Advanced Urothelial CarcinomaAdvanced Non Small Cell Lung Cancer
Investigational drug(s) / intervention(s)
PembrolizumabFF-10832
Pembrolizumab: Treatment at 200 mg pembrolizumab, administered intravenously (IV) on Day 1 of each 21-day cycle prior to infusion of FF-10832
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
Study summary
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
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. Written informed consent is provided by patient or legally acceptable representative;
2. Age ≥ 18 years;
3. Patient populations:
1. In the Safety Run-in, patients with histologically or cytologically confirmed advanced or metastatic solid tumors who have disease progression after treatment with standard therapies for metastatic disease that are known to confer clinical benefit, or are intolerant to treatment or refuse standard treatment will be enrolled in therapy
2. In Expansion Phase, patient must have urothelial or NSCLC, and have failed prior anti-PD-1 or anti-PD-L1
4. Have measurable disease per RECIST 1.1 as assessed by the local site investigator/radiology
5. Eastern Cooperative Oncology Group performance status of 0 to 1
6. Life expectancy of ≥ 3 months
Exclusion Criteria:
1. Positive urine pregnancy test within 72 hours prior to treatment
2. Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks (or 5 half-lives, whichever is shorter) prior to treatment;
3. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX 40, CD137), AND was discontinued from that treatment due to a Grade 3 or higher immune-related adverse event;
4. Has received prior radiotherapy within 2 weeks of start of study treatment.
5. For patients with NSCLC:
1. Patients who have received radiation therapy to the lung that is \>30 Gy within 6 months of the first dose of trial treatment are excluded;
2. Patients with mutations (e.g., EGFR mutations or ALK gene rearrangements) will be excluded unless they have been previously treated with all specific targeted therapies.
6. Has received a live or live-attenuated vaccine within 30 days prior to the first dose of study intervention.
7. Has had an allogeneic tissue /solid organ transplant.
Primary outcome measure(s)
Determine the incidence of Treament Emergent Adverse Events (TEAE) — 7 years 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.
Duration of Stable Disease in Monotherapy — 7 years 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
Duration of Stable Disease in Combination Therapy — 7 years 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
Trial sites (23)
Facility
City
Region
Status
Cancer and Blood Speciality Clinic
Long Beach
California
Sharp Memorial Hospital (Oncology Clinical Research)
San Diego
California
Sibley Memorial Hospital
Washington D.C.
District of Columbia
University of Kansas Cancer Center - Westwood
Westwood
Kansas
University of Kentucky Medical Center
Lexington
Kentucky
University of Louisville Brown Cancer Center
Louisville
Kentucky
Henry Ford Cancer - Detroit (Brigitte Harris Cancer Pavilion)
Detroit
Michigan
Washington University School of Medicine, Center for Adv Medicine
St Louis
Missouri
Nebraska Cancer Specialists - Legacy
Omaha
Nebraska
Comprehensive Cancer Centers of Nevada - Southern Hills
Las Vegas
Nevada
Atlantic Health System / Morristown Medical Center
Morristown
New Jersey
NYU Langone Health
New York
New York
Icahn School of Medicine at Mount Sinai
New York
New York
TriHealth Cancer Institute; Good Samaritan Hospital
Cincinnati
Ohio
Providence Cancer Institute Franz Clinic
Portland
Oregon
Hospital of the Univ of Pennsylvania Perlman Center
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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