Clinical trials are an important way to improve treatment for people with cancer. While most are continuing during the COVID-19 pandemic, the period of time that clinical trials are available and recruiting may change quickly. If you would like to get involved in a clinical trial, speak to your treatment team or the health service where the clinical trial is being undertaken, to confirm it is open and appropriate for you. For cancer information and support, call Cancer Council's experienced cancer nurses on 13 11 20 Monday to Friday from 9am-5pm.

NCT04987203 : 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

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

ThreePhase Three

18-130Age 18-130

Urinary System<br/>CancersCancer LocationUrinary System
Cancers

Systemic therapy | Urinary systemRenal cell carcinoma

Trial Overview Read MoreRead more

This phase III study is comparing the effectiveness of targeted therapy alone (tivozanib) to targeted therapy plus immunotherapy (tivozanib + nivolumab) in people with advanced kidney cancer who have had prior treatment.
 

This trial is treating patients with renal cell carcinoma.

This is a systemic therapy trial.

You may be able to join this trial if:

  • You are able to swallow medication by mouth.
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • Your cancer has not spread to other parts of the body.
  • Your cancer has spread to other parts of the body.

You may be excluded from this trial if:

  • You have a certain disease or psychological condition.
  • You have had certain treatments, surgical procedures or drugs.

Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.

Clinical Summary Read MoreRead more

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Scientific 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

Commercial Sponsor

AVEO Pharmaceuticals, Inc.

Summary

Eligible participants will be randomly allocated to one of two experimental arms. In Experimental Arm A, participants will receive 0.89mg of tivozanib once daily (orally) for three weeks followed by week off, plus nivolumab every 4 weeks on Day 1 of each Cycle. In Experimental Arm B, participants will receive 1.34mg of tivozanib once daily (orally) for 3 weeks followed by 1 week off.

Recruiting Hospitals Read MoreRead more

Cabrini Education and Research Precinct
Malvern
Micheleine Uhe
muhe@cabrini.com.au
(03) 9508 3481

Barwon Health, University Hospital Geelong
Geelong
Oncology Team
OncologyTrials@barwonhealth.org.au

St Vincent's Hospital, Medical and Radiation Oncology
Fitzroy
Ms Nadia Ranieri
oncology.research@svha.org.au
03 9231 3167

Trial Overview: General information about a clinical trial. This section provides an overview of who might be able to join this trial and what type of treatment is involved.

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