Study Comparing Savolitinib Plus Durvalumab to Sunitinib and Durvalumab Alone in Advanced Papillary Kidney Cancer

Sponsor: AstraZeneca

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT05043090

Provider View

This clinical trial is testing the effectiveness of combining savolitinib with durvalumab against sunitinib or durvalumab alone in treating advanced papillary renal cell carcinoma (PRCC) that cannot be surgically removed.

Patient Parameters

Program Overview

The study aims to find out if a combination of savolitinib and durvalumab is more effective than sunitinib or durvalumab alone in treating advanced papillary renal cell carcinoma (PRCC) that is driven by a specific gene (MET) and cannot be surgically removed. Participants will be randomly assigned to receive either the combination of savolitinib and durvalumab, sunitinib alone, or durvalumab alone. The trial will monitor the safety and effectiveness of these treatments in shrinking tumors and improving patient outcomes.

Description

This is a Phase III international study involving three groups of participants with advanced papillary renal cell carcinoma (PRCC) that cannot be surgically removed. The study will compare the effectiveness and safety of three treatments: savolitinib combined with durvalumab, sunitinib alone, and durvalumab alone. Participants will be randomly assigned to one of these groups.

  • Group 1 will receive savolitinib (600mg taken orally once a day) and durvalumab (1500mg given through an IV every four weeks).
  • Group 2 will receive sunitinib (50mg taken orally once a day for four weeks, followed by a two-week break).
  • Group 3 will receive durvalumab alone (1500mg given through an IV every four weeks).

Participants will continue their assigned treatment until their cancer progresses, they experience unacceptable side effects, they choose to stop, or another reason for stopping occurs. If participants in the durvalumab alone group experience cancer progression, they may switch to the combination of savolitinib and durvalumab without any other cancer treatment in between.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with advanced papillary renal cell carcinoma (PRCC) that cannot be surgically removed.
  • Cancer must be confirmed as driven by the MET gene using a specific test.
  • No previous cancer treatment for metastatic disease and no prior use of MET inhibitors, durvalumab, or sunitinib.
  • Karnofsky performance score above 70, indicating good general health.
  • At least one measurable tumor that has not been treated with radiation.
  • Sufficient organ and bone marrow function.
  • Expected to live at least 12 weeks from the start of the study.

Exclusion Criteria

  • History of liver cirrhosis or other serious liver diseases.
  • Spinal cord compression or brain metastases unless stable and not causing symptoms for at least 14 days before starting the study.
  • Recent heart disease or significant heart rhythm problems.
  • Active infections such as HIV, tuberculosis, hepatitis B, or hepatitis C.
  • Autoimmune or inflammatory disorders.
  • Received a live vaccine within 30 days before starting the study.

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