"We're in good shape to get the studies up and running by the end of this quarter." Glynn Wilson on 2/11/16
No specific promise in that video about the collaboration announcement by that date, that one is to be in Ovarian. The only study that they can get up and running by the end of this quarter is the TNBC. That protocol was added on 2/25 on the NCT registry. That means 30 days from that, the soonest the IRB can approve is the end of this month.
Folate Receptor Alpha Peptide Vaccine With GM-CSF in Patients With Triple Negative Breast Cancer
Tracking Information First Received Date ICMJE October 27, 2015 Last Updated Date February 25, 2016 Start Date ICMJE December 2015 Estimated Primary Completion Date June 2017 (final data collection date for primary outcome measure) Current Primary Outcome Measures ICMJE (submitted: October 30, 2015) Immune response [ Time Frame: 3 years ] [ Designated as safety issue: No ] Emergence of B and T cell immunity targeting the folate receptor alpha Original Primary Outcome Measures ICMJE Same as current Change History Complete list of historical versions of study NCT02593227 on ClinicalTrials.gov Archive Site Current Secondary Outcome Measures ICMJE (submitted: February 25, 2016) Folate receptor alpha expression [ Time Frame: Baseline ] [ Designated as safety issue: No ] To determine FRa expression status of primary tumors Relapse Free Survival [ Time Frame: 3 years ] [ Designated as safety issue: No ] RFS in relation to FR specific immune response Safety and tolerability (treatment emergent adverse events and injection site reactions) [ Time Frame: 3 years ] [ Designated as safety issue: Yes ] Incidence of treatment emergent adverse events and injection site reactions Original Secondary Outcome Measures ICMJE (submitted: October 30, 2015) Folate receptor alpha expression [ Time Frame: Baseline ] [ Designated as safety issue: No ] To determine FRa expression status of primary tumors Relapse Free Survival [ Time Frame: 3 years ] [ Designated as safety issue: No ] RFS in relation to FR specific immune response Objective response rate [ Time Frame: 3 years ] [ Designated as safety issue: No ] ORR in the subset of patients with residual disease Safety and tolerability (treatment emergent adverse events and injection site reactions) [ Time Frame: 3 years ] [ Designated as safety issue: Yes ] Incidence of treatment emergent adverse events and injection site reactions