ArticleJournal for immunotherapy of cancer2018
Neoadjuvant ipilimumab (3 mg/kg or 10 mg/kg) and high dose IFN-α2b in locally/regionally advanced melanoma: safety, efficacy and impact on T-cell repertoire.
Article in Journal for immunotherapy of cancer, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01608594 (Neoadjuvant Combination Biotherapy With Ipilimumab), which is not on this map. Cited by 44 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.
Neoadjuvant Combination Biotherapy With Ipilimumab (3 mg/kg or 10 mg/kg) and High Dose IFN-Α2B in Patients With Locally/Regionally Advanced/Recurrent Melanoma: a Randomized Safety, Efficacy and Biomarker Study
Who cites it
44 citing papers in PubMed, 2 syntheses or guidelines pooled it, 61 citations in OpenAlex.
- Neoadjuvant treatment for stage III and IV cutaneous melanoma.The Cochrane database of systematic reviews · 2023Pooled it
- Neoadjuvant Immunotherapy for Locally Advanced Melanoma.Current treatment options in oncology · 2020Pooled it
- Neoadjuvant cobimetinib and atezolizumab with or without vemurafenib for high-risk operable Stage III melanoma: the Phase II NeoACTIVATE trial.Nature communications · 2024Trial
- A Systematic Review and Meta-Analysis of Surgical Feasibility and Outcomes Following Neoadjuvant Immune Checkpoint Inhibition in Resectable Stage III and IV Melanoma.Annals of surgical oncology · 2026Article
- Targeting neutrophil-driven immunosuppression: A strategy to overcome immune checkpoint inhibitor resistance.Clinical and translational medicine · 2026Review
- New Standards in the Treatment of Advanced Metastatic Melanoma: Immunotherapy and BRAF-Targeted Therapies as Emerging Paradigms.Current pharmaceutical design · 2026Review
- Interferon signaling pathways in health and disease.Molecular biomedicine · 2025Review
- Effect of neoadjuvant therapy on survival outcomes in patients with melanoma: a systematic review and meta-analysis.EClinicalMedicine · 2025Article
- Cancer Immunotherapy in Combination with Radiotherapy and/or Chemotherapy: Mechanisms and Clinical Therapy.MedComm · 2025Review
- The rapidly evolving paradigm of neoadjuvant immunotherapy across cancer types.Nature cancer · 2025Review
- Radiotherapy-resistant prostate cancer cells escape immune checkpoint blockade through the senescence-related ataxia telangiectasia and Rad3-related protein.Cancer communications (London, England) · 2025Article
- Window of opportunity trials with immune checkpoint inhibitors in triple-negative breast cancer.ESMO open · 2024Review
- Combination anti-PD-1 and anti-CTLA-4 therapy generates waves of clonal responses that include progenitor-exhausted CD8Cancer cell · 2024Article
- Parkin activates innate immunity and promotes antitumor immune responses.The Journal of clinical investigation · 2024Article
- Targeting inflammation as cancer therapy.Journal of hematology & oncology · 2024Review
- Neoadjuvant Immunotherapy: A Promising New Standard of Care.International journal of molecular sciences · 2023Review
- Personalizing neoadjuvant immune-checkpoint inhibition in patients with melanoma.Nature reviews. Clinical oncology · 2023Review
- Neoadjuvant Therapy in Melanoma: Where Are We Now?Current oncology reports · 2023Review
- Combining PD-1/PD-L1 blockade with type I interferon in cancer therapy.Frontiers in immunology · 2023Review
- Educational Review: Neoadjuvant Approaches to Melanoma.Annals of surgical oncology · 2022Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
13 authors at 3 institutions in 2 countries.
Funding
Abstract
backgroundNeoadjuvant immunotherapy utilizing novel combinations has the potential to transform the standard of care for locally/regionally advanced melanoma. We hypothesized that neoadjuvant ipilimumab in combination with high dose IFNα2b (HDI) is safe and associated with durable pathologic complete responses (pCR).
methodsPatients with locally/regionally advanced melanoma were randomized to ipilimumab 3 or 10 mg/kg × 4 doses bracketing definitive surgery, then every 12 weeks × 4. HDI was given concurrently. We evaluated the safety and efficacy of the combination with ipilimumab 3 or 10 mg/kg. The impact on T-cell fraction and clonality were investigated in tumor and blood.
resultsThirty patients (age 37-76), 15 each at 3 and 10 mg/kg, 18 male and 12 female were treated. Considering immune related adverse events (irAEs) of interest, more grade 3/4 irAEs were seen with ipilimumab 10 mg/kg versus 3 mg/kg (p = 0.042). Among 28 evaluable patients, 11 relapsed, of whom 5 died. Median follow-up for 17 patients who have not relapsed was 32 months. The radiologic preoperative response rate was 36% (95% CI, 21-54); 4 patients at ipilimumab 3 mg/kg and 6 at 10 mg/kg and 2 (at 10 mg/kg) later relapsed. The pCR was 32% (95% CI, 18-51); 5 patients at ipilimumab 3 mg/kg and 4 at 10 mg/kg and one (at 3 mg/kg) had a late relapse. In patients with pCR, T-cell fraction was significantly higher when measured in primary melanoma tumors (p = 0.033). Higher tumor T-cell clonality in primary tumor and more so following neoadjuvant therapy was significantly associated with improved relapse free survival.
conclusionsNeoadjuvant ipilimumab-HDI was relatively safe and exhibited promising tumor response rates with an associated measurable impact on T-cell fraction and clonality. Most pCRs were durable supporting the value of pCR as a primary endpoint in neoadjuvant immunotherapy trials.
trial registrationClinicalTrials.gov, NCT01608594 . Registered 31 May 2012.
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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.