IMA950 mixed with Poly-ICLC administered subcutaneously

Pembrolizumab 200mg q3w IV and IMA950 mixed with Poly- ICLC administered subcutaneously

Glioblastoma Multiforme

Glioblastoma, Adult

Glioma of Brain

Glioblastoma Multiforme of Brain

IMA950/Poly-ICLC

IMA950 mixed with Poly-ICLC administered subcutaneously in combination with pembrolizumab

IMA950/Poly-ICLC and pembrolizumab

University Hospitals of Geneva

Pembrolizumab in Association With the IMA950/Poly-ICLC for Relapsing Glioblastoma

Pembrolizumab in Association With the Multipeptide Vaccine IMA950 Adjuvanted With Poly-ICLC for Relapsing Glioblastoma: a Randomized Phase I/ II Trial

To assess tolerability and safety of IMA950 adjuvanted with Poly-ICLC when given together with pembrolizumab, using CTCAE v.4.03

To estimate 6, 9 and 12-month progression-free survival (PFS) using gadolinium-enhanced MRI and clinical assessment according to revised iRANO criteria

To estimate OS, defined as the time between the date of study entry and the date of death due to any cause. Subjects who have not died at the time of last known follow-up will be censored

Quality of life patient-reported outcomes (EORTC QLQ-C30 questionnaire)

To assess synergy/immunogenicity of IMA950 plus Poly-ICLC when given together with Pembrolizumab using Tumor Infiltrating Lymphocyte (TIL) density assessment

To assess synergy/immunogenicity of IMA950 plus Poly-ICLC when given together with Pembrolizumab by assessing vaccine-induced peripheral immune responses by flow cytometry or IHC as surrogate markers

Pierre-Yves Dietrich

Principal Investigator

University Hospital, Geneva

After confirmation of high grade glioma, AdV-tk injection into wall of resection cavity. Valacyclovir starting 1-3 days post-surgery for 14 days. Radiation begins approximately day 8 and continues for 6 weeks. Temozolomide started after complete valacyclovir and stop when MGMT unmethylated result obtained. Nivolumab every 2 weeks x 26 doses up to 52 weeks. MRI every 8 weeks until progression.

After confirmation of high grade glioma, AdV-tk injection into wall of resection cavity. Valacyclovir starting 1-3 days post-surgery for 14 days. Radiation begins approximately day 8. Temozolomide started after complete valacyclovir and continue during radiation then 5 week break and then begin adjuvant temozolomide dosing. Nivolumab every 2 weeks x 26 doses up to 52 weeks. MRI every 8 weeks until progression.

Glioma, Malignant

AdV-tk

Given PO days 1-14; 1-3 days post surgery

Valacyclovir

Undergo RT, 60Gy in 30 daily fractions M-F for 6weeks

Radiation

Given PO during RT 75mg/m2 daily during RT Post RT cycle 1: 150mg/m2 days 1-5 150mg/m2 cycle 2-6: days 1-5 (150-200mg/m2)

Temozolomide

day 15 post surgery 240mg IV q2wks x 26 doses , up to 52 weeks

Nivolumab

Laboratory Biomarker Analysis

University of Alabama at Birmingham Comprehensive Cancer Center

Jonsson Comprehensive Cancer Center at UCLA

University of California San Francisco Medical Center

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Massachusetts General Hospital Cancer Center

Dana Farber Cancer Institute

Henry Ford Hospital

Memorial Sloan-Kettering Cancer Center

Wake Forest University Comprehensive Cancer Center

Cleveland Clinic Taussig Cancer Center

Abrams Cancer Center of the University of Pennsylvania

Hillman Cancer Center at University of Pittsburgh Cancer Institute

GMCI, Nivolumab, and Radiation Therapy in Treating Patients With Newly Diagnosed High-Grade Gliomas

Phase I Study of Neoadjuvant GMCI Plus Immune Checkpoint Inhibitor Combined With Standard of Care for Newly Diagnosed High-Grade Gliomas

National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 will be used for scoring toxicity and adverse events. The severity and frequency of toxicity will be tabulated by the tested dose or doses using descriptive statistics. The proportions of subjects who experienced grade 3 or above toxicities will be estimated, along with 95% confidence intervals by each type of toxicity.

To estimate overall survival - endpoint is death. Median time of survival along with 95% confidence interval will be estimated using the Kaplan-Meier method.

To estimate progression-free survival - endpoint is progression. Median time of progression-free survival along with 95% confidence interval will be estimated using Kaplan-Meier method.

Tumor profiling by immunohistochemistry and Nanostring at baseline and when samples available after treatment.

Mutational profiling by sequence or transcriptome analysis from tumor tissue

Standard descriptive statistics will be used to summarize proportion of PBMCs.

Immune characterization of surface and content proteins is determined by presence of cytokines in serum.

Immune characterization of surface and content proteins based on presence of extracellular vesicles in serum samples.

Advantagene, Inc. d.b.a. Candel Therapeutics

National Cancer Institute (NCI)

Newly diagnosed HGG: surgically eligible patients AdV-tk into wall of resection cavity; 1-3 days post-surgery Valacyclovir d1-14; Day 8 RT for 6 wks; day 15 TMZ 75mg/m2 daily; Nivo 240mgIV every 2 weeks

immunostimulator/dental caries

Pembrolizumab in Association With the IMA950/Poly-ICLC for Relapsing Glioblastoma

GMCI, Nivolumab, and Radiation Therapy in Treating Patients With Newly Diagnosed High-Grade Gliomas

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