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PD-L1 Inhibitor
INCB099280 for Liver Cancer (HCC Trial)
Phase 1
Waitlist Available
Led By Thomas Karasic, MD
Research Sponsored by Abramson Cancer Center at Penn Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from liver transplant until 1 month after liver transplant
Awards & highlights
HCC Trial Summary
This trial is testing the safety of a new drug called INCB099280 in patients with liver cancer who are waiting for a liver transplant.
Who is the study for?
This trial is for adults over 18 with Hepatocellular Carcinoma (HCC) who are candidates for liver transplant, have not had systemic HCC treatments, and can follow the study plan. They must have a Child-Pugh score of A5 to B7, resolved side effects from prior therapies to acceptable levels, and good organ function. Pregnant or breastfeeding women and those with certain health conditions like active drug/alcohol dependence or serious heart disease cannot join.Check my eligibility
What is being tested?
The trial is testing INCB099280, an oral PD-L1 inhibitor for safety in patients with HCC awaiting liver transplants. It's a pilot study which means it's preliminary research to see how well this new treatment works before larger trials.See study design
What are the potential side effects?
While specific side effects of INCB099280 aren't listed here, similar drugs often cause immune-related reactions such as inflammation in various organs, skin rashes, fatigue, digestive issues like diarrhea or nausea; some may also affect liver enzymes.
HCC Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at time of liver transplant, an average of 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at time of liver transplant, an average of 6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Acute Cellular Rejection of Liver Transplant Attributed to Study Therapy
Secondary outcome measures
Acute Cellular Rejection of Liver Transplant Within 1 Year
Acute Cellular Rejection of Liver Transplant Within 3 Months
Overall Survival at 1 Year After Transplant
+4 moreHCC Trial Design
1Treatment groups
Experimental Treatment
Group I: INCB099280Experimental Treatment1 Intervention
Study participants will receive the recommended phase II dose (400mg/kg) of INCB099280 orally on days 1 through 28 of each 28-day cycle until liver transplant.
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Who is running the clinical trial?
Incyte CorporationIndustry Sponsor
366 Previous Clinical Trials
55,400 Total Patients Enrolled
Abramson Cancer Center at Penn MedicineLead Sponsor
387 Previous Clinical Trials
145,629 Total Patients Enrolled
1 Trials studying Liver Cancer
18 Patients Enrolled for Liver Cancer
Thomas Karasic, MDPrincipal InvestigatorAbramson Cancer Center at the University of Pennsylvania
4 Previous Clinical Trials
45 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are the potential risks associated with INCB099280 for individuals undergoing treatment?
"Our team rates the safety of INCB099280 at level 1 on a scale from 1 to 3, as this is categorized as a Phase I trial with limited evidence supporting its safety and efficacy."
Answered by AI
Is this medical study currently accepting new participants?
"Per the details on clinicaltrials.gov, recruitment for this trial is not ongoing. Initially shared on May 1st, 2024, and last revised on March 22nd, 2024. While this specific study isn't actively enrolling participants currently, there are a substantial number of other trials seeking volunteers - precisely 2703 in total."
Answered by AI
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