Melanoma (Skin Cancer)NCT07830225
A Pilot Study of ctDNA-Guided Immune Checkpoint Inhibitor Duration in Patients With Advanced Melanoma.
A study testing A Pilot Study of ctDNA-guided immune checkpoint inhibitor duration in patients with advanced melanoma in people with Melanoma (Skin Cancer), run by Rutgers, The State University of New Jersey at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Melanoma (Skin Cancer)
- What is being tested?
- A Pilot Study of ctDNA-guided immune checkpoint inhibitor duration in patients with advanced melanoma
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Sep 2026to 30 Jun 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Rutgers Cancer Institute
New Brunswick, New Jersey, 08901
Olutobi Adewale, 1 732-423-4822, olutobi@rutgers.edu
About this study
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.
Read the detailed description
This is a study of patients with advanced melanoma who are potentially eligible to stop or shorten their duration of ICI. Patients with radiographic disease control and/or response with undetectable ctDNA levels will stop ICI therapy after 1 year. Patients who have responded to ICI but have experienced immune-related adverse events (irAE) requiring treatment interruption and immunosuppression are also eligible and will stop ICI therapy if ctDNA is undetectable. All patients with undetectable ctDNA who candidates are to stop treatment will undergo monitoring with standard of care imaging and ctDNA assessments every three months to assess for the primary outcome of the 12-month sustained ctDNA negativity rate. Undetectable ctDNA for the purposes of the treatment duration decision time point is defined as two consecutive negative ctDNA tests performed at least 4 weeks apart.
If ctDNA is detectable at the treatment duration decision time point, treatment will be continued as per an investigator's choice regimen. In patients whose ctDNA converts from undetectable to detectable during the monitoring period, the investigator may choose to restart ICI based upon imaging findings and/or other relevant clinical factors.
- Conditions
- Melanoma (Skin Cancer)
- Being tested
- A Pilot Study of ctDNA-guided immune checkpoint inhibitor duration in patients with advanced melanoma
- Keywords
- Advanced Melanoma, ctDNA, treatment duration
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A Pilot Study of ctDNA-guided immune checkpoint inhibitor duration in patients with advanced melanomaOther
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.
| Study group | Role | What they receive |
|---|---|---|
| ctDNA Feasibility | Experimental | feasibility of utilizing ctDNA levels to inform immunotherapy treatment duration decisions in patients with advanced melanoma, in conjunction with standard imaging assessments to judge response. Receives: Other: A Pilot Study of ctDNA-guided immune checkpoint inhibitor duration in patients with advanced melanoma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome
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
Measured: 12-month sustained ctDNA negativity rate after ICI discontinuation
Secondary outcomes (3)
Secondary Outcome 1
To evaluate progression-free survival (PFS) following ctDNA-guided discontinuation of ICI in patients with undetectable ctDNA
Measured: 1-year progression-free survival (PFS) among patients with undetectable ctDNA who discontinue ICI
Secondary Outcome 2
To evaluate overall survival (OS) following ctDNA-guided discontinuation of ICI in patients with undetectable ctDNA
Measured: 1-year overall survival (OS) among patients with undetectable ctDNA who discontinue ICI
Outcome measure 3
To evaluate treatment-free survival (TFS) following ctDNA-guided discontinuation of ICI in patients with undetectable ctDNA
Measured: 1-year treatment-free survival (TFS) among patients with undetectable ctDNA who discontinue ICI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2026
- Study start3 Sep 2026
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Melanoma (Skin Cancer)Studies of the same condition, open and under way.
- More trials run by Rutgers, The State University of New JerseyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sarah Weiss, Rutgers, The State University of New Jersey
- Investigators
- Sarah Weiss, MD, Principal investigator, Rutgers University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07830225
- Sponsor's protocol ID
- 092602
- Other IDs
- Pro2026001627
- Status last verified
- Sep 2026
- First submitted
- 15 Sep 2026
- Last updated
- 21 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Amiot M, Mortier L, Dalle S, Dereure O, Dalac S, Dutriaux C, Leccia MT, Maubec E, Arnault JP, Brunet-Possenti F, De Quatrebarbes J, Granel-Brocard F, Gaudy-Marqueste C, Pages C, Stoebner PE, Saiag P, Lesimple T, Dupuy A, Legoupil D, Montaudie H, Oriano B, Lebbe C, Porcher R. When to stop immunotherapy for advanced melanoma: the emulated target trials. EClinicalMedicine. 2024 Dec 4;78:102960. doi: 10.1016/j.eclinm.2024.102960. eCollection 2024 Dec.
