INCB099280 for Skin Cancer

Not currently recruiting at 159 trial locations

Overseen By Incyte Corporation Call Center (ex-US)

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Incyte Corporation

Must not be taking: Anti-PD-1, Immune modulators

Disqualifiers: Additional malignancy, CNS metastases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: Up to 2 years

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called INCB099280 for advanced Cutaneous Squamous Cell Carcinoma (cSCC), a type of skin cancer. The goal is to assess the safety and effectiveness of this treatment for individuals with cSCC that cannot be cured with surgery or radiation. Participants will receive one of three different doses of INCB099280 to determine which is most effective. This trial may suit those diagnosed with cSCC who have measurable disease and have not received certain immune therapies. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group of people.

Do I need to stop my current medications to join the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, certain conditions like using systemic antibiotics or probiotics, or receiving a live vaccine close to the trial start, are not allowed. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that INCB099280 has promising safety results in patients with advanced solid tumors, including skin cancer. One study found that patients generally tolerated the treatment well. Some side effects occurred, but they were mostly mild. Common side effects involved the skin, such as rashes or itching, similar to those seen with other treatments like immune checkpoint inhibitors.

Overall, safety data from previous studies suggest that INCB099280 is reasonably safe for humans, with manageable side effects. While these findings are encouraging, participating in a clinical trial will provide more specific information about how the treatment works for different individuals. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for skin cancer?

Researchers are excited about INCB099280 for skin cancer because it offers a new approach by targeting specific molecular pathways involved in cancer cell growth. Unlike traditional treatments, which often involve chemotherapy or surgery, INCB099280 is administered orally, twice daily, making it potentially more convenient for patients. The study is testing multiple doses to find the most effective one, which suggests a tailored approach to treatment. This targeted mechanism may lead to fewer side effects and improved outcomes, setting it apart from current standard therapies.

What evidence suggests that this trial's treatments could be effective for advanced Cutaneous Squamous Cell Carcinoma?

Research has shown that INCB099280, a type of medication, may help treat advanced skin cancers. In earlier studies, patients with advanced solid tumors, including skin cancer, responded well to this treatment. Specifically, about 50% of patients with tumors that couldn't be surgically removed saw their tumors shrink or disappear, with 17% experiencing a complete disappearance of their tumors. These early results suggest that INCB099280 could effectively treat advanced cutaneous squamous cell carcinoma. ^{1 2 3 4 6}

Who Is on the Research Team?

Incyte Medical Monitor

Principal Investigator

Incyte Corporation

Are You a Good Fit for This Trial?

This trial is for adults with advanced Cutaneous Squamous Cell Carcinoma (cSCC) that can't be cured by surgery or radiotherapy. Participants should have measurable disease, an ECOG score of 0 or 1 indicating they are fully active or restricted in physically strenuous activity but ambulatory, and a life expectancy over three months. They must not be at risk of pregnancy or fathering children.

Inclusion Criteria

I am fully active or have some restrictions but can still care for myself.

My condition is confirmed as cutaneous squamous cell carcinoma.

My skin cancer cannot be cured with surgery or radiation and has not been treated or has come back.

Exclusion Criteria

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive INCB099280 twice daily for up to 2 years

Up to 2 years

Pre dose and 1, 2 and 6 hours post dose on Cycle 1 Day 1 and Cycle 2 Day 1. Pre dose every other cycle until Cycle 11 Day 1

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

What Are the Treatments Tested in This Trial?

Interventions

• INCB099280

Trial Overview The study tests the safety and effectiveness of INCB099280 on patients with cSCC. It aims to find out how well this drug works and what side effects it might cause when given to people who either haven't been treated before or whose cancer has returned after treatment.

How Is the Trial Designed?

Group I: Part 2: INCB099280 Dose selected from Part 1 Experimental Treatment 1 Intervention

Participants will receive INCB099280 dose selected from Part 1 twice daily (BID) for up to 2 years.

Group II: Part 1: INCB099280 Dose 3 Experimental Treatment 1 Intervention

Participants will receive INCB099280 dose 3 twice daily (BID) for up to 2 years.

Group III: Part 1: INCB099280 Dose 2 Experimental Treatment 1 Intervention

Participants will receive INCB099280 dose 2 twice daily (BID) for up to 2 years.

Group IV: Part 1: INCB099280 Dose 1 Experimental Treatment 1 Intervention

Participants will receive INCB099280 dose 1 twice daily (BID) for up to 2 years.

