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Checkpoint Inhibitor

Tivozanib + Nivolumab for Kidney Cancer

Phase 3

Waitlist Available

Research Sponsored by AVEO Pharmaceuticals, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Histologically or cytologically confirmed RCC with a clear cell component

Eastern Cooperative Oncology Group performance status of 0 or 1

Timeline

Screening 3 weeks

Treatment Varies

Follow Up until progressive disease [pd] (approximately 30 months)

Awards & highlights

Study Summary

This trial will be testing whether adding tivozanib to nivolumab will be more effective than tivozanib alone in treating advanced RCC.

Who is the study for?

This trial is for adults with advanced kidney cancer who've had 1 or 2 previous treatments, including an immune therapy. They must have clear cell renal carcinoma, measurable disease, be in good physical condition (able to perform daily activities), and use contraception. Excluded are those with active autoimmune diseases, uncontrolled high blood pressure, more than one prior immune therapy in the metastatic setting, severe past reactions to immune therapies, certain treatment sequences or over two lines of prior therapy.Check my eligibility

What is being tested?

The study compares a combination of Tivozanib (a drug that targets tumor blood vessels) and Nivolumab (an immunotherapy) versus just Tivozanib alone in patients with advanced Renal Cell Carcinoma. It aims to see if adding Nivolumab improves outcomes for patients who have already tried other treatments.See study design

What are the potential side effects?

Tivozanib can cause high blood pressure, fatigue, and diarrhea while Nivolumab may lead to immune-related side effects like inflammation of organs such as lungs or intestines. Both drugs could potentially increase the risk of infections due to their impact on the body's defense systems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My kidney cancer has been confirmed with a lab test.

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I am fully active or can carry out light work.

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My kidney cancer worsened after 6 weeks of immunotherapy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ until progressive disease [pd] (approximately 30 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~until progressive disease [pd] (approximately 30 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and until progressive disease [pd] (approximately 30 months) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Secondary outcome measures

Duration of Response

Number of subjects with serious and non-serious adverse events

Objective Response Rate

+2 more

Side effects data

From 2014 Phase 3 trial • 277 Patients • NCT01076010

25%

Hypertension

14%

Diarrhoea

13%

Fatigue

12%

Asthenia

10%

Palmar-plantar erythrodysaesthesia syndrome

Dysphonia

Cough

Decreased appetite

Dyspnoea

Renal cancer

Neoplasm progression

Anaemia

Bile duct stone

Head injury

Bone pain

Apnoea

General physical health deterioration

Metastases to soft tissue

Cardio-respiratory arrest

Hypercalcaemia

Metastases to pleura

Metastases to the mediastinum

Pneumothorax

Ischaemic stroke

Transient ischaemic attack

Bronchitis

Jaundice cholestatic

Respiratory failure

Hypoglycaemia

Pleural effusion

Hypokalaemia

Cerebral infarction

Cholangitis

Pathological fracture

Acute myocardial infarction

Aortic aneurysm

Pulmonary embolism

Death

Multi-organ failure

Pelvic venous thrombosis

Body temperature increased

Cardiopulmonary failure

Myocardial infarction

Cardiac failure

Arteriosclerosis coronary artery

Delusional disorder, somatic type

Pleurisy

Sepsis

Myxoedema

Pancreatitis acute

Vena cava thrombosis

Skin lesion

100%

80%

60%

40%

20%

Study treatment Arm

Sorafenib Crossover to Tivozanib

First Line Tivozanib

First Line Sorafenib

Trial Design

2Treatment groups

Experimental Treatment

Group I: Tivozanib in Combination with NivolumabExperimental Treatment2 Interventions

Subjects with advanced RCC will receive 0.89 mg of tivozanib once daily (QD) for 3 weeks followed by 1 week off study drug and nivolumab every 4 weeks on Day 1 of each Cycle, until disease progression or unacceptable toxicities occur, other withdrawal criteria are met, or completion of 2 years of treatment [for nivolumab] whichever occurs first.

