Using Biomarkers to Help Guide Safe Immunotherapy Discontinuation in Patients With Unresectable Stage IIIB-IV Melanoma, The PET-Stop Trial

Location: Edward Cancer Center - Naperville
Edward Cancer Center - Plainfield
Nancy Knowles Cancer Center - Elmhurst

Purpose:

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.

Sponsor: ECOG-ACRIN

https://clinicaltrials.gov/ct2/show/NCT03793166

Eligibility:

• Patient must have active advanced melanoma, defined as unresectable stage IIIB-IV.
• Patient must have melanoma originating from cutaneous, acral-lentiginous, or mucosal primary sites. Patients with melanoma of unknown primary site are eligible. Patients must not have melanoma from an ocular primary site.
• Patient must have had measurable disease prior to start of initial anti-PD-1 therapy
• Patient must be actively receiving standard of care anti-PD-1 therapy, currently be 52 weeks (+/- 2 weeks) from start of anti-PD-1 therapy, and have not experienced a toxicity that prevents them from continuing on therapy. 
• HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.For patients with evidence of chronic hepatitis B virus infection, the viral load must be undetectable on suppressive therapy, if indicated.
• Patients with a history of hepatitis C virus infection must have been treated and cured. Patients with HCV who are currently on treatment are eligible if they have an undetectable viral load.
• Patient must have experienced complete response, partial response, or stable disease on restaging CT scans obtained at 1 year after start of anti-PD-1 therapy.
• Must be amenable to undergo a biopsy. 
• Patient must not be receiving concurrent anti-tumor therapies in addition to the standard of care anti-PD-1 regimens. Patients receiving treatment for bone metastases are eligible.
• Patient must not have brain metastases.

Time Commitment: Approx. 5-7 years