This is a multi-center Phase II study to determine the safety and efficacy of nivolumab when given in combination with cisplatin and gemcitabine as neoadjuvant treatment in patients with muscle-invasive bladder cancer (MIBC) prior to standard of care radical cystectomy. Patients will receive neoadjuvant treatment with nivolumab in combination with gemcitabine-cisplatin (GC) every 3 weeks for 4 treatment cycles over 12 weeks followed by standard of care radical cystectomy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
43
Nivolumab will be given at a fixed dose of 360 mg IV over 30 minutes on Day 8 every 21 days for 4 cycles.
Cisplatin will be given at 70 mg/m2 IV over 30 minutes on Day 1 every 21 days, and based on treating physician's discretion, split-dose cisplatin can be given at 35 mg/m2 IV Day 1 and Day 8 every 21 days for 4 cycles.
Gemcitabine will be given at 1000 mg/m2 IV over 30 minutes on days 1, 8, and every 21 days for 4 cycles.
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Masonic Cancer Center - University of Minnesota
Minneapolis, Minnesota, United States
Huntsman Cancer Institute - University of Utah Health
Salt Lake City, Utah, United States
Pathologic Response Rate (PaR) at Time of Radical Cystectomy. PaR is Defined as Absence of Residual MIBC at Cystectomy in the Surgical Specimen (Pathologic Down-staging to ≤pT1pN0 Which Includes pT0, pT1, pTa and pTis)
Incidence of Measurable Disease "pT" in the TNM staging system refers to the size and extend of the primary tumor. The higher the number after the T, the larger the tumor or the more it has grown into nearby tissues. T's may be further divided to provide more detail, such as T3a and T3b. pTa refers to noninvasive papillary carcinoma. pTis refers to carcinoma in situ (CIS) or a "flat tumor" stage. pN refers to lymph nodes. N0 mans cancer has not spread to nearby lymph nodes.
Time frame: Surgery Day 1
Safety of Nivolumab With Gemcitabine/Cisplatin (Cycle 1)
Count of participants with Adverse Events related to Nivolumab with Gemcitabine/Cisplatin
Time frame: Treatment Day 1 of cycle 1
Safety of Nivolumab With Gemcitabine/Cisplatin (Cycle 1)
Count of participants with Adverse Events related to Nivolumab with Gemcitabine/Cisplatin
Time frame: Treatment Day 8 of cycle 1
Safety of Nivolumab With Gemcitabine/Cisplatin (Cycle 2)
Count of participants with Adverse Events related to Nivolumab with Gemcitabine/Cisplatin
Time frame: Treatment Day 1 of cycle 2
Safety of Nivolumab With Gemcitabine/Cisplatin (Cycle 2)
Count of participants with Adverse Events related to Nivolumab with Gemcitabine/Cisplatin
Time frame: Treament day 8 of cycle 2
Safety of Nivolumab With Gemcitabine/Cisplatin (Cycle 3)
Count of participants with Adverse Events related to Nivolumab with Gemcitabine/Cisplatin
Time frame: Treatment day 1 of cycle 3
Safety of Nivolumab With Gemcitabine/Cisplatin (Cycle 3)
Count of participants with Adverse Events related to Nivolumab with Gemcitabine/Cisplatin
Time frame: Treatment day 8 of cycle 3
Safety of Nivolumab With Gemcitabine/Cisplatin (Cycle 4)
Count of participants with Adverse Events related to Nivolumab with Gemcitabine/Cisplatin
Time frame: Treatment day 1 of cycle 4
Safety of Nivolumab With Gemcitabine/Cisplatin (Cycle 4)
Count of participants with Adverse Events related to Nivolumab with Gemcitabine/Cisplatin
Time frame: Treatment day 8 of cycle 4
Safety of Nivolumab With Gemcitabine/Cisplatin
Incidence of Adverse Events
Time frame: 30 Days +/- 7 Days after last chemotherapy
Safety of Nivolumab With Gemcitabine/Cisplatin
Incidence of Adverse Events
Time frame: 4 weeks post radical cystectomy
Count of Participants Experiencing Progression Free Survival (PFS)
Count of participants experiencing Progression Free Survival (PFS)
Time frame: Every 3 Months for 2 Years
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