To confirm a recommended Phase 2 dose (RP2D) of FF-10832 (Gemcitabine Liposome Injection) given intravenously Day 1 of a 21-day cycle, in combination with 200 mg pembrolizumab given intravenously Day 1 of the same 21-day cycle, for treatment of advanced urothelial and non-small cell lung cancer
This is a Phase 2a, open label clinical trial evaluating FF-10832 in combination with pembrolizumab and as monotherapy. The trial will begin with a safety run-in phase of 10 patients receiving combination therapy with pembrolizumab; FF 10832 will be dosed at 40 mg/m2 with a fixed dose of pembrolizumab (200 mg). After confirmation of the appropriate FF-10832 dose for use with pembrolizumab, the trial will enroll up to an additional 100 patients in 2 cohorts (urothelial cancer \[UC\] and non-small cell lung cancer \[NSCLC\]) into 4 separate expansion treatment arms (approximately 25 patients in each treatment arm). The disease-defined cohorts will be patients who have progressed on PD-1/PD-L1 therapy who have UC or NSCLC. The UC cohort will be randomized (1:1) to one of two treatment arms (monotherapy or combination therapy) and the NSCLC cohort will be randomized (1:1) to one of two treatment arms (monotherapy or combination therapy), to further establish safety and gain preliminary information on antitumor activity of FF-10832 as monotherapy or in combination with pembrolizumab.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
120
Treatment at 200 mg pembrolizumab, administered intravenously (IV) on Day 1 of each 21-day cycle prior to infusion of FF-10832
Following administration of pembrolizumab, FF-10832 Gemcitabine Liposome Injection, 40 mg/m2 administered intravenously (IV) on Day 1 of each 21-day cycle
Determine the incidence of Treament Emergent Adverse Events (TEAE)
Safety and tolerability assessed by adverse events (AEs) and serious adverse events (SAEs) and to confirm dose (RP2D) of FF-10832 given intravenously Day 1 of a 21 day cycle, in combination with 200 mg pembrolizumab, given intravenously Day 1 of the same 21-day cycle, for treatment of advanced solid tumors.
Time frame: 7 years
Duration of Stable Disease in Monotherapy
To obtain a preliminary estimate of efficacy of FF-10832 monotherapy in expansion cohorts of patients with urothelial cancer (UC) and non-small cell lung cancer (NSCLC). Duration of Stable Disease is the length of time from the start of the treatment until the criteria for progression are met
Time frame: 7 years
Duration of Stable Disease in Combination Therapy
To obtain a preliminary estimate of efficacy of the combination in expansion cohorts of patients with UC and NSCLC. Duration of Stable Disease is the length of time from the start of the treatment until the criteria for progression
Time frame: 7 years
Determine Safety Profile of Monotherapy
To describe the safety profile of FF-10832 monotherapy 40 mg/m2 given intravenously Day 1 of a 21-day cycle, including treatment-emergent AEs. Safety assessed by adverse events (AEs) and serious adverse events (SAEs)
Time frame: 7 years
Determine Safety Profile of Combination Therapy
Describe the safety profile of the combination, including dose limiting toxicities, immune related toxicities, and other treatment emergent AEs. Safety assessed by adverse events (AEs) and serious adverse events (SAEs)
Time frame: 7 years
Overall Response Rate (ORR)
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Cancer and Blood Speciality Clinic
Long Beach, California, United States
Sharp Memorial Hospital (Oncology Clinical Research)
San Diego, California, United States
Sibley Memorial Hospital
Washington D.C., District of Columbia, United States
University of Kansas Cancer Center - Westwood
Westwood, Kansas, United States
University of Kentucky Medical Center
Lexington, Kentucky, United States
University of Louisville Brown Cancer Center
Louisville, Kentucky, United States
Henry Ford Cancer - Detroit (Brigitte Harris Cancer Pavilion)
Detroit, Michigan, United States
Washington University School of Medicine, Center for Adv Medicine
St Louis, Missouri, United States
Nebraska Cancer Specialists - Legacy
Omaha, Nebraska, United States
Comprehensive Cancer Centers of Nevada - Southern Hills
Las Vegas, Nevada, United States
...and 13 more locations
Overall Response Rate is determined by classification of solid tumors via RECIST v.1.1
Time frame: 7 years
Duration of Response (DOR)
Duration of Response is calculated from the date of first response to the date of progression or death
Time frame: 7 years
Progression-free survival (PFS)
Progression-free survival will be calculated from the date of first treatment to the date of progression or death
Time frame: 7 years
Overall survival (OS)
Overall survival will be calculated from the date of first treatment to the date of death from any cause
Time frame: 7 years