Apply to Trial

Compensation: Varies

Number of Visits: 15

Duration: 54 weeks

1545 Participants Needed

Everolimus for Kidney Cancer
(S0931 Trial)

Recruiting at 1002 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: SWOG Cancer Research Network

Must not be taking: CYP3A4 inhibitors, CYP3A4 inducers, Systemic steroids, Immunosuppressants

Disqualifiers: Cardiac disease, Liver disease, HIV, others

Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval

Prior Safety DataThis treatment has passed at least one previous human trial

Approved in 2 JurisdictionsThis treatment is already approved in other countries

Trial Summary

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop all current medications, but you cannot take strong CYP3A4 inhibitors or inducers, live vaccines, or chronic systemic steroids. Topical or inhaled corticosteroids are allowed.

What data supports the effectiveness of the drug Everolimus for kidney cancer?

Research shows that Everolimus, an mTOR inhibitor, is effective for patients with advanced kidney cancer, especially after other treatments like sunitinib or sorafenib have failed. In a clinical trial, Everolimus increased the time patients lived without their cancer getting worse from 1.9 months to 4.9 months.¹ ² ³ ⁴ ⁵

Is Everolimus safe for humans?

Everolimus is generally well tolerated, but it can cause side effects like mouth sores, tiredness, lung issues, and infections. Some people may experience more serious side effects like lung infections and kidney problems, and treatment may be stopped due to these issues.¹ ² ⁴ ⁶ ⁷

What makes the drug Everolimus unique for treating kidney cancer?

Everolimus is unique because it is the first oral drug that inhibits mTOR (a protein involved in cell growth) and is specifically approved for patients with advanced kidney cancer who have not responded to other treatments like sunitinib or sorafenib. It has been shown to significantly extend the time patients live without their cancer getting worse.¹ ² ³ ⁴ ⁸

What is the purpose of this trial?

RATIONALE: Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth or by blocking blood flow to the tumor.PURPOSE: This phase III trial is studying everolimus to see how well it works in treating patients with kidney cancer who have undergone surgery.

Research Team

Christopher W. Ryan, MD

Principal Investigator

OHSU Knight Cancer Institute

Eligibility Criteria

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.

Inclusion Criteria

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

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

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

See 16 more

Exclusion Criteria

I have unstable chest pain.

I have severe heart disease.

I have not had a heart attack in the last 6 months.

See 18 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive oral everolimus or placebo once daily for 54 weeks, with treatment repeating every 6 weeks for 9 courses

54 weeks

9 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment completion

2 years every 6 months, then annually for 8 years

Every 6 months for 2 years, then annually

Treatment Details

Interventions

Everolimus

Trial Overview 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.

Participant Groups

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.

Everolimus is already approved in United States, European Union for the following indications:

Approved in United States as Afinitor for:

Advanced renal cell carcinoma
Subependymal giant cell astrocytoma
Progressive neuroendocrine tumors of pancreatic origin
Advanced hormone receptor-positive, HER2-negative breast cancer
Tuberous sclerosis complex-associated partial-onset seizures

Approved in European Union as Votubia for:

Subependymal giant cell astrocytoma
Renal angiomyolipoma
Tuberous sclerosis complex-associated partial-onset seizures

Approved in United States as Zortress for:

Prevention of organ rejection in kidney transplant patients

Find a Clinic Near You

Who Is Running the Clinical Trial?

SWOG Cancer Research Network

Lead Sponsor

Trials

403

Recruited

267,000+

Southwest Oncology Group

Lead Sponsor

Trials

389

Recruited

260,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

Everolimus, an oral mTOR inhibitor, significantly improves progression-free survival in patients with clear cell renal cancer, increasing it from a median of 1.9 months to 4.9 months in a phase III trial with a hazard ratio of 0.33 (P < 0.001).

The treatment is generally well-tolerated, with mild to moderate side effects that can be managed, and it has been approved as a validated option for patients who have progressed on VEGFR inhibitors, with ongoing trials exploring its use in combination therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Everolimus: the first approved product for patients with advanced renal cell cancer after sunitinib and/or sorafenib.Coppin, C.[2021]

Everolimus, used in combination with aromatase inhibitors for treating metastatic ER-positive and HER2-negative breast cancer, can lead to serious side effects like interstitial lung disease and acute kidney injury.

This case highlights a patient who developed Pneumocystis pneumonia without typical respiratory symptoms and acute kidney injury while on everolimus, emphasizing the need for careful monitoring of lung and kidney health during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pneumocystis Pneumonia and Acute Kidney Injury Induced by Everolimus Treatment in a Patient with Metastatic Breast Cancer.Nakamura, M., Matsunuma, R., Yamaguchi, K., et al.[2020]