MelanomaNCT06146920
Use of Serial Plasma NGS as a New Efficacy Metric to Guide Immunotherapy Treatment Discontinuation
A study testing Evaluation of ctDNA using the F1T after 1 year of immunotherapy in people with Melanoma and Non-small Cell Lung Cancer, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The goal of this prospective study to investigate the use of circulating tumor DNA (ctDNA) to guide end of therapy decisions in patients with melanoma or non-small-cell lung cancer. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Melanoma, Non-small Cell Lung Cancer
- What is being tested?
- Evaluation of ctDNA using the F1T after 1 year of immunotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jan 2024to Nov 2028
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult patients age > 18) with unresectable, metastatic melanoma (cutaneous, acral, mucosal) or NSCLC who have evidence of disease control after at least 12 months of ICI based therapy (pembrolizumab, nivolumab, nivolumab-relatimab, ipilimumab/nivolumab, atezolizumab, ipilimumab, durvalumab, cemiplimab) with or without chemotherapy in the case of NSCLC. Any line of therapy is permitted with the exception of adjuvant therapy
- Participants must be actively receiving standard of care ICI-based therapy (ICI monotherapy or in combination)
- At time of enrollment patients must have received at least 12months (+/- 4 weeks) from the start of anti-PD-1 therapy and have not experienced a toxicity that prevented them from continuing therapy.
- Participants must have evidence of disease control (stable disease, partial response, or complete response) that is maintained on restaging CT scans or PET CT scans obtained at 12 months (+/- 4 weeks) from the start of initial ICI therapy
- Prior radiation to any site is allowed
- Available tumor tissue (archival) for baseline tissue testing with FoundationOne CDx or previous FoundationOne CDx testing results (within 2 years and prior test results must be after June 30, 2021)
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- Life expectancy of greater than 3 months
- Participants with a prior malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment are eligible for this trial.
- Ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- Participants with clinical or radiographic evidence of progressive disease in the 3 months prior to consideration of screening and enrollment
- Participants who are receiving an investigational agent (s)
- Participants who have had ICI discontinued due an immune-related adverse event.
- Patients with a history of an irAE but resumed ICI therapy and are receiving ICI at the time of screening are eligible to enroll.
- Participants on > 10mg of oral prednisone or its equivalent for treatment of ongoing immune-related toxicity.
- Participants who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities > Grade 1) with the exception of alopecia, endocrine toxicity requiring chronic supplementation
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- Participants with a concurrent, active malignancy
- Participants in whom F1CDx generation fails
- Participants without available tumor tissue for F1CDx test result or prior F1CDx
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Pilot Study Evaluation the Use of Serial Plasma Next-generation Sequencing (NGS) as a New Efficacy Metric to Guide Immunotherapy Treatment Discontinuation
The goal of this prospective study to investigate the use of circulating tumor DNA (ctDNA) to guide end of therapy decisions in patients with melanoma or non-small-cell lung cancer.
The main question it aims to answer is:
- Do patients with metastatic melanoma or non-small-cell lung cancer, who have received at least 12 months of immune checkpoint inhibition (monotherapy or in combination) with evidence of disease response/control on imaging and have no evidence of circulating tumor DNA, have an increased 12-month disease free survival in comparison to historical controls?
Read the detailed description
This is a prospective study using Simon's two stage design to investigate the use of ctDNA to guide end of therapy decisions. Approximately 39 patients with an established diagnosis of metastatic melanoma or NSCLC with evidence of disease control (SD, PR, or CR) will be enrolled in the study.
Patients that sign a pre-screening consent will have archival tumor tissue sent to Foundation Medicine for generation of the F1CDx. Patients may begin screening after 10 months of an ICI containing regimen with plan to complete at least 1 year of systemic therapy. After successful generation of F1CDx whole blood will be collected and analyzed for plasma ctDNA measurement.
Eligible patients for enrollment are ctDNA negative and have received at least 12 months but no more than 18moths of ICI. Eligible patients will be offered to consent to the main study and have standard of care imaging as well as blood draws for ctDNA assessment at screening, 1 month, 2 month, 3 months, 6 months, 9 months, and 12 month/end of study.
