phase 1a)","type":"PRIMARY","unitOfMeasure":"Participants"}