Evidence map›Paper›PMID 29666297›Full record

Trial reportThe oncologist2018

Phase II Study of Everolimus in Metastatic Malignant Melanoma (NCCTG-N0377, Alliance).

Jesus Vera Aguilera, Ravi D Rao, Jacob B Allred, Vera J Suman, Harold E Windschitl, Judith S Kaur, William J Maples, Val J Lowe, Edward T Creagan, Lori A Erickson and 1 more

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

Trial report in The oncologist, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
0.8field-weighted citation impact, top 25% 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

9 citing papers in PubMed, 14 citations in OpenAlex.

  1. Mitochondrial bioenergetics and networks in melanoma: an update.Apoptosis : an international journal on programmed cell death · 2025
    Review
  2. Article
  3. Autophagy Paradox: Strategizing Treatment Modality in Melanoma.Current treatment options in oncology · 2023
    Review
  4. Review
  5. Article
  6. Review
  7. Article
  8. Review
  9. Melanoma Cell Death Mechanisms.Chonnam medical journal · 2018
    Review
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 at 4 institutions in 1 country.

Jesus Vera AguileraMayo Clinic and Mayo Foundation, Rochester, Minnesota vera.jesus@mayo.edu.
Ravi D RaoSt. Agnes Cancer Center, Fresno, California.
Jacob B AllredMayo Clinic and Mayo Foundation, Rochester, Minnesota.
Vera J SumanMayo Clinic and Mayo Foundation, Rochester, Minnesota.
Harold E Windschitl
Judith S KaurMayo Clinic Jacksonville, Jacksonville, Florida.
William J Maples
Val J LoweMayo Clinic and Mayo Foundation, Rochester, Minnesota.
Edward T CreaganMayo Clinic and Mayo Foundation, Rochester, Minnesota.
Lori A EricksonMayo Clinic and Mayo Foundation, Rochester, Minnesota.
Svetomir MarkovicMayo Clinic and Mayo Foundation, Rochester, Minnesota.
Mayo Clinic · USAlliance Data (United States) · USJacksonville College · USSaint Agnes Medical Center · US

Funding

Member Site CoreU10CA180821 · NCI · BRIGHAM AND WOMEN'S HOSPITAL · PI Evanthia Galanis · 2014 to 2026
$177.3M
Statistics CoreU10CA180882 · NCI · MAYO CLINIC ROCHESTER · PI Sumithra Jay Mandrekar · 2014 to 2026
$115.0M
Naional Cancer Institute, Naitonal Clinical Trials Network U10 Lead Academic SiteU10CA180790 · NCI · MAYO CLINIC ROCHESTER · PI ALBERTS, STEVEN R, BOUGHEY, JUDY CAROLINE · 2014 to 2018
$6.6M
NCI NIH HHS U10 CA180790NCI NIH HHS U10 CA180821NCI NIH HHS U10 CA180882
6 · The paper itself

Abstract

lessons learnedEverolimus does not have sufficient activity to justify its use as single agent in metastatic melanoma.Patients treated with 10 mg per day dose were most likely to require dose reductions.Everolimus appeared to reduce the numbers of regulatory T cells in approximately half of the treated patients; unfortunately, these effects were not correlated with clinical outcomes.

backgroundEverolimus (RAD-001) is an orally active rapamycin analogue shown in preclinical data to produce cytostatic cell inhibition, which may be potentially beneficial in treating melanoma. We conducted a phase II study to evaluate the efficacy and safety of everolimus in patients with unresectable metastatic melanoma (MM).

methodsThis study included two cohorts; cohort 1 received 30 mg of everolimus by mouth (PO) weekly, and cohort 2 was dosed with 10 mg of everolimus PO daily. The endpoints of the study were safety, 16-week progression-free survival (PFS), overall survival (OS), and measures of immunomodulatory/antiangiogenic properties with therapy. Tumor samples before therapy and at week 8 of treatment were analyzed. Peripheral blood plasma or mononuclear cell isolates collected prior to therapy and at weeks 8 and 16 and at time of tumor progression were analyzed for vascular endothelial growth factor and regulatory T-cell (Treg) measurements.

resultsA total of 53 patients were enrolled in cohort 1 (

conclusionEverolimus does not have sufficient single-agent activity in MM; however, we have identified evidence of biological activity to provide a potential rationale for future combination studies.

Indexed as

AdultAgedAged, 80 and overAntineoplastic AgentsEverolimusFemaleHumansMaleMelanomaMiddle AgedNeoplasm MetastasisYoung AdultAntineoplastic AgentsEverolimus

Identifiers

PMID29666297
PMCPMC6156180
OpenAlexW2802842062

What OpenQuestion holds

Textmetadata
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.