{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"1.7","upperLimit":"5.4","value":"1.9"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"46"}],"units":"Participants"}],"description":"To determine the efficacy of M7824 in terms of the Progression Free Survival (PFS) assessed by the investigator according to the modified Response Evaluation Criteria in Solid Tumors (mRECIST) Version 1.1. Progression is defined using Response Evaluation Criteria in Solid Tumors (mRECIST) Version 1.1 as an increase of at least 20%in the sumof thediameters of viable (enhancing) target lesions, taking as reference the smallest sumof thediameters of the viable (enhancing) target lesions. The sum must also demonstrate an absoluteincrease of at least 5 mm.","dispersionType":"Full Range","groups":[{"description":"Bintrafusp alfa (M7824): 1200mg, over 60 minutes IV infusion The treatment will start within 1-5 days from enrollment. The treatment will be administered at day 1 of 14-day intervals .\n\nTreatment will be administered until unacceptable toxicity, loss of clinical benefit, disease progression or completion of 2 years of therapy. If the patient has benefit after 2 years, the trial chair and the sponsor must be consulted to evaluate how to continue with the treatment.","id":"OG000","title":"Experimental: Bintrafusp Alfa (M7824)"}],"paramType":"MEDIAN","populationDescription":"47 patients were enrolled in the study although patient 05000013 was finally considered as inclusion error and did not enter in the analysis.","reportingStatus":"POSTED","timeFrame":"From administration of first dose of bintrafusp alfa until objective tumor progression or death, up to 2 years.","title":"To Evaluate the Efficacy of the Treatment","type":"PRIMARY","unitOfMeasure":"Months"}