Advanced Urothelial CarcinomaPhase 2NCT05318573
A Study to Evaluate Safety, Efficacy of FF-10832 in Combo With Pembrolizumab in Urothelial & Non-small Cell Lung Cancer
A Phase 2 study testing Pembrolizumab and FF-10832 in people with Advanced Urothelial Carcinoma and Advanced Non Small Cell Lung Cancer, run by Fujifilm Pharmaceuticals U.S.A., Inc. at 23 sites in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Urothelial Carcinoma, Advanced Non Small Cell Lung Cancer
- What is being tested?
- Pembrolizumab and FF-10832
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 23 sitesUnited States
- Study dates
- 1 Jun 2022to Nov 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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;
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- 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.
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
United States23 sites
Medical University of South Carolina
Charleston, South Carolina, 29425
TriHealth Cancer Institute; Good Samaritan Hospital
Cincinnati, Ohio, 45220
University of Texas Southwestern Medical Center
Dallas, Texas, 75235
Henry Ford Cancer - Detroit (Brigitte Harris Cancer Pavilion)
Detroit, Michigan, 48202
Virginia Cancer Specialists, PC
Fairfax, Virginia, 22031
Comprehensive Cancer Centers of Nevada - Southern Hills
Las Vegas, Nevada, 89148
University of Kentucky Medical Center
Lexington, Kentucky, 40536
Cancer and Blood Speciality Clinic
Long Beach, California, 90806
University of Louisville Brown Cancer Center
Louisville, Kentucky, 40202
University of Wisconsin Clinical Science Center
Madison, Wisconsin, 53792
Atlantic Health System / Morristown Medical Center
Morristown, New Jersey, 07960
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
NYU Langone Health
New York, New York, 10016
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Nebraska Cancer Specialists - Legacy
Omaha, Nebraska, 68130
Hospital of the Univ of Pennsylvania Perlman Center
Philadelphia, Pennsylvania, 19104
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
Providence Cancer Institute Franz Clinic
Portland, Oregon, 97213
Sharp Memorial Hospital (Oncology Clinical Research)
San Diego, California, 92123
Avera Cancer Institute
Sioux Falls, South Dakota, 57105
Washington University School of Medicine, Center for Adv Medicine
St Louis, Missouri, 63110
Sibley Memorial Hospital
Washington D.C., District of Columbia, 20016
University of Kansas Cancer Center - Westwood
Westwood, Kansas, 66205
About this study
Official title: A Phase 2a Study With Safety Run-in to Evaluate the Safety, Tolerability, and Preliminary Efficacy of FF-10832 Monotherapy or in Combination With Pembrolizumab in Patients With Advanced Solid Tumors
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
Read the 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.
- Being tested
- Pembrolizumab, FF-10832
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PembrolizumabDrug
Also called KEYTRUDA®, MK-3475
Treatment at 200 mg pembrolizumab, administered intravenously (IV) on Day 1 of each 21-day cycle prior to infusion of FF-10832
FF-10832Drug
Also called Gemcitabine Liposome Injection
Following administration of pembrolizumab, FF-10832 Gemcitabine Liposome Injection, 40 mg/m2 administered intravenously (IV) on Day 1 of each 21-day cycle
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Drug: Pembrolizumab; Drug: FF-10832 |
| Urothelial Monotherapy - FF-10832 Expansion Phase | Experimental | FF-10832 will be dosed at 40 mg/m2 Receives: 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) Receives: Drug: Pembrolizumab; Drug: FF-10832 |
| NSCLC Monotherapy - FF-10832 Expansion Phase | Experimental | FF-10832 will be dosed at 40 mg/m2 Receives: 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) Receives: Drug: Pembrolizumab; Drug: FF-10832 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
Measured: 7 years
Secondary outcomes (6)
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)
Measured: 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)
Measured: 7 years
Overall Response Rate (ORR)
Overall Response Rate is determined by classification of solid tumors via RECIST v.1.1
Measured: 7 years
Duration of Response (DOR)
Duration of Response is calculated from the date of first response to the date of progression or death
