Study Name: A092105

Recruiting

Head and Neck

A092105, Randomized Phase 2 Study of Nivolumab and Ipilimumab with or without Cabozantinib in Patients with Advanced Nasopharyngeal Carcinoma that have Progressed After Platinum Treatment and Immunotherapy

NCT#06010095

clinicaltrials.gov/show/NCT06010095

This phase II trial tests how well nivolumab and ipilimumab immunotherapy with or without cabozantinib in treating patients with nasopharyngeal cancer that has come back (after a period of improvement) (recurrent), has spread from where it first started (primary site) to other places in the body (metastatic), or for which no treatment is currently available (incurable). Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Cabozantinib is in a class of medications called kinase inhibitors. It works by blocking the action of an abnormal protein that signals cancer cells to multiply. This helps slow or stop the spread of cancer cells. Giving immunotherapy with nivolumab and ipilimumab and targeted therapy with cabozantinib may help shrink and stabilize nasopharyngeal cancer.

Male and Female – 18 years and older

• Recurrent, metastatic and incurable disease treated with platinum-gemcitabine and prior PD-1/L1 blockade (as first or second-line therapy) where immunotherapy was part of the most recent prior line of therapy
• Patients are eligible regardless of prior smoking history, p16 immunohistochemistry status, PD-L1 expression status, EBV tumor status, EBV vial load at baseline, or tumor genomic alternation status
• Patients may have had no more than 2 prior lines of systemic therapy for recurrent, metastatic nasopharyngeal cancer

• No prior VEGF targeted therapy