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

NARecruitingINTERVENTIONAL
Enrollment

39

Participants

Timeline

Start Date

January 10, 2024

Primary Completion Date

November 30, 2027

Study Completion Date

November 30, 2028

Conditions
MelanomaNon-small Cell Lung Cancer
Interventions
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."

Trial Locations (1)

02114

RECRUITING

Massachusetts General Hospital, Boston

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Foundation Medicine

INDUSTRY

lead

Massachusetts General Hospital

OTHER

NCT06146920 - Use of Serial Plasma NGS as a New Efficacy Metric to Guide Immunotherapy Treatment Discontinuation | Biotech Hunter | Biotech Hunter