Evidence map›Paper›PMID 25210016›Full record

Trial reportAnnals of oncology : official journal of the European Society for Medical Oncology2014

Survival follow-up and ipilimumab retreatment of patients with advanced melanoma who received ipilimumab in prior phase II studies.

C Lebbé, J S Weber, M Maio, B Neyns, K Harmankaya, O Hamid, S J O'Day, C Konto, L Cykowski, M B McHenry and 1 more

Registry-linked trialAbstract readClinical Trial, Phase IIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Annals of oncology : official journal of the European Society for Medical Oncology, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00162123 (A Multi-Center, Open-Label, Phase II Study of Ipilimumab), which is not on this map. Cited by 73 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
73citing papers in PubMed, 6 pooled it
–field-weighted citation impact
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.

NCT00162123 phase2completednot on this map

A Multi-Center, Open-Label, Phase II Study of Ipilimumab (MDX-010 Extended-Treatment Monotherapy or Follow-up for Patients Previously Enrolled in Ipilimumab (MDX-010) Protocols.

TypeinterventionalSponsorBristol-Myers SquibbRan2006 to 2014Enrolled248ConditionsMelanomaArmsIpilimumab
3 · Its place in the literature

Who cites it

73 citing papers in PubMed, 6 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Pooled it
  6. Pooled it
  7. Trial
  8. Five-year survival outcomes for patients with advanced melanoma treated with pembrolizumab in KEYNOTE-001.Annals of oncology : official journal of the European Society for Medical Oncology · 2019
    Trial
  9. Trial
  10. Review
  11. Article
  12. Article
  13. Genes · 2025
    Review
  14. Review
  15. Article
  16. Review on radiomic analysis inCancer imaging : the official publication of the International Cancer Imaging Society · 2024
    Review
  17. Review
  18. Article
  19. Review
  20. Article

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

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors.

C LebbéDepartment of Dermatology, APHP, CIC, U976 Hôpital Saint-Louis University Paris Diderot, Paris, France. Electronic address: celeste.lebbe@sls.aphp.fr.
J S WeberDepartment of Cutaneous Oncology, H. Lee Moffitt Cancer Center and Research Institute, Tampa, USA.
M MaioMedical Oncology and Immunotherapy, Department of Oncology, University Hospital of Siena, Istituto Toscano Tumori, Siena, Italy.
B NeynsDepartment of Medical Oncology, Universitair Ziekenhuis Brussel, Brussels, Belgium.
K HarmankayaDepartment of Dermatology, Medical University of Vienna, Vienna, Austria.
O HamidMelanoma Therapeutics, Translational Research and Immunotherapy, The Angeles Clinic and Research Institute, Los Angeles.
S J O'DayLos Angeles Skin Cancer Institute at Beverly Hills Cancer Center, Beverly Hills.
C KontoGlobal Clinical Research.
L CykowskiGlobal Clinical Research.
M B McHenryGlobal Biometric Sciences, Bristol-Myers Squibb Company, Wallingford.
J D WolchokLudwig Center for Cancer Immunotherapy, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, USA.

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Nicholas D Socci · 1985 to 2026
$347.4M
NCI NIH HHS P30 CA008748
6 · The paper itself

Abstract

backgroundThis report provides a survival update at a follow-up of >5 years (5.5-6 years) for patients with advanced melanoma who previously received ipilimumab in phase II clinical trials. Safety and efficacy data following ipilimumab retreatment are also reported. PATIENTS AND

methodsPatients who previously received ipilimumab 0.3, 3, or 10 mg/kg in one of six phase II trials (CA184-004, CA184-007, CA184-008, CA184-022, MDX010-08, and MDX010-15) were eligible to enroll in the companion study, CA184-025. Upon enrollment, patients initially received ipilimumab retreatment, extended maintenance therapy, or were followed for survival only. Overall survival (OS) rates were evaluated in patients from studies CA184-004, CA184-007, CA184-008, and CA184-022. Safety and best overall response during ipilimumab retreatment at 10 mg/kg were assessed in study CA184-025.

resultsFive-year OS rates for previously treated patients who received ipilimumab induction at 0.3, 3, or 10 mg/kg were 12.3%, 12.3%-16.5%, and 15.5%-28.4%, respectively. Five-year OS rates for treatment-naive patients who received ipilimumab induction at 3 or 10 mg/kg were 26.8% and 21.4%-49.5%, respectively. Little to no change in OS was observed from year 5 up to year 6. The objective response rate among retreated patients was 23%. Grade 3/4 immune-related adverse events occurred in 25%, 5.9%, and 13.2% of retreated patients who initially received ipilimumab 0.3, 3, and 10 mg/kg, with the most common being observed in the skin (4.2%, 2.9%, 3.8%) and gastrointestinal tract (12.5%, 2.9%, 3.8%), respectively.

conclusionsAt a follow-up of 5-6 years, ipilimumab continues to demonstrate durable, long-term survival in a proportion of patients with advanced melanoma. In some patients, ipilimumab retreatment can re-establish disease control with a safety profile that is comparable with that observed during ipilimumab induction. Further studies are needed to determine the contribution of ipilimumab retreatment to OS. CLINICALTRIALSGOV: NCT00162123.

Indexed as

ImmunotherapyAdultAgedAntibodies, MonoclonalCTLA-4 AntigenDrug-Related Side Effects and Adverse ReactionsFemaleFollow-Up StudiesHumansIpilimumabKaplan-Meier EstimateMaleMelanomaMiddle AgedNeoplasm StagingSkin NeoplasmsAntibodies, MonoclonalCTLA-4 AntigenIpilimumabadvanced melanomacytotoxic T-lymphocyte antigen-4immunotherapyipilimumablong-term survivalsurvival rate

Identifiers

PMID25210016
PMCPMC4990834

What OpenQuestion holds

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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.