{"analyses":[{"groupDescription":"The primary analysis of PFS used a stratified log rank test statistic and is reported as two-sided test. Stratified Cox regression was used to estimate treatment hazard ratios for treatment effect. 95% two-sided intervals are reported. The Kaplan-Meier method was used to estimate PFS curves.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.005","pValueComment":"One sided P-value","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"41"},{"groupId":"OG001","value":"81"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"487"},{"groupId":"OG001","value":"483"}],"units":"Participants"}],"description":"Will be reported as the number of participants who have experienced death or progression, measured at two years. Progression will be measured according to the 2014 Lugano classification. Will test the null hypothesis (HR=1) for PFS using stratified log-rank test with a one-sided alpha of 0.021. The analysis will be based on modified intent-to-treat and will include all eligible patients as randomized regardless of treatment received. The one-sided alpha of .021 will control of the overall type-one error of the study (including the 2 interim superiority analyses) to be less than .025.","groups":[{"description":"Patients receive doxorubicin hydrochloride IV, vinblastine sulfate IV, dacarbazine IV, and nivolumab IV over 30 minutes on days 1 and 15. Patients may receive pegfilgrastim SC on days 2 and 16, or filgrastim SC or IV on days 6-10 and 21-25. Treatment repeats every 28 days for 6 cycles in the absence of disease progression or unacceptable toxicity. After completion of cycle 6, patients may receive radiation therapy 5 days per week for approximately 4 weeks at the discretion of the treating physician. Patients also undergo peripheral blood specimen collection and CT, PET/CT and MRI on study.\n\nBiospecimen Collection: Undergo peripheral blood collection\n\nComputed Tomography: Undergo PET/CT or CT scan\n\nDacarbazine: Given IV\n\nDoxorubicin Hydrochloride: Given IV\n\nFilgrastim: Given SC or IV\n\nMagnetic Resonance Imaging: Undergo MRI\n\nNivolumab: Given IV\n\nPegfilgrastim: Given SC\n\nPositron Emission Tomography: Undergo PET/CT scan\n\nQuality-of-Life Assessment: Ancillary studies\n\nQuestionnaire Administration: Ancillary studies\n\nRadiation Therapy: Receive radiation therapy\n\nVinblastine Sulfate: Given IV","id":"OG000","title":"Arm I (Chemotherapy, Nivolumab, Radiation)"},{"description":"Patients receive doxorubicin hydrochloride IV, vinblastine sulfate IV, dacarbazine IV, and brentuximab vedotin IV over 30 minutes on days 1 and 15. Patients may receive pegfilgrastim SC on days 2 and 16, or filgrastim SC or IV on days 6-10 and 21-25. Treatment repeats every 28 days for 6 cycles in the absence of disease progression or unacceptable toxicity. After completion of cycle 6, patients may receive radiation therapy 5 days per week for approximately 4 weeks at the discretion of the treating physician. Patients also undergo peripheral blood specimen collection and CT, PET/CT and MRI on study.\n\nBiospecimen Collection: Undergo peripheral blood collection\n\nBrentuximab Vedotin: Given IV\n\nComputed Tomography: Undergo PET/CT or CT scan\n\nDacarbazine: Given IV\n\nDoxorubicin Hydrochloride: Given IV\n\nFilgrastim: Given SC or IV\n\nMagnetic Resonance Imaging: Undergo MRI\n\nPegfilgrastim: Given SC\n\nPositron Emission Tomography: Undergo PET/CT scan\n\nQuality-of-Life Assessment: Ancillary studies\n\nQuestionnaire Administration: Ancillary studies\n\nRadiation Therapy: Receive radiation therapy\n\nVinblastine Sulfate: Given IV","id":"OG001","title":"Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"All the patients who underwent randomization except for those who were deemed to be ineligible by pathology review or owing to violation of the eligibility criteria.","reportingStatus":"POSTED","timeFrame":"From date of registration to date of first observation of progressive disease, or death due to any cause, assessed at 2 years","title":"Progression Free Survival (PFS)","type":"PRIMARY","unitOfMeasure":"Participants"}