Replies to post #511326 on NorthWest Biotherapeutics Inc (NWBO)

[SkyLimit2022]

Outside of this trial, SOC is RT and Temodar. Within this trial, DCVax is filling the role of SOC because every patient in both the experimental arm as well as the placebo arm are receiving DCVax-L. RT and Temodar are not filling the role of SOC within this trial.

“Filling the role of SOC” is not the same as SOC.

Group A (pembrolizumab, ATL-DC, poly ICLC)
Beginning 14 days prior to scheduled surgery, patients receive pembrolizumab IV over 30 minutes. After surgery, patients receive pembrolizumab IV over 30 minutes on day 1. Cycle repeats every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients also receive ATL-DC ID with poly ICLC IM every 2 weeks for up to 3 doses in the absence of disease progression or unacceptable toxicity.

Group B (placebo, ATL-DC, poly ICLC)
Beginning 14 days prior to scheduled surgery, patients receive placebo IV. After surgery, patients receive placebo IV on day 1. Cycle repeats every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients also receive ATL-DC ID with poly ICLC IM every 2 weeks for up to 3 doses in the absence of disease progression or unacceptable toxicity.

virtualtrials.org/dcvax.cfm

https://clinicaltrials.gov/ct2/show/NCT04201873