Pembrolizumab (MK3475), Gemcitabine, and Concurrent Hypofractionated Radiation Therapy for Muscle… (NCT02621151) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Pembrolizumab (MK3475), Gemcitabine, and Concurrent Hypofractionated Radiation Therapy for Muscle-Invasive Urothelial Cancer of the Bladder
United States60 participantsStarted 2016-08-11
Plain-language summary
This trial is to assess the efficacy of pembrolizumab (MK3475) added to concurrent radiation and gemcitabine in the management of patients with muscle-invasive urothelial cancer who are not candidates for or decline radical cystectomy.
Who can participate
Age range18 Years
SexALL
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:
* Histologically confirmed muscle-invasive urothelial cancer of the bladder within 60 days of study enrollment. Patients must be willing to provide a TURBT specimen during screening and prior to enrollment if adequate specimen (FFPE tissue block or 20 unstained slides) from initial TURBT documenting muscle-invasive urothelial bladder cancer is not available.
* Clinical stage T2-T4a, N0, M0 urothelial bladder cancer.
* Deemed to not be a candidate for radical cystectomy by attending urologic oncologist or refuse radical cystectomy.
* Be willing and able to provide written informed consent/assent for the trial.
* Be ≥ 18 years of age on day of signing informed consent.
* Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group Performance Scale.
* Demonstrate adequate organ function as defined below, all screening labs should be performed within 10 days of protocol enrollment.
* Absolute neutrophil count \>= 1,500 /mcL;
* Platelets \>= 100,000 /mcL;
* Hemoglobin \>= 9.0 g/dL;
* Serum creatinine \<=1.5 x upper limit of normal (ULN) or calculated creatinine clearance \>= 30 mL/min as calculated by Cockcrof-Gault formaulae or by 24 hour urine collection;
* Serum total bilirubin \<=1.5 x ULN or direct bilirubin \<= ULN for subjects with total bilirubin levels \> 1.5 x ULN;
* Aspartate aminotransferase and alanine aminotransferase \<= 1.5 x ULN;
* Albumin \>= 2.5 mg/dL;
* International normalized ratio or prothrombin time (P…
What they're measuring
1
Percentage of Participants Who Achieved Two-year Bladder-intact Disease-free Survival