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

NCT ID: NCT05318573

Last Updated: 2025-09-04

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-01
• Study Completion Date: 2029-11-30

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

Detailed Description

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.

Conditions

Advanced Urothelial Carcinoma; Advanced Non Small Cell Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Safety Run-in Phase

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

Group Type: EXPERIMENTAL

Pembrolizumab

Intervention Type: DRUG

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

FF-10832

Intervention Type: DRUG

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

Urothelial Monotherapy - FF-10832 Expansion Phase

FF-10832 will be dosed at 40 mg/m2

Group Type: EXPERIMENTAL

FF-10832

Intervention Type: DRUG

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

Urothelial Combination - FF-10832 + pembrolizumab Expansion Phase

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

Group Type: EXPERIMENTAL

Pembrolizumab

Intervention Type: DRUG

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

FF-10832

Intervention Type: DRUG

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

NSCLC Monotherapy - FF-10832 Expansion Phase

FF-10832 will be dosed at 40 mg/m2

Group Type: EXPERIMENTAL

FF-10832

Intervention Type: DRUG

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

NSCLC Combination - FF-10832 + pembrolizumab Expansion Phase

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

Group Type: EXPERIMENTAL

Pembrolizumab

Intervention Type: DRUG

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

FF-10832

Intervention Type: DRUG

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

Interventions

Pembrolizumab

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

Intervention Type: DRUG

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

Intervention Type: DRUG

Other Intervention Names

KEYTRUDA®; MK-3475; Gemcitabine Liposome Injection

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: collaborator

Fujifilm Pharmaceuticals U.S.A., Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Atlantic Health System / Morristown Medical Center

Morristown, New Jersey, United States

NYU Langone Health

New York, New York, United States

Icahn School of Medicine at Mount Sinai

New York, New York, United States

TriHealth Cancer Institute; Good Samaritan Hospital

Cincinnati, Ohio, United States

Providence Cancer Institute Franz Clinic

Portland, Oregon, United States

Hospital of the Univ of Pennsylvania Perlman Center

Philadelphia, Pennsylvania, United States

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, United States

Medical University of South Carolina

Charleston, South Carolina, United States

Avera Cancer Institute

Sioux Falls, South Dakota, United States

Sarah Cannon Research Institute

Nashville, Tennessee, United States

University of Texas Southwestern Medical Center

Dallas, Texas, United States

Virginia Cancer Specialists, PC

Fairfax, Virginia, United States

University of Wisconsin Clinical Science Center

Madison, Wisconsin, United States

Countries

United States

Other Identifiers

MK-3475-B57

Identifier Type: OTHER

Identifier Source: secondary_id

FF10832-PEM-201/KEYNOTE-B57

Identifier Type: -

Identifier Source: org_study_id