BMS has opened an expanded access protocol for their anti-PD1 drug nivolumab. Details can be found here: http://clinicaltrials.gov/ct2/show/NCT02142218?term=nivolumab+melanoma&rank=10
No sites are open yet, but several sites are actively working on opening up this study. Opening a study like this can take some time, with the delay varying considerably from site to site based on their own rules.
We will provide updates on open sites as soon as we have that information.
The program will be available for patients with Stage IV or unresectable Stage III melanoma, including cutaneous and mucosal melanoma.
Patients must have progressed on Yervoy (ipi) or some other anti-CTLA4 drug. If the patient has a BRAF mutated tumor they must also have progressed on a BRAF inhibitor.
Patients with active brain metastases are excluded. This includes patients with brain mets who are currently in radiation treatment or who are taking steroids following radiation treatment.
The good news is that anti-PD1 therapy will soon be available to more patients. The better news is that we are likely just a few months away from having one or two anti-PD1 drugs approved by the FDA.
Tim–MRF
