TiNivo-2
Research type
Research Study
Full title
TiNivo-2: A Phase 3, Randomized, Controlled, Multicenter, Open-label Study to Compare Tivozanib in Combination with Nivolumab to Tivozanib Monotherapy in Subjects with Renal Cell Carcinoma Who Have Progressed Following One or Two Lines of Therapy Where One Line has an Immune Checkpoint Inhibitor
IRAS ID
1003840
Contact name
Michael Needle
Contact email
Sponsor organisation
AVEO Pharmaceuticals, Inc.
Eudract number
2021-000050-26
Research summary
Renal cell carcinoma (RCC) accounts for 90% of all malignant kidney tumours. This is a study to compare the combination of tivozanib with nivolumab to tivozanib alone in patients with RCC whose cancer has returned or gotten worse during or after treatment (refractory advanced RCC). Tivozanib is a drug that blocks the development of 1blood vessels that trigger the cancer cells to divide and grow. Nivolumab is an approved cancer medicine that works with the immune system to interfere with the growth and spread of cancer cells. This type of cancer medicine is called an immune checkpoint inhibitor.
This study is being done to test the idea that tivozanib with nivolumab will work better than tivozanib alone for the treatment of patients with RCC who have progressed following treatment with an immune checkpoint inhibitor.
Participants will be randomly split into 2 treatment groups. About 50% of participants will receive tivozanib and nivolumab and about 50% will receive tivozanib alone. This study is “open label”, which means that both the participant and the study doctor will know which treatment group the participant is in.
Cycles of treatment will be repeated every 4 weeks (28 days). Participants will take tivozanib orally once daily for 3 weeks and then will stop for 1 week. Participants who receive nivolumab will receive an IV infusion of nivolumab given over a 30 minute period on Day 1 of each Cycle (once every 28 days).
Participants whose cancer does not change (stable disease) or whose cancer responds to the study treatment may continue to receive tivozanib therapy at the same dose and schedule until their cancer progresses, as long as they are able to tolerate tivozanib. Participants who receive nivolumab will receive nivolumab for a maximum of 2 years.
It is anticipated that approximately 326 participants will be recruited worldwide from 190 sites, with 16 of participants coming from the UK.
This study is sponsored by AVEO Pharmaceuticals, Inc.REC name
London - Brighton & Sussex Research Ethics Committee
REC reference
21/LO/0699
Date of REC Opinion
21 Dec 2021
REC opinion
Further Information Favourable Opinion