Aktuelle klinische Studien

NOA-16 Targeting IDH1R132H in WHO grade III-IV IDH1R132Hmutated gliomas by a peptide vaccine – a Phase I safety, tolerability and immunogenicity multicenter trial (EudraCT 2014-000503-27). Contribution of IMU: PBMC, serum and plasma processing for and IFNγ-ELISpot assay and IDH1R132H antibody response via ELISA as part of the primary endpoint analysis.

The NOA-16 trial is the first-in-man trial of the IDH1 (isocitrate dehydrogenase type 1) peptide vaccine targeting the IDH1R132H mutation (amino acid exchange from arginine to glutamine at position 132 of IDH1). The aim of this trial is to evaluate the safety and tolerability of and immune response to the IDH1 peptide vaccine in patients with IDH1R132H-mutated, WHO grade III-IV gliomas.

POSITIVE III Physical exercise program in lung cancer patients with non-operable disease undergoing palliative treatment - Lung Cancer Study - (NCT02055508). Contribution of IMU: PBMC, serum and plasma processing for and IFNᵞ-ELISpot assays, Cytokine screening and Treg FACS as part of the secondary endpoint analysis.

Patients with advanced stage non-small cell lung cancer (NSCLC) or small cell lung cancer (SCLC) often experience multidimensional impairments, affecting quality of life during their course of disease. In lung cancer patients with operable disease, several studies have shown that exercise has a positive impact on quality of life and physical functioning. There is limited evidence regarding efficacy for advanced lung cancer patients undergoing palliative treatment. Therefore, the POSITIVE study aims to evaluate the benefit of a 24-week exercise intervention during palliative treatment in a randomized controlled setting.

TNBC-MERIT / BN_0002-01 RNA Vaccination of breast tumor patients. Contribution of IMU: PBMC processing as part of the secondary endpoint analysis.

The Mutanome Engineered RNA Immuno-Therapy (MERIT) study introduces a novel concept for Individualized Cancer Immunotherapy (IVAC®) to treat each patient with the relevant and immunogenic RNA vaccines for a given patient's tumour. The TNBC-MERIT trial uses two complementary strategies, the IVAC® WAREHOUSE and the IVAC® MUTANOME concept, resulting in two custom-made IVAC® investigational medicinal products (IMPs) (IVAC_W_bre1_uID and IVAC_M_uID) for each individual patient.

VXM01-02-DE VXM01 phase I pilot study in patients with operable recurrence of a glioblastoma to examine safety, tolerability, immune and biomarker response to the investigational VEGFR-2 DNA vaccine VXM01 (EudraCT 2015-003067-10). Contribution of IMU: PBMC processing and IFNγ-ELISpot assay as part of the secondary endpoint analysis.

VXM01-03-DE VXM01 phase I study in patients with metastatic colorectal cancer with liver metastasis under second or third line therapy to examine safety, efficacy, and immune biomarkers after treatment with VXM01 (EudraCT 2015-003068-34). Contribution of IMU: PBMC processing as part of the secondary endpoint analysis.

ATACC Phase I Trial of Adoptive T cell Therapy with Activated P53 Specific T cells for Treatment of Advanced Colorectal Cancer (EudraCT 2013-000064-28). Contribution of IMU: QC of product process (p53+ T cell isolation), screening and monitoring of p53+ T cell responses via IFNγ-ELISpot assay.

FORCE Fostering efficacy of anti – PD-1 – treatment: Nivolumab plus radiotherapy in advanced NSCLC, Open label phase II trial (EudraCT 2015-005741-31). Beitrag der IMU: PBMC, Serum und Plasma Isolation, IFNγ-ELISpot Assay, FACS auf Checkpoint Inhibitoren, Luminex und TCR Sequenzierung als Teil des translationalen Forschungsprojektes.

AIO-YMO/TRK-0415 (FORCE) is a Phase 2, open-label of nivolumab, patients with metastatic non-squamous NSCLC with the necessity of radiotherapy of a metastatic site (e.g. bone) in 2nd-line or 3rd-line treatment for study group A and patients with metastatic non-squamous NSCLC without the necessity of radiotherapy in 2nd-line or 3rd-line treatment for study Group B

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