Clinical trials: Personalized Neoantigen Cancer Vaccine
Metastatic Melanoma
A Personal Cancer Vaccine (NEO-PV-01) and APX005M or Ipilimumab With Nivolumab in Patients With Advanced Melanoma
The primary purpose of this study is to demonstrate that the NEO-PV-01 vaccine, either with APX005M or ipilimumab, and nivolumab is safe for the treatment of patients with advanced or metastatic melanoma.
- Trial name
- NCT03597282
- Testing
- NEO-PV-01, Nivolumab, Adjuvant
- Where
- 8 sites in United States
- Volunteers
- 22 people
- Sponsor
- BioNTech US Inc.
Non Small Cell Lung Cancer
FRAME-001 Personalized Vaccine in NSCLC
Despite encouraging results of programmed cell death protein -1 (PD-1) immune checkpoint inhibitor treatment combined with chemotherapy in advanced non-small cell lung cancer (NSCLC), only the minority of approximately 20% of…
- Trial name
- NCT04998474
- Testing
- FRAME-001 personalized vaccine
- Where
- 3 sites in Netherlands
- Volunteers
- 15 people
- Sponsor
- Frame Pharmaceuticals B.V.
Neoplasms
Pilot Study of Neoantigen Peptides for the Treatment of Neoplasms
This research is a pilot clinical trial using personalized neoantigen peptide vaccines with an adjuvant (Montanide ISA-51 VG), in patients with different types of cancer
- Trial name
- NCT04509167
- Testing
- Neoantigen Peptides
- Where
- Mexico
- Volunteers
- 30 people
- Sponsor
- Instituto de Medicina Regenerativa
Pancreas Cancer, Pancreas Cancer, Duct Cell Adenocarcinoma
A Study of mRNA Vaccines AK154 Monotherapy or in Combination With AK104/AK112,and Sequential mFOLFIRINOX in Surgically Resected PDAC
To explore safety and efficacy of neoantigen personalized mRNA vaccines AK154 monotherapy or in combination with AK104/AK112 and sequential mFOLFIRINOX regime in Resected PDAC
- Trial name
- NCT06913218
- Testing
- AK154, Cadonilimab, Ivonescimab (SMT112 or AK112) Injection
- Where
- China
- Volunteers
- 60 people
- Sponsor
- Akeso
Non-Small Cell Lung Cancer, Colorectal Cancer
A Study of a Personalized Cancer Vaccine Targeting Shared Neoantigens
The purpose of this study is to evaluate the dose, safety, immunogenicity and early clinical activity of GRT-C903 and GRT-R904, a neoantigen-based therapeutic cancer vaccine, in combination with immune checkpoint blockade, in…
- Conditions
- Non-Small Cell Lung Cancer, Colorectal Cancer, Pancreatic Cancer, Solid Tumor
- Trial name
- NCT03953235
- Testing
- GRT-C903, GRT-R904, nivolumab
- Where
- 12 sites in United States
- Volunteers
- 39 people
- Sponsor
- Gritstone bio, Inc.
Endometrial Carcinoma, Endometrial Carcinoma Stage III
GYNORYLAQ™-VLINIVAL™: Ψ-Guided Personalized Neoantigen Peptide Vaccine for High-Risk Endometrial Cancer
GYNORYLAQ-VLINIVAL is an Early Phase I, non-randomized, single-arm, open-label clinical trial enrolling 40 patients with high-risk or recurrent endometrial carcinoma.
- Trial name
- GYNORYLAQ™ (NCT07316361)
- Testing
- • Biological: GYNORYLAQ-TM Personalized Neoantigenic Peptide Vaccine
- Where
- Greece
- Volunteers
- 40 people
- Sponsor
- Biogenea Pharmaceuticals Ltd.
NSCLC (Non-small Cell Lung Cancer), Squamous Lung Cancer With FGFR1 Amplification
Clinical Study of the Therapeutic Effectiveness of In-silico-Designed, Machine Learning Inspired, and Quantum-molecularly Coupled Personalized Neoantigenic Vaccines Microlyvaq™ in Patients With Advanced Non-small Cell Lung Cancer
Microlyvaq™ is a first-line, non-randomized, two-arm clinical trial in advanced non-small cell lung cancer (NSCLC). In both arms, patients receive a personalized multi-epitope vaccine (Microlyvaq™) on top of standard-of-care…
- Conditions
- NSCLC (Non-small Cell Lung Cancer), Squamous Lung Cancer With FGFR1 Amplification, Non-Squamous Non Small Cell Lung Cancer
- Trial name
- Microlyvaq™ (NCT07285434)
- Testing
- Microlyvaq™ (Personalized Multi-Epitope Immunotherapeutic)
- Where
- Greece
- Volunteers
- 90 people
- Sponsor
- Biogenea Pharmaceuticals Ltd.
