Evidence map›Paper›PMID 28327988›Full record

Trial reportAnnals of oncology : official journal of the European Society for Medical Oncology2017

Efficacy and safety of nilotinib in patients with KIT-mutated metastatic or inoperable melanoma: final results from the global, single-arm, phase II TEAM trial.

J Guo, R D Carvajal, R Dummer, A Hauschild, A Daud, B C Bastian, S N Markovic, P Queirolo, A Arance, C Berking and 11 more

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase II
In one paragraph

Trial report in Annals of oncology : official journal of the European Society for Medical Oncology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01028222 (The TEAM Trial), which is not on this map. Cited by 86 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
86citing papers in PubMed, 2 pooled it
6.0field-weighted citation impact, top 3% 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.

NCT01028222 phase2completednot on this map

The TEAM Trial (Tasigna Efficacy in Advanced Melanoma): A Phase II, Open Label, Multi-center, Single-arm Study to Assess the Efficacy of Tasigna ® in the Treatment of Patients With Metastatic and/or Inoperable Melanoma Harboring a c-Kit Mutation

TypeinterventionalSponsorNovartis PharmaceuticalsRan2010 to 2014Enrolled55ConditionsMelanomaArmsNilotinib, DTIC
3 · Its place in the literature

Who cites it

86 citing papers in PubMed, 2 syntheses or guidelines pooled it, 164 citations in OpenAlex.

  1. SEOM-GEM clinical guidelines for cutaneous melanoma (2023).Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2024
    Guideline
  2. Guideline
  3. Trial
  4. Article
  5. Review
  6. Review
  7. Article
  8. Review
  9. Bridging the Gap: Incorporating Lifileucel Into Management of Advanced PD-1 Blockade Resistant Melanomas.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2025
    Article
  10. Review
  11. A Phase I Study of Nilotinib in Combination with Paclitaxel in Patients with Advanced Solid Tumors.Clinical cancer research : an official journal of the American Association for Cancer Research · 2025
    Article
  12. Article
  13. Review
  14. Pathologica · 2025
    Article
  15. Article
  16. Review
  17. Review
  18. Article
  19. Precision Oncology in Melanoma: Changing Practices.Journal of nuclear medicine : official publication, Society of Nuclear Medicine · 2024
    Review
  20. Article

26 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

21 authors at 17 institutions in 9 countries.

J GuoDepartment of Renal Cancer & Melanona, Peking University Cancer Hospital & Institute, Beijing, China.
R D CarvajalDivision of Hematology/Oncology, Columbia University Medical Center, New York, USA.
R DummerSkin Cancer Center, University Hospital of Zurich, Zurich, Switzerland.
A HauschildDepartment of Dermatology, University Hospital Schleswig-Holstein (UKSH), Campus Kiel, Kiel, Germany.
A DaudHelen Diller Family Comprehensive Cancer Center, University of California, San Francisco, San Francisco.
B C BastianHelen Diller Family Comprehensive Cancer Center, University of California, San Francisco, San Francisco.
S N MarkovicDepartment of Hematology/Oncology, Mayo Clinic Cancer Center, Rochester, USA.
P QueiroloDepartment of Medical Oncology, National Research Institute for Cancer, Genova, Italy.
A AranceDepartment of Medical Oncology, Hospital Clinic, Barcelona, Spain.
C BerkingDepartment of Dermatology & Allergology, University Hospital Munich (LMU), Munich, Germany.
V CamargoDepartment of Medical Oncology, Cancer Institute of São Paulo, São Paulo.
D HerchenhornDepartment of Clinical Oncology, National Institute of Cancer, Rio de Janeiro, Brazil.
T M PetrellaDepartment of Medical Oncology, Sunnybrook Health Sciences Center, Toronto, Canada.
D SchadendorfDepartment of Dermatology, Essen University Hospital, Essen, Germany.
W SharfmanDepartment of Oncology & Dermatology, Sidney Kimmel Comprehensive Cancer Center/Johns Hopkins Medicine, Lutherville, USA.
A TestoriMelanoma and Muscle Cutaneous Sarcoma Division, European Institute of Oncology, Milano, Italy.
S NovickOncology Business Unit, Novartis Pharmaceuticals Corporation, East Hanover, USA.
S HertleOncology Business Unit, Novartis Pharma AG, Basel, Switzerland.
C NourryOncology Business Unit, Novartis Pharma AG, Basel, Switzerland.
Q ChenOncology Business Unit, Novartis Pharmaceuticals Corporation, East Hanover, USA.
F S HodiMelanoma Center, Dana-Farber Cancer Institute, Boston, USA.
Novartis (Switzerland) · CHNovartis (United States) · USUCSF Helen Diller Family Comprehensive Cancer Center · USBoston University · USCancer Institute (WIA) · INColumbia University Irving Medical Center · USEssen University Hospital · DEEuropean Institute of Oncology · ITHospital Clínic de Barcelona · ESInstituto Nacional do Câncer · BRLudwig-Maximilians-Universität München · DEMayo Clinic · USPeking University Cancer Hospital · CNSidney Kimmel Comprehensive Cancer Center · USSunnybrook Health Science Centre · CAUniversity Hospital of Zurich · CHUniversity of Lübeck · DE

