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Anti-metabolites

FF-10832 + Pembrolizumab for Cancer

Phase 2
Recruiting
Research Sponsored by Fujifilm Pharmaceuticals U.S.A., Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patient populations in the Expansion Phase: patient must have urothelial or NSCLC, and have failed prior anti-PD-1 or anti-PD-L1
Patient must have Eastern Cooperative Oncology Group performance status of 0 to 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7 years
Awards & highlights

Study Summary

This trial is testing a new cancer drug, given in combination with another drug that is already used to treat cancer.

Who is the study for?
Adults (18+) with advanced solid tumors that have worsened after standard treatments, or those who cannot tolerate or refuse such treatments. They must be able to consent, have a life expectancy of at least 3 months, and an ECOG performance status of 0-1. Pregnant individuals, recent recipients of certain cancer therapies or vaccines, and patients with specific genetic mutations not previously treated are excluded.Check my eligibility
What is being tested?
The trial is testing the combination of FF-10832 (a liposome injection) and Pembrolizumab in adults with advanced solid tumors. FF-10832 is given intravenously on Day 1 every three weeks alongside Pembrolizumab to determine the safety and effective dose for Phase 2 trials.See study design
What are the potential side effects?
Possible side effects include reactions related to immune system activation which may affect organs, infusion-related reactions from the IV treatment process, fatigue due to treatment burden on the body's resources, as well as potential impacts on blood cell counts increasing infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have urothelial or NSCLC cancer and previous treatments targeting PD-1 or PD-L1 didn't work for me.
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I am fully active or restricted in physically strenuous activity but can do light work.
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I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 7 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Determine the incidence of Treament Emergent Adverse Events (TEAE)
Duration of Stable Disease in Combination Therapy
Duration of Stable Disease in Monotherapy
Secondary outcome measures
Determine Safety Profile of Combination Therapy
Determine Safety Profile of Monotherapy
Duration of Response (DOR)
+3 more

Trial Design

5Treatment groups
Experimental Treatment
Group I: Urothelial Monotherapy - FF-10832 Expansion PhaseExperimental Treatment1 Intervention
FF-10832 will be dosed at 40 mg/m2
Group II: Urothelial Combination - FF-10832 + pembrolizumab Expansion PhaseExperimental Treatment2 Interventions
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 III: Safety Run-in PhaseExperimental Treatment2 Interventions
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 IV: NSCLC Monotherapy - FF-10832 Expansion PhaseExperimental Treatment1 Intervention
FF-10832 will be dosed at 40 mg/m2
Group V: NSCLC Combination - FF-10832 + pembrolizumab Expansion PhaseExperimental Treatment2 Interventions
FF-10832 in combination therapy with pembrolizumab; FF-10832 will be dosed at 40 mg/m2 with a fixed dose of pembrolizumab (200 mg)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
FDA approved

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme LLCIndustry Sponsor
3,868 Previous Clinical Trials
5,051,733 Total Patients Enrolled
Fujifilm Pharmaceuticals U.S.A., Inc.Lead Sponsor
8 Previous Clinical Trials
546 Total Patients Enrolled

Media Library

FF-10832 (Anti-metabolites) Clinical Trial Eligibility Overview. Trial Name: NCT05318573 — Phase 2
Solid Tumors Research Study Groups: Urothelial Monotherapy - FF-10832 Expansion Phase, NSCLC Monotherapy - FF-10832 Expansion Phase, Urothelial Combination - FF-10832 + pembrolizumab Expansion Phase, NSCLC Combination - FF-10832 + pembrolizumab Expansion Phase, Safety Run-in Phase
Solid Tumors Clinical Trial 2023: FF-10832 Highlights & Side Effects. Trial Name: NCT05318573 — Phase 2
FF-10832 (Anti-metabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05318573 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are researchers still recruiting participants for this trial?

"Affirmative, clinicaltrials.gov affirms the active recruitment of participants for this trial that was first advertised on June 1st 2022 and recently revised on October 19th 2022. The research necessitates enlisting 10 patients between 3 medical locations."

Answered by AI

Has FF-10832 been granted authorization from the Food and Drug Administration?

"FF-10832 was estimated to have a safety score of 2 due to limited clinical data corroborating its efficacy, though there is some information indicating that it may be safe for use."

Answered by AI

How many participants is the maximum capacity for this trial?

"Merck Sharp & Dohme LLC are the primary sponsors of this trial and will be recruiting 10 eligible patients from two separate locations: Hospital of the Univ of Pennsylvania Perlman Center in Philadelphia, PA and Sarah Cannon Research Institute in Nashville, TN."

Answered by AI

What are the fundamental aims of this research initiative?

"According to the research sponsor, Merck Sharp & Dohme LLC, this clinical trial will be measuring a primary outcome of Stable Disease Duration in Monotherapy over 7 years. Additionally, secondary objectives are established to Gauge Safety Profile of Monotherapy and Combination Therapy through observed Adverse Events (AEs) or Serious Adverse Events (SAEs). Moreover, the efficacy of treatment is assessed by determining Duration of Response from date first response until progression or mortality occurs."

Answered by AI
~80 spots leftby May 2029