Who Is Running the Clinical Trial?

Incyte Corporation

Lead Sponsor

Trials

408

Recruited

66,800+

Steven Stein

Incyte Corporation

Chief Medical Officer since 2015

MD from University of Witwatersrand

Hervé Hoppenot

Incyte Corporation

Chief Executive Officer since 2014

MBA from ESSEC Business School

Published Research Related to This Trial

Immune checkpoint blockade (ICB) therapies, which enhance the immune system's ability to fight cancer, can lead to serious dermatologic adverse events (DAEs) such as Stevens-Johnson syndrome and toxic epidermal necrolysis, potentially limiting their use.

Proper identification and management of these high-grade DAEs are crucial, as they may indicate a positive response to cancer treatment and patients often have few alternative options for therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High Grade Dermatologic Adverse Events Associated With Immune Checkpoint Blockade for Cancer. Kuo, AM., Markova, A.[2022]

The identification of driver mutations in tumors has led to the rise of personalized medicine in cancer treatment, allowing for targeted therapies like the BRAF inhibitor vemurafenib, which was approved for metastatic melanoma in 2012.

While targeted treatments are generally well-tolerated, they come with a new range of side effects that healthcare providers must understand and manage to ensure optimal patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Side effects of systemic oncological therapies in dermatology. Zimmer, L., Vaubel, J., Livingstone, E., et al.[2012]

A study analyzing 8213 reports of skin-related adverse drug reactions linked to immune checkpoint inhibitors found that 3.8% of these reports involved psoriasis or psoriasiform reactions, highlighting a significant safety concern.

Most patients (70.8%) who developed psoriasis had a pre-existing condition, indicating that those with a history of psoriasis may be at higher risk when treated with immune checkpoint inhibitors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psoriasis and psoriasiform reactions secondary to immune checkpoint inhibitors. Cutroneo, P., Ingrasciotta, Y., Isgrò, V., et al.[2021]

In a 10-year study of 102 melanoma patients, 135 skin adverse events (AEs) were identified, with immune checkpoint blockade (ICB) causing 81 AEs and targeted therapies (TT) causing 54 AEs, highlighting the distinct skin toxicity associated with different treatment types.

The incidence of skin AEs was significantly higher with targeted therapies (18.54%) compared to immune checkpoint blockade (9.64%), and while most AEs were low-grade, 19.21% were classified as severe (Grades 3 or 4), indicating the need for careful monitoring during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cutaneous Adverse Events of Systemic Melanoma Treatments: A Retrospective Single-Center Analysis. Kraehenbuehl, L., Schneider, S., Pawlik, L., et al.[2023]

Citations

1. ascopubs.org ascopubs.org/doi/10.1200/JCO.2024.42.16_suppl.2608

A phase 1 study of the small-molecule PD-L1 inhibitor ... Results: As of January 14, 2023, 179 pts had received INCB099280 at doses from 100 mg qd to 800 mg bid (median age, 63 years [range, 21-86]; ≥2 ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05879822

NCT05879822 | A Study to Evaluate INCB099280 in ... This study is being conducted to determine the safety, tolerability, and preliminary efficacy of INCB099280 in participants with advanced solid tumors.

3. incytemi.com incytemi.com/document/Poster/ASCO%202024%20-%20INCB099280%20in%20Advanced%20Solid%20Tumors_Updated%20Results%20(poster).pdf

ASCO 2024 - INCB099280 in Advanced Solid ... ... INCB099280 in Select Advanced Solid Tumors: Updated Safety, Efficacy, and Pharmacokinetics Results. ○ Blockade of the programmed death ...

4. withpower.com withpower.com/trial/phase-2-carcinoma-5-2023-adfd7

INCB099280 for Skin Cancer · Info for Participants This trial is testing a new drug called INCB099280 to see if it is safe and works well for people with advanced skin cancer.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10340306/

Management of Cutaneous Head and Neck Squamous ... The overall response rate was 50% for locally advanced, unresectable patients, with complete response rate of 17% [96,97]. In those with locally ...

6. ctv.veeva.com ctv.veeva.com/study/a-study-to-evaluate-incb099280-in-participants-with-advanced-cutaneous-squamous-cell-carcinoma

A Study to Evaluate INCB099280 in Participants With ... This study is being conducted to determine the safety, tolerability, and preliminary efficacy of INCB099280 in participants with advanced Cutaneous Squamous ...