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A Pilot Study of ctDNA-Guided Immune Checkpoint Inhibitor Duration in Patients with Advanced Melanoma.

Primary objective:
To determine whether ctDNA can safely and feasibly guide ICI treatment duration decisions in patients with advanced melanoma by measuring the proportion of patients who demonstrate persistently undetectable ctDNA in the 12 months following treatment discontinuation.

Secondary Objective:
- To evaluate progression-free survival (PFS) following ctDNA-guided discontinuation of ICI in patients with undetectable ctDNA

- To evaluate overall survival (OS) following ctDNA-guided discontinuation of ICI in patients with undetectable ctDNA

- To evaluate treatment-free survival (TFS) following ctDNA-guided discontinuation of ICI in patients with undetectable ctDNA

Protocol Number: 092602
Phase: Phase II
Applicable Disease Sites: Melanoma, Skin
Principal Investigator: Sarah Weiss
Scope: Local
Participating Institutions:
  • RWJBarnabas Health
    • Community Medical Center
    • Jersey City Medical Center, Jersey City
    • Monmouth Medical Center
  • Rutgers University

For further information about clinical trials, please contact us at 732-235-7356.