Lead Investigator: Lea Dousset, Translational Research Institute, The University of Queensland
Title of Proposal Research: Immunotherapy as Prophylaxis: Exploring the Potential Impact on Hyper-Chronic Non-Melanoma Skin Cancers in Retrospective Melanoma Cohorts
Vivli Data Request: 9793
Funding Source: None
Potential Conflicts of Interest: None
Summary of the Proposed Research:
Project Background:
skin cancer, including non-melanoma skin cancers (NMSCs), is a prevalent condition affecting many people worldwide. Non-melanoma skin cancer refers to a group of cancers that slowly develop in the upper layers of the skin. The term ‘non-melanoma’ distinguishes these more common kinds of skin cancer from the less common skin cancer known as melanoma, which spreads faster in the body and can be life-threatening. These cancers often occur on areas of the skin exposed to the sun and can cause discomfort and scarring.
Explanation of Terms:
Hyper-chronic non-melanoma skin cancers: skin cancer that is not melanoma and tends to be persistent or recurring over time.
Immunotherapy: medical treatment that boosts the body’s immune system to help fight diseases, including cancer. It works by stimulating the body’s natural defenses to target and destroy cancer cells.
Melanoma: Melanoma is a type of skin cancer that originates in the pigment-producing cells (melanocytes) of the skin.
Hyper-chronic: This term suggests that the NMSCs in question are particularly persistent or recurring over time, indicating the chronic nature of the condition.
Research Approach:
Our research aims to investigate whether immunotherapy (IO), a promising treatment for advanced skin cancer, could also help prevent the development of NMSCs in patients previously treated for melanoma. We will conduct a retrospective study, analyzing data from melanoma patients who have received immunotherapy and those who have not. By comparing the incidence of NMSCs between these two groups, we hope to understand whether immunotherapy may have a preventative effect on these non-melanoma skin cancers.
Methodology:
To conduct this research, we will collect and analyze medical records from melanoma patients, focusing on whether they received immunotherapy as part of their treatment. We will then compare the rates of NMSC occurrence between patients who received immunotherapy and those who did not. Additionally, we will explore various factors such as age, gender, and treatment duration to understand how these variables may influence NMSC incidence. By using statistical analyses, we can determine if there’s a significant difference in NMSC rates between the two groups and whether immunotherapy plays a role in preventing these skin cancers.
In summary, our research seeks to shed light on the potential benefits of immunotherapy in preventing non-melanoma skin cancers in patients previously treated for melanoma. If successful, this could lead to new strategies for managing skin cancer and improving patient outcomes.
Requested Studies:
In this phase 2 trial of treatment-naïve patients with BRAF wild-type melanoma (CheckMate 069), the combination of nivolumab and ipilimumab demonstrated a statistically significant improvement in objective response rate and longer progression-free survival compared with ipilimumab alone. There were two arms: IPI+NIVO (95 pts) vs IPI (47 pts)
Data Contributor: Bristol Myers Squibb
Study ID: NCT01927419
Sponsor ID: NCT01927419
Checkmate037 is a randomized, controlled, open-label phase III trial. Patients with advanced-stage melanoma with disease progression after receiving treatment with the anti-CTLA-4 antibody ipilimumab were randomly assigned to receive either nivolumab (n = 272) or investigator’s choice of chemotherapy (ICC; dacarbazine or carboplatin plus paclitaxel; n = 133).
Data Contributor: Bristol Myers Squibb
Study ID: NCT01721746
Sponsor ID: NCT01721746