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Re: HyGro post# 511134

Monday, 09/05/2022 7:10:51 PM

Monday, September 05, 2022 7:10:51 PM

Post# of 707756
DCVax is filling the role of SOC in the Keytruda trial—you misunderstood—it is filling the role of SOC within the trial because every patient in both the experimental arm as well as the placebo arm are receiving DCVax-L.

NCI, Merck, & PHASE ONE are today supporting collaborators on the UCLA Keytruda trial—100% of patients in both the experimental group AND the placebo group receive DCVax. Only Keytruda in combo is being investigated—everyone receives DCVax as if it were 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
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