{"calculatePct":false,"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"4"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"2"},{"groupId":"OG005","value":"0"},{"groupId":"OG006","value":"0"},{"groupId":"OG007","value":"0"},{"groupId":"OG008","value":"4"},{"groupId":"OG009","value":"1"},{"groupId":"OG010","value":"2"},{"groupId":"OG011","value":"1"},{"groupId":"OG012","value":"1"},{"groupId":"OG013","value":"0"},{"groupId":"OG014","value":"3"},{"groupId":"OG015","value":"10"},{"groupId":"OG016","value":"1"},{"groupId":"OG017","value":"6"}]}],"title":"Immune-related Complete Response"},{"categories":[{"measurements":[{"groupId":"OG000","value":"26"},{"groupId":"OG001","value":"31"},{"groupId":"OG002","value":"6"},{"groupId":"OG003","value":"5"},{"groupId":"OG004","value":"4"},{"groupId":"OG005","value":"0"},{"groupId":"OG006","value":"0"},{"groupId":"OG007","value":"3"},{"groupId":"OG008","value":"7"},{"groupId":"OG009","value":"4"},{"groupId":"OG010","value":"5"},{"groupId":"OG011","value":"15"},{"groupId":"OG012","value":"10"},{"groupId":"OG013","value":"2"},{"groupId":"OG014","value":"4"},{"groupId":"OG015","value":"24"},{"groupId":"OG016","value":"7"},{"groupId":"OG017","value":"15"}]}],"title":"Immune-related Partial Response"},{"categories":[{"measurements":[{"groupId":"OG000","value":"80"},{"groupId":"OG001","value":"78"},{"groupId":"OG002","value":"60"},{"groupId":"OG003","value":"20"},{"groupId":"OG004","value":"53"},{"groupId":"OG005","value":"9"},{"groupId":"OG006","value":"3"},{"groupId":"OG007","value":"26"},{"groupId":"OG008","value":"20"},{"groupId":"OG009","value":"31"},{"groupId":"OG010","value":"21"},{"groupId":"OG011","value":"61"},{"groupId":"OG012","value":"40"},{"groupId":"OG013","value":"15"},{"groupId":"OG014","value":"44"},{"groupId":"OG015","value":"61"},{"groupId":"OG016","value":"29"},{"groupId":"OG017","value":"61"}]}],"title":"Immune-related Stable Disease"},{"categories":[{"measurements":[{"groupId":"OG000","value":"36"},{"groupId":"OG001","value":"21"},{"groupId":"OG002","value":"69"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"5"},{"groupId":"OG006","value":"1"},{"groupId":"OG007","value":"14"},{"groupId":"OG008","value":"11"},{"groupId":"OG009","value":"10"},{"groupId":"OG010","value":"10"},{"groupId":"OG011","value":"27"},{"groupId":"OG012","value":"6"},{"groupId":"OG013","value":"1"},{"groupId":"OG014","value":"33"},{"groupId":"OG015","value":"62"},{"groupId":"OG016","value":"62"},{"groupId":"OG017","value":"44"}]}],"title":"Immune-related Progressive Disease"},{"categories":[{"measurements":[{"groupId":"OG000","value":"40"},{"groupId":"OG001","value":"22"},{"groupId":"OG002","value":"32"},{"groupId":"OG003","value":"35"},{"groupId":"OG004","value":"31"},{"groupId":"OG005","value":"7"},{"groupId":"OG006","value":"14"},{"groupId":"OG007","value":"7"},{"groupId":"OG008","value":"9"},{"groupId":"OG009","value":"7"},{"groupId":"OG010","value":"6"},{"groupId":"OG011","value":"21"},{"groupId":"OG012","value":"5"},{"groupId":"OG013","value":"2"},{"groupId":"OG014","value":"19"},{"groupId":"OG015","value":"41"},{"groupId":"OG016","value":"33"},{"groupId":"OG017","value":"27"}]}],"title":"Not Evaluable"}],"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":"irBOR defined as best response of any of immune related complete response (irCR), immune related partial response (irPR), immune related stable disease (irSD) and immune related progressive disease (irPD) recorded from baseline until immune related disease progression and determined according to modified irRC per investigator assessment. irCR: Complete disappearance of all tumor lesions (both index and non-index lesions with no new measurable/unmeasurable lesions). irPR: At least 30% reduction from baseline in the sum of the longest diameter (SLD) of all lesions). irSD: SLD of target and new measurable lesions neither irCR, irPR, or irPD. irPD: SLD 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. Number of participants with immune-related best overall response in each category (irCR, irPR, irSD, irPD) was reported.","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":"COUNT_OF_PARTICIPANTS","populationDescription":"Full analysis set (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: Number of Participants With Immune Related Best Overall Response (irBOR) According to Modified Immune-Related Response Criteria (irRC)","type":"SECONDARY","unitOfMeasure":"Participants"}