Savolitinib + Durvalumab vs. Sunitinib for Kidney Cancer

(SAMETA Trial)

Recruiting in Palo Alto (17 mi)

+140 other locations

Overseen by Toni Choueiri, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: AstraZeneca

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

A clinical trial to compare the effectiveness of savolitinib plus durvalumab versus sunitinib in MET-driven (hepatocyte growth factor receptor), unresectable and locally advanced or metastatic PRCC (Papillary Renal Cell Carcinoma).

Research Team

Toni Choueiri, MD

Principal Investigator

Dana-Farber Cancer Institute

Eligibility Criteria

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.

Inclusion Criteria

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

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

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

Exclusion Criteria

I have a history of serious liver disease or cirrhosis.

I have or had an autoimmune or inflammatory disorder.

My brain or spinal tumors are stable and I've been symptom-free for at least 14 days.

Treatment Details

Interventions

• Durvalumab (Monoclonal Antibodies)
• Savolitinib (Kinase Inhibitor)
• Sunitinib (Kinase Inhibitor)

Trial Overview 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.

Participant Groups

Group I: Arm C Experimental Treatment 1 Intervention

durvalumab 1500mg

Group II: Arm A Experimental Treatment 2 Interventions

savolitinib 600mg plus durvalumab 1500mg

Group III: Arm B Active Control 1 Intervention

sunitinib 50mg

Durvalumab is already approved in Japan for the following indications:

Approved in Japan as Imfinzi for:

• Not specified in provided sources

Who Is Running the Clinical Trial?

AstraZeneca

Lead Sponsor

Trials

4,491

Recruited

290,540,000+

Sir Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Dr. Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology