drugset / Trial / NCT04462406
Using Biomarkers to Help Guide Safe Immunotherapy Discontinuation in Patients With Unresectable Stage IIIB-IV Melanoma, The PET-Stop Trial
Phase 2
Active not recruiting
150 enrolled
ECOG-ACRIN Cancer Research Group
National Cancer Institute (NCI) · collab
Non-randomizedSequentialOpen-labelTreatment
Summary
This phase II trial investigates how well biomarkers on PET/CT imaging drive early discontinuation of anti-PD-1 therapy in patients with stage IIIB-IV melanoma that cannot be removed by surgery (unresectable). Anti-PD-1 therapy has become a standard therapy option for patients with unresectable melanoma. This trial is being done to determine if doctors can safely shorten the use of standard of care anti-PD1 therapy for melanoma by using biomarkers seen on PET/CT imaging and tumor biopsy.
Timeline
- Start
- 2021-02-09
- Primary completion
- 2027-01-31
- Completion
- 2030-09-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Nivolumab | Monoclonal antibody | — | Intravenous |
| Subject | Pembrolizumab | Monoclonal antibody | — | Intravenous |
| Background | Ipilimumab | Monoclonal antibody | — | Intravenous |