ArticleJournal of translational medicine2015
Safety and immunologic correlates of Melanoma GVAX, a GM-CSF secreting allogeneic melanoma cell vaccine administered in the adjuvant setting.
Article in Journal of translational medicine, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 45 papers, 1 of them a synthesis that pooled it.
What it found
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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.
A Feasibility and Toxicity Study of a Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) Secreting Allogeneic Melanoma Vaccine Administered Alone or in Combination With Cyclophosphamide in Subjects With Surgically Resected At-Risk Melanoma
A Study of BRIA-OTS Cellular Immunotherapy in Metastatic Recurrent Breast Cancer
Who cites it
45 citing papers in PubMed, 1 synthesis or guideline pooled it, 94 citations in OpenAlex.
- Tumor infiltrating lymphocytes as an endpoint in cancer vaccine trials.Frontiers in immunology · 2023Pooled it
- Regression of Breast Cancer Metastases Following Treatment with Irradiated SV-BR-1-GM, a GM-CSF Overexpressing Breast Cancer Cell Line: Intellectual Property and Immune Markers of Response.Recent patents on anti-cancer drug discovery · 2022Trial
- A feasibility study of combined epigenetic and vaccine therapy in advanced colorectal cancer with pharmacodynamic endpoint.Clinical epigenetics · 2021Trial
- Immunotherapy for Solid Tumours: Current Clinical Landscape and Future Directions.European surgical research. Europaische chirurgische Forschung. Recherches chirurgicales europeennes · 2026Review
- Review
- Radiofrequency Combined with Intratumoral Immunotherapy: Preclinical Results and Safety in Metastatic Colorectal Carcinoma.Pharmaceutics · 2024Article
- In situ vaccination via tissue-targeted cDC1 expansion enhances the immunogenicity of chemoradiation and immunotherapy.The Journal of clinical investigation · 2024Article
- Dose-Specific Intratumoral GM-CSF Modulates Breast Tumor Oxygenation and Antitumor Immunity.Journal of immunology (Baltimore, Md. : 1950) · 2023Article
- Assessing the Future of Solid Tumor Immunotherapy.Biomedicines · 2022Review
- Emerging biomaterial-based strategies for personalized therapeutic in situ cancer vaccines.Biomaterials · 2022Review
- Fueling Cancer Vaccines to Improve T Cell-Mediated Antitumor Immunity.Frontiers in oncology · 2022Review
- Development of Cancer Immunotherapies.Cancer treatment and research · 2022Article
- Current Trends of Immunotherapy in the Treatment of Cutaneous Melanoma: A Review.Dermatology and therapy · 2021Review
- Review
- Lymphangiogenesis-inducing vaccines elicit potent and long-lasting T cell immunity against melanomas.Science advances · 2021Article
- Immuno-oncology: a narrative review of gastrointestinal and hepatic toxicities.Annals of translational medicine · 2021Review
- IL-32γ potentiates tumor immunity in melanoma.JCI insight · 2020Article
- Article
- An update on GM-CSF and its potential role in melanoma management.Melanoma management · 2020Review
- Biomaterial-based platforms for in situ dendritic cell programming and their use in antitumor immunotherapy.Journal for immunotherapy of cancer · 2019Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
15 authors at 2 institutions in 1 country.
Funding
Abstract
backgroundLimited adjuvant treatment options exist for patients with high-risk surgically resected melanoma. This first-in-human study investigated the safety, tolerability and immunologic correlates of Melanoma GVAX, a lethally irradiated granulocyte-macrophage colony stimulating factor (GM-CSF)-secreting allogeneic whole-cell melanoma vaccine, administered in the adjuvant setting.
methodsPatients with stage IIB-IV melanoma were enrolled following complete surgical resection. Melanoma GVAX was administered intradermally once every 28 days for four cycles, at 5E7 cells/cycle (n = 3), 2E8 cells/cycle (n = 9), or 2E8 cells/cycle preceded by cyclophosphamide 200 mg/m(2) to deplete T regulatory cells (Tregs; n = 8). Blood was collected before each vaccination and at 4 and 6 months after treatment initiation for immunologic studies. Vaccine injection site biopsies and additional blood samples were obtained 2 days after the 1st and 4th vaccines.
resultsAmong 20 treated patients, 18 completed 4 vaccinations. Minimal treatment-related toxicity was observed. One patient developed vitiligo and patches of white hair during the treatment and follow-up period. Vaccine site biopsies demonstrated complex inflammatory infiltrates, including significant increases in eosinophils and PD-1+ lymphocytes from cycle 1 to cycle 4 (P < 0.05). Serum GM-CSF concentrations increased significantly in a dose-dependent manner 48 h after vaccination (P = 0.0086), accompanied by increased numbers of activated circulating monocytes (P < 0.0001) and decreased percentages of myeloid-derived suppressor cells among monocytes (CD14+ , CD11b+ , HLA-DR low or negative; P = 0.002). Cyclophosphamide did not affect numbers of circulating Tregs. No significant changes in anti-melanoma immunity were observed in peripheral T cells by interferon-gamma ELIPSOT, or immunoglobulins by serum Western blotting.
conclusionMelanoma GVAX was safe and tolerable in the adjuvant setting. Pharmacodynamic testing revealed complex vaccine site immune infiltrates and an immune-reactive profile in circulating monocytic cell subsets. These findings support the optimization of Melanoma GVAX with additional monocyte and dendritic cell activators, and the potential development of combinatorial treatment regimens with synergistic agents.
trial registrationNCT01435499.
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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.