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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 belowSelect...
My kidney cancer has spread to small blood vessels but not to distant parts.
Select...
My condition is classified as intermediate high-risk or very high-risk.
Select...
I have had surgery to remove my kidney and any affected lymph nodes.
Select...
My kidney cancer diagnosis was confirmed through lab tests.
Select...
I can carry out all my usual activities without help.
Select...
My kidney function, measured by creatinine levels, is within the normal range.
Select...
My surgery removed all visible cancer.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
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.
Select...
I have tested positive for HIV.
Select...
I cannot have IV iodine-based or gadolinium contrast due to health reasons.
Select...
I have not received any treatment for kidney cancer before.
Select...
I am not currently taking steroids or other drugs that weaken my immune system.
Select...
I do not have an uncontrolled serious heart rhythm problem.
Select...
I do not have severe liver disease or cirrhosis.
Select...
My stomach and intestines work well and don't have diseases that affect medication absorption.
Select...
I can safely receive IV iodine-based contrast or gadolinium.
Select...
I am allergic to everolimus, sirolimus, temsirolimus, or their ingredients.
Select...
I have a lung condition that is not currently under control.
Select...
I haven't had a live vaccine in the last 7 days.
Select...
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
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 • NCT0317623863%
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%
Headache
12%
Upper respiratory tract infection
12%
Nausea
11%
Back pain
11%
Pruritus
9%
Myalgia
9%
Blood lactate dehydrogenase increased
9%
Insomnia
8%
Productive cough
8%
Dyspnoea
8%
Dyspepsia
8%
Oedema peripheral
8%
Arthralgia
7%
Dysgeusia
7%
Pain in extremity
6%
Constipation
6%
Pyrexia
6%
Hypertension
5%
Epistaxis
5%
Aphthous ulcer
5%
Hypercholesterolaemia
5%
Lymphoedema
5%
Dyslipidaemia
5%
Urinary tract infection
5%
Asthenia
5%
Pneumonia
5%
Blood alkaline phosphatase increased
5%
Neutrophil count decreased
5%
Dry skin
5%
Thrombocytopenia
4%
Acne
4%
Rhinorrhoea
4%
Abdominal pain
4%
Peripheral swelling
4%
Blood creatinine increased
4%
Hypokalaemia
4%
Hypophosphataemia
4%
Urticaria
4%
Mouth ulceration
4%
Toothache
3%
Abdominal discomfort
3%
Paraesthesia
3%
Cellulitis
3%
Alopecia
3%
Abdominal pain upper
3%
Nail disorder
3%
Diabetes mellitus
3%
Depression
3%
Hyperlipidaemia
3%
Oropharyngeal pain
3%
Influenza
3%
Hyperkalaemia
3%
Face oedema
3%
Non-cardiac chest pain
3%
Nasopharyngitis
3%
Pharyngitis
3%
Haemoglobin decreased
3%
White blood cell count decreased
3%
Dermatitis acneiform
3%
Vomiting
2%
Musculoskeletal pain
2%
Onychomadesis
2%
Pleural effusion
2%
Dizziness
2%
Hypoaesthesia
2%
Influenza like illness
2%
Mucosal inflammation
2%
Pain
2%
Blood triglycerides increased
2%
Platelet count decreased
2%
Vitamin D deficiency
2%
Flank pain
2%
Neck pain
2%
Eczema
2%
Rash maculo-papular
2%
Haemorrhoids
1%
Cardiopulmonary failure
1%
Soft tissue infection
1%
Hyponatraemia
1%
Joint effusion
1%
Hydrocephalus
1%
Dental caries
1%
Left ventricular failure
1%
Haemoptysis
1%
Onycholysis
1%
Pulmonary oedema
1%
Gastric haemorrhage
1%
Central nervous system haemorrhage
1%
Dysphagia
1%
Herpes virus infection
1%
Gastroenteritis
1%
Abdominal hernia
1%
Ascites
1%
Furuncle
1%
Skin ulcer
1%
Lethargy
1%
Interstitial lung disease
1%
Atypical pneumonia
1%
Tumour pain
1%
Respiratory failure
1%
Ventricular tachycardia
1%
Acute kidney injury
1%
Metastases to lung
1%
Lower respiratory tract infection
1%
Dyspnoea exertional
1%
Wheezing
1%
Leukopenia
1%
Gait inability
1%
Renal failure
1%
Abdominal distension
1%
Musculoskeletal chest pain
1%
Pulmonary embolism
1%
Asthma
1%
Palmar-plantar erythrodysaesthesia syndrome
1%
Vision blurred
1%
