Clinical Trials Logo

Clinical Trial Summary

The primary objective is to assess tolerability and safety of a personalized neo-antigen vaccine containing up to 15 peptides derived from somatic mutation of the individual patient's cancer, with CAF09b as adjuvant. The vaccine formulation will be administered in combination with an approved anti-PD-1 or anti-PD-L1 inhibitor to patients with advanced solid tumors. The endpoint is the characterization of adverse events (AE) assessed by CTCAE 4.0. The secondary objective is feasibility to manufacture a personalized neo-antigen vaccine within 6 weeks of enrolment with the PIONEER pipeline, and to evaluate the immune response before, during and after treatment with the personalized neo-antigen vaccine. And evaluate the effect on the immune response correlated to dose escalation of peptides in the vaccine. The endpoint is to evaluate the induction of adaptive immune responses to the personalized neo-antigen vaccine measured by functional assays and peptide-MHC multimer stainings. The tertiary objective is to evaluate the clinical efficacy of the treatment. The endpoints will be objective responses (OR), progression free survival (PFS) and overall survival (OS).


Clinical Trial Description

Cancer immunotherapy has shown the ability to improve the survival of patients with multiple types of advanced cancers. The human immune system can recognize the products of somatic genetic alterations in tumors, or neo-antigens, which are not expressed on normal cells. These neoantigens are an attractive immune target because their selective expression on tumors can minimize immune tolerance as well as the risk of side effects such as autoimmune reaction. Although neoantigens are ideal targets for cancer immunotherapies, most neoantigens arise from unique mutations and are not shared between individual patients. Thus, neoantigen-directed immunotherapy will need to be personalized. Novel technical advances in next-generation sequencing allow fast and systematic prediction of cancer neoantigens for each individual patient. Initial attempts of therapeutic cancer vaccination targeting individual neo-antigens have proven non-toxic and met their immunological endpoints. In this study investigators will use the proprietary platform PIONEER for fast and accurate identification of a neo-antigen vaccine tailored to each individual patient. The vaccine, based on 5-15 peptides derived from a patient's tumor individual neo-antigens, will be formulated with a novel adjuvant to strengthen CD8+ T cell immunity to cancer. Immune checkpoint inhibitors targeting PD-1 or PD-L1 will be administered both before, during and after vaccination to unleash the activity of vaccine-induced immune responses. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03715985
Study type Interventional
Source Herlev Hospital
Contact
Status Active, not recruiting
Phase Phase 1/Phase 2
Start date January 28, 2019
Completion date December 1, 2022

See also
  Status Clinical Trial Phase
Terminated NCT03168464 - Radiation and Immune Checkpoints Blockade in Metastatic NSCLC (BMS # CA209-632) Phase 1/Phase 2
Recruiting NCT05117242 - Safety and Efficacy Study of GEN1046 as a Single Agent or in Combination With Pembrolizumab for Treatment of Recurrent (Non-small Cell) Lung Cancer Phase 2
Completed NCT04470440 - Thyroid Dysfunction and Nivolumab Reponse in NSCLC
Completed NCT03304093 - Immunotherapy by Nivolumab for HIV+ Patients Phase 2
Terminated NCT04069936 - Marrow Infiltrating Lymphocytes - Non-Small Cell Lung Cancer (MILs™ - NSCLC) Alone or in Combination With Nivolumab With or Without Tadalafil in Locally Advanced and Unresectable or Metastatic NSCLC Phase 2
Active, not recruiting NCT03307785 - Study of Niraparib, TSR-022, Bevacizumab, and Platinum-Based Doublet Chemotherapy in Combination With TSR-042 Phase 1
Recruiting NCT06100796 - Effect of DM on Outcomes and Response Rate in Patients With Advanced NSCLC on ICI
Recruiting NCT03533127 - A Study of LY01008 and Bevacizumab Combined With Paclitaxel and Carboplatin for Treatment of Naïve Subjects With Metastatic or Recurrent Nonsquamous Non-small Cell Lung Cancer Phase 3
Completed NCT04187768 - Immunological Profile Changes In Patients With Advanced Non-Small Cell Lung Cancer
Active, not recruiting NCT04951583 - Fecal Microbial Transplantation Non-Small Cell Lung Cancer and Melanoma Phase 2
Active, not recruiting NCT03133546 - Osimertinib and Bevacizumab Versus Osimertinib Alone as Second-line Treatment in Stage IIIb-IVb NSCLC With Confirmed EGFRm and T790M (BOOSTER) Phase 2
Completed NCT03845270 - Her2-positive Lung Cancer Treated With Dedicated Drug Phase 2
Recruiting NCT05274451 - A Study to Investigate LYL797 in Adults With Solid Tumors Phase 1
Recruiting NCT03774732 - PD-1 Inhibitor and Chemotherapy With Concurrent Irradiation at Varied Tumour Sites in Advanced Non-small Cell Lung Cancer Phase 3
Recruiting NCT04621188 - Lorlatinib After Failure of First-line TKI in Patients With Advanced ROS1-positive NSCLC (ALBATROS) Phase 2
Active, not recruiting NCT03235765 - Cancer Panel From Blood of Lung Cancer Patients
Not yet recruiting NCT03732482 - Temozolomide Combine With Intensity Modulated Radiation Therapy With Simultaneous Integrated Boost for Non Small Cell Lung Cancer Brain Metastases Phase 2/Phase 3
Active, not recruiting NCT02978404 - Combining Radiosurgery and Nivolumab in the Treatment of Brain Metastases Phase 2
Recruiting NCT05853887 - Liquid Biopsy Based NGS in Newly Diagnosed NSCLC N/A
Recruiting NCT05429320 - A Study of Local Ablative Therapy (LAT) in People With Non-Small Cell Lung Cancer (NSCLC) Phase 2