PD1/Yervoy sequential combo trials
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Here is the link: http://clinicaltrials.gov/ct2/show/NCT01783938 Trials opening April 15th in 9 locations, with small accrual. Must be treatment naive of Yervoy and PD1 (not had either) but could have other treatments. Very interesting trial..
VERY interesting Catherine and it tells me some things, all good: 1. This is a phase II trial. The earlier combo BMS trial at Sloan and Yale was a phase I and maybe, is providing enough encouraging results to move ahead with a Phase II trial.
2. Previous BMS PD1 was known as MDX-1106. This one now has a name. Hopefully it’s an improvement on MDX-1106 or a specific variant for combination with IPI.
3. PD1 dose is 3mg where as the phase I trial had a 1mg combo arm to it. Seems they’ve decided on the PD1 dosing level.
4. Radiation is not excluded.
5. Would seem to exclude prior IL-2, which is not good IMO.
Seems BMS is making a real effort here to check the combo out. It would be interesting to see how they would use this data if PD1 gets approved fairly quickly. For example, if both IPI and PD1 are approved for use then this trial can provide data and basis to recommend a dosing and sequencing protocol in combo with IPI when PD1 hits the street.
I love it when a plan starts to come together.
Jeff
Jeff, I looked through the exclusion criteria and didn’t see anything about IL2? Where did you see that as I know one doctor said it would not be exclusion.
Catherine: In the exclusions section there was item excluding “prior immunotherapies”, which I assumed would be IL-2 and Interferon. If I’m wrong, that’s good (!). I hope I’m wrong.
Where did you find the location information?
Jeff
MDX 1106 and BMS 936558 and Nivolumab are exactly the same thing. No new formulation. Nothing different except the name. By whatever name they choose to call it…this is the Bristol Meyers Squibb anti-PD1 product. (Which I have been taking for the past 2 years, 3 months at Moffitt in Tampa.) What this does say is that the marketing folks at BMS think that it will be marketed soon… therefore the “cute” name. The study referred to is a sequential study. Some folks get ipi followed by the anti=PD1 product. Others get the anti-PD1 product followed by ipi. Something Dr. Weber (in Tampa) has mentioned before as something he would like to see analyzed. The inclusion criteria states that it allows folks who have progressed after “one prior systemic treatment for advanced disease”. However, it requires measurable disease. Exclusion criteria includes: Steroids within 14 days prior. Prior therapy with PD1, PD-L1, and any other immunotherapies, including BRAF. Hope this helps. C My oncologist, who moonlights for BMS, told me Wednesday that he expects the newly named anti PD1, Nivolumab, to be approved and on the market early in 2015. Their “ARMS” section doesn’t completely clarify what the sequencing is? It is interesting to note that there is no explicit requirement of testing for PD-L1 although that is a requirement of the Phase III MDX-1106/ BMS 936558 trial. I agree with the idea that they are looking at approval for metastatic melanoma around 2015 with the possibility of prior approval for NSCLC. All the trial dates point in this direction.
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