ctDNA-guided stopping of immune therapy in advanced melanoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a phase II pilot study that uses circulating tumor DNA (ctDNA) to decide when to stop or continue standard anti-PD-1-based immune checkpoint inhibitors in adults with unresectable or metastatic melanoma. Patients with undetectable ctDNA and radiographic disease control after at least 6–12 months of therapy may stop treatment after 12 months, with monitoring every three months by imaging and ctDNA tests. If ctDNA remains undetectable, the trial assesses the primary outcome of sustained ctDNA negativity. If ctDNA is detectable at the decision point, treatment may continue per investigator choice; if ctDNA becomes detectable during follow-up, restarting ICI may be considered. The study evaluates feasibility and safety of ctDNA-guided treatment duration decisions in real-world settings.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. 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.
2. Any line of therapy, with the exception of adjuvant therapy.
3. Ability to understand and the willingness to sign a written informed consent document.
4. Patients with brain metastasis may be included only if there was also presence of extracranial disease.
5. ECOG performance status 0-2.

Exclusion Criteria:

1. Participants who are receiving investigational therapies.
2. Inadequate tumor quantity or quality to conduct initial Signatera ctDNA testing.
3. Intracranial-only metastatic melanoma.
4. Patients with best response of progressive disease at time of screening.
5. Patients who have had their melanoma completely surgically resected such that response to immunotherapy is no longer evaluable.
6. Patients who are unwilling to continue or stop ICI therapy using ctDNA guidance in combination with imaging response.
7. History of a life-threatening or severe irAE that would make ICI rechallenge unsafe. These cases will be discussed with the Principal Investigator.
8. Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study.

Where it's running

• Rutgers Cancer Institute
  New Brunswick, New Jersey, United States Recruiting

Study contacts

• Principal investigator: Sarah Weiss, MD — Rutgers University
• Study coordinator: Sarah Weiss, MD
• Email: saweiss@cinj.rutgers.edu
• Phone: 732-235-2465

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.