Evidence map›Paper›PMID 39893343›Full record

Trial reportAnnals of surgical oncology2025

Adjuvant Pembrolizumab in Stage II Melanoma: Outcomes by Primary Tumor Location in the Randomized, Double-Blind, Phase III KEYNOTE-716 Trial.

Charles H Yoon, Merrick I Ross, Brian R Gastman, Jason J Luke, Paolo A Ascierto, Georgina V Long, Piotr Rutkowski, Muhammad Khattak, Michele Del Vecchio, Luis de la Cruz Merino and 10 more

Registry-linked trialAbstract readClinical Trial, Phase IIIRandomized Controlled TrialMulticenter Study
PubMed Publisher
In one paragraph

Trial report in Annals of surgical oncology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03553836 (Adjuvant Therapy With Pembrolizumab Versus Placebo in Resected High-risk Stage II Melanoma), which is not on this map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing 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.

NCT03553836 phase3active not recruitingnot on this map

Adjuvant Therapy With Pembrolizumab Versus Placebo in Resected High-risk Stage II Melanoma: A Randomized, Double-blind Phase 3 Study (KEYNOTE-716)

TypeinterventionalSponsorMerck Sharp & Dohme LLCRan2018 to 2033Enrolled976ConditionsMelanomaArmsPembrolizumab, Placebo
3 · Its place in the literature

Who cites it

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

  1. Pooled it
  2. Review
  3. Review
  4. 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

20 authors.

Charles H YoonDana-Farber Brigham Cancer Center, Boston, MA, USA. cyoon@bwh.harvard.edu.
Merrick I RossThe University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Brian R GastmanCleveland Clinic Foundation, Cleveland, OH, USA.
Jason J LukeUPMC Hillman Cancer Center, University of Pittsburgh, Pittsburgh, PA, USA.
Paolo A AsciertoCancer Immunotherapy and Development Therapeutics Unit, Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale", Naples, Italy.
Georgina V LongMelanoma Institute Australia, The University of Sydney, Royal North Shore and Mater Hospitals, Sydney, NSW, Australia.
Piotr RutkowskiMaria Sklodowska-Curie National Research Institute of Oncology, Warsaw, Poland.
Muhammad KhattakFiona Stanley Hospital and Edith Cowan University, Perth, WA, Australia.
Michele Del VecchioFondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.
Luis de la Cruz MerinoHospital Universitario Virgen Macarena, Seville, Spain.
Jacek MackiewiczPoznan University of Medical Sciences, Poznan, Poland.
Vanna Chiarion-SileniVeneto Institute of Oncology IOV-IRCCS, Veneto, Italy.
Dirk SchadendorfComprehensive Cancer Center, Universitaetsklinikum Essen and German Cancer Consortium, Essen, Germany.
Matteo S CarlinoMelanoma Institute Australia, The University of Sydney, Westmead and Blacktown Hospitals, Sydney, NSW, Australia.
Yujie ZhaoMerck & Co., Inc., Rahway, NJ, USA.
Mizuho Fukunaga-KalabisMerck & Co., Inc., Rahway, NJ, USA.
Clemens KreplerMerck & Co., Inc., Rahway, NJ, USA.
Alexander M M EggermontUniversity Medical Center Utrecht, Utrecht, The Netherlands.
Jeffrey E GershenwaldThe University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Vernon K SondakMoffitt Cancer Center, Tampa, FL, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPrevious results from the KEYNOTE-716 trial demonstrated significantly improved recurrence-free survival (RFS) and distant metastasis-free survival (DMFS) with adjuvant pembrolizumab versus placebo in patients with resected stage IIB or IIC melanoma. We present a post hoc analysis of efficacy according to primary tumor location.

methodsKEYNOTE-716 (NCT03553836) is a randomized, multicenter, double-blind, phase III study. Patients aged ≥ 12 years with newly diagnosed, resected stage IIB or IIC melanoma (sentinel node-negative) were randomly assigned (1:1) to pembrolizumab 200 mg every 3 weeks (2 mg/kg up to 200 mg for pediatric patients) or placebo. This post hoc analysis evaluated RFS and DMFS by primary tumor location of the head/neck, trunk, or extremities.

resultsOverall, 976 patients were assigned to pembrolizumab (n = 487) or placebo (n = 489). Median follow-up was 39.4 months (range 26.0-51.4). The hazard ratios {HRs (95% confidence interval [CI])} for RFS were 0.60 (0.38-0.93) for the head/neck subgroup, 0.57 (0.38-0.84) for the trunk subgroup, and 0.69 (0.47-1.02) for the extremities subgroup. The HRs (95% CI) for DMFS were 0.65 (0.37-1.14) for the head/neck subgroup, 0.59 (0.38-0.92) for the trunk subgroup, and 0.53 (0.31-0.90) for the extremities subgroup.

conclusionRFS and DMFS consistently favored adjuvant pembrolizumab over placebo in most subgroups analyzed in this post hoc analysis from the KEYNOTE-716 trial. These results support the benefit of adjuvant pembrolizumab on RFS and DMFS in patients with resected high-risk stage II melanoma, irrespective of primary tumor location.

Indexed as

Antibodies, Monoclonal, HumanizedAntineoplastic Agents, ImmunologicalHead and Neck NeoplasmsMelanomaNeoplasm Recurrence, LocalSkin NeoplasmsAdolescentAdultAgedChemotherapy, AdjuvantChildDouble-Blind MethodExtremitiesFemaleFollow-Up StudiesHumansAntibodies, Monoclonal, HumanizedAntineoplastic Agents, ImmunologicalpembrolizumabAdjuvantAdjuvant therapyImmune checkpoint inhibitorsMelanomaPembrolizumabSkin neoplasmsSurgery

Identifiers

PMID39893343

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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.