A Phase 1/2 Study of SL-701, a Subcutaneously Injected Multivalent Glioma-Associated Antigen Vaccine, in Adult Patients with Recurrent Glioblastoma Multiforme

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Investigator: Nicholas Butowski, MD
Sponsor: Stemline Therapeutics, Inc

Location(s): United States

Description

Primary Outcome Measures:

Characterize the safety and tolerability of SL-701

Estimate the percent of patients alive 12 months after the initiation of SL-701 (OS-12

Estimate the objective response rate (ORR)  

Secondary Outcome Measures:

Estimate duration of response

Estimate the percent of patients alive and progression-free survival at 6 months (PFS-6) after the initiation of SL-701.

Estimate the distributions of progression-free survival (PFS) and overall survival (OS). 

 

Estimated Enrollment: 76

Study Start Date: May 2014

Estimated Study Completion Date: April 2017

Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)