Non Small Cell Lung Cancer, Colorectal Cancer
A Study of Personalized Neoantigen Cancer Vaccines
The purpose of this study is 1) to evaluate the feasibility of manufacturing a patient-specific neoantigen cancer vaccine, which involves predicting the patient's neoantigens and generating a vaccine that encodes the predicted…
- Conditions
- Non Small Cell Lung Cancer, Colorectal Cancer, Gastroesophageal Adenocarcinoma, Urothelial Carcinoma
- Trial name
- NCT03794128
- Testing
- Blood collection for research (next-generation sequencing [NGS]), Blood collection for research (HLA typing)
- Where
- 5 sites in United States
- Volunteers
- 93 people
- Sponsor
- Gritstone bio, Inc.
Non Small Cell Lung Cancer, Neoepitopes
AImmune - Artificial Intelligence Algorithm for Identification of Immunogenic Neoepitopes of Cancer to Predict and Boost Patient's Response to Immunotherapies.
The goal of the project is to develop and validate A.I.mmune technology. It performs complex analyses of patients' tumor and immune system state using data derived from next-generation sequencing of tumor and healthy tissue to…
- Conditions
- Non Small Cell Lung Cancer, Neoepitopes, Neoantigens, Immunotherapy
- Trial name
- NCT04145232
- Testing
- Collection of biopsy (FFPE), blood (PBMC) and stool
- Where
- Poland
- Volunteers
- 30 people
- Sponsor
- Ardigen
Esophageal Cancer, Non Small Cell Lung Cancer
Clinical Study of Personalized mRNA Vaccine Encoding Neoantigen in Patients With Advanced Esophageal Cancer and Non-small Cell Lung Cancer
A single arm, open-label pilot study is designed to determine the safety, tolerability and effectiveness of personalized mRNA tumor vaccine encoding neoantigen in Patients with advanced esophageal cancer and non-small cell lung…
- Trial name
- NCT03908671
- Testing
- Personalized mRNA Tumor Vaccine
- Where
- China
- Volunteers
- 24 people
- Sponsor
- Stemirna Therapeutics
Neoplasms
Pilot Study of Neoantigen Peptides and Leukine for the Treatment of Neoplasms
The present study is a pilot clinical trial using personalized neoantigen peptide vaccines with the addition of Leukine (Sargramostim), in patients with different types of cancer.
- Trial name
- NCT05475106
- Testing
- Neoantigen Peptides
- Where
- Mexico
- Volunteers
- 100 people
- Sponsor
- Instituto de Medicina Regenerativa
Metastatic Colorectal Cancer, Stage II/III Colon Cancer
A Screening Study Targeting Tumor-specific Antigens
The purpose of this study is to identify patients who may be eligible to participate in a separate Phase 2/3 treatment study evaluating an individualized neoantigen vaccine GRANITE for first line (1L) maintenance treatment of…
- Trial name
- NCT05158621
- Testing
- blood collection for research (next generation sequencing [NGS]), blood collection for research (HLA typing), blood collection for research (circulating tumor DNA [ctDNA])
- Where
- 6 sites in United States
- Volunteers
- 22 people
- Sponsor
- Gritstone bio, Inc.
Non Small Cell Lung Cancer, Colorectal Cancer
A Study of a Personalized Neoantigen Cancer Vaccine
The purpose of this study is to evaluate the safety, dose, immunogenicity and early clinical activity of GRT-C901 and GRT-R902, a personalized neoantigen cancer vaccine, in combination with nivolumab and ipilimumab, in patients…
- Conditions
- Non Small Cell Lung Cancer, Colorectal Cancer, Gastroesophageal Adenocarcinoma, Urothelial Carcinoma
- Trial name
- NCT03639714
- Testing
- GRT-C901, GRT-R902, nivolumab
- Where
- 11 sites in United States, Australia
- Volunteers
- 29 people
- Sponsor
- Gritstone bio, Inc.
