{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"2.76","upperLimit":"5.49","value":"4.04"},{"groupId":"OG001","lowerLimit":"5.42","upperLimit":"9.69","value":"6.93"},{"groupId":"OG002","lowerLimit":"1.38","upperLimit":"2.50","value":"1.64"},{"groupId":"OG003","lowerLimit":"1.35","upperLimit":"2.53","value":"1.81"},{"groupId":"OG004","lowerLimit":"2.76","upperLimit":"5.95","value":"4.14"},{"groupId":"OG005","lowerLimit":"1.41","upperLimit":"5.82","value":"2.79"},{"comment":"Due to small number of events, estimates (Median and upper limit of 95% confidence interval) from Kaplan-Meier survival curves could not derive.","groupId":"OG006","lowerLimit":"1.38","upperLimit":"NA","value":"NA"},{"groupId":"OG007","lowerLimit":"2.40","upperLimit":"5.49","value":"3.81"},{"groupId":"OG008","lowerLimit":"2.79","upperLimit":"11.04","value":"6.83"},{"groupId":"OG009","lowerLimit":"3.94","upperLimit":"12.45","value":"6.18"},{"groupId":"OG010","lowerLimit":"2.63","upperLimit":"9.46","value":"4.07"},{"groupId":"OG011","lowerLimit":"2.69","upperLimit":"5.42","value":"4.04"},{"groupId":"OG012","lowerLimit":"5.98","upperLimit":"13.04","value":"8.34"},{"groupId":"OG013","lowerLimit":"2.69","upperLimit":"11.24","value":"6.90"},{"groupId":"OG014","lowerLimit":"1.51","upperLimit":"3.84","value":"2.60"},{"groupId":"OG015","lowerLimit":"1.48","upperLimit":"2.76","value":"2.46"},{"groupId":"OG016","lowerLimit":"1.31","upperLimit":"1.41","value":"1.35"},{"groupId":"OG017","lowerLimit":"2.66","upperLimit":"4.14","value":"2.83"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"184"},{"groupId":"OG001","value":"156"},{"groupId":"OG002","value":"168"},{"groupId":"OG003","value":"60"},{"groupId":"OG004","value":"90"},{"groupId":"OG005","value":"21"},{"groupId":"OG006","value":"18"},{"groupId":"OG007","value":"50"},{"groupId":"OG008","value":"51"},{"groupId":"OG009","value":"53"},{"groupId":"OG010","value":"44"},{"groupId":"OG011","value":"125"},{"groupId":"OG012","value":"62"},{"groupId":"OG013","value":"20"},{"groupId":"OG014","value":"103"},{"groupId":"OG015","value":"198"},{"groupId":"OG016","value":"132"},{"groupId":"OG017","value":"153"}],"units":"Participants"}],"description":"The irPFS time was defined as the time from first administration of study treatment until first documentation of immune-related progressive disease (irPD) or death when death occurred within 12 weeks of the last tumor assessment or first administration of study treatment (whichever was later). irPD: sum of the longest diameters of target and new measurable lesions increases greater than or equal to \\[\\>=\\] 20%, confirmed by a repeat, consecutive observations at least 4 weeks from the date first documented. The analysis of irPFS will be performed with a Kaplan-Meier method. Data for immune related progression-free survival time has been reported.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants with non-small cell lung cancer (NSCLC), who had progressed after 1 line of platinum-containing doublet chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.","id":"OG000","title":"Primary Expansion Cohort: NSCLC, Post-platinum Doublet"},{"description":"Participants with non-small cell lung cancer (NSCLC), first line received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.","id":"OG001","title":"Primary Expansion Cohort: NSCLC, First Line"},{"description":"Participants with metastatic breast cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.","id":"OG002","title":"Primary Expansion Cohort: Metastatic Breast Cancer"},{"description":"Participants with gastric and gastroesophageal cancer who progressed on or after first-line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.","id":"OG003","title":"Primary Expansion Cohort: GC/GEJC Progressed"},{"description":"Participants with gastric and gastroesophageal cancer who non-progressed on or after first-line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.","id":"OG004","title":"Primary Expansion Cohort: GC/GEJC Non Progressed"},{"description":"Participants with colorectal cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.","id":"OG005","title":"Secondary Expansion Cohort: Colorectal Cancer"},{"description":"Participants with castrate-resistant prostate cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.","id":"OG006","title":"Secondary Expansion Cohort: Castrate-resistant Prostate Cancer"},{"description":"Participants with adrenocortical carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.","id":"OG007","title":"Secondary Expansion Cohort: Adrenocortical Carcinoma"},{"description":"Participants with melanoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.","id":"OG008","title":"Secondary Expansion Cohort: Melanoma"},{"description":"Participants with mesothelioma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.","id":"OG009","title":"Secondary Expansion Cohort: Mesothelioma"},{"description":"Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.","id":"OG010","title":"Secondary Expansion Cohort: Urothelial Carcinoma"},{"description":"Participants with ovarian carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.","id":"OG011","title":"Secondary Expansion Cohort: Ovarian Cancer"},{"description":"Participants with Renal cell carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a first-line therapy in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.","id":"OG012","title":"Secondary Expansion Cohort: Renal Cell Carcinoma (First Line)"},{"description":"Participants with Renal cell carcinoma who failed 1 prior systemic first-line regimen received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a second line treatment in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.","id":"OG013","title":"Secondary Expansion Cohort: Renal Cell Carcinoma (Second Line)"},{"description":"Participants with ovarian carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.","id":"OG014","title":"Efficacy Expansion Cohort: Ovarian Cancer"},{"description":"Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.","id":"OG015","title":"Efficacy Expansion Cohort: Urothelial Carcinoma"},{"description":"Participants with gastric (GC) and gastroesophageal junction cancer (GEJC) who have failed both a first-line chemotherapy regimen and subsequent ramucirumab therapy, received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a third-line treatment in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.","id":"OG016","title":"Efficacy Expansion Cohort: GC/GEJC, Third Line"},{"description":"Participants with head and neck squamous cell carcinoma (HNSCC) received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.","id":"OG017","title":"Efficacy Expansion Cohort: HNSCC"}],"paramType":"MEDIAN","populationDescription":"FAS included all participants who have received at least 1 dose of study treatment. Here \"Overall Number of Participants Analyzed\" signifies those participants who were evaluable for this outcome measure.","reportingStatus":"POSTED","timeFrame":"Dose Expansion: Baseline up to Day 2023","title":"Dose Expansion Cohort: Immune Related Progression-Free Survival (irPFS) Time According to Modified Immune-Related Response Criteria (irRC)","type":"SECONDARY","unitOfMeasure":"Months"}