PubMed 39717261Jansen YJL, Rozeman EA, Mason R, Goldinger SM, Geukes Foppen MH, Hoejberg L, Schmidt H, van Thienen JV, Haanen JBAG, Tiainen L, Svane IM, Makela S, Seremet T, Arance A, Dummer R, Bastholt L, Nyakas M, Straume O, Menzies AM, Long GV, Atkinson V, Blank CU, Neyns B. Discontinuation of anti-PD-1 antibody therapy in the absence of disease progression or treatment limiting toxicity: clinical outcomes in advanced melanoma. Ann Oncol. 2019 Jul 1;30(7):1154-1161. doi: 10.1093/annonc/mdz110.
PubMed 30923820Robert C, Ribas A, Hamid O, Daud A, Wolchok JD, Joshua AM, Hwu WJ, Weber JS, Gangadhar TC, Joseph RW, Dronca R, Patnaik A, Zarour H, Kefford R, Hersey P, Zhang J, Anderson J, Diede SJ, Ebbinghaus S, Hodi FS. Durable Complete Response After Discontinuation of Pembrolizumab in Patients With Metastatic Melanoma. J Clin Oncol. 2018 Jun 10;36(17):1668-1674. doi: 10.1200/JCO.2017.75.6270. Epub 2017 Dec 28.
PubMed 29283791Schroeder C, Gatidis S, Kelemen O, Schutz L, Bonzheim I, Muyas F, Martus P, Admard J, Armeanu-Ebinger S, Guckel B, Kustner T, Garbe C, Flatz L, Pfannenberg C, Ossowski S, Forschner A. Tumour-informed liquid biopsies to monitor advanced melanoma patients under immune checkpoint inhibition. Nat Commun. 2024 Oct 9;15(1):8750. doi: 10.1038/s41467-024-52923-0.
PubMed 39384805Warburton L, Reid A, Amanuel B, Calapre L, Millward M, Gray E. Detectable ctDNA at the time of treatment cessation of ipilimumab and nivolumab for toxicity predicts disease progression in advanced melanoma patients. Front Oncol. 2023 Dec 19;13:1280730. doi: 10.3389/fonc.2023.1280730. eCollection 2023.
PubMed 38179171Warburton L, Calapre L, Pereira MR, Reid A, Robinson C, Amanuel B, Ziman M, Millward M, Gray E. Circulating Tumour DNA in Advanced Melanoma Patients Ceasing PD1 Inhibition in the Absence of Disease Progression. Cancers (Basel). 2020 Nov 23;12(11):3486. doi: 10.3390/cancers12113486.
PubMed 33238616
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of ctDNA-Guided Immune Checkpoint Inhibitor Duration in Patients With Advanced Melanoma.
- ClinicalTrials.gov ID
- NCT07830225
- Acronym / sponsor ID
- 092602
- Conditions
- Melanoma (Skin Cancer)
- Keywords
- Advanced Melanoma, ctDNA, treatment duration
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Study start
- 3 Sep 2026 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 21 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a study of patients with advanced melanoma who are potentially eligible to stop or shorten their duration of ICI. Patients with radiographic disease control and/or response with undetectable ctDNA levels will stop ICI therapy after 1 year. Patients who have responded to ICI but have experienced immune-related adverse events (irAE) requiring treatment interruption and immunosuppression are also eligible and will stop ICI therapy if ctDNA is undetectable. All patients with undetectable ctDNA who candidates are to stop treatment will undergo monitoring with standard of care imaging and ctDNA assessments every three months to assess for the primary outcome of the 12-month sustained ctDNA negativity rate. Undetectable ctDNA for the purposes of the treatment duration decision time point is defined as two consecutive negative ctDNA tests performed at least 4 weeks apart.
