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mTOR inhibitor

Everolimus for Kidney Cancer (S0931 Trial)

Phase 3

Waitlist Available

Led By Christopher W. Ryan, MD

Research Sponsored by SWOG Cancer Research Network

Eligibility Criteria Checklist

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

Must have

Patients with microvascular invasion of the renal vein of any grade or stage (as long as M0) are eligible

Considered pathologically either intermediate high-risk or very high-risk disease

Must not have

Unstable angina pectoris

NYHA class III-IV cardiac disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years from registration

Awards & highlights

Pivotal Trial

Summary

This trial is studying everolimus to see how effective it is in treating kidney cancer patients who have undergone surgery.

Who is the study for?

This trial is for adults who've had surgery for kidney cancer, with no remaining or spreading cancer detectable by CT/MRI scans. They should be in good physical condition (Zubrod status 0-1), have proper organ function, and not be pregnant. Participants must use effective contraception and be able to take oral medications. Those with heart disease, severe liver impairment, HIV, uncontrolled diabetes or cholesterol levels, allergies to everolimus components, or other recent cancers are excluded.

What is being tested?

The study is testing the effectiveness of Everolimus in preventing kidney cancer from returning after surgery. Patients will either receive Everolimus or a placebo (a pill without active medication) to compare outcomes between the two groups.

What are the potential side effects?

Everolimus may cause side effects like mouth sores, infections due to a weakened immune system, lung problems such as coughing and shortness of breath, elevated blood sugar and cholesterol levels, skin issues like rash or acneiform dermatitis.

Eligibility Criteria

Inclusion Criteria

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

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My kidney cancer has spread to small blood vessels but not to distant parts.

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My condition is classified as intermediate high-risk or very high-risk.

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I have had surgery to remove my kidney and any affected lymph nodes.

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My kidney cancer diagnosis was confirmed through lab tests.

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I can carry out all my usual activities without help.

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My kidney function, measured by creatinine levels, is within the normal range.

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My surgery removed all visible cancer.

Exclusion Criteria

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

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I have unstable chest pain.

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I have severe heart disease.

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My cholesterol is over 300 mg/dL and my triglycerides are more than 2.5 times the upper limit.

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I have tested positive for HIV.

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I cannot have IV iodine-based or gadolinium contrast due to health reasons.

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I have not received any treatment for kidney cancer before.

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I am not currently taking steroids or other drugs that weaken my immune system.

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I do not have an uncontrolled serious heart rhythm problem.

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I do not have severe liver disease or cirrhosis.

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My stomach and intestines work well and don't have diseases that affect medication absorption.

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I can safely receive IV iodine-based contrast or gadolinium.

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I am allergic to everolimus, sirolimus, temsirolimus, or their ingredients.

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I have a lung condition that is not currently under control.

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I haven't had a live vaccine in the last 7 days.

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I am not currently taking any cancer treatments or experimental drugs.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years from registration

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years from registration

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years from registration for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

5-year Recurrence-free Survival (RFS)

Secondary study objectives

5-year Overall Survival (OS)

Frequency and Severity of Toxicities

Side effects data

From 2019 Phase 3 trial • 235 Patients • NCT03176238

63%

Stomatitis

27%

Decreased appetite

26%

Hyperglycaemia

25%

Aspartate aminotransferase increased

24%

Rash

23%

Alanine aminotransferase increased

22%

Cough

19%

Anaemia

16%

Fatigue

16%

Blood cholesterol increased

16%

Weight decreased

15%

Diarrhoea

15%

Gamma-glutamyltransferase increased

13%

Pneumonitis

12%

Hypertriglyceridaemia

12%

Upper respiratory tract infection

12%

Headache

12%

Nausea

11%

Back pain

11%

Pruritus

Myalgia

Blood lactate dehydrogenase increased

Insomnia

Productive cough

Dyspnoea

Dyspepsia

Oedema peripheral

Arthralgia

Dysgeusia

Pain in extremity

Constipation

Pyrexia

Hypertension

Dyslipidaemia

Aphthous ulcer

Lymphoedema

Hypercholesterolaemia

Urinary tract infection

Epistaxis

Asthenia

Pneumonia

Blood alkaline phosphatase increased

Neutrophil count decreased

Dry skin

Thrombocytopenia

Rhinorrhoea

Acne

Abdominal pain

Peripheral swelling

Blood creatinine increased

Hypokalaemia

Hypophosphataemia

Urticaria

Mouth ulceration

Toothache

Abdominal discomfort

Influenza

Hyperlipidaemia

Nail disorder

Cellulitis

Paraesthesia

Alopecia

Abdominal pain upper

Diabetes mellitus

Oropharyngeal pain

Depression

Hyperkalaemia

Face oedema

Non-cardiac chest pain

Nasopharyngitis

Pharyngitis

Haemoglobin decreased

White blood cell count decreased

Dermatitis acneiform

Vomiting

Musculoskeletal pain

Pleural effusion

Onychomadesis

Dizziness

Hypoaesthesia

Influenza like illness

Mucosal inflammation

Pain

Blood triglycerides increased

Platelet count decreased

Vitamin D deficiency

Flank pain

Neck pain

Eczema

Rash maculo-papular

Haemorrhoids

Soft tissue infection

Left ventricular failure

Hyponatraemia

Hydrocephalus

Pulmonary oedema

Respiratory failure

Eye pain

Gastric haemorrhage

Tumour pain

Central nervous system haemorrhage

Dysphagia

Herpes virus infection

Gastroenteritis

Haemoptysis

Abdominal hernia

Ascites

Furuncle

Lower respiratory tract infection

Interstitial lung disease

Atypical pneumonia

Skin ulcer

Cardiopulmonary failure

Lethargy

Ventricular tachycardia

Acute kidney injury

Joint effusion

Dyspnoea exertional

Wheezing

Leukopenia

Metastases to lung

Gait inability

Renal failure

Abdominal distension

Musculoskeletal chest pain

Pulmonary embolism

Asthma

Palmar-plantar erythrodysaesthesia syndrome

Vision blurred

Folliculitis

Cardiac failure

Contrast media allergy

Dry eye

Gingivitis

Muscular weakness

Dental caries

Intracranial aneurysm

Onycholysis

Oral herpes

Sinusitis

Hypocalcaemia

Hypomagnesaemia

Bone pain

Joint stiffness

Pain in jaw

Spinal pain

Breast pain

Ingrowing nail

Rash papular

Rash pruritic

Hot flush

Atrial fibrillation

Cardiac arrest

Gastric ulcer

Haematochezia

Large intestinal haemorrhage

Urethritis

Urosepsis

Viral infection

Cartilage injury

Femur fracture

Ligament sprain

Overdose

Eastern cooperative oncology group performance status worsened

Liver function test increased

Dehydration

Diabetes mellitus inadequate control

Tumour necrosis

Neutropenia

Tachycardia

Gastrooesophageal reflux disease

Oral pain

100%

80%

60%

40%

20%

Study treatment Arm

Asian

Non-Asian

Awards & Highlights

Pivotal Trial

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

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Arm IExperimental Treatment1 Intervention

Patients receive oral everolimus once daily on days 1-42. Treatment repeats every 6 weeks for 9 courses in the absence of disease progression or unacceptable toxicity.

Group II: Arm IIPlacebo Group1 Intervention

Patients receive oral placebo once daily on days 1-42. Treatment repeats every 6 weeks for 9 courses in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

everolimus

2005

Completed Phase 4

~1490

0 / 22Eligibility criteria met