Folliculitis
1%
Cardiac failure
1%
Contrast media allergy
1%
Dry eye
1%
Gingivitis
1%
Muscular weakness
1%
Eye pain
1%
Intracranial aneurysm
1%
Oral herpes
1%
Sinusitis
1%
Hypocalcaemia
1%
Hypomagnesaemia
1%
Bone pain
1%
Joint stiffness
1%
Pain in jaw
1%
Spinal pain
1%
Breast pain
1%
Ingrowing nail
1%
Rash papular
1%
Rash pruritic
1%
Hot flush
1%
Atrial fibrillation
1%
Cardiac arrest
1%
Gastric ulcer
1%
Haematochezia
1%
Large intestinal haemorrhage
1%
Urethritis
1%
Urosepsis
1%
Viral infection
1%
Cartilage injury
1%
Femur fracture
1%
Ligament sprain
1%
Overdose
1%
Eastern cooperative oncology group performance status worsened
1%
Liver function test increased
1%
Dehydration
1%
Diabetes mellitus inadequate control
1%
Tumour necrosis
1%
Neutropenia
1%
Tachycardia
1%
Gastrooesophageal reflux disease
1%
Oral pain
100%
80%
60%
40%
20%
0%
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
Find a Location
Who is running the clinical trial?
SWOG Cancer Research NetworkLead Sponsor
398 Previous Clinical Trials
264,071 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,938 Previous Clinical Trials
41,021,625 Total Patients Enrolled
Southwest Oncology GroupLead Sponsor
388 Previous Clinical Trials
258,656 Total Patients Enrolled
Christopher W. Ryan, MDPrincipal InvestigatorOHSU Knight Cancer Institute
4 Previous Clinical Trials
120 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have unstable chest pain.I have severe heart disease.I have not had a heart attack in the last 6 months.My cholesterol is over 300 mg/dL and my triglycerides are more than 2.5 times the upper limit.My blood sugar levels are controlled and monitored.My kidney cancer has spread to small blood vessels but not to distant parts.I have tested positive for HIV.I cannot have IV iodine-based or gadolinium contrast due to health reasons.I have no cancer history, except for certain skin cancers, early-stage cancers in remission, or any cancer I've been free from for 5 years.I have not received any treatment for kidney cancer before.I am not currently taking steroids or other drugs that weaken my immune system.My condition is classified as intermediate high-risk or very high-risk.I do not have an uncontrolled serious heart rhythm problem.I have had surgery to remove my kidney and any affected lymph nodes.My kidney cancer diagnosis was confirmed through lab tests.Your ANC (absolute neutrophil count) is at least 1,500 per cubic millimeter.I do not have severe liver disease or cirrhosis.I haven't taken strong CYP3A4 affecting drugs in the last 14 days.My stomach and intestines work well and don't have diseases that affect medication absorption.I can safely receive IV iodine-based contrast or gadolinium.My cholesterol levels are controlled and will be monitored.Your platelet count is at least 100,000 per cubic millimeter.Your bilirubin level in the blood is not more than 1.5 times the upper limit of normal.Your SGOT and SGPT liver enzyme levels are not more than 2.5 times the upper limit of normal.My kidney cancer has not spread into the wall of the renal vein.I registered for the trial within 84 days after my first tumor surgery.I can carry out all my usual activities without help.My kidney function, measured by creatinine levels, is within the normal range.I can take pills by mouth.I am allergic to everolimus, sirolimus, temsirolimus, or their ingredients.I can have MRI scans if I can't have CT scans with contrast.My surgery removed all visible cancer.My cancer can be clear cell or non-clear cell type.I have a lung condition that is not currently under control.I haven't had a live vaccine in the last 7 days.My blood sugar levels are not controlled and are higher than normal.I am not currently taking any cancer treatments or experimental drugs.My recent scans show no signs of kidney cancer after surgery.
Research Study Groups:
This trial has the following groups:- Group 1: Arm I
- Group 2: Arm II
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.