- Conditions
- Melanoma, Non-small Cell Lung Cancer
- Being tested
- Evaluation of ctDNA using the F1T after 1 year of immunotherapy
- Medical subject headings
- Melanoma, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of ctDNA using the F1T after 1 year of immunotherapyOther
Also called Discontinue Immune Checkpoint Inhibitor
Patients with evidence of disease control after at least 10months of an ICI-based therapy will initially undergo a pre-screen. In patients with successful F1CDx baseline tissue testing whole blood will be collected and evaluated for plasma ctDNA measurement. If there is detectable ctDNA during the pre-screening period, patients will be excluded from enrollment. If there is no detectable ctDNA, patients will be eligible to screen and enroll in the main study.
If enrolled, patients will stop ICI- based treatment and continue with serial ctDNA at pre-specified timepoints. The treating physician will not be blinded to the serial ctDNA results There will be no proscriptive therapeutic measures outlined if ctDNA becomes detectable while on study.
| Study group | Role | What they receive |
|---|---|---|
| Active Surveillance | Other | Patients with 12 month history of immune checkpoint inhibitors (ICI) with stable or partial or complete responses and negative ctDNA at pre-screening, will stop ICI therapy and begin active surveillance with blood draws and standard of care imaging for 12 months. Receives: Other: Evaluation of ctDNA using the F1T after 1 year of immunotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the 12month disease-free survival (DFS) in ctDNA negative patients
Disease-free survival is defined as the time of determination of ctDNA negativity to the earlier of progression or death. This will be measured in days.
Measured: 12 months
Secondary outcomes (1)
Overall survival of the ctDNA negative cohort
Overall survival is defined as the time of determination of ctDNA negativity to death. This will be measured in days.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2023
- Study start10 Jan 2024
- Primary completionNov 2027 (estimated)
- Study completionNov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All consented participants with evidence of disease control / response after at least 1 year of immune checkpoint inhibition (monotherapy or in combination) with negative ctDNA will be invited to stop systemic therapy and continue with active surveillance.
- Masking
- None (open label)
- Enrolment
- 39 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Foundation Medicine
- Responsible party
- Principal investigator, Meghan Mooradian, Massachusetts General Hospital
- Investigators
- Meghan Mooradian, MD, Principal investigator, Massachusetts General Brigham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06146920
- Sponsor's protocol ID
- 23-357
- Status last verified
- Aug 2026
- First submitted
- 10 Nov 2023
- Last updated
- 17 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study Evaluation the Use of Serial Plasma Next-generation Sequencing (NGS) as a New Efficacy Metric to Guide Immunotherapy Treatment Discontinuation
- ClinicalTrials.gov ID
- NCT06146920
- Acronym / sponsor ID
- 23-357
- Conditions
- Melanoma, Non-small Cell Lung Cancer
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 39 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Foundation Medicine
- Study start
- 10 Jan 2024 (actual)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Nov 2028 (estimated)
- First posted
- 27 Nov 2023 (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.
The goal of this prospective study to investigate the use of circulating tumor DNA (ctDNA) to guide end of therapy decisions in patients with melanoma or non-small-cell lung cancer.
The main question it aims to answer is:
- Do patients with metastatic melanoma or non-small-cell lung cancer, who have received at least 12 months of immune checkpoint inhibition (monotherapy or in combination) with evidence of disease response/control on imaging and have no evidence of circulating tumor DNA, have an increased 12-month disease free survival in comparison to historical controls?
Detailed description
This is a prospective study using Simon's two stage design to investigate the use of ctDNA to guide end of therapy decisions. Approximately 39 patients with an established diagnosis of metastatic melanoma or NSCLC with evidence of disease control (SD, PR, or CR) will be enrolled in the study.
Patients that sign a pre-screening consent will have archival tumor tissue sent to Foundation Medicine for generation of the F1CDx. Patients may begin screening after 10 months of an ICI containing regimen with plan to complete at least 1 year of systemic therapy. After successful generation of F1CDx whole blood will be collected and analyzed for plasma ctDNA measurement.
