Clinical Trial Information
Protocol – ECOG – EA6192
Please Note: Below is a brief description of eligibility, please contact GHCI Research Department to discuss full eligibility requirements.
- Patient must be ≥ 18 years of age.
- 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.
- 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
- 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.
- Patient must have an ECOG performance status of 0-2.
- Patient must not have brain metastases.
- 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.
- Patient must have experienced complete response, partial response, or stable disease on restaging CT scans by imRECIST that is maintained on restaging scans obtained at week 52 (+/- 2 weeks) from start of initial anti-PD-1 therapy.