NCT05810623: MINERVA

Single-Dose Intravesical Chemotherapy After Diagnostic URS

Not yet recruiting Phase 3 Last updated 12 April 2023

What this trial tests

Phase 3 trial testing Intravesical Solution in Upper Urinary Tract Urothelial Carcinoma in 394 participants. Not yet recruiting.

Timeline

1 June 2023

Primary endpoint
31 December 2025

31 December 2026

Quick facts

Lead sponsor	David D'Andrea
Phase	Phase 3
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	394
Start date	1 June 2023
Primary completion	31 December 2025
Estimated completion	31 December 2026
Sites	2 locations across Austria

Drugs / interventions tested

• Intravesical Solution — full drug profile →

Conditions studied

• Upper Urinary Tract Urothelial Carcinoma — all drugs for Upper Urinary Tract Urothelial Carcinoma →
• Bladder Cancer — all drugs for Bladder Cancer →

Sponsor

David D'Andrea

Who can join

18 and older, any sex, with Upper Urinary Tract Urothelial Carcinoma or Bladder Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Study design This study is a Phase III, randomized, open-label, multi-center, global study to determine the efficacy of a single immediate intravesical chemotherapy instillation (SI) in the prophylaxis of intravesical recurrence after diagnostic uretero-renoscopy (URS) of patients 18 years of age or older with the fist diagnosis of UTUC.

This study will randomize 394 patients globally Patients will be randomized in a 1:1 ratio to the interventional arm or to observation.

Study period This study will include a screening period, a treatment and disease assessment period, safety follow-up visits and a 5-year survival follow-up period to begin immediately after the treatment.

Screening period: The period up to 28 days prior to intervention during which the screening procedures occur.

Treatment and disease assessment period: The period starting the day of diagnostic URS (Day 0) during which patients receive their assigned treatment (Day 0 to day 1) and disease assessments are performed. All patients must follow the disease assessment schedule, which includes disease assessments at screening and every 3 months (±1 week) from the date of intervention until 24 months from the date of randomization, and then every 6 months for up to 5 years. The treatment and disease assessment period will end at the time of intravesical recurrence, death, or MINERVA-CTU decision to terminate the trial early.

Safety follow-up visits: Every patient in this study will be assessed for the occurrence of adverse events (AEs) and serious adverse events from the time of signed informed consent until 90 days after the administration of SI. All patients who receive SI will have safety visits 4, 8, and 12 weeks following administration of SI. Safety assessments include targeted physical examination, complications according to Dindo-Clavien classification and patient-reported outcomes (PRO) assessments.

Survival follow-up period: Patients will be followed up at in-clinic site visits, by telephone contact, or by contact with the patient's current physician for up to 5 years from the date of randomized into this study.

Objectives Primary objective Efficacy of a SI in the prophylaxis of intravesical recurrence after diagnostic URS for UTUC

Secondary objectives

* Time to intravesical recurrence
* 5-years intravesical recurrence rates
* Incidence of high-grade BCa recurrence
* Incidence and gravity of adverse events (AEs) due to the SI
* To collect and store blood, urine and tissue samples according to each country's local and ethical procedures for identifying candidate markers that may correlate with likelihood of clinical benefit (optional)
* To collect and store DNA according to each country's local and ethical procedures for future exploratory research into somatic mutations and genes/genetic variations that may influence oncologic outcomes, to study treatments and susceptibility to disease (optional)
* To assess disease-related symptoms and HRQoL in patients with UTUC treated with SI compared those undergoing observation
* To assess patient-reported treatment tolerability directly using specific PRO-CTCAE symptoms

Target study population The study population includes patients 18 years of age or older with a primary diagnosis of UTUC, scheduled for diagnostic URS

Duration of treatment Patients randomized to the interventional arm will receive a SI within 24h after diagnostic URS. In case of multiple diagnostic URS during the follow-up (including 2nd look for incomplete ablation, non-diagnostic first URS or UTUC recurrence) patients randomized to the interventional arm will receive a SI after each diagnostic URS for 2 years after the day of first diagnostic URS.

Follow-up of subjects post discontinuation of study treatment Patients who have discontinued study treatment due to toxicity, symptomatic deterioration, intravesical recurrence or investigator's decision will be followed up for survival until 5 years from the date of diagnostic URS.

Survival All randomized patients, regardless of disease status, will be followed up for survival until 5 years from the date of diagnostic URS.

Investigational product, dosage, and mode of administration Patients randomized to the interventional arm will receive a SI. The chemotherapy will be at investigator's discretion and institutional availability.

The selected chemotherapy must be approved by the MINERVA-CTU in discussion with the local investigator.

Statistical methods This study will randomize 394 patients globally. Patients will be randomized 1:1 to SI or observation.

Randomization will be stratified by the following factors:

1. Center
2. EAU UTUC risk stratification

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Intravesical Therapy for Upper Urinary Tract Urothelial Carcinoma: A Comprehensive Review.
   Wang Z, Shi H, Xu Y, Fang Y, et al · · 2023 · cited 3× · PMID 37894387 · DOI 10.3390/cancers15205020