Using blood tests to decide when to stop immunotherapy for cancer
Pilot Study Evaluation the Use of Serial Plasma Next-generation Sequencing (NGS) as a New Efficacy Metric to Guide Immunotherapy Treatment Discontinuation
This study is testing if blood tests can help decide when it's safe for people with advanced melanoma or lung cancer to stop their immunotherapy treatment after seeing positive results.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 39 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Massachusetts General Hospital Academic / other |
| Drugs / interventions | pembrolizumab, nivolumab, relatimab, ipilimumab, atezolizumab, durvalumab, cemiplimab, chemotherapy, radiation, prednisone |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT06146920 on ClinicalTrials.gov |
What this trial studies
This prospective study aims to evaluate the effectiveness of circulating tumor DNA (ctDNA) as a metric for guiding treatment discontinuation in patients with metastatic melanoma or non-small cell lung cancer (NSCLC). The study will enroll approximately 39 patients who have shown disease control after at least 12 months of immune checkpoint inhibition therapy. Participants will undergo blood tests to measure ctDNA levels at various intervals, and the results will be compared to historical controls to assess the impact on disease-free survival. The study employs a two-stage design to ensure robust data collection and analysis.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with unresectable, metastatic melanoma or NSCLC who have shown disease control after at least 12 months of immunotherapy.
Not a fit: Patients who have not received at least 12 months of immunotherapy or those with evidence of active disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could help determine the optimal time to discontinue immunotherapy, potentially improving patient outcomes and quality of life.
How similar studies have performed: While the use of ctDNA in treatment decision-making is gaining traction, this specific approach is novel and has not been extensively tested in similar studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion 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. Exclusion Criteria: * 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
Where this trial is running
Boston, Massachusetts
- Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Meghan Mooradian, MD — Massachusetts General Brigham
- Study coordinator: Aleigha Lawless, BS
- Email: alawless@mgb.org
- Phone: 617-643-3578
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.