Mets Days 1015: Which MPDL320a trial?

In my discussions this week with Dr. Apolo and Dr. Aragon-Ching, the MPDL3280a study that we were considering was a Phase II single-arm trial (ClinicalTrials.gov Identifier NCT02108652), where all patients would receive the MPDL3280a immunotherapy drug. Both Drs. Apolo and Aragon-Ching understood that Georgetown's Lombardi Cancer Center was offering that trial; both of them contacted Dr. Nancy Dawson on my behalf; and yesterday I was scheduled for an appointment with Dr. Dawson  for next Tuesday.

I asked Dr. Dawson's research nurse to email me the clinical trial consent forms so I could review them and compile a list of questions. This morning I started reading through the 40 pages of information, disclosures, warnings, and disclaimers, and was surprised to learn that the clinical trial that Geogetown was running was actually a Phase III double-armed study comparing patients who received MPDL3280a to patients receiving a taxene-based chemotherapy (ClinicalTrials.gov Identifier NCT02302807). Half the patients in that trial would be randomized into the chemotherapy arm, and the other half in the MPDL3280a arm.

I have no interest in getting chemotherapy at this time. Been there, done that, got the neuropathy to show it. Maybe at some later point, I'll get a platinum and taxene-based chemo, but only when my tumors are widespread. The Phase III trial chemotherapy arm is only a single-drug regimen, although some would be given vinflunine, and others would get either paclitaxel, or docetaxel. Strangely enough, Georgetown's list of clinical trials for bladder cancer identifies the Phase II trial that I'm interested in, but does not include the Phase III trial. I've sent an email to Dr. Dawson's research nurse seeking clarification, since I don't want to go down the path for randomization into the Phase III chemo arm. Of course, if I randomized into the MPDL3280a arm, that would be just fine. But if Georgetown is also doing the Phase II study, then I'd prefer enrolling in that instead of rolling the dice on randomization.

I did some more digging and found that, aside from Georgetown, the other local medical center that is participating in the Phase II MPDL3280a trial (where everyone gets the drug) is Fairfax Inova. The Phase II trial appears on their list of clinical trials. I called Dr. Alexander Spira, who is heading that study, and spoke with his research nurse, who scheduled me for an appointment next Friday at 2 pm. So it looks like I'll have the choice between MPDL3280a trials.