Symptoms and General Pathology

All Conditions

Neoplasms

Rare Diseases

Recurrence

Glioblastoma

Astrocytoma

Glioma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Neuroepithelioma

All Drugs and Chemicals

Antineoplastic Agents

Antibodies

Vaccines

Avelumab

Immunoglobulins

Antineoplastic Agents, Immunological

Combination of VXM01, Ty21a transformed with a eukaryotic expression cassette encoding VEGFR-2, and anti-PD-L1 Checkpoint Inhibitor Avelumab

Ty21a transformed with a eukaryotic VEGFR-2 Expression Plasmid

VXM01

Wolfgang Wick, MD

VXM01 in combination with avelumab in n=30 patients with progressive glioblastoma following standard treatment, with or without second surgery

The trial is conducted as a multicenter, open-label, Phase I/II trial to evaluate the efficacy and safety of VXM01 in combination with avelumab in subjects with resectable and non-resectable progressive glioblastoma following tumor resection and radiochemotherapy containing temozolomide.

The trial will be performed in 30 subjects with progressive glioblastoma:

* 24 subjects who will not be candidates for a tumor re-operation (non-resectable subjects)
* 6 subjects who will be candidates for a tumor re-operation (resectable subjects) The trial, for each subject, will consist of a screening period, a treatment and observatioon phase of 60 weeks including, a treatment phase of up to 48 weeks with prime and boosting administrations of VXM01 in combination with avelumab and an observation phase of 12 weeks and with an end of trial visit at Week 60.

Subjects will receive VXM01 in combination with avelumab up to Week 48. The end of study (EoS) visit assessments will be performed Week 60.

VXM01 Plus Avelumab Combination Study in Progressive Glioblastoma

An Open-label, Phase I/II Multicenter Clinical Trial of VXM01 in Combination With Avelumab in Patients With Progressive Glioblastoma Following Standard Treatment, With or Without Second Surgery

AEs listed together with information on onset, duration, severity, seriousness, relationship to the study drug, relationship to chemotherapy and to the underlying disease, outcome, and action taken. Frequency tables by System Organ Class and preferred term.

TTP is defined from the day of trial entry to the day of local tumor progression based on MRI (in days)

PFS is defined from the day of trial entry to the day of local tumor progression or recurrence after reoperation, based on MRI, or further positive biopsy, or the day of death of any cause. Subjects free of progression/recurrence will be censored at the day of last tumor assessment (in days)

RFS is defined from the day of trial entry to the day of recurrence after reoperation, based on MRI (in days)

OSOS will be defined by death of any cause and subjects alive at trial end will be censored at last contact day (in days)

The proportion of subjects with OR will be estimated together with 95% confidence intervals constructed using the binomial Distribution (in %)

The DoR on MRI according to iRANO will be summarized descriptively for the two subgroups and illustrated using a Kaplan-Meier plot

Merck KGaA, Darmstadt, Germany

Pfizer

Vaximm GmbH

Digestive System Diseases

Gland and Hormone Related Diseases

Pancreatic Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

Pharmaceutical Solutions

Gemcitabine

Angiogenesis Inhibitors

Investigational anti-angiogenic live cancer vaccine

Live anti-angiogenic cancer vaccine drink solution, escalating dose

Placebo

Thomas Schmidt, MD

First-in-human phase I dose escalation study in patients with locally advanced, inoperable and stage IV pancreatic cancer to examine safety, tolerability, and immune response to the investigational VEGFR-2 DNA vaccine VXM01 to examine safety and tolerability, clinical and immunogenic response to the investigational vascular endothelial growth factor receptor 2 (VEGFR-2) DNA vaccine VXM01, and to define the maximum tolerated dose.

VXM01 Phase I Dose Escalation Study in Patients With Locally Advanced, Inoperable and Stage IV Pancreatic Cancer

VXM01 Phase I Dose Escalation Study in Patients With Locally Advanced, Inoperable and Stage IV Pancreatic Cancer to Examine Safety, Tolerability, and Immune Response to the Investigational VEGFR-2 DNA Vaccine VXM01

Number of dose-limiting toxicities and maximum tolerated dose

Tumor staging according to RECIST criteria

Neoplasm Metastasis

Colorectal Neoplasms

Intestinal Neoplasms

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Hematinics

Immunomodulating Agents

Liver Extracts

Carsten Gruellich, MD

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

VXM01 Phase I Study in Patients With Metastatic Colorectal Cancer With Liver Metastasis

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

Patient-individual VEGFR-2 specific T-cell responses determined by ELISpot using cryopreserved peripheral blood mononuclear cells (PBMC)

Immune biomarker including T-cell infiltration, Treg, myeloid derived suppressor cells (MDSC) by tumor tissue immunohistochemistry staining

Serum VEGF A and collagen IV measured by ELISA

Tumor staging according to the response criteria in solid tumors (RECIST) and investigation of the primary tumor and metastasis, e.g., determination of primary tumor size, number and size of metastasis.

Bacterial vector tissue biodistribution, persistence, and shedding of viable Ty21a bacteria (VXM01) determined by cultivation of stool samples

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
VXM01 Plus Avelumab Combination Study in Progressive Glioblastoma	NCT03750071	Recurrent Gliob...	VXM01 Avelumab	18 Years -	Vaximm GmbH
VXM01 Phase I Dose Escalation Study in Patients With Locally Advanced, Inoperable and Stage IV Pancreatic Cancer	NCT01486329	Stage IV Pancre...	VXM01 Placebo	18 Years -	Vaximm GmbH
VXM01 Phase I Dose Escalation Study in Patients With Locally Advanced, Inoperable and Stage IV Pancreatic Cancer	NCT01486329	Stage IV Pancre...	VXM01 Placebo	18 Years -	Vaximm GmbH
VXM01 Phase I Study in Patients With Metastatic Colorectal Cancer With Liver Metastasis	NCT02718430	Colorectal Canc...	VXM01	18 Years -	Vaximm GmbH

Spots Global Cancer Trial Database for vxm01

Every month we try and update this database with for vxm01 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for vxm01

Every month we try and update this database with for vxm01 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for vxm01 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.