# TiNivo-2

Source: https://onco.cc/trials/tinivo-2/  
OnCo record `tinivo-2` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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.

## Fields

- Kind: Trial
- Status: negative
- Last checked: 2026-09-07
- Tags: lesson:io-rechallenge
- Registry id: NCT04987203
- Phase: 3
- Setting: Advanced RCC after progression on a PD-1/PD-L1 inhibitor: tivozanib + nivolumab vs tivozanib
- Sponsor: AVEO (LG Chem)
- Enrolled: 343
- Result: PFS HR 1.10; no benefit from nivolumab rechallenge.
- Outcomes: Progression-free survival: Tivozanib + nivolumab 5.7 months vs Tivozanib 7.4 months, HR 1.1
- Replication: Consistent with CONTACT-03.

## Sources

- ClinicalTrials.gov NCT04987203: https://clinicaltrials.gov/study/NCT04987203

## Connected records

- cancers: [Renal cell carcinoma](https://onco.cc/cancers/rcc/)
- technologies: [Anti-angiogenic therapy](https://onco.cc/technologies/antiangiogenic/), [Small-molecule kinase inhibitors](https://onco.cc/technologies/kinase-inhibitors/)
- drugs: [Nivolumab](https://onco.cc/drugs/nivolumab/), [Tivozanib](https://onco.cc/drugs/tivozanib/)
- companies: [AVEO Oncology (LG Chem)](https://onco.cc/companies/aveo/)
- pairings: [Caution: PD-1 rechallenge after progression on immunotherapy (RCC)](https://onco.cc/pairings/io-rechallenge-caution-rcc/)

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