Phase 2 pilot uses ctDNA to guide checkpoint-inhibitor discontinuation in advanced melanoma with disease control

Rutgers Cancer Institute of New Jersey is conducting a pilot study of serial circulating tumor DNA (ctDNA) measurements to help guide discontinuation of immune checkpoint treatment in unresectable stage III or metastatic stage IV melanoma with radiographic disease control. Eligible prior regimens include PD-1 monotherapy and protocol-allowed combinations such as nivolumab/ipilimumab or nivolumab/relatlimab. The intervention is a treatment-duration strategy for patients with disease control, rather than a new drug for checkpoint-resistant melanoma.

The protocol combines blood testing with imaging and clinical assessment in patients being considered for treatment discontinuation, including specified response and treatment-duration circumstances. A key outcome is sustained ctDNA negativity during the 12 months after stopping treatment. The potential benefit is avoiding unnecessary continued exposure, toxicity, and treatment burden while retaining disease control. However, ctDNA-negative blood tests do not prove that all cancer has been eradicated, and this pilot cannot by itself establish that ctDNA-guided stopping is as safe as continued therapy for every responding patient.