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Closed (no longer recruiting)Last updated: 17 October 2023

RAMPART: This phase III trial is trying to assess whether using a single type of immunotherapy or a combination of two types of immunotherapy will improve survival outcomes for people with renal cell carcinoma that has been surgically removed, when compared to current standard-of-care (active monitoring)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

Clinical summary

Summary

This trial comprises of three different arms. Participants randomly assigned to the first arm (Arm A) will be actively monitored for 1-year, in line with current standard-of-care practice in people with resected primary renal cell carcinoma (RCC) at high- or intermediate- risk of relapse. Participants randomly allocated to the second arm (Arm B) will receive durvalumab (1500mg) every 4 weeks for 1-year (up to 13 cycles). Participants randomly allocated to the third arm (Arm C) will receive durvalumab (like those in Arm B) and tremelimumab (75mg) on day 1 and week 4 visits.

Conditions

This trial is treating patients with renal cell carcinoma.

Cancer

Urinary System Cancers Urinary System

Age

People18+

Phase

III

Trial Acronym

RAMPART

More information

Trial Identifiers

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Commercial Sponsor

AstraZeneca, University College London Hospitals

Scientific Title

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

Eligibility

Inclusion

  • You have had a certain type of treatment or surgical procedure.
  • Your cancer has not spread to other parts of the body.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
  • You have previously been treated (or are currently being treated) on a clinical trial.
Message

Clinical trials have complex eligibility criteria.

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