The purpose of this study is to see how well the study drugs called Ipilimumab plus Nivolumab (IPI-NIVO) work when added to another study drug called Sacituzumab Govitecan for people who have metastatic bladder cancer.
The phase I component of this study will evaluate fixed doses of ipilimumab and nivolumab (3 mg/kg and 1 mg/kg, respectively) IV every 3 weeks x 4 cycles combined with a starting dose of sacituzumab govitecan Level 1 of 8 mg/kg IV days 1,8 every 3 weeks (1 cycle) x 4 cycles. One dose escalation to 10 mg/kg and one dose reduction to dose level minus 1 of sacituzumab govitecan 6 mg/kg days 1,8 every 3 weeks is allowed. The phase II component will be conducted as two-stage trial enrolling 34 patients with a futility interim analysis after stage 1 (13 patients). After 4 cycles, patients will continue maintenance nivolumab 360 mg IV every Q 21 days along with RP2 dose of SG D1,8 Q21 days till progression of disease or intolerable toxicities or patient decision. Radiographic imaging is performed every 12 weeks to assess response.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
46
Participants will receive Ipilimumab 3 mg/kg
Participants will receive Nivoumab 1mg/kg
Participants will be treated at 1 of 2 dose levels of Sacituzumab govitecan, either at 8 mg/kg, 10 mg/kg, or 6 mg/kg.
Moffitt Cancer Center
Tampa, Florida, United States
Phase 1: Maximum Tolerated Dose
Determine the Maximum Tolerated Dose (MTD)/ Recommended Phase 2 dose (RP2D) of Sacituzumab Govitecan when combined with Ipilimumab and Nivolumab
Time frame: Up to 12 months
Phase 2: Overall Response Rate
Overall Response Rate (ORR) of Sacituzumab Govitecan with Ipilimumab and Nivolumab combination. ORR is defined as the rate of the best overall response as complete response (CR) or partial response (CR). OR will be summarized by the percentage of responses with a 95% confidence interval as calculated from Clopper-Pearson method.
Time frame: Up to 30 months
Phase 1: Overall Response Rate
Overall Response Rate is defined as the rate of the best overall response as complete response (CR) or partial response (PR)
Time frame: Up to 12 months
Phase 1: Duration of Response (DOR)
Duration of Response will be calculated as the date of the first evaluation showing documented response, partial response (PR) or complete response (CR), to the date of the first progressive disease (PD) or death.
Time frame: Up to 12 months
Phase 1: Progression Free Survival (PFS)
Progression Free Survival defined as the time from start of treatment to the first event of death or progressive disease (PD) per RECIST 1.1.
Time frame: Up to 12 months
Phase 2: Progression Free Survival (PFS)
Progression Free Survival defined as the time from start of treatment to the first event of death or progressive disease (PD) per RECIST 1.1.
Time frame: Up to 30 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Phase 2: Duration of Response (DOR)
Duration of Response will be calculated as the date of the first evaluation showing documented response, partial response (PR) or complete response (CR), to the date of the first progressive disease (PD) or death.
Time frame: Up to 30 months
Phase 2: Overall Survival (OS)
Overall Survival defined as the length of time from start of treatment until death by any cause. Participants will be evaluated using Kaplan- Meier estimation for survival for up to 6 months after discontinuation of study treatment; patients surviving longer than 6 months will be censored.
Time frame: Up to 30 months