Saturday, December 15, 2012

New Trials for Melanoma

 New Anti-PD1 adjunctive trial:
According to Dr. Weber, he was "just" notified of a new anti-PD1 adjunctive trial set to start.  (These are the trials that I feel are essential for prevention of the later development of non-resectable melanoma, but have little availability.) I am not sure if this is for the BMS or Merck product, but patients will be given anti-PD1 or placebo (nothing) every 2 weeks until progression.  His main worry in trials like this (a couple more to follow) is related to accumulated side effects.  When talking about NED patients, you could be dealing with years before progression, which is great!!!....but how much drug can a body take?!!!!

BMS 936558 vs Dacarbazine or Carboplatin and Paclitaxel (investigator's choice) Phase 3 trial:
To run (?) 23 months, started in November 2012, with BMS anti-PD1 given every 2 weeks at 3mg/kg, while the other arm is given their drug every 3 weeks in patients with Stage III/IV unresectable melanoma who progressed during or after 2 or fewer treatment regimens (including failing ipi).  Exclusions include:  prior BMS anti-PD1, corticosteriods 14 days prior trial, autoimmune disease, active brain mets, ocular mel, prior anti-PD1, anti-PD-L1, or anti-PD-L2.  Search NCT01721746 for locations.

New Phase I/II trial for Stage III/IV melanoma unresected:
An adenovirus vector engineered to express hIL-12 (INXN-2001) is injected into the tumor directly while an activator ligand (INXN-1001) is taken orally in 4 cohorts of 5, 20, 100, and 160mg/kg in 7 daily doses per study cycle with a max of 6 cycles. One intratumoral injection will be done per study cycle for a max of 6 cycles.  Exclusions:  No treatment drugs 28 days prior. If drug was ipi, 90 days of a washout is needed.  If on prior anti-PD1 an evaluation regarding when and if participation will be allowed will be made by the "medical monitor".  No occular melanoma. No symptomatic brain mets. No autoimmune disease requiring steroids.  Search NCT01397708 for more info.  NOTE:  The idea here is that the drug injected into the tumor will increase the immune response and possibly decrease the blood flow available to the tumor while the oral drug will, in theory, activate the immune response as well.

This is just the gist of these trials.  Search for more and better information.  Make your oncologist get busy on your behalf!

And, finally, when talking about some of these trial options with Dr. Weber, he acknowledged that had ipi or anti-PD1 had been discovered first....Dacarbazine would never have attained FDA approval...yet, we continue to use it.  Incredible.

Best of luck to each of you. - c


  1. The beginning treatments for cancer were presented as rather barbaric in The Enemy Within. Although it is obvious things have come a long way, some things still just don't add up for me. Allowing melanoma patients to get NOTHING (while they are hoping for a miracle) seems wrong. Continuing to use drugs that are ineffectual combined with serious side effects does as well...

  2. I know what you mean. Yet, we look down on the Greeks who viewed the body and illness and pain as "humours" moving within. Perhaps they were not that far off. We certainly have a great deal more to learn.