A Study to Evaluate Safety, Efficacy of FF-10832 in Combo With Pembrolizumab in Urothelial & Non-small Cell Lung Cancer

NCT05318573 | Active Not Recruiting Phase 2 FDA Drug

• 2 other identifiers: FF10832-PEM-201/KEYNOTE-B57MK-3475-B57
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 23

Brief 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

Conditions

Advanced Urothelial Carcinoma; Advanced Non Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (3)

• 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.

  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

  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

  7 years

Secondary Outcomes (6)

• Determine Safety Profile of Monotherapy

  7 years

• Determine Safety Profile of Combination Therapy

  7 years

• Overall Response Rate (ORR)

  7 years

• Duration of Response (DOR)

  7 years

• Progression-free survival (PFS)

  7 years

Study Arms (5)

Safety Run-in Phase

EXPERIMENTAL

FF-10832 in combination therapy with pembrolizumab; FF-10832 will be dosed at 40 mg/m2 with a fixed dose of pembrolizumab (200 mg)

Drug: Pembrolizumab; Drug: FF-10832

Urothelial Monotherapy - FF-10832 Expansion Phase

EXPERIMENTAL

FF-10832 will be dosed at 40 mg/m2

Drug: FF-10832

Urothelial Combination - FF-10832 + pembrolizumab Expansion Phase

EXPERIMENTAL

FF-10832 in combination therapy with pembrolizumab; FF-10832 will be dosed at 40 mg/m2 with a fixed dose of pembrolizumab (200 mg)

Drug: Pembrolizumab; Drug: FF-10832

NSCLC Monotherapy - FF-10832 Expansion Phase

EXPERIMENTAL

FF-10832 will be dosed at 40 mg/m2

Drug: FF-10832

NSCLC Combination - FF-10832 + pembrolizumab Expansion Phase

EXPERIMENTAL

FF-10832 in combination therapy with pembrolizumab; FF-10832 will be dosed at 40 mg/m2 with a fixed dose of pembrolizumab (200 mg)

Drug: Pembrolizumab; Drug: FF-10832

Interventions

Pembrolizumab DRUG

Treatment at 200 mg pembrolizumab, administered intravenously (IV) on Day 1 of each 21-day cycle prior to infusion of FF-10832

Also known as: KEYTRUDA®, MK-3475

NSCLC Combination - FF-10832 + pembrolizumab Expansion Phase; Safety Run-in Phase; Urothelial Combination - FF-10832 + pembrolizumab Expansion Phase

FF-10832 DRUG

Following administration of pembrolizumab, FF-10832 Gemcitabine Liposome Injection, 40 mg/m2 administered intravenously (IV) on Day 1 of each 21-day cycle

Also known as: Gemcitabine Liposome Injection

NSCLC Combination - FF-10832 + pembrolizumab Expansion Phase; NSCLC Monotherapy - FF-10832 Expansion Phase; Safety Run-in Phase; Urothelial Combination - FF-10832 + pembrolizumab Expansion Phase; Urothelial Monotherapy - FF-10832 Expansion Phase

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent is provided by patient or legally acceptable representative;
• Age ≥ 18 years;
• Patient populations:
• 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
• In Expansion Phase, patient must have urothelial or NSCLC, and have failed prior anti-PD-1 or anti-PD-L1
• Have measurable disease per RECIST 1.1 as assessed by the local site investigator/radiology
• Eastern Cooperative Oncology Group performance status of 0 to 1
• Life expectancy of ≥ 3 months

You may not qualify if:

• Positive urine pregnancy test within 72 hours prior to treatment
• Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks (or 5 half-lives, whichever is shorter) prior to treatment;
• 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;
• Has received prior radiotherapy within 2 weeks of start of study treatment.
• For patients with NSCLC:
• 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;
• 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.
• Has received a live or live-attenuated vaccine within 30 days prior to the first dose of study intervention.
• Has had an allogeneic tissue /solid organ transplant.

Sponsors & Collaborators

• Fujifilm Pharmaceuticals U.S.A., Inc.: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (23)

Cancer and Blood Speciality Clinic

Long Beach, California, 90806, United States

Location

Sharp Memorial Hospital (Oncology Clinical Research)

San Diego, California, 92123, United States

Location

Sibley Memorial Hospital

Washington D.C., District of Columbia, 20016, United States

Location

University of Kansas Cancer Center - Westwood

Westwood, Kansas, 66205, United States

Location

University of Kentucky Medical Center

Lexington, Kentucky, 40536, United States

Location

University of Louisville Brown Cancer Center

Louisville, Kentucky, 40202, United States

Location

Henry Ford Cancer - Detroit (Brigitte Harris Cancer Pavilion)

Detroit, Michigan, 48202, United States

Location

Washington University School of Medicine, Center for Adv Medicine

St Louis, Missouri, 63110, United States

Location

Nebraska Cancer Specialists - Legacy

Omaha, Nebraska, 68130, United States

Location

Comprehensive Cancer Centers of Nevada - Southern Hills

Las Vegas, Nevada, 89148, United States

Location

Atlantic Health System / Morristown Medical Center

Morristown, New Jersey, 07960, United States

Location

NYU Langone Health

New York, New York, 10016, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

TriHealth Cancer Institute; Good Samaritan Hospital

Cincinnati, Ohio, 45220, United States

Location

Providence Cancer Institute Franz Clinic

Portland, Oregon, 97213, United States

Location

Hospital of the Univ of Pennsylvania Perlman Center

Philadelphia, Pennsylvania, 19104, United States

Location

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, 15232, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Avera Cancer Institute

Sioux Falls, South Dakota, 57105, United States

Location

Sarah Cannon Research Institute

Nashville, Tennessee, 37203, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75235, United States

Location

Virginia Cancer Specialists, PC

Fairfax, Virginia, 22031, United States

Location

University of Wisconsin Clinical Science Center

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Interventions

pembrolizumab

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: March 29, 2022
• First Posted: April 8, 2022
• Study Start: June 1, 2022
• Primary Completion (Estimated): May 1, 2029
• Study Completion (Estimated): November 1, 2029
• Last Updated: September 4, 2025

Record last verified: 2025-09

Locations

US (23)