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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

Must not have

Subjects who received a single agent tyrosine kinase inhibitor (TKI) in the first line setting followed by a single agent immune checkpoint inhibitor (ICI) in the second line setting or more than 2 prior lines of therapy in the advanced or metastatic setting

Uncontrolled hypertension

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

No Placebo-Only Group

Pivotal Trial

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I've had a TKI as my first treatment and an ICI as my second for advanced cancer.

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My high blood pressure is not under control.

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I have an active autoimmune disease or stopped IO therapy due to side effects.

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I have had a severe reaction to previous immune therapy.

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I've had more than one treatment with immunotherapy for my advanced cancer.

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I have a history of serious lung disease or currently have lung inflammation.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Progression free survival

Secondary study objectives

Duration of Response

Number of subjects with serious and non-serious adverse events

Objective Response Rate

+1 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

Bronchitis

Cerebral infarction

Bone pain

Head injury

Cardio-respiratory arrest

Hypoglycaemia

Hypokalaemia

Jaundice cholestatic

Metastases to soft tissue

Pathological fracture

Ischaemic stroke

Metastases to pleura

Respiratory failure

Apnoea

Pneumothorax

General physical health deterioration

Transient ischaemic attack

Metastases to the mediastinum

Pleural effusion

Hypercalcaemia

Bile duct stone

Cholangitis

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

2015

Completed Phase 3

~4010