Evidence map›Paper›PMID 21106722›Full record

Trial reportClinical cancer research : an official journal of the American Association for Cancer Research2011

Extended dose ipilimumab with a peptide vaccine: immune correlates associated with clinical benefit in patients with resected high-risk stage IIIc/IV melanoma.

Amod A Sarnaik, Bin Yu, Daohai Yu, Dawn Morelli, Maclean Hall, Dilip Bogle, Lulu Yan, Stephan Targan, Jolie Solomon, Geoff Nichol and 2 more

Open access · bronzeAbstract readClinical Trial, Phase II
In one paragraph

Trial report in Clinical cancer research : an official journal of the American Association for Cancer Research, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 90 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
90citing papers in PubMed, 4 pooled it
6.9field-weighted citation impact, top 2% of its field
1 · What the graph read from 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.

2 · The registry

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.

3 · Its place in the literature

Who cites it

90 citing papers in PubMed, 4 syntheses or guidelines pooled it, 199 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Combination Nivolumab, CD137 Agonism, and Adoptive Cell Therapy with Tumor-Infiltrating Lymphocytes for Patients with Metastatic Melanoma.Clinical cancer research : an official journal of the American Association for Cancer Research · 2022
    Trial
  6. Trial
  7. Safety, correlative markers, and clinical results of adjuvant nivolumab in combination with vaccine in resected high-risk metastatic melanoma.Clinical cancer research : an official journal of the American Association for Cancer Research · 2015
    Trial
  8. Trial
  9. Trial
  10. Article
  11. Article
  12. Article
  13. Article
  14. Cold and hot tumors: from molecular mechanisms to targeted therapy.Signal transduction and targeted therapy · 2024
    Review
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  16. Article
  17. Article
  18. Review
  19. Review
  20. Article

30 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

12 authors at 2 institutions in 1 country.

Amod A SarnaikDepartment of Cutaneous Oncology, Moffitt Cancer Center, Tampa, Florida 33612, USA.
Bin Yu
Daohai Yu
Dawn Morelli
Maclean Hall
Dilip Bogle
Lulu Yan
Stephan Targan
Jolie Solomon
Geoff Nichol
Michael Yellin
Jeffrey S Weber
Moffitt Cancer Center · USCedars-Sinai Medical Center · US

Funding

TRANSLATIONAL RESEARCHP30CA076292 · NCI · UNIVERSITY OF SOUTH FLORIDA · PI KENNETH Lynn WRIGHT · 1998 to 2026
$93.5M
CTLA-4 Inhibition and Autoimmunity in MelanomaR01CA109307 · NCI · UNIVERSITY OF SOUTHERN CALIFORNIA · PI WEBER, JEFFREY S · 2004 to 2008
$2.4M
NCI NIH HHS CA 109307NCI NIH HHS P30 CA076292NCI NIH HHS R01 CA109307
6 · The paper itself

Abstract

purposeTo determine safety and feasibility of adjuvant ipilimumab following resection of high-risk melanoma and to identify surrogate markers for benefit. EXPERIMENTAL

designIn this phase II trial, 75 patients with resected stage IIIc/IV melanoma received the CTLA-4 antibody ipilimumab every 6 to 8 weeks for 1 year. Eligible patients received further maintenance treatments. The first 25 patients received 3 mg/kg of ipilimumab, and an additional 50 patients received 10 mg/kg. HLA-A*0201+ patients received multipeptide immunizations in combination with ipilimumab. Leukapheresis was performed prior to and 6 months after initiation of treatment.

resultsMedian overall and relapse-free survivals were not reached after a median follow-up of 29.5 months. Significant immune-related adverse events were observed in 28 of 75 patients and were positively associated with longer relapse-free survival. Antigen-specific T cell responses to vaccine were variable, and vaccine combination was not associated with additional benefit. No effects on T regulatory cells were observed. Higher changes in Th-17 inducible frequency were a surrogate marker of freedom from relapse (P = 0.047), and higher baseline C-reactive protein (CRP) levels were associated with freedom from relapse (P = 0.035).

conclusionsAdjuvant ipilimumab following resection of melanoma at high risk for relapse appeared to be associated with improved outcome compared to historical reports. Significant immune-related adverse events were generally reversible and appeared to be associated with improved relapse-free survival. Although vaccination failed to induce a consistent in vitro measurable response, a higher change in Th-17 inducible cells and higher baseline CRP levels were positively associated with freedom from relapse.

Indexed as

Adjuvants, ImmunologicAdultAgedAntibodies, MonoclonalAntineoplastic AgentsCancer VaccinesFemaleHumansIpilimumabKaplan-Meier EstimateMaleMelanomaMiddle AgedMonocytesNeoplasm Recurrence, LocalNeoplasm StagingAdjuvants, ImmunologicAntibodies, MonoclonalAntineoplastic AgentsCancer VaccinesIpilimumabVaccines, Subunit

Identifiers

PMID21106722
PMCPMC3041838
OpenAlexW2123264723

What OpenQuestion holds

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Read underepoch 390

Registered trials

None linked

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.