Eligible patients for enrollment are ctDNA negative and have received at least 12 months but no more than 18moths of ICI. Eligible patients will be offered to consent to the main study and have standard of care imaging as well as blood draws for ctDNA assessment at screening, 1 month, 2 month, 3 months, 6 months, 9 months, and 12 month/end of study.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All consented participants with evidence of disease control / response after at least 1 year of immune checkpoint inhibition (monotherapy or in combination) with negative ctDNA will be invited to stop systemic therapy and continue with active surveillance.
| Arm | Type | Receives |
|---|---|---|
| Active Surveillance | Other | Other: Evaluation of ctDNA using the F1T after 1 year of immunotherapyPatients with 12 month history of immune checkpoint inhibitors (ICI) with stable or partial or complete responses and negative ctDNA at pre-screening, will stop ICI therapy and begin active surveillance with blood draws and standard of care imaging for 12 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Adult patients age > 18) with unresectable, metastatic melanoma (cutaneous, acral, mucosal) or NSCLC who have evidence of disease control after at least 12 months of ICI based therapy (pembrolizumab, nivolumab, nivolumab-relatimab, ipilimumab/nivolumab, atezolizumab, ipilimumab, durvalumab, cemiplimab) with or without chemotherapy in the case of NSCLC. Any line of therapy is permitted with the exception of adjuvant therapy
- Participants must be actively receiving standard of care ICI-based therapy (ICI monotherapy or in combination)
- At time of enrollment patients must have received at least 12months (+/- 4 weeks) from the start of anti-PD-1 therapy and have not experienced a toxicity that prevented them from continuing therapy.
- Participants must have evidence of disease control (stable disease, partial response, or complete response) that is maintained on restaging CT scans or PET CT scans obtained at 12 months (+/- 4 weeks) from the start of initial ICI therapy
- Prior radiation to any site is allowed
Key exclusion criteria (9 listed)
- Participants with clinical or radiographic evidence of progressive disease in the 3 months prior to consideration of screening and enrollment
- Participants who are receiving an investigational agent (s)
- Participants who have had ICI discontinued due an immune-related adverse event.
- Patients with a history of an irAE but resumed ICI therapy and are receiving ICI at the time of screening are eligible to enroll.
- Participants on > 10mg of oral prednisone or its equivalent for treatment of ongoing immune-related toxicity.
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 |
|---|---|---|
| Evaluation of ctDNA using the F1T after 1 year of immunotherapyAlso: Discontinue Immune Checkpoint InhibitorPatients with evidence of disease control after at least 10months of an ICI-based therapy will initially undergo a pre-screen. In patients with successful F1CDx baseline tissue testing whole blood will be collected and evaluated for plasma ctDNA measurement. If there is detectable ctDNA during the pre-screening period, patients will be excluded from enrollment. If there is no detectable ctDNA, patients will be eligible to screen and enroll in the main study. If enrolled, patients will stop ICI- based treatment and continue with serial ctDNA at pre-specified timepoints. The treating physician will not be blinded to the serial ctDNA results There will be no proscriptive therapeutic measures outlined if ctDNA becomes detectable while on study. | Other | Active Surveillance |
Primary outcome
Evaluate the 12month disease-free survival (DFS) in ctDNA negative patients
Time frame: 12 months
Disease-free survival is defined as the time of determination of ctDNA negativity to the earlier of progression or death. This will be measured in days.
1 secondary outcome
Overall survival of the ctDNA negative cohort
Time frame: 12 months
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 17 Aug 2026.
- Individual participant dataSharing planned: Yes. The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
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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. This study is not recruiting at the moment.
Meghan Mooradian, MD principal investigator
Massachusetts General Brigham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Evaluation of ctDNA using the F1T after 1 year of immunotherapy in people with Melanoma and Non-small Cell Lung Cancer, run by Massachusetts General Hospital 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 9 inclusion and 9 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: under way, not looking for participants, as of the sponsor's last update on 17 Aug 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the 12month disease-free survival (DFS) in ctDNA negative patients (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Aug 2026.