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INCB099280 for Skin Cancer
Study Summary
This trial is testing a new drug to treat advanced skin cancer in people.
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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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- I am not taking probiotics during the study.I am not in another clinical study while taking INCB099280.I have brain metastases needing treatment or a condition affecting the lining of my brain.I have previously been treated with specific immune therapy drugs.I am fully active or have some restrictions but can still care for myself.My condition is confirmed as cutaneous squamous cell carcinoma.I am still experiencing side effects from my previous cancer treatment.My skin cancer cannot be cured with surgery or radiation and has not been treated or has come back.I have a history of lung conditions not caused by infections.I am currently on medication for an infection.I have had another type of cancer in the past.I have had an organ or stem cell transplant.I have heart problems that affect my daily activities.I had chest radiation therapy within the last 6 months.I have a primary immune deficiency or take more than 10 mg of steroids daily.I have not taken antibiotics in the last 28 days.I have a stomach or intestine condition that affects how drugs are absorbed.I have not received a live vaccine in the last 28 days.My organs are not functioning properly.
- Group 1: Part 1: INCB099280 Dose 2
- Group 2: Part 1: INCB099280 Dose 1
- Group 3: Part 1: INCB099280 Dose 3
- Group 4: Part 2: INCB099280 Dose selected from Part 1
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
Is enrollment open for this clinical research program?
"This medical research is still open, with the initial posting on August 28th 2023 and the last update occurring on August 4th of this same year."
Has the federal government authorized Part 1: INCB099280 Dose 1?
"Given the Phase 2 nature of Part 1: INCB099280 Dose 1, our team at Power rated its safety as a 2 on account of clinical evidence that supports its security but not yet efficacy."
How many participants are currently included in this investigation?
"To complete this clinical trial, 240 suitable participants must be recruited. In order to accommodate these patients, Border Medical Oncology Research Unit in Albury, New South Wales and Townsville Cancer Centre in Townsville, Victoria have been selected as locations for the study."
How many healthcare facilities are taking part in the experimental research?
"The trial has 106 different sites, for instance Border Medical Oncology Research Unit in Albury, Townsville Cancer Centre in Townsville and Box Hill Hospital in Box Hill. Additionally there are other locations that have joined the study."
What goals are the scientists hoping to achieve with this clinical experiment?
"According to the study sponsor, Incyte Corporation, this trial's primary outcome measure will span a maximum duration of 2 years and assess Treatment-emergent Adverse Events (TEAEs). Additionally, secondary outcomes including Duration Of Response (DOR), Disease Control Rate (DCR) and Time to Response (TTR) will be monitored. DOR is defined as the time from earliest CR or PR until progression or death; DCR measures best overall response after 15 weeks; TTR tracks time from first dose until confirmed CR/PR."
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