This trial is aiming to examine the safety and effectiveness of experimental treatment DF6002 alone or in combination with nivolumab (Opdivo)in the treatment of advanced solid tumors, including melanoma. The main outcomes to be measured are drug toxicity, and response rate of patients to the drug. This trial is being carried out in New York, Rhode Island, and Tennessee, the United States.
Advanced tumors are tumors that have spread outside the organ they originated in or metastasized to distant organs. They can be difficult to treat. DF6002 is a new drug that is being trialled to treat solid advanced tumors. DF6002 is an immune protein that stops the spread and growth of cancerous cells. Nivolumab is an immunotherapy approved for the treatment of several tumors.
This trial is evaluating the safety and effectiveness of DF6002 alone or in combination with nivolumab for the treatment of advanced tumors. The main outcomes evaluated will be side effects and tumor response.
Who are they looking for?
This trial is looking to recruit 260 patients with confirmed advanced solid tumors, including melanoma. Participants must have adequate blood cell counts, kidney and liver function, and must have had a clearance of any side effects experienced from previous therapies before the trial. They must also agree to have a tissue sample (biopsy) taken.
Patients will be excluded from this trial if they have previously received treatment with similar drugs to DF6002. Patients who have had another cancer in the previous 3 years will also be excluded. Patients with rapidly progressing disease, those with ongoing anti-cancer treatment, active lung, and nervous system disease, immunosuppression within the last 3 years will not be included. Patients with serious heart disease will also be excluded from this trial.
How will it work
There will be 5 groups in this trial. The groups will be separated depending on what type of primary solid tumor they have. The first 3 groups will receive treatment with DF6002 only. Patients in groups 4 and 5 will receive combination therapy with DF6002 and nivolumab.
Drug toxicity will be measured, as well as the response to treatment. Patients will be followed up for up to 2 years.