An International Phase III Randomized Controlled Trial of Adjuvant Therapy Using Durvalumab With or Without Tremelimumab in Patients With Resected Renal Cell Carcinoma at High or Intermediate Risk of Relapse

What this Trial Is About

Researchers are evaluating treatment options for patients with localized renal cell carcinoma RCC who have undergone nephrectomy and are at intermediate or high risk of disease recurrence. This phase III randomized controlled platform trial, called RAMPART, aims to assess whether durvalumab alone or combined with tremelimumab can improve disease-free survival or overall survival compared to the current standard care of active monitoring. The study includes patients with Leibovich scores between 3 and 11, focusing on those at intermediate and high risk of relapse after surgery. Participants will be randomly assigned to one of three groups active monitoring for one year, durvalumab monotherapy given as 1500 mg infusions every four weeks for up to 13 cycles, or a combination of durvalumab same dosing with tremelimumab administered twice during the first month. The trial monitors patients over several years to compare outcomes between these groups, including disease-free survival, overall survival, and metastasis-free survival. During the study, participants will undergo clinical and radiological assessments, including post-operative CT scans before randomization and routine follow-ups during treatment and observation. Researchers will collect tissue samples and blood for future research. Safety and health will be closely monitored through laboratory tests, ECGs, and performance status evaluations. The study may last up to 20 years for the longest follow-up on overall survival and other outcomes.

Renal Adjuvant MultiPle Arm Randomised Trial