In short
There is currently 1 ongoing clinical trial for nasal sinus cancer, focusing on testing pembrolizumab combined with chemotherapy before surgery in patients with locally advanced sinonasal carcinoma. This trial is being conducted in Italy and aims to evaluate whether this combination treatment can help shrink tumors and improve surgical outcomes.
Clinical trial locations
Study of Pembrolizumab and Chemotherapy for Patients with Locally Advanced Sinonasal Carcinoma
This trial is investigating a treatment combination for locally advanced sinonasal carcinoma, a type of cancer affecting the nasal cavity and sinuses. The study examines whether pembrolizumab (also known as MK-3475), an immunotherapy medication, combined with chemotherapy can effectively shrink tumors when given before surgery.
Main focus and goal: The primary aim of this study is to evaluate the safety and effectiveness of pembrolizumab combined with chemotherapy as a neoadjuvant therapy, which means treatment given before surgery. Researchers will closely monitor how well the cancer responds to this combination, looking for signs of complete or partial remission where the tumor shrinks or disappears. The treatment is administered as an infusion directly into the bloodstream and will be monitored over a period of up to 48 weeks.
Investigational drugs: The trial uses two main types of treatment. Pembrolizumab is an immunotherapy drug that helps the body's immune system recognize and attack cancer cells by blocking a specific protein on cancer cells. Chemotherapy involves cancer-fighting drugs that kill or slow the growth of cancer cells. Together, these treatments work to reduce tumor size before surgical removal, potentially improving surgical outcomes.
Who can participate - inclusion criteria:
- Patients must have locally advanced sinonasal carcinoma at stage III or IVa-b that has not been treated before and can be treated with local therapies
- Must be 18 years of age or older
- Must have a tumor that can be measured according to specific medical guidelines
- Must have a performance status of 0 or 1, meaning they are either fully active or have some symptoms but can still perform light work
- Must have organs that are functioning properly, as confirmed by medical tests
- Must be willing to provide a tumor tissue sample, preferably from a newly obtained biopsy
- Male patients must agree to use birth control during treatment and for at least 180 days afterward, and should not donate sperm during this period
- Female patients must not be pregnant or breastfeeding and must agree to use birth control during treatment and for at least 180 days afterward, unless they are unable to have children
Who cannot participate - exclusion criteria:
- Patients with other types of cancer not specific to this study
- Those who have received recent cancer treatment
- Patients with serious health problems that could interfere with the study
- Pregnant or breastfeeding women
- Those unable to follow study procedures
- Patients with allergies to the study medications
- Those currently participating in another clinical trial
Summary
Currently, there is only one active clinical trial for nasal sinus cancer, specifically targeting locally advanced sinonasal carcinoma. This trial is located in Italy and represents an important research effort to explore new treatment options for this rare form of cancer. The study focuses on combining immunotherapy with pembrolizumab and traditional chemotherapy as a pre-surgical treatment approach, which may offer patients better outcomes by shrinking tumors before surgical removal.
The trial is investigating whether strengthening the body's immune response against cancer cells, combined with chemotherapy's direct tumor-fighting effects, can provide an effective treatment strategy. This approach is particularly relevant for patients with locally advanced disease who may benefit from tumor reduction before surgery. The limited number of trials highlights the rarity of this condition and the ongoing need for research to develop better treatment options for patients facing this diagnosis.
