This trial is aiming to examine the effectiveness of APG-115 with pembrolizumab (Keytruda) in the treatment of metastatic melanoma. The main outcomes to be measured will be the maximum dose tolerated and the overall response to the drug. This trial is recruiting in multiple locations in the United States.
The details
Melanoma is a form of skin cancer that comes from pigment-producing cells called melanocytes. Advanced melanomas are difficult to treat and new therapies are needed. Pembrolizumab is an immunotherapy approved for the treatment of advanced melanoma. It works by activating the immune system to detect and kill cancer cells. APG-115 is an experimental drug that activates a gene that blocks tumor growth. it has shown good anti-tumor activity in combination with pembrolizumab in small studies.
This trial is examining the safety and effectiveness of APG-115 in combination with pembrolizumab in patients with advanced melanoma. The main outcomes to be measured are maximum tolerable doses and the overall response to the treatment.
Who are they looking for?
This trial is looking to recruit 67 patients. Patients will be included if they have a confirmed diagnosis of metastatic melanoma, or advanced solid tumors who have failed standard therapy options. Patients in this trial must also have adequate organ and bone marrow function.
Patients will be excluded in the trial if they have received previous treatment similar to APG-115, chemotherapy within 21 days prior to starting this trial, and hormonal or biologic treatment within 21 days prior to this trial.
How will it work
There is one group in this trial. All patients will receive increasing doses of APG-115 tablets every other day over a course of 2 weeks. Pembrolizumab will be given on day 1 of a 3-week cycle.
The main outcomes evaluated will be the maximum dose tolerated and overall response to treatment. Follow-up will be up to 12 months following treatment.
