INCB099280 for Skin Cancer

Recruiting at 129 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

63 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new drug called INCB099280 to see if it is safe and works well for people with advanced skin cancer. The drug aims to stop the cancer cells from growing by blocking certain signals.

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.

What safety data exists for INCB099280 or similar treatments for skin cancer?

The safety data for treatments similar to INCB099280, such as immune checkpoint inhibitors, show that they can cause skin-related side effects. These include various types of rashes and more serious conditions like Stevens-Johnson syndrome and toxic epidermal necrolysis, which require careful monitoring by doctors. ^{1 2 3 4 5}

Research Team

Incyte Medical Monitor

Principal Investigator

Incyte Corporation

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

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]

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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

High Grade Dermatologic Adverse Events Associated With Immune Checkpoint Blockade for Cancer. [2022]

2. Germany pubmed.ncbi.nlm.nih.gov

Side effects of systemic oncological therapies in dermatology. [2012]

3. England pubmed.ncbi.nlm.nih.gov

Serious Cutaneous Toxicities with Immune Checkpoint Inhibitors in the U.S. Food and Drug Administration Adverse Event Reporting System. [2020]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Cutaneous Adverse Events of Systemic Melanoma Treatments: A Retrospective Single-Center Analysis. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Psoriasis and psoriasiform reactions secondary to immune checkpoint inhibitors. [2021]