Trial Name

Renal Adjuvant MultiPle Arm Randomised Trial (RAMPART):  An international investigator-led phase III multi-arm multi-stage multi-centre randomised controlled platform trial of adjuvant therapy in patients with resected primary renal cell carcinoma (RCC) at high or intermediate risk of relapse (ANZUP1606)(CTC 0153)

Background

Removing the kidney (or part of a kidney) by surgery is currently the best treatment if you have kidney cancer. The current standard treatment after surgery is ‘active monitoring’. This means no further treatment, but having regular checks so that if the cancer does come back further treatment options can be considered as early as possible. Surgery, together with ongoing regular follow-up and observation, is the standard approach for people diagnosed with kidney cancer that has required removal of the kidney (or part of a kidney) by surgery. For some people the cancer may return which is when other treatment is offered. We are aiming to find out whether taking one drug (durvalumab) or a combination of two drugs (durvalumab and tremelimumab) can prevent or delay kidney cancer coming back.

Overview

Multi- Arm, Multi-Stage, Multi-Centre Phase 3 Randomised Controlled Trial of adjuvant therapy in patients with resected primary renal cell carcinoma (RCC) at high or intermediate risk of relapse. 3 trial arms (A, B and C), duration of treatment arms for one year and follow up until primary outcome reaches maturity.  Single-arm, multicentre, phase 2 trial to determine the activity and safety of pembrolizumab and denosumab in advanced clear cell renal cell carcinoma (ccRCC). Clinical assessments every 3 weeks until disease progression. Tumour imaging at pre-surgery, baseline, then weeks 16, 32, 52 and then half yearly until follow up ends.  Blood and tissue for translational studies once at prior to randomisation.