A RANDOMIZED PHASE II TRIAL OF ADJUVANT NIVOLUMAB WITH OR WITHOUT CABOZANTINIB IN PATIENTS WITH RESECTED MUCOSAL MELANOMA

Brief description of study

The study is designed to help patients with different stages of mucosal melanoma, a type of skin cancer. There are three groups, or arms, in the study. In the first two arms, patients who had surgery to remove the cancer are registered and then randomly assigned to one of two treatment groups. In the first group, patients receive a combination of Nivolumab and Cabozantinib after surgery. In the second group, patients receive Nivolumab and a placebo (a harmless pill with no medicine). Before assigning the treatment, patients are tested to see if they have high or low levels of a protein called PD-L1. Other factors like where the cancer started, whether it has spread to nearby lymph nodes, and if the patient had radiation therapy are also considered.

For patients whose cancer couldn't be completely removed or has spread to other parts of the body, they are assigned to the third arm, called the advanced arm. In this group, patients receive treatment with Nivolumab and Cabozantinib. The same factors mentioned earlier are used to determine the treatment plan for these patients.

The duration of treatment depends on the arm. In the first two arms, treatment is given for 1 year or until the cancer gets worse or the treatment causes serious side effects. In the advanced arm, treatment continues for 2 years or until the cancer gets worse or the treatment causes serious side effects. Patients will be checked regularly after treatment. Every 3 months, their condition will be monitored to see if the cancer is getting worse. After that, they will be followed up every 6 months for up to 5 years from when they joined the study or until they pass away, whichever happens first.


Clinical Study Identifier: s23-00346
ClinicalTrials.gov Identifier: NCT05111574
Principal Investigator: Maya Dimitrova.


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