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Active (not recruiting) Phase 3 2024-513219-29-00

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

Phase 3 – large-scale trial before approval
Conditions: Renal Cell Carcinoma

Sponsor: University College London

trial.available_in: БГ
Overview
Trial status: Authorised Metastasis Free Survival (MFS), defined as the interval from randomisation to first evidence of metastases or death from RCC., RCC specific survival time, defined as the time from randomisation to death from RCC., Quality of life, Toxicity, Patient preferences for adjuvant immunotherapy Disease Free Survival - defined as the interval from randomisation to first evidence of local recurrence, new primary RCC, distant metastases, or death from any cause, whichever occurs first., Overall Survival - defined as all-cause mortality, the time from randomisation to death from any cause (including RCC).
Description
Metastasis Free Survival (MFS), defined as the interval from randomisation to first evidence of metastases or death from RCC., RCC specific survival time, defined as the time from randomisation to death from RCC., Quality of life, Toxicity, Patient preferences for adjuvant immunotherapy
Who can participate
Age group: 65+ years, 18-64 years Gender: Female, Male Target enrollment: 203 participants
Interventions
IMFINZI 50 mg/mL concentrate for solution for infusion.
Drug
IMJUDO 20 mg/ml concentrate for solution for infusion.
Drug
Locations 2
France (1)
Spain (1)
Technical details
Status
Active (not recruiting)
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
16.10.2024
Registry ID
2024-513219-29-00
Source
euclinicaltrials.eu
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