ArticleCancer immunology research2015
Phase I Trial of a Yeast-Based Therapeutic Cancer Vaccine (GI-6301) Targeting the Transcription Factor Brachyury.
Article in Cancer immunology research, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01519817 (An Open Label Phase I Study to Evaluate the Safety and Tolerability of GI-6301 Vaccine Consisting of Whole, Heat-Killed Recombinant Saccharomyces Cerevisiae), which is not on this map. Cited by 75 papers, 3 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
An Open Label Phase I Study to Evaluate the Safety and Tolerability of GI-6301 Vaccine Consisting of Whole, Heat-Killed Recombinant Saccharomyces Cerevisiae (Yeast) Genetically Modified to Express Brachyury Protein in Adults With Solid Tumors
Who cites it
75 citing papers in PubMed, 3 syntheses or guidelines pooled it, 137 citations in OpenAlex.
- Pooled it
- The efficacy and safety of tyrosine kinase inhibitors in the treatment of advanced or metastatic chordoma: a single-arm meta-analysis.Neurosurgical review · 2025Pooled it
- Targeted Therapy for Chordoma: Key Molecular Signaling Pathways and the Role of Multimodal Therapy.Targeted oncology · 2021Pooled it
- Bacillus Calmette-Guérin (BCG) in combination with PANVAC™ vs. BCG alone in adults with high-grade BCG-refractory non-muscle-invasive bladder cancer.Urologic oncology · 2025Trial
- Trial
- Neoadjuvant PROSTVAC prior to radical prostatectomy enhances T-cell infiltration into the tumor immune microenvironment in men with prostate cancer.Journal for immunotherapy of cancer · 2020Trial
- Samarium-153-EDTMP (Quadramet®) with or without vaccine in metastatic castration-resistant prostate cancer: A randomized Phase 2 trial.Oncotarget · 2016Trial
- Systemic Treatment of Advanced Chordoma With Molecular Targeted Therapies: A Large Multicentre European Retrospective Case Series.Cancer reports (Hoboken, N.J.) · 2026Article
- The evolution of vaccine strategies for colorectal cancer: from conventional approaches to the mRNA era.Frontiers in immunology · 2026Review
- Harnessing live vectors for cancer vaccines: Advancing therapeutic immunotherapy.Human vaccines & immunotherapeutics · 2025Review
- Emerging Frontiers in Colorectal Cancer Therapy: From Targeted Molecules to Immunomodulatory Breakthroughs and Cell-Based Approaches.Digestive diseases and sciences · 2025Review
- Engineering Saccharomyces cerevisiae for medical applications.Microbial cell factories · 2025Review
- Molecular insights into clinical trials for immune checkpoint inhibitors in colorectal cancer: Unravelling challenges and future directions.World journal of gastroenterology · 2024Review
- Dysregulation of noncoding RNA in chordoma; implications in identifying potential targets for novel therapeutic approaches.Molecular biology reports · 2024Review
- Immune microenvironment and immunotherapy for chordoma.Frontiers in oncology · 2024Review
- RNA Vaccines: Yeast as a Novel Antigen Vehicle.Vaccines · 2023Review
- The NIH pediatric/young adult chordoma clinic and natural history study: Making advances in a very rare tumor.Pediatric blood & cancer · 2023Article
- Activity of pemetrexed in pre-clinical chordoma models and humans.Scientific reports · 2023Article
- Fungal β-Glucan-Based Nanotherapeutics: From Fabrication to Application.Journal of fungi (Basel, Switzerland) · 2023Review
- The role of tumor immune microenvironment in chordoma: promising immunotherapy strategies.Frontiers in immunology · 2023Review
15 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
12 authors at 2 institutions in 1 country.
Funding
Abstract
The nuclear transcription factor brachyury has previously been shown to be a strong mediator of the epithelial-to-mesenchymal transition (EMT) in human carcinoma cells and a strong negative prognostic factor in several tumor types. Brachyury is overexpressed in a range of human carcinomas as well as in chordoma, a rare tumor for which there is no standard systemic therapy. Preclinical studies have shown that a recombinant Saccharomyces cerevisiae (yeast) vaccine encoding brachyury (GI-6301) can activate human T cells in vitro. A phase I dose-escalation (3+3 design) trial enrolled 34 patients at 4 dose levels [3, 3, 16, and 11 patients, respectively, at 4, 16, 40, and 80 yeast units (YU)]. Expansion cohorts were enrolled at 40- and 80-YU dose levels for analysis of immune response and clinical activity. We observed brachyury-specific T-cell immune responses in the majority of evaluable patients despite most having been heavily pretreated. No evidence of autoimmunity or other serious adverse events was observed. Two chordoma patients showed evidence of disease control (one mixed response and one partial response). A patient with colorectal carcinoma, who enrolled on study with a large progressing pelvic mass and rising carcinoembryonic antigen (CEA), remains on study for greater than 1 year with stable disease, evidence of decreased tumor density, and decreased serum CEA. This is the first-in-human study to demonstrate the safety and immunogenicity of this therapeutic cancer vaccine and provides the rationale for exploration in phase II studies. A randomized phase II chordoma study is now enrolling patients.
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What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.