A clinical trial to compare the effectiveness of Savolitinib Plus Durvalumab Versus Sunitinib and Durvalumab Monotherapy in MET-Driven, Unresectable and Locally Advanced or Metastatic Papillary Renal Cell Carcinoma
- Conditions
- Health Condition 1: - Health Condition 2: C649- Malignant neoplasm of unspecifiedkidney, except renal pelvis
- Registration Number
- CTRI/2022/05/042839
- Lead Sponsor
- abcorp Drug Development India Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Histologically confirmed unresectable and locally advanced or metastatic PRCC
PRCC must be centrally confirmed as MET-driven using a sponsor-designated central laboratory validated NGS assay
No prior systemic anti-cancer treatment in the metastatic setting; no prior exposure to MET inhibitors, Durvalumab or Sunitinib in any setting
Karnofsky Score >70
At least one lesion, not previously irradiated, that can be accurately measured at baseline
Adequate organ and bone marrow function
Life expectancy �12weeks at Day 1
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
Spinal cord compression or brain metastases, unless asymptomatic and stable on treatment for at least 14 days prior to study intervention
Active or prior cardiac disease (within past 6 months) or clinically significant ECG abnormalities and/or factors/medications that may affect QT and/or QTc intervals
Active infection including HIV, TB, HBV and HCV
Active or prior documented autoimmune or inflammatory disorders
Receipt of live attenuated vaccine within 30 days prior to the first dose of study intervention
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method