NEoadjuvant Dose-dense MVAC In cOmbination With Durvalumab and Tremelimumab in Muscle-invasive Ur… (NCT03549715) | Clinical Trial Compass
UnknownPhase 1/2
NEoadjuvant Dose-dense MVAC In cOmbination With Durvalumab and Tremelimumab in Muscle-invasive Urothelial Carcinoma
France121 participantsStarted 2018-12-06
Plain-language summary
This is an open label, phase I/II clinical trial to evaluate the efficacy and safety of 2 cycles of durvalumab without (Arm A) or with (Arm B) tremelimumab in association with ddMVAC as neoadjuvant therapy in patients with MIUC.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Written informed consent and any locally required authorization (e.g., EU Data Privacy Directive in the EU) obtained from the patient prior to performing any protocol-related procedures, including screening evaluations
. Age ≥18 years at time of study entry
. Histologically confirmed MIUC (also termed TCC) of the bladder. Patients with mixed histologies are required to have a dominant transitional cell pattern (urothelial carcinoma must be \> 50%)
. Localized MIUC of the bladder with clinical stage T2-T4a and ≤N1 disease ( the single lymph node must be \< 15 mm (short axis) on imaging
. Patients with urothelial carcinoma of the prostatic urethra
. Bodyweight \>45kg
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Toxicity Grade
Timeframe: 68 months
2
pathologic complete response
Timeframe: 1 year
Trial details
NCT IDNCT03549715
SponsorAssociation Pour La Recherche des Thérapeutiques Innovantes en Cancérologie
. Patients eligible for cisplatin-based neoadjuvant chemotherapy, including:
. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Exclusion criteria
. Urothelial carcinoma of the upper tract
. Any approved anti-cancer therapy for urothelial carcinoma, including chemotherapy, or immunotherapy prior to initiation of study treatment. Of note, previous intravesical BCG injections are allowed if administered for non-muscle invasive urothelial carcinoma
. Primary chemoradiation for bladder preservation for urothelial carcinoma of the bladder
. Impaired renal function (glomerular filtration rate \[GFR\]\<60 mL/min); GFR should be assessed by calculation from serum/plasma creatinine (MDRD formula)
. Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent
. Grade 2 or greater hearing loss that contraindicates cisplatin use. Threshold shift of \>25 decibel averaged at 2 contiguous test frequencies in least one ear.
. Grade 2 or greater peripheral neuropathy
. Oral anticoagulation treatment (vitamin K antagonist should be replaced by low-molecular-weight heparin).