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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

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.Check my eligibility
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.See study design
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 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.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Progression-Free Survival (PFS) /savolitinib plus durvalumab relative to sunitinib
Secondary outcome measures
Assessment of patient-reported symptoms, functioning, and HRQoL /savolitinib plus durvalumab relative to sunitinib
Disease Control Rate (DCR) at 24 and 48 weeks /savolitinib plus durvalumab relative to sunitinib
Duration of Response (DoR) / savolitinib plus durvalumab relative to durvalumab monotherapy
+10 more

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Arm CExperimental Treatment1 Intervention
durvalumab 1500mg
Group II: Arm AExperimental Treatment2 Interventions
savolitinib 600mg plus durvalumab 1500mg
Group III: Arm BActive Control1 Intervention
sunitinib 50mg
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
savolitinib
2014
Completed Phase 2
~1000
durvalumab
2017
Completed Phase 2
~400

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,302 Previous Clinical Trials
288,624,379 Total Patients Enrolled
Toni ChoueiriPrincipal InvestigatorDana-Farber Cancer Institute

Media Library

Durvalumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05043090 — Phase 3
Kidney Cell Carcinoma Research Study Groups: Arm B, Arm A, Arm C
Kidney Cell Carcinoma Clinical Trial 2023: Durvalumab Highlights & Side Effects. Trial Name: NCT05043090 — Phase 3
Durvalumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05043090 — Phase 3
~51 spots leftby May 2025
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