Clinical trials
INTERCEPT H3 - A Multicenter Phase I Peptide Vaccine Trial to Exploit Neoepitope-Specific T Cells for the treatment of H3-Mutated Gliomas; status: open
The INTERCEPT H3 trial combines H3K27M peptide vaccination with radiotherapy and checkpoint inhibitor treatment in patients with diffuse midline gliomas.
Contribution of IMU: Coordination of sample logisitics and collection, training of external labs, processing of PBMC, serum, plasma, CSF and tumor for immune assays, including IFNγ ELISpot assays for immunogenicity assessment (primary endpoint), flow-cytometry, ELISA and TCR repertoire analysis for secondary endpoints and translational research.
NECVAX-NEO1-LT An open-label, phase I monocenter, clinical trial of NECVAX-NEO1
in addition to anti-PD-1 or anti-PD-L1 monoclonal antibody checkpoint inhibitor monotherapy in patients with solid tumors; status: recruiting
This trial makes use of a patient-individual salmonella Ty21a carrier-based DNA plasmid vaccine that can be orally administered and enrolls patients of different tumor entities.
Contribution of IMU: Training of external labs, logistic of PBMC collection, evaluation of antigen-specific T cell responses.
AMPLIVY NEOVAC (NOA-21) AMPLIFYing NEOepitope-specific VACcine Responses in progressive diffuse glioma – a randomized, open label, 3 arm multicenter Phase I trial to assess safety, tolerability and immunogenicity of IDH1R132H-specific peptide vaccine in combination with checkpoint inhibitor Avelumab; Status: recruiting
The trial will address safety and tolerability of the combination of the IDH1R132H-specific vaccine with checkpoint blockade and seeks to explore predictive biomarkers for response to checkpoint blockade in post-treatment tumor tissue.
Contribution of IMU: Tumor, PBMC, serum and plasma processing for IFNᵞ-ELISpot assays and anti-IDHR132H-ELISA as part of the secondary endpoint analysis; cytokine screening, flow cytometric profiling of immune cell subsets and TCR repertoire analysis for evaluation of explorative endpoints and translational research. Coordination of sample logistics and distribution.
Contribution of IMU: PBMC, serum and plasma isolation, flow cytometric analysis of immune biomarkers in fresh blood samples, multiplexed cytokine profiling, coordination of sample logistics and distribution.
FORCE Fostering efficacy of anti – PD-1 – treatment: Nivolumab plus radiotherapy in advanced NSCLC, Open label phase II trial; status: recruitment closed
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.
Contribution of IMU: PBMC, serum and plasma isolation, IFNγ-ELISpot Assay, FACS of checkpoint Inhibitory molecules, Luminex and TCR sequencing as part of the accompanying translational research.
POSITIVE III Physical exercise program in lung cancer patients with non-operable disease undergoing palliative treatment - Lung Cancer Study; status: recruitment closed
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.
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.
TNBC-MERIT / BN_0002-01 RNA Vaccination of breast tumor patients; status: recruitment closed
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.
Contribution of IMU: PBMC processing as part of the secondary endpoint analysis.
RADIMMUNE - A randomized phase II study of radiation induced immune boost in operable non-small cell lung cancer, status: recruitment closed
The goal of this randomized trial is to assess if a preoperative single fraction low-dose radiation is able to improve anti-tumor immune response in operable early stage lung cancer.
Contribution of IMU: Tissue collection and dissociation, in vitro expansion and flow cytometric analysis of tumor-infiltrating lymphocytes, TCR repertoire analysis.