NCT02078648

Safety and Efficacy Study of SL-701, a Glioma-Associated Antigen Vaccine To Treat Recurrent Glioblastoma Multiforme

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 74 (actual)
• Sponsor: Stemline Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the safety and efficacy of SL-701 as a treatment for recurrent glioblastoma multiform (GBM).

Detailed description

This is a multicenter, open-label Phase 1/2 study evaluating the efficacy and safety of SL-701 as a treatment for recurrent GBM, divided into 2 stages. Seventy-four (74) participants were treated in the study, 46 in Stage 1 and 28 in Stage 2, men and women at least 18 years of age, all of whom showed unequivocal evidence of either a first tumor recurrence or progression during or following an initial treatment regimen before enrollment in this study. At least 54 of the 74 treated participants had measurable disease based on contrast-enhanced magnetic resonance imaging or computed tomography scans.

Conditions

• Adult Brain Glioblastoma
• Glioblastoma Multiforme

Interventions

Type	Name	Description
DRUG	SL-701; poly-ICLC (polyinosinic-polycytidylic acid stabilized with polylysine and carboxymethyl cellulose)	1.0 mL injection taken from 0.7 mL of SL-701 mixed at a 1:1 (v/v) ratio with 0.7 mL of Montanide. Preferred site of SC injection is in the right or left upper arms. Within 20 minutes following the administration of the SL-701 emulsion, poly-ICLC should be administered as an IM injection in the same extremity (within 3 cm whenever possible) as was administered the SL-701 (deltoid muscle, unless contraindicated).
DRUG	Bevacizumab	Following the administration of SL-701 and poly-ICLC, bevacizumab will be administered IV at a dose of 10 mg/kg. Bevacizumab infusions may occur over 30, 60 or 90 minutes in accordance with institutional practices and guidelines.
DRUG	SL-701 + GM-CSF	1.0 mL injection taken from 0.7 mL of SL-701 mixed at a 1:1 (v/v) ratio with 0.7 mL of Montanide. Preferred site of SC injection is in the right or left upper arms. 150 μg GM-CSF should be administered as a SC injection immediately after SL-701 emulsion administration and within 1 cm from the center of the SL-701 emulsion injection site.
DRUG	Imiquimod	Within 5 minutes following the administration of the SL-701 emulsion, approximately 125 mg of imiquimod cream will be applied topically on the injection site. The imiquimod cream should be rubbed in until the cream is no longer visible.

Timeline

• Start date: 2014-05-01
• Primary completion: 2017-09-01
• Completion: 2018-01-22
• First posted: 2014-03-05
• Last updated: 2025-02-03
• Results posted: 2023-12-06

Locations

16 sites across 1 country: United States