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

Caregivers, spouse, friends, relatives of PD patients, have blood draws, MEG.

PD patients that receive placebo, have blood draw, physical exam and UPDRS part III assessment, MEG, Motion analysis.

PD patients that receive Leukine, have blood draw, physical exam and UPDRS part III assessment, MEG, Motion analysis.

Parkinson's Disease

blood draw

physical exam and UPDRS part III assessment

lyophilized 250 micrograms/vial
6 micrograms/kg daily subcutaneous injection
56 days

sargramostim

saline solution daily subcutaneous injection 56 days

placebo

Motion Analysis

Neurology Consultants of Nebraska PC

University of Nebraska Medical Center

Leukine (Sargramostim) for Parkinson's Disease

An adverse event is defined as any undesirable physical, psychological, or behavioral effect experienced by a patient in conjunction with the use of the study drug.

Score from part III motor examination of the Unified Parkinson's Disease Rating Scale Score Sheet.

Comprehensive metabolic panel, complete blood count with white blood cell differential (CBC/dif), and total T cell counts blood analyses

Physical examination including temperature, blood pressure, pulse, and skin, lung, liver, heart, and abdomen assessments.

T cell markers analyzed by fluorescence-activated cell sorting.

Regulatory T cells isolated from peripheral blood are tested for their ability to suppress proliferation of activated T cells.

Magnetoencephalography measurements during behavioral tasks

Motion analysis including biomechanical assessments of the subject's mobility, postural balance, upper extremity motor control and resting state tremor.

Howard Gendelman, MD

Margaret R. Larson Professor of Internal Medicine and Infectious Diseases;Chairman, Department of Pharmacology and Experimental Neuroscience;Director of the Center for Neurodegenerative Diseases

Sanofi

National Institute of Neurological Disorders and Stroke (NINDS)

UNeMed

Nebraska Neuroscience Alliance

Eligible subjects will be randomized to one of the two treatment group in1:1 ratio to receive either DEX or matching placebo (PBO, LR).

Subjects undergoing one or two level spinal fusion surgery will be screened for eligibility to participate in the study. Subject will be screened, recruited and randomized during the preadmission visit or the day of surgery. Eligible subjects will be randomized to one of the two treatment group in1:1 ratio to receive either DEX or matching placebo (PBO, LR).

Placebo Group

Fifty six subjects (28 in each arm) will be enrolled. Subjects undergoing one or two level spinal fusion surgery will be screened for eligibility to participate in the study. Subject will be screened, recruited and randomized during the preadmission visit or the day of surgery. Eligible subjects will be randomized to one of the two treatment group in1:1 ratio to receive either DEX or matching placebo (PBO, LR).

Dexmedetomidine Group

Total

Sex: Female, Male

The QoR-40 is a 40 item questionnaire in which each question is answered with a score of 1-5. QoR-40 scores range from 40 (extremely poor quality of recovery) to 200 (excellent quality of recovery).

Anesthesia maintained with propofol/fentanyl/dexmedetomidine

Dexmedetomidine Group (PFD)

Anesthesia maintained with propofol/fentanyl/saline

Placebo Group (PFS)

Quality of Recovery Score (QoR-40)

Concentration of TNF-alpha

Concentration of IL-1a

Concentration of IL-6

Concentration of IL-8

Overall Study

Alex Bekker

Spinal Stenosis

Inflammation

Dexmedetomidine group

Placebo group

NYU Langone Medical Center, Department of Anesthesiology

Hospital for Special Surgery

Pilot Study on the Effect of Dexmedetomidine on Inflammatory Responses in Patients Undergoing Lumbar Spinal Fusion

NYU Langone Health

Hospira, now a wholly owned subsidiary of Pfizer

Stage III or Stage IV Melanoma

Two intradermal treatments each week for first 4 weeks followed by one intradermal treatment per week for second 4 weeks.

immunostimulator/fatigue

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

Leukine (Sargramostim) for Parkinson's Disease

Pilot Study on the Effect of Dexmedetomidine on Inflammatory Responses in Patients Undergoing Lumbar Spinal Fusion

Safety Study of CADI-05 in Patients With Advanced Stage Melanoma

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