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Monoclonal Antibodies

Savolitinib + Durvalumab vs. Sunitinib for Kidney Cancer (SAMETA Trial)

Phase 3

Recruiting

Led By Toni Choueiri

Research Sponsored by AstraZeneca

Eligibility Criteria Checklist

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

Must have

No prior systemic anti-cancer treatment in the metastatic setting; no prior exposure to MET inhibitors, Durvalumab or Sunitinib in any setting

PRCC must be centrally confirmed as MET-driven using a sponsor-designated central laboratory validated NGS assay

Must not have

History of liver cirrhosis of any origin and clinical stage; or history of other serious liver disease or chronic disease with relevant liver involvement, with or without normal LFTs

Active or prior documented autoimmune or inflammatory disorders

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 28 months and 42 months post first subject randomized

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Summary

This trial is testing a new drug combo vs. an existing drug to see which is more effective in treating a particular type of kidney cancer.

Who is the study for?

This trial is for adults with MET-driven, unresectable and locally advanced or metastatic Papillary Renal Cell Carcinoma (PRCC). Participants must have measurable lesions, good organ/bone marrow function, a life expectancy of at least 12 weeks, no prior cancer treatments in the metastatic setting or exposure to the drugs being tested. They should not have serious liver disease, brain metastases unless stable and asymptomatic, significant heart issues within the past 6 months, active infections like HIV/TB/HBV/HCV or autoimmune/inflammatory disorders.

What is being tested?

The study compares savolitinib combined with durvalumab against sunitinib alone and durvalumab alone in patients with PRCC that's driven by MET gene changes. The goal is to see which combination works better for this type of kidney cancer that can't be removed by surgery.

What are the potential side effects?

Potential side effects include immune-related reactions due to durvalumab affecting organs like lungs or intestines; high blood pressure and fatigue from sunitinib; and liver issues from savolitinib. Side effects vary per individual based on their health condition.

Eligibility Criteria

Inclusion Criteria

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

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I haven't had any cancer treatment in the metastatic stage or been treated with MET inhibitors, Durvalumab, or Sunitinib.

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My PRCC is confirmed to be MET-driven by a specific lab test.

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I am able to care for myself but may not be able to do active work.

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My kidney cancer cannot be surgically removed and has spread.

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I have at least one tumor that can be measured and has not been treated with radiation.

Exclusion Criteria

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

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I have a history of serious liver disease or cirrhosis.

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I have or had an autoimmune or inflammatory disorder.

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I have heart issues or take medication that affects my heart's rhythm.

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I do not have an active infection like HIV, TB, hepatitis B, or hepatitis C.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 28 months and 42 months post first subject randomized

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximately 28 months and 42 months post first subject randomized

This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 28 months and 42 months post first subject randomized for reporting.