NCT06146920

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

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 39 (estimated)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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. 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.

Conditions

• Melanoma
• Non-small Cell Lung Cancer

Interventions

Type	Name	Description
OTHER	Evaluation of ctDNA using the F1T after 1 year of immunotherapy	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.

Timeline

• Start date: 2024-01-10
• Primary completion: 2027-11-01
• Completion: 2028-11-01
• First posted: 2023-11-27
• Last updated: 2025-11-18

Locations

1 site across 1 country: United States