{"entity":{"id":"tinivo-2","kind":"trial","name":"TiNivo-2","aka":[],"tldr":"A second trial confirming that restarting immunotherapy after it fails does not help kidney cancer patients.","summary":"TiNivo-2, trial NCT04987203 sponsored by AVEO, now part of LG Chem, and reported in 2024 with a final analysis in 2026, was the second trial confirming that restarting immunotherapy after it fails does not help kidney cancer patients. It randomised 343 patients with advanced renal cell carcinoma after progression on a PD-1 or PD-L1 inhibitor to tivozanib plus nivolumab or tivozanib alone and found no progression-free survival benefit from adding nivolumab. OnCo links it to renal cell carcinoma, tivozanib, nivolumab and the caution pairing about PD-1 rechallenge after progression, and the result is consistent with CONTACT-03. Together the two trials settle the rechallenge question in kidney cancer for now, while tivozanib monotherapy remains an option after prior therapy on the basis of TIVO-3.","status":"negative","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT04987203","url":"https://clinicaltrials.gov/study/NCT04987203"}],"tags":["lesson:io-rechallenge"],"related":[],"cancers":["rcc"],"sections":[],"technologies":["antiangiogenic","kinase-inhibitors"],"targets":[],"drugs":["tivozanib","nivolumab"],"companies":["aveo"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04987203","phase":"3","setting":"Advanced RCC after progression on a PD-1/PD-L1 inhibitor: tivozanib + nivolumab vs tivozanib","sponsor":"AVEO (LG Chem)","result":"PFS HR 1.10; no benefit from nivolumab rechallenge.","started":"2021-09-09","startedType":"actual","yearReported":2024,"enrolled":343,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival","primary":true,"unit":"months","arms":[{"name":"Tivozanib + nivolumab","n":171,"value":5.7},{"name":"Tivozanib","n":172,"value":7.4}],"hr":1.1,"ci":[0.84,1.43],"source":"https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(24)01758-6/fulltext"}],"replication":"Consistent with CONTACT-03."},"route":"/trials/tinivo-2/","neighbours":{"cancer":[{"id":"rcc","kind":"cancer","name":"Renal cell carcinoma","route":"/cancers/rcc/"}],"technology":[{"id":"antiangiogenic","kind":"technology","name":"Anti-angiogenic therapy","route":"/technologies/antiangiogenic/"},{"id":"kinase-inhibitors","kind":"technology","name":"Small-molecule kinase inhibitors","route":"/technologies/kinase-inhibitors/"}],"drug":[{"id":"nivolumab","kind":"drug","name":"Nivolumab","route":"/drugs/nivolumab/"},{"id":"tivozanib","kind":"drug","name":"Tivozanib","route":"/drugs/tivozanib/"}],"company":[{"id":"aveo","kind":"company","name":"AVEO Oncology (LG Chem)","route":"/companies/aveo/"}],"pairing":[{"id":"io-rechallenge-caution-rcc","kind":"pairing","name":"Caution: PD-1 rechallenge after progression on immunotherapy (RCC)","route":"/pairings/io-rechallenge-caution-rcc/"}]}}