Funding

Women's Cancer ProgramP30CA015083 · NCI · MAYO CLINIC ROCHESTER · PI Felicity Enders · 1985 to 2026
$151.3M
NCI NIH HHS P30 CA015083
6 · The paper itself

Abstract

backgroundThe single-arm, phase II Tasigna Efficacy in Advanced Melanoma (TEAM) trial evaluated the KIT-selective tyrosine kinase inhibitor nilotinib in patients with KIT-mutated advanced melanoma without prior KIT inhibitor treatment. PATIENTS AND

methodsForty-two patients with KIT-mutated advanced melanoma were enrolled and treated with nilotinib 400 mg twice daily. TEAM originally included a comparator arm of dacarbazine (DTIC)-treated patients; the design was amended to a single-arm trial due to an observed low number of KIT-mutated melanomas. Thirteen patients were randomized to DTIC before the protocol amendment removing this study arm. The primary endpoint was objective response rate (ORR), determined according to Response Evaluation Criteria In Solid Tumors.

resultsORR was 26.2% (n = 11/42; 95% CI, 13.9%-42.0%), sufficient to reject the null hypothesis (ORR ≤10%). All observed responses were partial responses (PRs; median response duration, 7.1 months). Twenty patients (47.6%) had stable disease and 10 (23.8%) had progressive disease; 1 (2.4%) response was unknown. Ten of the 11 responding patients had exon 11 mutations, four with an L576P mutation. The median progression-free survival and overall survival were 4.2 and 18.0 months, respectively. Three of the 13 patients on DTIC achieved a PR, and another patient had a PR following switch to nilotinib.

conclusionNilotinib activity in patients with advanced KIT-mutated melanoma was similar to historical data from imatinib-treated patients. DTIC treatment showed potential activity, although the low patient number limits interpretation. Similar to previously reported results with imatinib, nilotinib showed greater activity among patients with an exon 11 mutation, including L576P, suggesting that nilotinib may be an effective treatment option for patients with specific KIT mutations. CLINICAL

trial registrationClinicalTrials.gov, NCT01028222.

Indexed as

MutationAgedAntineoplastic AgentsDacarbazineExonsFemaleHumansMaleMiddle AgedNeoplasm MetastasisProto-Oncogene Proteins c-kitPyrimidinesSurvival AnalysisAntineoplastic AgentsDacarbazinenilotinibProto-Oncogene Proteins c-kitPyrimidinesdacarbazineimatinibKITmelanomanilotinibtyrosine kinase inhibitor

Identifiers

PMID28327988
PMCPMC5452069
OpenAlexW2591748434

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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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.