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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

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

SAMETA Trial 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.

SAMETA Trial 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.

Select...

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.

SAMETA Trial 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.

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

SAMETA 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

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor

4,267 Previous Clinical Trials

288,606,761 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who would be most likely to benefit from enrolling in this study?

"To qualify for this study, which is testing a new cancer treatment, patients must have had no prior systemic anti-cancer treatments in the metastatic setting. Additionally, they must not have any previous exposure to MET inhibitors or similar drugs, and they must have a Karnofsky Score of over 70. Finally, participants must be aged between 18 and 130 and have a life expectancy of at least 12 weeks."

Answered by AI

If savolitinib is used, what are the potential risks for patients?

"Savolitinib's safety has been corroborated by multiple rounds of clinical testing, so it received a score of 3."

Answered by AI

Are elders welcome to enroll in this clinical trial?

"The age limit for patients enrolling in this clinical trial is 18-130 years old. In comparison, there are 94 trials underway for patients that are younger and 3022 studies recruiting older adults."

Answered by AI

What indications does savolitinib usually treat?

"Savolitinib is most typically used to ameliorate disease progression. However, it has also been shown to be helpful in treating conditions such as metastatic pancreatic neuroendocrine tumors, advanced renal cell carcinoma (arcc), and unresectable stage iii non-small cell lung cancer."

Answered by AI

In how many different medical clinics is this study being carried out today?

"Presently, this clinical trial is looking for participants from 7 sites. These locations include Columbia, Montreal and Whittier among others. If you are considering enrolling in the trial, it may be best to select a location nearest to you to limit travel requirements."

Answered by AI

Are there any other instances of savolitinib being used in medical research?

"The first mention of savolitinib in the medical literature was in a 2006 study out of University of Texas MD Anderson Cancer Center. As of now, there have been a total 366 completed trials with 382 currently active studies. There is a significant presence for this research drug in Columbia, Maryland."

Answered by AI

Are there other similar medical trials to this one?

"There are 382 ongoing savolitinib trials in 1659 cities and 58 countries. The very first trial was completed in 2006 by Pfizer. That study had a total of 64 participants and reached Phase 2 drug approval. In the 15 years since then, 366 more trials have been conducted."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Savolitinib Plus Durvalumab Versus Sunitinib and Durvalumab Monotherapy in MET-Driven, Unresectable and Locally Advanced or Metastatic PRCC

2021. "Savolitinib Plus Durvalumab Versus Sunitinib and Durvalumab Monotherapy in MET-Driven, Unresectable and Locally Advanced or Metastatic PRCC". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05043090.

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