Clinical trial · Observational
A Study of Personalized Neoantigen Cancer Vaccines
An Observational Feasibility Study for the Production of a Patient-Specific Neoantigen Cancer Vaccine and Screening Study for a Shared Neoantigen Cancer Vaccine in Patients With Advanced Cancer
NCT03794128CI-TRIAL-00047123completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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 neoantigens; and, 2) to identify and select patients who may be eligible for a shared neoantigen cancer vaccine where their tumor contains a specific shared mutation and who have the correct HLA allele capable of presenting the neoantigen derived from the tumor-specific mutation.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Gastroesophageal Adenocarcinoma | — | UNRESOLVED | — |
| Non Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| Pancreatic Ductal Adenocarcinoma | Pancreatic Ductal Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Urothelial Carcinoma | Urothelial Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood collection for research (HLA typing) | Procedure | — | UNRESOLVED |
| Blood collection for research (next-generation sequencing [NGS]) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- 1 - patient-specific neoantigen cancer vaccine production
- interventionNames
- Procedure: Blood collection for research (next-generation sequencing [NGS])
- Procedure: Blood collection for research (HLA typing)
- label
- 2 - shared neoantigen cancer vaccine screening
- interventionNames
- Procedure: Blood collection for research (HLA typing)
Primary outcomes (3)
- measure
- Group 1 only: Presence of neoantigens sufficient to warrant patient-specific vaccine manufacture
- timeFrame
- At study enrollment
- measure
- Group 1 only: Percentage of patients for whom patient-specific vaccine is successfully manufactured (defined as meeting release criteria)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Group 1 Inclusion Criteria: * Provide a signed and dated informed consent form prior to initiation of study-specific procedures * Patients with the indicated advanced or metastatic solid tumor as follows: 1. NSCLC who have received ≤ 1 cycle of systemic treatment with cytotoxic, platinum-based chemotherapy (Note: patients with NSCLC who are receiving pembrolizumab monotherapy as first line systemic monotherapy are eligible) 2. GEA who have received ≤ 1 cycle of systemic treatment with cytotoxic, platinum-based chemotherapy 3. mUC who have received ≤ 1 cycle of systemic treatment with cytotoxic, platinum-based chemotherapy 4. CRC-microsatellite stable (MSS) who have received ≤ 1 cycle of second line systemic therapy including a fluoropyrimidine and oxaliplatin or irinotecan (Note: patients receiving first-line systemic therapy are eligible) * 18 years of age or older * ECOG Performance Status 0 or 1 * Available FFPE tumor specimen for sequencing and neoantigen selection * Measurable disease according to RECIST v1.1 Have adequate organ function, as measured by laboratory values (criteria listed in protocol) Group 1 Exclusion Criteria: * Tumors with genetic characteristics as follows: 1. For NSCLC, patients with a known driver genomic alteration in EGFR, ALK, ROS1, RET, or TRK 2. For CRC or GEA, patients with MSI disease 3. For CRC, patients with a known BRAF mutation or patients with peritoneal carcinomatosis Group 2 Inclusion Criteria: * Provide a signed and dated informed consent form prior to initiation of study-specific procedures * Patient's tumor possesses one of the mutations listed in the clinical study protocol, as determined per local institutional standard * Patients with an advanced or metastatic solid tumor as follows: 1. MSS-CRC who are currently receiving systemic treatment with a fluoropyrimidine and oxaliplatin or irinotecan that may include a VEGF or EGFR targeting therapy as their first-line or second-line therapy for metastatic disease 2. NSCLC who are currently receiving systemic treatment with cytotoxic, platinum-based chemotherapy in combination with an anti-PD-(L)1 antibody 3. PDA who are currently receiving systemic cytotoxic chemotherapy as their first-line therapy for metastatic disease Group 2 Exclusion Criteria * Patients with MSI disease * Patients with NSCLC with a known driver genomic alteration in EGFR, ALK, ROS1, RET, or TRK Complete inclusion and exclusion criteria are listed in the clinical study protocol.
References
Publications (0)
Data not yet available
No reference posted for this study.