{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0.0","upperLimit":"45.9","value":"0.0"},{"groupId":"OG001","lowerLimit":"0.0","upperLimit":"41.0","value":"0.0"},{"groupId":"OG002","lowerLimit":"0.0","upperLimit":"45.9","value":"0.0"},{"groupId":"OG003","lowerLimit":"0.0","upperLimit":"45.9","value":"0.0"},{"groupId":"OG004","lowerLimit":"0.3","upperLimit":"44.5","value":"10.0"},{"groupId":"OG005","lowerLimit":"0.2","upperLimit":"36.0","value":"7.7"},{"groupId":"OG006","lowerLimit":"0.0","upperLimit":"30.8","value":"0.0"},{"groupId":"OG007","lowerLimit":"0.0","upperLimit":"7.4","value":"1.4"},{"groupId":"OG008","lowerLimit":"6.0","upperLimit":"18.1","value":"11.0"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"7"},{"groupId":"OG002","value":"6"},{"groupId":"OG003","value":"6"},{"groupId":"OG004","value":"10"},{"groupId":"OG005","value":"13"},{"groupId":"OG006","value":"10"},{"groupId":"OG007","value":"73"},{"groupId":"OG008","value":"118"}],"units":"Participants"}],"description":"ORR was defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (v1.1) as the percentage of participants with a confirmed best overall response of complete response (CR) or partial response (PR) at any post-Baseline visits prior to first disease progression and alternative cancer therapy use. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \\<10 millimeters (mm). PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. Pleural mesothelioma was evaluated using modified RECIST criteria. Confidence intervals were calculated based on the exact method for binomial distributions (Clopper Pearson). Two participants evaluable for PFS were not evaluable for response.","dispersionType":"95% Confidence Interval","groups":[{"description":"INCB001158 was administered orally at 50 milligrams (mg) twice daily (BID) in participants with advanced/metastatic solid tumors.","id":"OG000","title":"Part 1A: INCB001158 50 mg"},{"description":"INCB001158 was administered orally at 75 mg BID in participants with advanced/metastatic solid tumors.","id":"OG001","title":"Part 1A: INCB001158 75 mg"},{"description":"INCB001158 was administered orally at 100 mg BID in participants with advanced/metastatic solid tumors.","id":"OG002","title":"Part 1A: INCB001158 100 mg"},{"description":"INCB001158 was administered orally at 150 mg BID in participants with advanced/metastatic solid tumors.","id":"OG003","title":"Part 1A: INCB001158 150 mg"},{"description":"INCB001158 was administered orally at 50 mg BID in combination with pembrolizumab at 200 mg intravenously (IV) every 3 weeks (Q3W).","id":"OG004","title":"Part 1B: INCB001158 50 mg + Pembrolizumab"},{"description":"INCB001158 was administered orally at 75 mg BID in combination with pembrolizumab at 200 mg IV Q3W.","id":"OG005","title":"Part 1B: INCB001158 75 mg + Pembrolizumab"},{"description":"INCB001158 was administered orally at 100 mg BID in combination with pembrolizumab at 200 mg IV Q3W.","id":"OG006","title":"Part 1B: INCB001158 100 mg + Pembrolizumab"},{"description":"INCB001158 was administered orally at 100 mg BID in participants with advanced/metastatic solid tumors.","id":"OG007","title":"Part 2: INCB001158 100 mg"},{"description":"INCB001158 was administered orally at 100 mg BID (50 mg BID for Part 1c renally impaired participants) in combination with pembrolizumab at 200 mg IV Q3W.","id":"OG008","title":"Part 1c and Part 3: INCB001158 100 mg + Pembrolizumab"}],"paramType":"NUMBER","populationDescription":"Response Efficacy Evaluable Population (REEP): received ≥1 dose of INCB001158 or pembrolizumab, completed a Baseline scan, and met ≥1 protocol-defined criteria. Part 1c participants had renal impairment and received INCB001158 50 mg + pembrolizumab, which was half the recommended Phase 2 dose of INCB001158. It was pre-specified to combine Part 1c and Part 3 participants for efficacy analysis based on planned comparable dosing according to renal function.","reportingStatus":"POSTED","timeFrame":"Until disease progression/study discontinuation (up to approximately 5 years)","title":"Objective Response Rate (ORR)","type":"SECONDARY","unitOfMeasure":"percentage of participants"}