A Screening Study Targeting Tumor-specific Antigens
Completed
Conditions studied: Metastatic Colorectal Cancer, Stage II/III Colon Cancer
In brief
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.
Key facts
- Study ID
- NCT05158621
- Run by
- Gritstone bio, Inc.
- People needed
- 22
- Starts
- 2021-12-14
- Expected to finish
- 2022-08-15
- Last updated by the study team
- 2022-10-18
Who can join
Age: 12 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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
Where it is running
- Miami Cancer Institute — Miami, Florida, United States
- Advanced Research — Tamarac, Florida, United States
- Astera Cancer Care — East Brunswick, New Jersey, United States
- The Christ Hospital — Cincinnati, Ohio, United States
- Sarah Cannon — Nashville, Tennessee, United States
- Virginia Cancer Specialists — Fairfax, Virginia, United States
Full record on ClinicalTrials.gov
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