A Study to Evaluate Safety, Feasibility, Efficacy of Multiple Dosing With VB10.NEO Immunotherapy in Patients With Locally Advanced or Metastatic Cancer
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|ClinicalTrials.gov Identifier: NCT03548467|
Recruitment Status : Recruiting
First Posted : June 7, 2018
Last Update Posted : June 25, 2018
|Condition or disease||Intervention/treatment||Phase|
|Locally Advanced or Metastatic Solid Tumours||Drug: VB10.NEO||Phase 1 Phase 2|
This open labelled first in human dose phase 1/2a study is designed to evaluate safety, feasibility and efficacy of multiple dosing with individualised VB10.NEO immunotherapy in patients with locally advanced or metastatic solid tumours including melanoma, non-small cell lung cancer (NSCLC), clear renal cell carcinoma, urothelial cancer or squamous cell carcinoma of the head and neck (SCCHN), who did not reach complete responses with immune checkpoint inhibitor (CPI) therapy as their standard of care (SOC) treatment.
Upon screening, the patients must have been receiving for at least 12 weeks a CPI (anti-PD-1 or anti-PD-L1) as the patient's standard of care, and according to currently approved indications. The VB10.NEO vaccine will be added to this continuing CPI treatment and shall not replace, omit, postpone or terminate the standard therapy. Patients will be enrolled in case of some benefit to CPI treatment is expected, as defined by partial remission, stable disease or disease progression (in case of a mixed response to CPI, provided at least one lesion shows measurable regression and patient, according to the investigator, would have a clinical benefit of continued immunotherapy).
The assumption is to combine the immuno-stimulating effect of CPIs with immune responses towards specific neo-antigens in the vaccine, which may possibly increase the anti-tumour effect to reach durable efficacy
The study will be conducted in two parts. Part A will evaluate safety, feasibility and efficacy of individualised VB10.NEO immunotherapy. The expansion part B will explore efficacy and safety in further patients with selected types of cancer showing signs of effect during part A.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||65 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Open Label|
|Masking:||None (Open Label)|
|Official Title:||An Open Labelled First Human Dose Phase 1/2a Study to Evaluate Safety, Feasibility, Efficacy of Multiple Dosing With Individualised VB10.NEO Immunotherapy in Patients With Locally Advanced or Metastatic Melanoma, Non-small Cell Lung Cancer (NSCLC), Clear Renal Cell Carcinoma, Urothelial Cancer or Squamous Cell Carcinoma of Head and Neck, Who Did Not Reach Complete Responses With Current Standard of Care Immune Checkpoint Blockade|
|Actual Study Start Date :||April 4, 2018|
|Estimated Primary Completion Date :||January 2023|
|Estimated Study Completion Date :||March 2023|
Treatment with individualized VB10.NEO immunotherapy will commence as soon as the patient-specific VB10.NEO vaccine is available and if the patient-specific vaccine meets all pre-specified product release criteria after manufacturing. The vaccinations will be given as intramuscular injection by the study personnel at the study centres.
VB10.NEO is a vaccine and is supplied as a sterile, ready to use solution (14 vaccinations will be given).
- Rate of Adverse Events including SAEs (Safety/tolerability) [ Time Frame: Up to 24 months ]Total number, severity (CTCAE grade) of adverse events(AEs), and if AE is leading to treatment discontinuation.
- Immunogenicity by T-cell activity to each neoepitope of VB10.NEO immunotherapy [ Time Frame: Up to 24 months ]Descriptive analyses for each patient of of the immune-response to each neoepiotope
- Objective Response Rate (ORR) [ Time Frame: Up to 24 months ]Description of tumor response by iRECIST at regular intervals
- Duration of Response (DOR) [ Time Frame: Up to 24 months ]Descriptive analysis of DOR by iRECIST at regular intervals
- Progression-free survival (PFS) [ Time Frame: Up to 24 months ]Descriptive analysis of PFS by iRECIST at regular intervals
- Survival at end of treatment (EoT) and end of study (EoS) [ Time Frame: At 14 months and 24 months ]Proportion of patients who are live at EoT and EoS
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03548467
|Contact: Hedda Wold||+47 email@example.com|
|Krankenhaus Nordwest gGmbH||Recruiting|
|Frankfurt, Germany, 60488|
|Contact: Elke Jäger, PhD|
|University Hospital Heidelberg, NCT, Im Neuenheimer Feld 460||Recruiting|
|Heidelberg, Germany, 69120|
|Contact: Jürgen Krauss, Dr. +49-6221- 56 - 32837 mailto:firstname.lastname@example.org|
|Contact: Jutta Schreiber mailto:Jutta.email@example.com|
|Klinik und Poliklinik für Innere Medizin III, Hämatologie und Onkologie||Recruiting|
|Munich, Germany, 81675|
|Contact: Angela Krackhardt, PhD|
|Study Director:||Mads Axelsen, MD||Sponsor GmbH|