A Phase II Study of Biomarker Driven Early Discontinuation of Anti-PD-1 Therapy in Patients with Advanced Melanoma (PET-Stop)

Protocol – ECOG – EA6192

SCHEMA EA6192

Please Note: Below is partial eligibility, for full eligibility requirement’s,  please contact GHCI Research Department at (810) 762-8181, (810) 762-8079 and/or (810) 762-8038. Thank you!

Eligibility:

1. Must be at least 18 years of age.
2. Patient must have active advanced melanoma, defined as unresectable stage IIIB-IV by AJCC 8th edition. Patients with mucosal melanoma defined as unresectable stage III or regional/distant metastatic disease are eligible.
3. Patient must have melanoma originating from cutaneous, acrallentiginous, or mucosal primary sites. Patients with melanoma of unknown primary site are eligible. Patients must not have melanoma from an ocular primary site.
4. Patient must have had measurable disease.
5. 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. Permitted systemic anti-PD-1 therapy regimens include:
   • Nivolumab 240mg IV Q2weeks or 480mg IV Q4weeks
   • Pembrolizumab 200mg IV Q3weeks or 400mg IV Q6weeks
   • Nivolumab 1mg/kg plus Ipilimumab 3mg/kg IV Q3weeks induction
   x 4 doses, followed by Nivolumab 240mg IV Q2weeks or 480mg
   IV Q4weeks maintenance
   • Nivolumab 3mg/kg plus Ipilimumab 1mg/kg IV Q3weeks induction
   x 4 doses, followed by Nivolumab 240mg IV Q2weeks or 480mg
   IV Q4weeks maintenance
   • Pembrolizumab 2mg/kg (or 200mg flat dose) plus Ipilimumab
   1mg/kg IV Q3weeks induction x 4 doses, followed by
   Pembrolizumab 200mg IV Q3weeks or 400mg IV Q6weeks
   maintenance
6. Patient must not be receiving concurrent anti-tumor therapies in addition to the standard of care anti-PD-1 regimens. Patients who are receiving bisphosphonates and RANKL inhibitors for management of bone metastases are eligible.
7. ECOG Performance Status 0-2.
8. Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.