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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
AstraZeneca
Study ID
NCT05043090
Phase
PHASE3
Status
Active Not Recruiting

Conditions

  • Papillary Renal Cell Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 130 Years
Healthy Volunteers
Not accepted

Interventions

  • savolitinib — DRUG
    Tablets : 3 × 200 mg tablets once daily
  • durvalumab — DRUG
    Concentrate for solution for IV infusion : 1500 mg durvalumab every 4 weeks
  • sunitinib — DRUG
    Capsules : 2 x 25mg capsules once daily 4 weeks on, 2 weeks off

Study Details

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).

Key Dates

Start date
Oct 28, 2021
Status verified
May 2026
Primary completion
Dec 31, 2025
Completion
Feb 1, 2027

Study Design

Enrollment
148 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A
    savolitinib 600mg plus durvalumab 1500mg
  • Active Comparator: Arm B
    sunitinib 50mg
  • Experimental: Arm C
    durvalumab 1500mg

Primary Outcome Measure

Progression-Free Survival (PFS) /savolitinib plus durvalumab relative to sunitinib [ Time Frame: Approximately 28 months post first subject randomized ]

Locations (2)

FacilityCityStateZIPSite coordinators
Research SiteBostonMassachusetts02215-
Research SiteNew YorkNew York10065-

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