Trial reportCancer immunology, immunotherapy : CII2011
A phase II study of the cancer vaccine TG4010 alone and in combination with cytokines in patients with metastatic renal clear-cell carcinoma: clinical and immunological findings.
Trial report in Cancer immunology, immunotherapy : CII, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 53 papers.
What it found
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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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
53 citing papers in PubMed, 103 citations in OpenAlex.
- Viral based vaccine TG4010 induces broadening of specific immune response and improves outcome in advanced NSCLC.Journal for immunotherapy of cancer · 2017Trial
- Reviving cancer vaccines in renal cell carcinoma: a new chapter in immunotherapy for kidney cancer.Immuno-oncology technology · 2026Review
- Cancer Vaccines in Genitourinary Malignancies: Current Advances and Future Directions.Vaccines · 2026Review
- Discovery of tumor antigens in renal cell carcinoma and prospects for clinical application.Frontiers in immunology · 2026Review
- Mucin-1: a promising pan-cancer therapeutic target.NPJ precision oncology · 2025Review
- Research progress of MUC1 in genitourinary cancers.Cellular & molecular biology letters · 2024Review
- Mucin1 as a potential molecule for cancer immunotherapy and targeted therapy.Journal of Cancer · 2024Review
- [Research Progress of Lung Cancer Vaccines].Zhongguo fei ai za zhi = Chinese journal of lung cancer · 2023Review
- Antigenic targets in clear cell renal cell carcinoma.Kidney cancer (Clifton, Va.) · 2023Review
- Article
- A New Generation of Vaccines in the Age of Immunotherapy.Current oncology reports · 2021Review
- A MUCINs expression signature impacts overall survival in patients with clear cell renal cell carcinoma.Cancer medicine · 2021Article
- Mucins as anti-cancer targets: perspectives of the glycobiologist.Glycoconjugate journal · 2021Review
- Current status of antigen-specific T-cell immunotherapy for advanced renal-cell carcinoma.Human vaccines & immunotherapeutics · 2021Review
- Cancer Vaccines for Genitourinary Tumors: Recent Progresses and Future Possibilities.Vaccines · 2021Review
- A Phase 2 Randomized Placebo-Controlled Adjuvant Trial of GI-4000, a Recombinant Yeast Expressing Mutated RAS Proteins in Patients with Resected Pancreas Cancer.Journal of pancreatic cancer · 2021Article
- Molecular Aspects and Future Perspectives of Cytokine-Based Anti-cancer Immunotherapy.Frontiers in cell and developmental biology · 2020Review
- Cancer Vaccines: Toward the Next Breakthrough in Cancer Immunotherapy.Journal of immunology research · 2020Review
- Cancer-associated mucins: role in immune modulation and metastasis.Cancer metastasis reviews · 2019Review
- Therapeutic Cancer Vaccine and Combinations With Antiangiogenic Therapies and Immune Checkpoint Blockade.Frontiers in immunology · 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 11 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
MUC1 over-expression in renal clear-cell carcinoma (RCC) is associated with poor prognosis. This phase II study determined the efficacy and tolerability of TG4010, a cancer vaccine based on a modified vaccinia virus expressing MUC1 and interleukin-2, in combination with cytokines, as first-line therapy in metastatic RCC. Thirty-seven patients with progressive, MUC1-positive RCC received TG4010 10(8) pfu/inj weekly for 6 weeks, then every 3 weeks until progression, when TG4010 was continued in combination with interferon-α2a and interleukin-2. Assessments included clinical response (primary endpoint), safety, time to treatment failure (TTF), overall survival (OS), and immune response. No objective clinical responses occurred. Five of the 27 evaluable patients (18%) had stable disease for >6 months with TG4010 alone and six of 20 patients (30%) had stable disease for >6 months with TG4010 plus cytokines. Median TTF was 4.1, 3.6, and 9.3 months for monotherapy, combination therapy, and overall, respectively. Median OS was 19.3 months for all patients and 22.4 months combination therapy recipients. The most frequent TG4010-related adverse events were minor-to-moderate injection-site reactions, fatigue, and flu-like symptoms. Six of 28 patients showed a MUC1 CD4+ T cell proliferative response during therapy. Anti-MUC1 CD8+ T cells were detected before and after therapy in 3 and 4 patients, respectively. MUC1-specific CD8+ T cell responses were associated with longer survival. Therapy with TG4010 plus cytokines appears to be feasible and well tolerated in patients with metastatic RCC. However, these data should be interpreted with caution, as additional prospective studies are necessary to clarify the clinical efficacy of this therapy.
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