Evidence map›Paper›PMID 26534966›Full record

ArticleClinical cancer research : an official journal of the American Association for Cancer Research2016

Phase I Clinical Trial of Ipilimumab in Pediatric Patients with Advanced Solid Tumors.

Melinda S Merchant, Matthew Wright, Kristin Baird, Leonard H Wexler, Carlos Rodriguez-Galindo, Donna Bernstein, Cindy Delbrook, Maya Lodish, Rachel Bishop, Jedd D Wolchok and 2 more

Abstract readClinical Trial, Phase IMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Article in Clinical cancer research : an official journal of the American Association for Cancer Research, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 184 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
184citing papers in PubMed, 4 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.

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

184 citing papers in PubMed, 4 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Trial
  6. Trial
  7. Trial
  8. Article
  9. Review
  10. Review
  11. Article
  12. Retinoblastoma and Its Tumor Microenvironment.Current oncology (Toronto, Ont.) · 2026
    Review
  13. Review
  14. Article
  15. Review
  16. Article
  17. Article
  18. Review
  19. Article
  20. Review

124 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

12 authors.

Melinda S MerchantPediatric Oncology Branch, National Cancer Institute, National Institutes of Health, Bethesda, MD. mackallc@mail.nih.gov.
Matthew WrightPediatric Oncology Branch, National Cancer Institute, National Institutes of Health, Bethesda, MD.
Kristin BairdPediatric Oncology Branch, National Cancer Institute, National Institutes of Health, Bethesda, MD.
Leonard H WexlerDepartment of Pediatrics, Memorial Sloan Kettering Cancer Center, New York, NY and Weill-Cornell Medical College, New York, NY.
Carlos Rodriguez-GalindoPediatric Oncology, Dana Farber Cancer Institute, Boston, MA.
Donna BernsteinPediatric Oncology Branch, National Cancer Institute, National Institutes of Health, Bethesda, MD.
Cindy DelbrookPediatric Oncology Branch, National Cancer Institute, National Institutes of Health, Bethesda, MD.
Maya LodishNational Institute of Child Health and Human Development, NIH, Bethesda, MD.
Rachel BishopNational Eye Institute, NIH, Bethesda, MD.
Jedd D WolchokDepartment of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY. Weill-Cornell Medical College, New York, NY.
Howard StreicherInvestigational Drug Branch, National Cancer Institute, NIH, Bethesda, MD.
Crystal L MackallPediatric Oncology Branch, National Cancer Institute, National Institutes of Health, Bethesda, MD.

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Elisa de Stanchina · 1985 to 2026
$347.4M
Intramural NIH HHS Z99 CA999999NCI NIH HHS P30 CA008748
6 · The paper itself

Abstract

purposeIpilimumab is a first-in-class immune checkpoint inhibitor approved for treatment of metastatic melanoma but not studied in children until this phase I protocol. EXPERIMENTAL

designThis study examined safety, pharmacokinetics, and immunogenicity, and immune correlates of ipilimumab administered to subjects ≤21 years old with recurrent or progressive solid tumors. Dose escalation cohorts received 1, 3, 5, or 10 mg/m(2) intravenously every 3 weeks in a 3 + 3 design. Response was assessed after 6 weeks and 12 weeks, and then every 3 months. Treatment was continued until disease progression or unacceptable toxicity.

resultsThirty-three patients received 72 doses of ipilimumab. Patients enrolled had melanoma (n = 12), sarcoma (n = 17), or other refractory solid tumors (n = 4). Immune-related adverse events included pancreatitis, pneumonitis, colitis, endocrinopathies, and transaminitis with dose-limiting toxicities observed at 5 and 10 mg/kg dose levels. Pharmacokinetics revealed a half-life of 8 to 15 days. At day 21, subjects had increased levels of cycling T cells, but no change in regulatory T-cell populations. Six subjects had confirmed stable disease for 4 to 10 cycles (melanoma, osteosarcoma, clear cell sarcoma, and synovial sarcoma).

conclusionsIpilimumab was safely administered to pediatric patients using management algorithms for immune-related toxicities. The spectrum of immune-related adverse events is similar to those described in adults; however, many of the pediatric toxicities were evident after a single dose. Although no objective tumor regressions were observed with ipilimumab as a single agent, subjects with immune-related toxicities had an increased overall survival compared with those who showed no evidence of breaking tolerance.

Indexed as

AdolescentAdultAntibodies, MonoclonalAntineoplastic AgentsBrainChildChild, PreschoolCombined Modality TherapyDrug MonitoringFemaleHumansImmunomodulationIpilimumabMagnetic Resonance ImagingMaleNeoplasmsAntibodies, MonoclonalAntineoplastic AgentsIpilimumab

Identifiers

PMID26534966
PMCPMC5027962

What OpenQuestion holds

Textmetadata
LicenceTDM
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.