BMS has launched an Expanded Access Protocol for the combination of ipi and nivo, their anti-CTLA4 and anti-PD1 drugs. Earlier this year both Merck and BMS opened EAP programs for the PD1 drugs alone.
The combination of ipi and nivo has some very strong results. In one study, 88% of patients with metastatic melanoma were alive after two years. Side effects are a concern, with about 2/3 of paitents having Grade 3 or Grade 4 toxicities. The doctors involved with the study felt that these issues were rather easily managed.
This was just announced this morning, so no sites are open yet. As we have seen, sometimes these sites do take a while to open. For more information you can go to the EAP posting on clinicaltrials.gov.
--mucosal melanoma is included
--must not have had prior treatment with ipi
--brain mets are allowed, if MRI confirms no progression in 2 weeks
I hope to have more information soon, but in the interim here is the link to the posting: