OnCo
trialsTrialNegative

TiNivo-2

A second trial confirming that restarting immunotherapy after it fails does not help kidney cancer patients.

PFS 5.7 vs 7.4 months (HR 1.10); final analysis presented 2026 confirmed no benefit. Together with CONTACT-03, settles the IO-rechallenge question in RCC for now. Tivozanib monotherapy remains an option after prior therapy (TIVO-3).

Setting
Advanced RCC after progression on a PD-1/PD-L1 inhibitor: tivozanib + nivolumab vs tivozanib
Phase
Phase 3
Sponsor
AVEO (LG Chem)
Registry
NCT04987203
Headline result
PFS HR 1.10; no benefit from nivolumab rechallenge.
Reported
2024
Enrolled
343
Replication
Consistent with CONTACT-03.

Outcomes

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In plain words
What these results mean for people, not percentages
343 people took part
Progression-free survivalprimarysurrogate endpoint
  • Median 5.7 vs 7.4 months with Tivozanib + nivolumab compared with Tivozanib; about 1.7 months shorter for half the group.
  • A median is a midpoint: half the people did better than this and half did worse, so it is not a prediction for any one person.
  • Put another way, the treated group had about 10 percent higher chance of the event at any given time (hazard ratio 1.1, likely range 0.84 to 1.43).
  • The likely range for the hazard ratio crosses 1, so the difference could be due to chance.
  • This is a surrogate endpoint: it measures the cancer being controlled or absent on scans and tests, which often, but not always, translates into living longer.
  • These results apply to the people the trial enrolled: Advanced RCC after progression on a PD-1/PD-L1 inhibitor: tivozanib + nivolumab vs tivozanib. People in a different situation may not see the same effect.
  • The trial selected people by a biomarker (PD-1); the result should not be assumed for people whose cancer does not have it.

Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.

343 participants enrolled.

Progression-free survivalprimary
HR 1.1 (0.84–1.43)
Tivozanib + nivolumab
5.7 mo
Tivozanib
7.4 mo
Source
EndpointArmnValueHR (95% CI)pSource
Progression-free survivalprimaryTivozanib + nivolumab1715.7 months1.1 (0.84–1.43)—link
Tivozanib1727.4 months
Replication
Consistent with CONTACT-03.

Connected

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Pages like this

not linked directly; found by shared links

cancers

1
Renal cell carcinoma

drugs

2
ApprovedMonoclonal antibody (anti-PD-1)
Nivolumab · Opdivo / Opdivo Qvantig (SC)
ApprovedSmall-molecule kinase inhibitor (VEGFR)
Tivozanib · Fotivda

pairings

1
Caution: PD-1 rechallenge after progression on immunotherapy (RCC)