If ctDNA is detectable at the treatment duration decision time point, treatment will be continued as per an investigator's choice regimen. In patients whose ctDNA converts from undetectable to detectable during the monitoring period, the investigator may choose to restart ICI based upon imaging findings and/or other relevant clinical factors.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ctDNA Feasibility | Experimental | Other: A Pilot Study of ctDNA-guided immune checkpoint inhibitor duration in patients with advanced melanomafeasibility of utilizing ctDNA levels to inform immunotherapy treatment duration decisions in patients with advanced melanoma, in conjunction with standard imaging assessments to judge response. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A Pilot Study of ctDNA-guided immune checkpoint inhibitor duration in patients with advanced melanomaThis 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. | Other | ctDNA Feasibility |
Primary outcome
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
3 secondary outcomes
Secondary Outcome 1
Time frame: 1-year progression-free survival (PFS) among patients with undetectable ctDNA who discontinue ICI
Secondary Outcome 2
Time frame: 1-year overall survival (OS) among patients with undetectable ctDNA who discontinue ICI
Outcome measure 3
Time frame: 1-year treatment-free survival (TFS) among patients with undetectable ctDNA who discontinue ICI
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Background: PubMed 39717261Amiot M, Mortier L, Dalle S, Dereure O, Dalac S, Dutriaux C, Leccia MT, Maubec E, Arnault JP, Brunet-Possenti F, De Quatrebarbes J, Granel-Brocard F, Gaudy-Marqueste C, Pages C, Stoebner PE, Saiag P, Lesimple T, Dupuy A, Legoupil D, Montaudie H, Oriano B, Lebbe C, Porcher R. When to stop immunotherapy for advanced melanoma: the emulated target trials. EClinicalMedicine. 2024 Dec 4;78:102960. doi: 10.1016/j.eclinm.2024.102960. eCollection 2024 Dec.
- Background: PubMed 30923820Jansen YJL, Rozeman EA, Mason R, Goldinger SM, Geukes Foppen MH, Hoejberg L, Schmidt H, van Thienen JV, Haanen JBAG, Tiainen L, Svane IM, Makela S, Seremet T, Arance A, Dummer R, Bastholt L, Nyakas M, Straume O, Menzies AM, Long GV, Atkinson V, Blank CU, Neyns B. Discontinuation of anti-PD-1 antibody therapy in the absence of disease progression or treatment limiting toxicity: clinical outcomes in advanced melanoma. Ann Oncol. 2019 Jul 1;30(7):1154-1161. doi: 10.1093/annonc/mdz110.
- Background: PubMed 29283791Robert C, Ribas A, Hamid O, Daud A, Wolchok JD, Joshua AM, Hwu WJ, Weber JS, Gangadhar TC, Joseph RW, Dronca R, Patnaik A, Zarour H, Kefford R, Hersey P, Zhang J, Anderson J, Diede SJ, Ebbinghaus S, Hodi FS. Durable Complete Response After Discontinuation of Pembrolizumab in Patients With Metastatic Melanoma. J Clin Oncol. 2018 Jun 10;36(17):1668-1674. doi: 10.1200/JCO.2017.75.6270. Epub 2017 Dec 28.
- Background: PubMed 39384805Schroeder C, Gatidis S, Kelemen O, Schutz L, Bonzheim I, Muyas F, Martus P, Admard J, Armeanu-Ebinger S, Guckel B, Kustner T, Garbe C, Flatz L, Pfannenberg C, Ossowski S, Forschner A. Tumour-informed liquid biopsies to monitor advanced melanoma patients under immune checkpoint inhibition. Nat Commun. 2024 Oct 9;15(1):8750. doi: 10.1038/s41467-024-52923-0.
- Background: PubMed 38179171Warburton L, Reid A, Amanuel B, Calapre L, Millward M, Gray E. Detectable ctDNA at the time of treatment cessation of ipilimumab and nivolumab for toxicity predicts disease progression in advanced melanoma patients. Front Oncol. 2023 Dec 19;13:1280730. doi: 10.3389/fonc.2023.1280730. eCollection 2023.
- Background: PubMed 33238616Warburton L, Calapre L, Pereira MR, Reid A, Robinson C, Amanuel B, Ziman M, Millward M, Gray E. Circulating Tumour DNA in Advanced Melanoma Patients Ceasing PD1 Inhibition in the Absence of Disease Progression. Cancers (Basel). 2020 Nov 23;12(11):3486. doi: 10.3390/cancers12113486.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sarah Weiss, MD principal investigator
Rutgers University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A Pilot Study of ctDNA-guided immune checkpoint inhibitor duration in patients with advanced melanoma in people with Melanoma (Skin Cancer), run by Rutgers, The State University of New Jersey at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sarah Weiss, MD (732-235-2465, saweiss@cinj.rutgers.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Outcome (time frame: 12-month sustained ctDNA negativity rate after ICI discontinuation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07830225, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.