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FF-10832 + Pembrolizumab for Cancer
Study Summary
This trial is testing a new cancer drug, given in combination with another drug that is already used to treat cancer.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
Media Library
- I have urothelial or NSCLC cancer and previous treatments targeting PD-1 or PD-L1 didn't work for me.My cancer has spread, didn't respond to standard treatments, or I can't tolerate/refuse them.I have not had a live vaccine in the last 30 days.I have received an organ or tissue transplant from another person.I haven't had cancer treatment or experimental drugs in the last 4 weeks.I am fully active or restricted in physically strenuous activity but can do light work.I am 18 years old or older.I had radiotherapy less than 2 weeks before starting the study treatment.I stopped a cancer immunotherapy due to severe side effects.I haven't had lung radiation over 30 Gy in the last 6 months and have tried all treatments for my lung cancer mutations.
- Group 1: Urothelial Monotherapy - FF-10832 Expansion Phase
- Group 2: NSCLC Monotherapy - FF-10832 Expansion Phase
- Group 3: Urothelial Combination - FF-10832 + pembrolizumab Expansion Phase
- Group 4: NSCLC Combination - FF-10832 + pembrolizumab Expansion Phase
- Group 5: Safety Run-in Phase
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
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."
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