A Phase III, Open Label, Randomised, 3 Arm, Multi Centre Study of Savolitinib plus Durvalumab versus Sunitinib and Durvalumab Monotherapy in Participants with MET Driven, Unresectable and Locally Advanced or Metastatic Papillary Renal Cell Carcinoma (PRCC)

A Phase III, Open Label, Randomised, 3 Arm, Multi Centre Study of Savolitinib plus Durvalumab versus Sunitinib and Durvalumab Monotherapy in Participants with MET Driven, Unresectable and Locally Advanced or Metastatic Papillary Renal Cell Carcinoma (PRCC) - SAMETA

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON54072

Enrollment

Registered

2021-06-30

Start date

2021-12-21

Completion date

Unknown

Last updated

2024-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal tumour

Interventions

The treatments options include 1) treatment with 2 investigational drugs, savolitinib and durvalumab in combination

2) treatment with 1 investigational drug, durvalumab, alone

and 3) treatment with sunitinib which is a standard treatment for PRCC. See also protocol v1.0 par 6. Study Intervention

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: • 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

Exclusion criteria

Exclusion criteria: • History of serious liver disease, with or without, normal LFTs, such as cirrhosis or Wilson*s disease • 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

Design outcomes

Primary

Measure	Time frame
Primary Endpoint: - Progression-Free Survival More details see protocol v1.0 par 9.5.2.1	—

Secondary

Measure	Time frame
Secondary Endpoints: - Overall Survival - Objective Response Rate - Duration of Response - Disease Control Rate - Time from Randomisation to Second Progression or Death (PFS2) - Clinical Outcome Assessments More details see protocol v1.0 par 9.5.2.2	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)