Clinical trial · Observational
A Screening Study Targeting Tumor-specific Antigens
A Screening Study for the Selection of Patients for Clinical Studies Targeting Tumor-specific Antigens
NCT05158621CI-TRIAL-00061505completedClinicalTrials.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 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 metastatic, microsatellite-sable colorectal cancer (MSS-CRC) sponsored by Gritstone bio. This may include the manufacturing of an individualized vaccine, which involves neoantigen prediction and generating a vaccine targeting neoantigens.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Stage II/III Colon Cancer | Colorectal Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| blood collection for research (circulating tumor DNA [ctDNA]) | Procedure | — | UNRESOLVED |
| 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
- Advanced/Metastatic Colorectal Cancer
- description
- Eligible patients include those with newly-diagnosed or recurrent advanced/metastatic CRC who are initiating fluoropyrimidine and oxaliplatin (FOLFOX or CAPEOX) in combination with bevacizumab. Patients will then be assessed to determine if sufficient neoantigens are identified using Gritstone's proprietary prediction algorithm, EDGE(TM), to warrant manufacturing of an individualized vaccine. Patients with sufficient neoantigens will have vaccine manufactured while receiving FOLFOX or CAPEOX/bevacizumab.
- interventionNames
- Procedure: blood collection for research (next generation sequencing [NGS])
- Procedure: blood collection for research (HLA typing)
- label
- Localized Colon Cancer
- description
- Eligible patients include those with high-risk Stage II or Stage III colon cancer who have MRD based on the presence of ctDNA following surgical resection. Patients with MRD will then be assessed to determine if sufficient neoantigens are identified using Gritstone's proprietary prediction algorithm, EDGE(TM), to warrant manufacturing of an individualized vaccine.
- interventionNames
- Procedure: blood collection for research (next generation sequencing [NGS])
- Procedure: blood collection for research (HLA typing)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 12 Years
Show eligibility criteria text
ADVANCED/METASTATIC COLORECTAL CANCER Inclusion Criteria: * signed and dated ICF prior to initiation of study-specific procedures * histologically confirmed metastatic CRC who are planned for or who have received no more than one cycle of first-line treatment in the advanced/metastatic setting with a fluoropyrimidine and oxaliplatin in combination with bevacizumab * measurable and unresectable disease according to RECIST v1.1 * known KRAS status * availability of FFPE tumor specimens from biopsy within the previous 12 months for sequencing and neoantigen prediction * ≥ 12 years of age * ECOG performance status of 0 or 1 or equivalent for patients of 12-17 years of age * adequate organ function (further defined in protocol) Exclusion Criteria: * known microsatellite instability (MSI)hi disease based on institutional standard * known tumor mutation burden \<1 nonsynonymous mutations/MB * patients with BRAF V600E mutations LOCALIZED COLON CANCER Inclusion Criteria: * signed and dated ICF prior to initiation of study-specific procedures * high-risk stage II or stage III colon cancer planned for or have completed surgical resection and have not initiated or received more than 4 weeks of adjuvant chemotherapy and be known ctDNA-positive via the Signatera assay * availability of FFPE tumor specimens for sequencing, determination of mutations for detecting and monitoring ctDNA to identify patients with minimal residual disease, and neoantigen prediction * ≥ 12 years of age * ECOG performance status of 0 or 1 or equivalent for patients of 12-17 years of age * adequate organ function (further defined in protocol) Exclusion Criteria: * known microsatellite instability (MSI)hi disease based on institutional standard * known tumor mutation burden \<1 nonsynonymous mutations/MB Complete list of inclusion and exclusion criteria are listed in the clinical study protocol
References
Publications (0)
Data not yet available
No reference posted for this study.