NCT07830225 · Rutgers, The State University of New Jersey
A Pilot Study of ctDNA-Guided Immune Checkpoint Inhibitor Duration in Patients With Advanced Melanoma.
What this study is about
This is a phase II pilot study evaluating the use of circulating tumor DNA (ctDNA) to guide the optimal duration of the usual treatment 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.
View original scientific description
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.
Interventions
OTHER
A Pilot Study of ctDNA-guided immune checkpoint inhibitor duration in patients with advanced melanoma
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.
Primary outcome measures
Primary Outcome
Time frame: 12-month sustained ctDNA negativity rate after ICI discontinuation
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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
Exclusion criteria
- Participants who are receiving investigational therapies.
- Inadequate tumor quantity or quality to conduct initial Signatera ctDNA testing.
- Intracranial-only metastatic melanoma.
- Patients with best response of progressive disease at time of screening.
- 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.
- History of a life-threatening or severe irAE that would make ICI rechallenge unsafe. These cases will be discussed with the Principal Investigator.
- Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study.
Where
- New Brunswick, New Jersey
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 21, 2026 · Source of record for eligibility and locations