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

Korábbi kezelés

• Participants who are receiving investigational therapies.
• Patients who have had their melanoma completely surgically resected such that response to immunotherapy is no longer evaluable.
• Patients who are unwilling to continue or stop ICI therapy using ctDNA guidance in combination with imaging response.

Más betegség

• Patients with best response of progressive disease at time of screening.
• History of a life-threatening or severe irAE that would make ICI rechallenge unsafe. These cases will be discussed with the Principal Investigator.

Laborértékek

• Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study.

Egyéb

• Inadequate tumor quantity or quality to conduct initial Signatera ctDNA testing.
• Intracranial-only metastatic melanoma.

• Age \> 18 with any subtype of unresectable stage III or stage IV melanoma treated with anti-PD-1-based ICI which includes both anti-PD-1 monotherapy and dual checkpoint inhibitor regimens such as ipilimumab plus nivolumab and nivolumab plus relatlimab.
  • Disease control after at least 6-12 months of anti-PD-1-based ICI defined as a radiographic RECIST CR, PR, or SD and planned for at least 1 year of treatment
  • OR
  • Development of an irAE(s) on an anti-PD-1-based regimen requiring treatment interruption and immunosuppression where the investigator is considering treatment discontinuation. Patients must have a radiographic RECIST PR or CR at the treatment duration decision time point.
• Any line of therapy, with the exception of adjuvant therapy.
• Ability to understand and the willingness to sign a written informed consent document.
• Patients with brain metastasis may be included only if there was also presence of extracranial disease.
• ECOG performance status 0-2.