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 range18 Years
SexALL
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Inclusion criteria
âś“. 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
âś“. 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
âś“. Patients with urothelial carcinoma of the prostatic urethra
âś“. Bodyweight \>45kg
âś“. Patients eligible for cisplatin-based neoadjuvant chemotherapy, including:
âś“. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Exclusion criteria
âś•. Urothelial carcinoma of the upper tract
âś•. 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
âś•. Primary chemoradiation for bladder preservation for urothelial carcinoma of the bladder
âś•. Impaired renal function (glomerular filtration rate \[GFR\]\<60 mL/min); GFR should be assessed by calculation from serum/plasma creatinine (MDRD formula)
âś•. 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
âś•. 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.
âś•. Grade 2 or greater peripheral neuropathy
âś•. Oral anticoagulation treatment (vitamin K antagonist should be replaced by low-molecular-weight heparin).