{"denoms":[{"counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}],"units":"Participants"}],"description":"Rate of response is the percentage of patients with response after re-initiation of immune checkpoint inhibitor (ICI) therapy after progression post-registration. Rate of response will be assessed using RECIST 1.1. A chi-square test (or Fisher's exact test) will be used to determine whether there is an association between the best tumor response prior to trial enrollment and that achieved upon ICI re-challenge.","groups":[{"description":"CONTINUATION OF ICI TREATMENT:\n\nPatients receive either pembrolizumab intravenously (IV) over 30 minutes on day 1, nivolumab IV over 30 minutes on days 1 and 15, atezolizumab IV over 30-60 minutes on day 1, durvalumab IV over 60 minutes on days 1 and 15, or avelumab IV over 60 minutes on days 1 and 15. Cycles repeat every 21 or 42 days for pembrolizumab, every 21 days for atezolizumab, and 28 days for nivolumab, durvalumab, and avelumab in the absence of disease progression or unacceptable toxicity.\n\nPembrolizumab: Given IV\n\nNivolumab: Given IV\n\nAtezolizumab: Given IV\n\nDurvalumab: Given IV\n\nAvelumab: Given IV","id":"OG000","title":"Arm A (Immune Checkpoint Inhibitor)"},{"description":"DISCONTINUATION OF ICI TREATMENT:\n\nPatients receiving ICI treatment will discontinue ICI treatment within 1 cycle length after randomization. Cycle length is determined by the ICI regimen the patient is receiving at randomization. At disease progression patients may restart the same ICI treatment they were receiving upon randomization at physician discretion.\n\nPembrolizumab: Given IV\n\nNivolumab: Given IV\n\nAtezolizumab: Given IV\n\nDurvalumab: Given IV\n\nAvelumab: Given IV","id":"OG001","title":"Arm B (Immune Checkpoint Inhibitor)"}],"populationDescription":"All patients randomized to arm B withdrew from trial before beginning treatment. No data is available to perform analysis.","reportingStatus":"POSTED","timeFrame":"Up to 5 years","title":"Rate of Response After Immune Checkpoint Inhibitor (ICI) Rechallenge (Arm B)","type":"SECONDARY"}