Trial reportThe New England journal of medicine2011
gp100 peptide vaccine and interleukin-2 in patients with advanced melanoma.
Trial report in The New England journal of medicine, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00019682 (A Phase III Multi-Institutional Randomized Study of Immunization With the gp100), which is not on this map. Cited by 432 papers, 2 of them syntheses 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 Phase III Multi-Institutional Randomized Study of Immunization With the gp100: 209-217 (210M) Peptide Followed by High Dose IL-2 vs. High Dose IL-2 Alone in Patients With Metastatic Melanoma
Who cites it
432 citing papers in PubMed, 2 syntheses or guidelines pooled it, 881 citations in OpenAlex.
- Efficacy and safety of cancer vaccine therapy in malignant melanoma: a systematic review.International journal of clinical oncology · 2025Pooled it
- Systemic treatments for metastatic cutaneous melanoma.The Cochrane database of systematic reviews · 2018Pooled it
- Multipeptide vaccines for melanoma in the adjuvant setting: long-term survival outcomes and post-hoc analysis of a randomized phase II trial.Nature communications · 2024Trial
- Phase I/II trial of a long peptide vaccine (LPV7) plus toll-like receptor (TLR) agonists with or without incomplete Freund's adjuvant (IFA) for resected high-risk melanoma.Journal for immunotherapy of cancer · 2021Trial
- Characterization and comparison of innate and adaptive immune responses at vaccine sites in melanoma vaccine clinical trials.Cancer immunology, immunotherapy : CII · 2021Trial
- Early phase II study of mixed 19-peptide vaccine monotherapy for refractory triple-negative breast cancer.Cancer science · 2020Trial
- Mixed 20-peptide cancer vaccine in combination with docetaxel and dexamethasone for castration-resistant prostate cancer: a randomized phase II trial.Cancer immunology, immunotherapy : CII · 2020Trial
- Bempegaldesleukin selectively depletes intratumoral Tregs and potentiates T cell-mediated cancer therapy.Nature communications · 2020Trial
- Multiple antigen-engineered DC vaccines with or without IFNα to promote antitumor immunity in melanoma.Journal for immunotherapy of cancer · 2019Trial
- Trial
- Negative modulation of suppressive HIV-specific regulatory T cells by IL-2 adjuvanted therapeutic vaccine.PLoS pathogens · 2017Trial
- Combined treatment with ipilimumab and intratumoral interleukin-2 in pretreated patients with stage IV melanoma-safety and efficacy in a phase II study.Cancer immunology, immunotherapy : CII · 2017Trial
- Predicting Neoantigen Immunogenicity frombioRxiv : the preprint server for biology · 2026Article
- Messenger RNA delivery of a dual CD25/CD122 affinity-tuned IL-2 variant prolongs exposure and potentiates antitumor T cell immunity.Science advances · 2026Article
- Cancer Vaccine Development: Toward Artificial Intelligence-Assisted Personalized Cell Membrane Nanovaccine.Small (Weinheim an der Bergstrasse, Germany) · 2026Review
- Review
- Does the ERBB/EGF Signaling Network Serve as a Nexus for Oncogenic Signals in Uveal Melanoma?Biomolecules · 2026Review
- Cellular immunotherapy in melanoma: the next frontier in cancer treatment.Journal of experimental & clinical cancer research : CR · 2026Review
- Review
- New Perspectives and Open Issues in the Adjuvant and Neoadjuvant Treatment of Melanoma.Cancers · 2026Review
372 more citing papers are in PubMed but not listed here.
Corrections and comments
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Authors and funding
26 authors at 20 institutions in 2 countries.
Funding
Abstract
backgroundStimulating an immune response against cancer with the use of vaccines remains a challenge. We hypothesized that combining a melanoma vaccine with interleukin-2, an immune activating agent, could improve outcomes. In a previous phase 2 study, patients with metastatic melanoma receiving high-dose interleukin-2 plus the gp100:209-217(210M) peptide vaccine had a higher rate of response than the rate that is expected among patients who are treated with interleukin-2 alone.
methodsWe conducted a randomized, phase 3 trial involving 185 patients at 21 centers. Eligibility criteria included stage IV or locally advanced stage III cutaneous melanoma, expression of HLA*A0201, an absence of brain metastases, and suitability for high-dose interleukin-2 therapy. Patients were randomly assigned to receive interleukin-2 alone (720,000 IU per kilogram of body weight per dose) or gp100:209-217(210M) plus incomplete Freund's adjuvant (Montanide ISA-51) once per cycle, followed by interleukin-2. The primary end point was clinical response. Secondary end points included toxic effects and progression-free survival.
resultsThe treatment groups were well balanced with respect to baseline characteristics and received a similar amount of interleukin-2 per cycle. The toxic effects were consistent with those expected with interleukin-2 therapy. The vaccine-interleukin-2 group, as compared with the interleukin-2-only group, had a significant improvement in centrally verified overall clinical response (16% vs. 6%, P=0.03), as well as longer progression-free survival (2.2 months; 95% confidence interval [CI], 1.7 to 3.9 vs. 1.6 months; 95% CI, 1.5 to 1.8; P=0.008). The median overall survival was also longer in the vaccine-interleukin-2 group than in the interleukin-2-only group (17.8 months; 95% CI, 11.9 to 25.8 vs. 11.1 months; 95% CI, 8.7 to 16.3; P=0.06).
conclusionsIn patients with advanced melanoma, the response rate was higher and progression-free survival longer with vaccine and interleukin-2 than with interleukin-2 alone. (Funded by the National Cancer Institute and others; ClinicalTrials.gov number, NCT00019682.).
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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.