We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study to Evaluate Safety, Efficacy of FF-10832 in Combination With Pembrolizumab in Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05318573
Recruitment Status : Recruiting
First Posted : April 8, 2022
Last Update Posted : October 20, 2022
Sponsor:
Collaborator:
Merck Sharp & Dohme LLC
Information provided by (Responsible Party):
Fujifilm Pharmaceuticals U.S.A., Inc.

Tracking Information
First Submitted Date  ICMJE March 29, 2022
First Posted Date  ICMJE April 8, 2022
Last Update Posted Date October 20, 2022
Actual Study Start Date  ICMJE June 1, 2022
Estimated Primary Completion Date May 2029   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 7, 2022)
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 7, 2022)
  • Determine Safety Profile of Monotherapy [ Time Frame: 7 years ]
    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)
  • Determine Safety Profile of Combination Therapy [ Time Frame: 7 years ]
    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)
  • Overall Response Rate (ORR) [ Time Frame: 7 years ]
    Overall Response Rate is determined by classification of solid tumors via RECIST v.1.1
  • Duration of Response (DOR) [ Time Frame: 7 years ]
    Duration of Response is calculated from the date of first response to the date of progression or death
  • Progression-free survival (PFS) [ Time Frame: 7 years ]
    Progression-free survival will be calculated from the date of first treatment to the date of progression or death
  • Overall survival (OS) [ Time Frame: 7 years ]
    Overall survival will be calculated from the date of first treatment to the date of death from any cause
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate Safety, Efficacy of FF-10832 in Combination With Pembrolizumab in Solid Tumors
Official Title  ICMJE 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
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 solid tumors.
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). The dose of FF-10832 may be reduced to 30 mg/m2 and tested in 10 patients after review of safety data by a safety review committee (SRC). Lower or intermediate doses of FF-10832 may be explored if necessary 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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Treatment
Condition  ICMJE Advanced Solid Tumor
Intervention  ICMJE
  • Drug: Pembrolizumab
    Treatment at 200 mg pembrolizumab, administered intravenously (IV) on Day 1 of each 21-day cycle prior to infusion of FF-10832
    Other Names:
    • Keytruda
    • MK-3475
  • 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
    Other Name: Gemcitabine Liposome Injection
Study Arms  ICMJE Experimental: 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)
Interventions:
  • Drug: Pembrolizumab
  • Drug: FF-10832
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 7, 2022)
10
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2029
Estimated Primary Completion Date May 2029   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Written informed consent is provided by patient or legally acceptable representative;
  2. Age ≥ 18 years;
  3. Patient populations:

    a. 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 this study

  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. I
  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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: FPHU Study Coordinator fphucontact@fujifilm.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05318573
Other Study ID Numbers  ICMJE FF10832-PEM-201/KEYNOTE-B57
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Plan Description: undecided
Current Responsible Party Fujifilm Pharmaceuticals U.S.A., Inc.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Fujifilm Pharmaceuticals U.S.A., Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Merck Sharp & Dohme LLC
Investigators  ICMJE Not Provided
PRS Account Fujifilm Pharmaceuticals U.S.A., Inc.
Verification Date October 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP