This trial is examining if adding antibody drug rituximab (Rituxan) and enzyme drug hyaluronidasehuman (Hycela) can increase the effectiveness of the standard treatment for melanoma. The main outcomes of this trial will be to examine the side effects experienced by patients and tumor response. This study is recruiting in Atlanta, GA.
Melanoma is a type of skin cancer. Often it is treated using immunotherapy drugs such as nivolumab (Opdivo) and ipilimumab (Yervoy) (NI). These drugs help to activate the patient’s immune cells to fight the cancer. However, they are not effective for all patients. Rituximab is an immunotherapy drug which has been successful in several different cancers. Hyaluronidase helps to boost its effects.
This trial aims to compare the side effects and the effectiveness of NI with the combination of NI, rituximab, and hyaluronidase (NIRH). The main outcomes will be side effects experienced by patients and the effectiveness of the drugs.
Who are they looking for?
This study is recruiting 44 patients. Patients with advanced melanoma must be 18 or over. Patients must be eligible to receive antibody drugs. Patients must have healthy blood profiles. Patients must have good kidney and liver function.
Patients who have received certain antibody drugs in the past year cannot participate. Patients with allergies to rituximab or hyaluronidase cannot participate. Patients with cancer in the brain or spine cannot participate. Patients with infections including HIV, Hepatitis B or C cannot participate. Female patients who are pregnant or breastfeeding cannot participate. Patients with autoimmune diseases or inflammatory bowel disease cannot participate. Patients receiving steroid treatment cannot participate.
How will it work
Patients will be divided into two groups. Group A will receive NI. Group B will receive NIRH.
Side effects will be monitored for 6 months after treatment starts. Tumor response, patient survival and patient survival without cancer worsening will be measured for 1 year after treatment starts.