Group II: TivozanibExperimental Treatment1 Intervention

Subjects with advanced RCC will receive 1.34 mg of tivozanib once daily (QD) for 3 weeks followed by 1 week off study drug until disease progression or unacceptable toxicities occur, or other withdrawal criteria are met.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Tivozanib

2010

Completed Phase 3

~810

Nivolumab

2014

Completed Phase 3

~4750

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

AVEO Pharmaceuticals, Inc.Lead Sponsor

45 Previous Clinical Trials

3,607 Total Patients Enrolled

ParexelIndustry Sponsor

303 Previous Clinical Trials

100,483 Total Patients Enrolled

Bristol-Myers SquibbIndustry Sponsor

2,638 Previous Clinical Trials

4,128,171 Total Patients Enrolled

Media Library

Nivolumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04987203 — Phase 3

Kidney Cancer Research Study Groups: Tivozanib in Combination with Nivolumab, Tivozanib

Kidney Cancer Clinical Trial 2023: Nivolumab Highlights & Side Effects. Trial Name: NCT04987203 — Phase 3

Nivolumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04987203 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals still able to join this research project?

"Yes, this is an active trial that is enrolling patients. As of 8/10/2022, there were 326 patients enrolled across 38 locations."

Answered by AI

Are there any harmful side effects associated with taking Tivozanib?

"Tivozanib is a Phase 3 trial drug, so it has some efficacy data and multiple rounds of safety data supporting it. This gives it a score of 3 on Power's scale."

Answered by AI

At what age limit does this research include?

"The age range that is eligible for this clinical trial, as stipulated by the inclusion criteria, are patients aged 18-130."

Answered by AI

Is Tivozanib a new experimental drug?

"As of right now, there are 750 Tivozanib clinical trials underway with 82 in the third and final phase. Most of these studies originate from Basel, BE; however, 40328 locations worldwide are researching this medication."

Answered by AI

Does this clinical trial differ significantly from others like it?

"Tivozanib has been under clinical study for a decade. In 2010, the first trial was undertaken by Medarex and involved 127 participants. The success of this initial Phase 1 study led to Tivozanib's drug approval. Currently, there are over 750 active trials taking place in 2347 cities across 50 different nations."

Answered by AI

In how many locations is this trial being conducted?

"This clinical trial is being conducted at 38 different medical facilities, including John Hopkins Medicine - Hematology/oncology in Baltimore, Cleveland Clinic in Cleveland, Memorial Sloan Kettering Cancer Center - Westchester in Harrison, and 35 other locations."

Answered by AI

What are the common indications for Tivozanib?

"Tivozanib is a medication that has shown success in treating malignant neoplasms. However, it can also be used to fight krn 951, unresectable melanoma, and squamous cell carcinoma."

Answered by AI

Which group of people is this clinical trial meant for?

"This clinical trial is looking for 326 patients aged 18-130 who have carcinoma. In addition to meeting this general criteria, participants must also fit the following profile: They must have recovered from prior therapy or returned to baseline., They must have radiographic disease progression during or after at least 6 weeks of treatment with ICI for locally advanced or metastatic RCC with a clear cell component either in first-line or second-line treatment., They must be histologically or cytologically confirmed to have RCC with a clear cell component., Their measurable disease per RECIST criteria Version 1.1., Their Eastern Cooperative Oncology Group"

Answered by AI

How many people are participating in this experiment?

"In order to commence this study, 326 patients that fit the bill in terms of inclusion criteria are needed. These potential participants can be located at John Hopkins Medicine - Hematology/oncology in Baltimore, Maryland and Cleveland Clinic in Cleveland, Ohio among other places."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study to Compare Tivozanib in Combination With Nivolumab to Tivozanib Monotherapy in Subjects With Renal Cell Carcinoma

2021. "Study to Compare Tivozanib in Combination With Nivolumab to Tivozanib Monotherapy in Subjects With Renal Cell Carcinoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04987203.

All > Renal Cell Carcinoma