This trial aims to test the safety and effectiveness of adding a new drug called NKTR-214 to treatment with nivolumab (Opdivo) is better than just using nivolumab alone.
The main outcomes that will be measured are how many people respond to treatment, how long the patients go without cancer growing or spreading, and overall survival.
The details
Nivolumab is a common medication to treat melanoma. However, advanced melanoma does not have a high cure rate, even with treatment. NKTR-214 is a new medicine being developed for the treatment of melanoma. It works by stimulating the patient's immune system to kill cancer cells.
The trial aims to evaluate the effectiveness and safety of NKTR-214 and nivolumab compared to nivolumab alone in the treatment of advanced melanoma. The main outcomes that will be measured are how many people respond to treatment, how long the patients go without cancer progressing, and overall survival.
Who are they looking for?
This trial is looking to recruit 764 patients with advanced untreated melanoma.
Patients will be excluded from the trial if they have active cancer in the brain or an autoimmune disease.
How will it work
This trial will consist of two groups. One group will receive treatment with NKTR-214 and nivolumab. The other group will receive treatment with nivolumab alone. The patients will be followed up for up to 5 years for a response to treatment, survival without cancer growing or spreading, and overall survival. Side effects of the treatment will also be evaluated.
