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HIF-2 Alpha Inhibitor

Belzutifan vs Everolimus for Renal Cell Carcinoma

Phase 3

Waitlist Available

Research Sponsored by Merck Sharp & Dohme Corp.

Eligibility Criteria Checklist

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

Must have

Has had disease progression on or after having received systemic treatment for locally advanced or metastatic RCC with both Programmed cell death 1 ligand 1 (PD-1/L1) checkpoint inhibitor and a vascular endothelial growth factor - tyrosine kinase inhibitor (VEGF-TKI) in sequence or in combination

Has unresectable, locally advanced or metastatic clear cell renal cell carcinoma (RCC)

Must not have

Is unable to swallow orally administered medication or has a gastrointestinal disorder affecting absorption (e.g., gastrectomy, partial bowel obstruction, malabsorption)

Has received prior treatment with everolimus or any other specific or selective target of rapamycin complex 1 (TORC1)/ phosphatidylinositol 3-kinase (PI3K)/ protein kinase B (AKT) inhibitor (e.g., temsirolimus) in the advanced disease setting

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 49 months

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is comparing two cancer drugs to see which one is more effective in terms of survival rate and progression-free survival.

Who is the study for?

This trial is for adults with advanced renal cell carcinoma who've had no more than three prior treatments, are not pregnant or breastfeeding, and agree to use contraception. They must have progressed after treatment with specific cancer drugs (PD-1/L1 inhibitors and VEGF-TKIs) and have good organ function. Exclusions include other active cancers within 3 years, brain metastases, significant heart issues, allergies to the study drugs, recent major surgery or certain medications.

What is being tested?

The study aims to see if Belzutifan improves survival without cancer progression compared to Everolimus in patients with advanced kidney cancer. It's a head-to-head comparison of these two drugs' effectiveness over time.

What are the potential side effects?

Possible side effects of Belzutifan and Everolimus may include fatigue, nausea, decreased appetite, changes in blood counts leading to increased risk of infections or bleeding problems; high blood pressure; mouth sores; skin rash; abnormal liver tests suggesting liver injury.

Eligibility Criteria

Inclusion Criteria

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

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My kidney cancer worsened after treatment with PD-1/L1 and VEGF-TKI.

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My kidney cancer cannot be surgically removed and has spread.

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I have had 3 or fewer treatments for advanced kidney cancer.

Exclusion Criteria

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

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I cannot take pills by mouth or have a condition that affects how my body absorbs medication.

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I have been treated with drugs targeting specific cancer pathways before.

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I have not had major surgery in the last 3 weeks.

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I have not received a live vaccine in the last 30 days.

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I do not have severe heart problems like recent heart attacks or advanced heart failure.

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I have been treated with belzutifan or a similar drug before.

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I have active tuberculosis.

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I am currently being treated for an infection.

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I am taking strong or moderate medication that affects liver enzymes and cannot stop during the study.

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I have a history of Hepatitis B or active Hepatitis C.

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I am taking medication that strongly or moderately affects liver enzymes and cannot stop during the study.

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I have an immune system disorder or have been on high-dose steroids or other immune-weakening medicines recently.

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My liver is not working well (moderate to severe issues).

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 49 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 49 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 49 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

Overall Survival (OS)

Progression-free Survival (PFS) per Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)

Secondary study objectives

Change From Baseline in Disease Symptoms Using the FKSI-DRS Items 1-9 Score

Change From Baseline in HRQoL Using the EORTC QLQ-C30 Items 29 and 30 Score

Change From Baseline in Physical Functioning Using the EORTC QLQ-C30 Items 1- 5 Score

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