Colorectal Neoplasms
A Study of a Patient-Specific Neoantigen Vaccine in Combination With Immune Checkpoint Blockade for Patients With Metastatic Colorectal Cancer
The primary objective of the Phase 2 portion of the study is to characterize the clinical activity of maintenance therapy with GRT-C901/GRT-R902 (patient-specific vaccines) in combination with checkpoint inhibitors in addition to…
- Trial name
- NCT05141721
- Testing
- GRT-C901, GRT-R902, Atezolizumab
- Where
- 43 sites in United States
- Volunteers
- 700 people
- Sponsor
- Seattle Project Corporation
Melanoma
An Efficacy Study of Adjuvant Treatment With the Personalized Cancer Vaccine mRNA-4157 and Pembrolizumab in Participants With High-Risk Melanoma (KEYNOTE-942)
The purpose of this study is to assess whether postoperative adjuvant therapy with mRNA-4157 and pembrolizumab improves recurrence free survival (RFS) compared to pembrolizumab alone in participants with complete resection of…
- Trial name
- NCT03897881
- Testing
- mRNA-4157, Pembrolizumab
- Where
- 23 sites in United States, Australia
- Volunteers
- 267 people
- Sponsor
- ModernaTX, Inc.
Pancreatic Ductal Adenocarcinoma (PDAC)
Expanded Access to PCNAT-01 for Patients With Resected Pancreatic Ductal Adenocarcinoma Following Surgical Resection and Adjuvant Therapy
This expanded access program provides a potential pathway for eligible patients with resected pancreatic ductal adenocarcinoma (PDAC) to receive PCNAT-01, an investigational, personalized tumor neoantigen peptide vaccine, outside…
- Trial name
- NCT07612930
- Testing
- PCNAT-01
- Sponsor
- Anda Biopharmaceutical Development (Shenzhen) Co., Ltd.
Colorectal Cancer Metastatic, Colorectal Cancer Stage III
COLONYVAQ™, a Quantum-Classical Guided Personalized Neoantigen Vaccine for MSS Stage III Colorectal Cancer
This is an early phase I, single-arm, open-label clinical study designed to evaluate the safety, tolerability, and feasibility of COLONYVAQ-CRC, a physics-aware, quantum-classical AI-guided personalized neoantigen peptide…
- Conditions
- Colorectal Cancer Metastatic, Colorectal Cancer Stage III, Colorectal Cancer Stage IV
- Trial name
- COLONYVAQ™-CRC (NCT07328087)
- Testing
- Experimental: COLONYVAQ-CRC + mFOLFOX6 or CAPOX + Nivolumab
- Where
- Greece
- Volunteers
- 12 people
- Sponsor
- Biogenea Pharmaceuticals Ltd.
Pancreatic Tumor
Clinical Trial on Personalized Neoantigen Vaccine for Pancreatic Tumor
This clinical trial is to evaluate the safety and impact on prognosis of personalized neoantigen peptide-based vaccines, which are based on next-generation sequencing and major histocompatibility complex affinity prediction…
- Trial name
- NCT03558945
- Testing
- Personalized neoantigen vaccine
- Where
- China
- Volunteers
- 30 people
- Sponsor
- Anda Biopharmaceutical Development (Shenzhen) Co., Ltd.
Cancer, Solid Tumor, Adult
Personalized Neoantigen Cancer Vaccine for Patients With Solid Tumors
This clinical trial aims to evaluate the safety, immunogenicity, and preliminary efficacy of a personalized neoantigen peptide vaccine in patients with advanced cancer or at high risk of recurrence.
- Trial name
- NCT06614140
- Testing
- Personalized Neoantigen Peptide Vaccine with Poly-ICLC and Checkpoint Inhibitors
- Where
- Thailand
- Volunteers
- 8 people
- Sponsor
- Seqker Biosciences, Inc.
Non-small Cell Lung Cancer (NSCLC)
A Study of the Efficacy and Safety of RO7198457 in Combination With Atezolizumab Versus Atezolizumab Alone Following Adjuvant Platinum-Doublet Chemotherapy in Participants Who Are ctDNA Positive After Surgical Resection of Stage II-III Non-Small Cell Lung Cancer
This study will evaluate the efficacy, safety, pharmacokinetics, immunogenicity and biomarkers of RO7198457 plus atezolizumab compared with atezolizumab alone in patients with Stage II-III non-small cell lung cancer (NSCLC) who…
- Trial name
- NCT04267237
- Testing
- Atezolizumab, RO7198457
- Sponsor
- Hoffmann-La Roche