NCT07830225Recruiting
A Pilot Study of ctDNA-Guided Immune Checkpoint Inhibitor Duration in Patients With Advanced Melanoma.
Source: ClinicalTrials.gov · Last updated 21 Sept 2026
Brief summary (registry, in English)
This is a phase II pilot study evaluating the use of circulating tumor DNA (ctDNA) to guide the optimal duration of standard of care immune checkpoint inhibitor (ICI) therapy in patients with unresectable and/or metastatic melanoma who have radiographic evidence of disease control and/or response to treatment.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 35 (estimated)
- First submitted
- 15 Sept 2026
- Start date
- 3 Sept 2026
- Primary completion date
- 30 Jun 2028
- Lead sponsor
- Rutgers, The State University of New Jersey
- Diseases
- Melanoma
- NCT number
- NCT07830225
What you commit to
- Study type: Interventional
- Planned participants: 35
- From 3 Sept 2026 to the primary completion date, 30 Jun 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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.
Lab values
- Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study.
Other
- Inadequate tumor quantity or quality to conduct initial Signatera ctDNA testing.
- Intracranial-only metastatic melanoma.
Who the study is looking for
- 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.
Age in the registry: 18 years to 90 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Rutgers Cancer Institute Coordinator of this site? Confirm its status | New Brunswick | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.