A Study of Risk Enabled Therapy After Neoadjuvant Immunochemotherapy for Bladder Cancer (NCT04506554) | Clinical Trial Compass
Active — Not RecruitingPhase 2
A Study of Risk Enabled Therapy After Neoadjuvant Immunochemotherapy for Bladder Cancer
United States81 participantsStarted 2020-12-01
Plain-language summary
Neoadjuvant accelerated methotrexate/vinblastine/adriamycin/cisplatin (AMVAC) in combination with nivolumab is under evaluation for the treatment of muscle invasive bladder cancer (MIBC). Patients with pre-specified tumor mutations and complete clinical response with neoadjuvant therapy will preserve their bladders and go on active surveillance.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Male or female patients ≥18 years
* Primary urothelial or predominantly urothelial carcinoma of the bladder confirmed from pathology report. Patients with some component of variant histology mixed with predominant urothelial carcinoma will be allowed. Upper tract urothelial carcinoma patients are not allowed.
* Urothelial carcinoma of the prostatic urethra in men is allowed
* Histologic evidence of muscularis propria invasion.
* AJCC23 clinical stage T2-T3 N0M0.
* No radiographic evidence of lymph node positive disease as per RECIST 1.1 (≥15 mm short axis diameter). Lymph node positive disease is defined as clinical lymphadenopathy on staging CT or MRI greater than 1.4 cm in the short axis. If a lymph node is greater than 1.4 cm, it has to be biopsy proven negative for the patient to be eligible.
* No metastatic disease (M0).
* ECOG performance status 0, or 1.
* Left ventricular ejection fraction ≥ 50% by MUGA or ECHO within 6 months of study entry.
* Negative pregnancy test in women of child bearing potential within 24 hours of study registration. If the pregnancy test is positive, the patient must not receive protocol treatment and must not be enrolled in the study.
* Normal organ and bone marrow function (Leukocytes ≥ 3,000/mcL, Absolute neutrophil count ≥ 1,500/mcL, Platelets ≥ 100,000/mcL, Total bilirubin ≤ institutional upper limit of normal (ULN) unless patient has known Gilbert's disease, in which case an elevated bilirubin is allowed, AST(SGOT)…