Evidence map›Paper›PMID 30202085›Full record

Trial reportBritish journal of cancer2018

Antitumour activity of pembrolizumab in advanced mucosal melanoma: a post-hoc analysis of KEYNOTE-001, 002, 006.

Omid Hamid, Caroline Robert, Antoni Ribas, F Stephen Hodi, Euan Walpole, Adil Daud, Ana S Arance, Ewan Brown, Christoph Hoeller, Laurent Mortier and 5 more

3 registry-linked trialsAbstract readRandomized Controlled Trial
In one paragraph

Trial report in British journal of cancer, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 101 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
101citing papers in PubMed, 1 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.

NCT01295827 phase1completednot on this map

Phase I Study of Single Agent Pembrolizumab (MK-3475) in Patients With Progressive Locally Advanced or Metastatic Carcinoma, Melanoma, and Non-Small Cell Lung Carcinoma (KEYNOTE 001)

TypeinterventionalSponsorMerck Sharp & Dohme LLCRan2011 to 2018Enrolled1,260ConditionsCancer, Solid TumorArmsPembrolizumab
NCT01704287 phase2completednot on this map

Randomized, Phase II Study of Pembrolizumab (MK-3475) Versus Chemotherapy in Patients With Advanced Melanoma (KEYNOTE 002)

TypeinterventionalSponsorMerck Sharp & Dohme LLCRan2012 to 2019Enrolled540ConditionsMalignant MelanomaArmsPembrolizumab, Carboplatin, Paclitaxel, Dacarbazine, Temozolomide
NCT01866319 phase3completednot on this map

A Multicenter, Randomized, Controlled, Three-Arm, Phase III Study to Evaluate the Safety and Efficacy of Two Dosing Schedules of Pembrolizumab (MK-3475) Compared to Ipilimumab in Patients With Advanced Melanoma

TypeinterventionalSponsorMerck Sharp & Dohme LLCRan2013 to 2019Enrolled834ConditionsMelanomaArmsPembrolizumab, Ipilimumab
3 · Its place in the literature

Who cites it

101 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Guideline
  2. Trial
  3. Trial
  4. Trial
  5. Trial
  6. Atezolizumab plus Bevacizumab in Patients with Unresectable or Metastatic Mucosal Melanoma: A Multicenter, Open-Label, Single-Arm Phase II Study.Clinical cancer research : an official journal of the American Association for Cancer Research · 2022
    Trial
  7. Trial
  8. Trial
  9. Trial
  10. Article
  11. Article
  12. Article
  13. Article
  14. Article
  15. Review
  16. Article
  17. Article
  18. Mucosal Melanoma: An Overview of Recent Therapies.Current pharmaceutical design · 2026
    Review
  19. Review
  20. Article

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

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

15 authors.

Omid HamidThe Angeles Clinic and Research Institute, Los Angeles, CA, USA. ohamid@theangelesclinic.org.
Caroline RobertGustave Roussy and Paris-Sud University, Villejuif, France.
Antoni RibasUniversity of California, Los Angeles, Los Angeles, CA, USA.
F Stephen HodiDana-Farber Cancer Institute, Boston, MA, USA.
Euan WalpolePrincess Alexandra Hospital, Brisbane, Australia.
Adil DaudUniversity of California, San Francisco, San Francisco, CA, USA.
Ana S AranceHospital Clinic de Barcelona, Barcelona, Spain.
Ewan BrownEdinburgh Cancer Research Centre and Western General Hospital, Edinburgh, Scotland, UK.
Christoph HoellerMedical University of Vienna, Vienna, Austria.
Laurent MortierCentre Hospitalier Régional Universitaire de Lille, Université Lille, Lille, France.
Jacob SchachterElla Lemelbaum Institute for Melanoma, Sheba Medical Center, Tel Hashomer, Israel.
Jianmin LongMerck & Co., Inc, Kenilworth, NJ, USA.
Scot EbbinghausMerck & Co., Inc, Kenilworth, NJ, USA.
Nageatte IbrahimMerck & Co., Inc, Kenilworth, NJ, USA.
Marcus ButlerPrincess Margaret Cancer Centre, Toronto, ON, Canada.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundMucosal melanoma is an aggressive melanoma with poor prognosis. We assessed efficacy of pembrolizumab in patients with advanced mucosal melanoma in KEYNOTE-001 (NCT01295827), -002 (NCT01704287), and -006 (NCT01866319).

methodsPatients received pembrolizumab 2 mg/kg every 3 weeks (Q3W) or 10 mg/kg Q2W or Q3W. Response was assessed by independent central review per RECIST v1.1.

results1567 patients were treated and 84 (5%) had mucosal melanoma. Fifty-one of 84 were ipilimumab-naive. In patients with mucosal melanoma, the objective response rate (ORR) was 19% (95% CI 11-29%), with median duration of response (DOR) of 27.6 months (range 1.1 + to 27.6). Median progression-free survival (PFS) was 2.8 months (95% CI 2.7-2.8), with median overall survival (OS) of 11.3 months (7.7-16.6). ORR was 22% (95% CI 11-35%) and 15% (95% CI 5-32%) in ipilimumab-naive and ipilimumab-treated patients.

conclusionPembrolizumab provides durable antitumour activity in patients with advanced mucosal melanoma regardless of prior ipilimumab.

Indexed as

AdolescentAdultAgedAged, 80 and overAntibodies, Monoclonal, HumanizedAntineoplastic Agents, ImmunologicalDrug Administration ScheduleFemaleHumansIpilimumabMaleMelanomaMiddle AgedSurvival AnalysisTreatment OutcomeYoung AdultAntibodies, Monoclonal, HumanizedAntineoplastic Agents, ImmunologicalIpilimumabpembrolizumab

Identifiers

PMID30202085
PMCPMC6173747

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.