ACTIVE_NOT_RECRUITING

Use of Serial Plasma NGS as a New Efficacy Metric to Guide Immunotherapy Treatment Discontinuation

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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?

Official Title

Pilot Study Evaluation the Use of Serial Plasma Next-generation Sequencing (NGS) as a New Efficacy Metric to Guide Immunotherapy Treatment Discontinuation

Quick Facts

Study Start:2024-01-10

Study Completion:2028-11

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06146920

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* 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) * 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.	* 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 * Participants with a concurrent, active malignancy * Participants in whom F1CDx generation fails * Participants without available tumor tissue for F1CDx test result or prior F1CDx

Inclusion Criteria

Exclusion Criteria

* 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)
* 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.

* 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
* Participants with a concurrent, active malignancy
* Participants in whom F1CDx generation fails
* Participants without available tumor tissue for F1CDx test result or prior F1CDx

Contacts and Locations

Principal Investigator

Meghan Mooradian, MD

PRINCIPAL_INVESTIGATOR

Massachusetts General Brigham

Study Locations (Sites)

Massachusetts General Hospital

Boston, Massachusetts, 02114

United States

Collaborators and Investigators

Sponsor: Massachusetts General Hospital

Meghan Mooradian, MD, PRINCIPAL_INVESTIGATOR, Massachusetts General Brigham

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-01-10

Study Completion Date2028-11

Study Record Updates

Study Start Date2024-01-10

Study Completion Date2028-11

Terms related to this study

Additional Relevant MeSH Terms

Melanoma
Non-small Cell Lung Cancer