Measured: 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
Measured: 7 years
Overall survival (OS)
Overall survival will be calculated from the date of first treatment to the date of death from any cause
Measured: 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2022
- Study start1 Jun 2022
- Primary completionMay 2029 (estimated)
- Study completionNov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Urothelial CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujifilm Pharmaceuticals U.S.A., Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05318573
- Sponsor's protocol ID
- FF10832-PEM-201/KEYNOTE-B57
- Other IDs
- MK-3475-B57
- Status last verified
- Sep 2025
- First submitted
- 29 Mar 2022
- Last updated
- 4 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2a Study With Safety Run-in to Evaluate the Safety, Tolerability, and Preliminary Efficacy of FF-10832 Monotherapy or in Combination With Pembrolizumab in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT05318573
- Acronym / sponsor ID
- FF10832-PEM-201/KEYNOTE-B57
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Fujifilm Pharmaceuticals U.S.A., Inc.Industry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- May 2029 (estimated)
- Study completion
- Nov 2029 (estimated)
- First posted
- 8 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Safety Run-in Phase | Experimental | Drug: Pembrolizumab, Drug: FF-10832FF-10832 in combination therapy with pembrolizumab; FF-10832 will be dosed at 40 mg/m2 with a fixed dose of pembrolizumab (200 mg) |
| Urothelial Monotherapy - FF-10832 Expansion Phase | Experimental | Drug: FF-10832FF-10832 will be dosed at 40 mg/m2 |
| Urothelial Combination - FF-10832 + pembrolizumab Expansion Phase | Experimental | Drug: Pembrolizumab, Drug: FF-10832FF-10832 in combination therapy with pembrolizumab; FF-10832 will be dosed at 40 mg/m2 with a fixed dose of pembrolizumab (200 mg) |
| NSCLC Monotherapy - FF-10832 Expansion Phase | Experimental | Drug: FF-10832FF-10832 will be dosed at 40 mg/m2 |
| NSCLC Combination - FF-10832 + pembrolizumab Expansion Phase | Experimental | Drug: Pembrolizumab, Drug: FF-10832FF-10832 in combination therapy with pembrolizumab; FF-10832 will be dosed at 40 mg/m2 with a fixed dose of pembrolizumab (200 mg) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Written informed consent is provided by patient or legally acceptable representative;
- Age ≥ 18 years;
- Patient populations:
- 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
Key exclusion criteria (9 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PembrolizumabAlso: KEYTRUDA®, MK-3475Treatment at 200 mg pembrolizumab, administered intravenously (IV) on Day 1 of each 21-day cycle prior to infusion of FF-10832 | Drug | NSCLC Combination - FF-10832 + pembrolizumab Expansion Phase, Safety Run-in Phase, Urothelial Combination - FF-10832 + pembrolizumab Expansion Phase |
| FF-10832Also: Gemcitabine Liposome InjectionFollowing administration of pembrolizumab, FF-10832 Gemcitabine Liposome Injection, 40 mg/m2 administered intravenously (IV) on Day 1 of each 21-day cycle | Drug | 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 |
Primary outcome
Determine the incidence of Treament Emergent Adverse Events (TEAE)
Time frame: 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
Time frame: 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
Time frame: 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
6 secondary outcomes
Determine Safety Profile of Monotherapy
Time frame: 7 years
Determine Safety Profile of Combination Therapy
Time frame: 7 years
Overall Response Rate (ORR)
Time frame: 7 years
Duration of Response (DOR)
Time frame: 7 years
Progression-free survival (PFS)
Time frame: 7 years
Overall survival (OS)
Time frame: 7 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2025.
- Individual participant dataSharing planned: Undecided. undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pembrolizumab and FF-10832 in people with Advanced Urothelial Carcinoma and Advanced Non Small Cell Lung Cancer, run by Fujifilm Pharmaceuticals U.S.A., Inc. at 23 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 4 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine the incidence of Treament Emergent Adverse Events (TEAE) (time frame: 7 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2025.