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Tuesday, January 18, 2022 8:25:04 PM
“Brief Summary:
The study comprises a Phase I component during which the optimal dose of DCVax-Direct for the treatment of solid tissue tumors will be identified, followed by a Phase II component to determine if the injection of DCVax-Direct into selected solid tissue tumors has the ability to reduce tumor growth.”
The primary measure was safety:
“Primary Outcome Measures :
Number of patients with adverse events [ Time Frame: 6 months ]
Secondary Outcome Measures :
Number of patients with tumor response [ Time Frame: 18 months ]
Other Outcome Measures:
Number of patients surviving [ Time Frame: 24 months ]
Number of patients surviving without tumor progression [ Time Frame: 24 months ]”
https://www.clinicaltrials.gov/ct2/show/NCT01882946?term=Northwest+Biotherapeutics&rank=2
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