RAMPART: A phase III multi-arm multi-stage trial of adjuvant checkpoint inhibitors in patients with resected primary renal cell carcinoma (RCC) at high or intermediate risk of relapse.
Contemp Clin Trials
; 108: 106482, 2021 09.
Article
em En
| MEDLINE
| ID: mdl-34538402
ABSTRACT
BACKGROUND:
20-60% of patients with initially locally advanced Renal Cell Carcinoma (RCC) develop metastatic disease despite optimal surgical excision. Adjuvant strategies have been tested in RCC including cytokines, radiotherapy, hormones and oral tyrosine-kinase inhibitors (TKIs), with limited success. The predominant global standard-of-care after nephrectomy remains active monitoring. Immune checkpoint inhibitors (ICIs) are effective in the treatment of metastatic RCC; RAMPART will investigate these agents in the adjuvant setting. METHODS/DESIGN:
RAMPART is an international, UK-led trial investigating the addition of ICIs after nephrectomy in patients with resected locally advanced RCC. RAMPART is a multi-arm multi-stage (MAMS) platform trial, upon which additional research questions may be addressed over time. The target population is patients with histologically proven resected locally advanced RCC (clear cell and non-clear cell histological subtypes), with no residual macroscopic disease, who are at high or intermediate risk of relapse (Leibovich score 3-11). Patients with fully resected synchronous ipsilateral adrenal metastases are included. Participants are randomly assigned (3,22) to Arm A - active monitoring (no placebo) for one year, Arm B - durvalumab (PD-L1 inhibitor) 4-weekly for one year; or Arm C - combination therapy with durvalumab 4-weekly for one year plus two doses of tremelimumab (CTLA-4 inhibitor) at day 1 of the first two 4-weekly cycles. The co-primary outcomes are disease-free-survival (DFS) and overall survival (OS). Secondary outcomes include safety, metastasis-free survival, RCC specific survival, quality of life, and patient and clinician preferences. Tumour tissue, plasma and urine are collected for molecular analysis (TransRAMPART). TRIAL REGISTRATION ISRCTN # ISRCTN53348826, NCT # NCT03288532, EUDRACT # 2017-002329-39, CTA # 20363/0380/001-0001, MREC # 17/LO/1875, ClinicalTrials.gov Identifier NCT03288532, RAMPART grant number MC_UU_12023/25, TransRAMPART grant number A28690 Cancer Research UK, RAMPART Protocol version 5.0.Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Carcinoma de Células Renais
/
Neoplasias Renais
Tipo de estudo:
Clinical_trials
/
Etiology_studies
/
Guideline
/
Prognostic_studies
/
Risk_factors_studies
Aspecto:
Patient_preference
Limite:
Humans
Idioma:
En
Revista:
Contemp Clin Trials
Assunto da revista:
MEDICINA
/
TERAPEUTICA
Ano de publicação:
2021
Tipo de documento:
Article