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Patients will receive SL-701 with the vaccine adjuvants granulocyte macrophage-colony stimulating factor (GM-CSF) injection and imiquimod topical cream.

A complete dose of study drug consists of the administration of a sequence of 3 agents, SL-701 emulsion SC injection, GM-CSF SC injection, and imiquimod topical cream, within a 5-minute time frame. Topical application of imiquimod cream at the injection site is repeated at 24 hours after each SL-701 emulsion injection. For each patient, SL-701 emulsion (SL-701 in Montanide®) will be administered by SC injection beginning on Day 1 with imiquimod topical cream 5% applied immediately (within 5 minutes after SL-701 emulsion injection) to the SL-701 emulsion injection site.

In addition to the SL-701 emulsion injection, the patient will receive a SC injection of GM-CSF 150 μg close to the injection site of SL-701 emulsion. An additional dose of imiquimod cream will be applied at the same site by the patient 24 hours later.

SL-701 emulsion and the adjuvant poly-ICLC will be administered twice weekly for the initial 2 weeks, every 7 days during the subsequent 3 doses, and subsequently every 14 days for the subsequent 9 doses (16 doses total) through Week 22, and every 4 weeks thereafter. Bevacizumab will be administered every 2 weeks, subsequent to the administration of SL-701/poly-ICLC.

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).

SL-701; poly-ICLC (polyinosinic-polycytidylic acid stabilized with polylysine and carboxymethyl cellulose)

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.

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.

SL-701 + GM-CSF

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.

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

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) patients 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 patients had measurable disease based on contrast-enhanced magnetic resonance imaging or computed tomography scans.

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 Patients With Recurrent Glioblastoma Multiforme (GBM)

OS-12 after the initiation of SL-701, per Kaplan-Meier estimate.

The ORR was the percentage of subjects who had at least 1 overall tumor response of CR or PR documented on 2 consecutive MRIs ≥4 weeks apart by modified Response Assessment in Neuro-Oncology criteria.

Measure the number of subjects with a CR or PR. A CR requires all of the following: complete disappearance of all enhancing measurable and nonmeasurable disease sustained for at least 4 weeks; no new lesions; and stable or improved nonenhancing (T2/FLAIR) lesions. Patients must be off corticosteroids (or on physiologic replacement doses only) and stable or improved clinically. A PR requires all of the following: ≥50% decrease, compared with baseline; the sum of products of perpendicular diameters of all measurable enhancing lesions sustained for at least 4 weeks; no progression of nonmeasurable disease; no new lesions; stable or improved nonenhancing (T2/FLAIR) lesions on the same or a lower dose of corticosteroids compared with baseline scan; and the patient being on a corticosteroid dose not greater than the dose at time of the baseline scan and stable or improved clinically.

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

Stemline Therapeutics, Inc.

Patients received SL-701 with the vaccine adjuvants GM-CSF injection and imiquimod topical cream.

A complete dose of study drug consisted of the administration of a sequence of 3 agents, SL-701 emulsion SC injection, GM-CSF SC injection, and imiquimod topical cream, within a 5-minute time frame. Topical application of imiquimod cream at the injection site was repeated at 24 h after each SL-701 emulsion injection. For each patient, SL-701 emulsion (SL-701 in Montanide®) was administered by SC injection beginning on Day 1 with imiquimod topical cream 5% applied immediately (within 5 minutes after SL-701 emulsion injection) to the SL-701 emulsion injection site.

In addition to the SL-701 emulsion injection, the patient received a SC injection of GM-CSF 150 μg close to the injection site of SL-701 emulsion (immediately following the SL-701 emulsion injection, before the application of topical imiquimod). An additional dose of imiquimod cream was applied at the same site by the patient 24 h later.

SL-701; GM-CSF; Imiquimod

SL-701 emulsion and the adjuvant poly-ICLC was administered twice weekly for the initial 2 weeks, every 7 days during the subsequent 3 doses, and subsequently every 14 days for the subsequent 9 doses (16 doses total) through Week 22, and every 4 weeks thereafter. Bevacizumab was administered every 2 weeks, after the administration of SL-701/poly-ICLC.

SL-701; poly-ICLC (polyinosinic-polycytidylic acid stabilized with polylysine and carboxymethyl cellulose): Within 20 minutes following the administration of the SL-701 emulsion, poly-ICLC was administered as an IM injection in the same extremity (within 3 cm whenever possible) as was administered the SL-701 (deltoid muscle, unless contraindicated).

Bevacizumab: Following the administration of SL-701 and poly-ICLC, bevacizumab was administered IV at a dose of 10 mg/kg. Bevacizumab infusions occurred over 30, 60 or 90 minutes in accordance with institutional practices and guidelines.

SL-701; Poly-ICLC 1.6mg; Bevacizumab

SL-701 + GMCSF + Imiquimod GMCSF+Imiquimod

SL-701 + Poly-ICLC + Bevacizumab

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Body Mass Index

Carlos A. Garay, MD, Senior Vice President, Clinical Development & Medical Affairs - Solid Tumors

Spots Global Cancer Trial Database for glioma associated antigen