Evidence map›Paper›PMID 32673170›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2020

Pembrolizumab Monotherapy for Recurrent or Metastatic Cutaneous Squamous Cell Carcinoma: A Single-Arm Phase II Trial (KEYNOTE-629).

Jean-Jacques Grob, Rene Gonzalez, Nicole Basset-Seguin, Olga Vornicova, Jacob Schachter, Abhishek Joshi, Nicolas Meyer, Florent Grange, Josep M Piulats, Jessica R Bauman and 4 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03284424 (A Phase 2, Open-Label, Single Arm Study to Evaluate the Safety and Efficacy of Pembrolizumab in Participants With Recurrent or Metastatic Cutaneous Squamous Cell Carcinoma), which is not on this map. Cited by 164 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
164citing papers in PubMed, 4 pooled it
24.0field-weighted citation impact, top 1% 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.

NCT03284424 phase2completednot on this map

A Phase 2, Open-Label, Single Arm Study to Evaluate the Safety and Efficacy of Pembrolizumab in Participants With Recurrent or Metastatic Cutaneous Squamous Cell Carcinoma (R/M cSCC)

TypeinterventionalSponsorMerck Sharp & Dohme LLCRan2017 to 2023Enrolled159ConditionsSquamous Cell CarcinomaArmsPembrolizumab
3 · Its place in the literature

Who cites it

164 citing papers in PubMed, 4 syntheses or guidelines pooled it, 277 citations in OpenAlex.

  1. Pooled it
  2. Immune checkpoint inhibitors in advanced cutaneous squamous cell carcinoma: A systemic review and meta-analysis.Skin research and technology : official journal of International Society for Bioengineering and the Skin (ISBS) [and] International Society for Digital Imaging of Skin (ISDIS) [and] International Society for Skin Imaging (ISSI) · 2023
    Pooled it
  3. Pooled it
  4. Pooled it
  5. Trial
  6. Phase II (Alliance A091802) Randomized Trial of Avelumab Plus Cetuximab Versus Avelumab Alone in Advanced Cutaneous Squamous Cell Carcinoma.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2025
    Trial
  7. Trial
  8. Trial
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  10. Pilot Phase II Trial of Neoadjuvant Immunotherapy in Locoregionally Advanced, Resectable Cutaneous Squamous Cell Carcinoma of the Head and Neck.Clinical cancer research : an official journal of the American Association for Cancer Research · 2021
    Trial
  11. Trial
  12. Review
  13. Short-course immunotherapy in surgically resectable, high risk cutaneous squamous cell carcinoma.Journal of the European Academy of Dermatology and Venereology : JEADV · 2026
    Article
  14. Review
  15. Article
  16. Article
  17. Article
  18. Review
  19. Review
  20. Article

104 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

14 authors at 11 institutions in 5 countries.

Jean-Jacques GrobAix-Marseille University, Marseille, France.
Rene GonzalezCentro Estatal de Cancerologiade Chihuahua, Chihuahua, Mexico.
Nicole Basset-SeguinHôpital Saint-Louis, Paris, France.
Olga VornicovaRambam Health Care Campus, Haifa, Israel.
Jacob SchachterChaim Sheba Medical Center at Tel HaShomer, Ramat Gan, Israel.
Abhishek JoshiTownsville University Hospital, Townsville, QLD, Australia.
Nicolas MeyerInstitut Universitaire du Cancer and CHU de Toulouse, Toulouse, France.
Florent GrangeCentre Hospitalier Universitaire de Reims-Hôpital Robert Debre, Reims, France.
Josep M PiulatsHospital Duran i Reinals L'Institut Català d'Oncologia de Hospitalet, Idibell, Oncobell, Ciberonc, Barcelona, Spain.
Jessica R BaumanFox Chase Cancer Center, Philadelphia, PA.
Pingye ZhangMerck & Co, Kenilworth, NJ.
Burak GumuscuMerck & Co, Kenilworth, NJ.
Ramona F SwabyMerck & Co, Kenilworth, NJ.
Brett G M HughesRoyal Brisbane and Women's Hospital, Herston, QLD, Australia.
Merck & Co., Inc., Rahway, NJ, USA (United States) · USAix-Marseille Université · FRCentre Hospitalier Universitaire de Reims · FRCentre Hospitalier Universitaire de Toulouse · FRFox Chase Cancer Center · USHôpital Saint-Louis · FRInstitut Català d'Oncologia · ESRambam Health Care Campus · ILSheba Medical Center · ILTownsville Hospital · AUUniversity of Queensland · AU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeTreatment options are limited for patients with recurrent and/or metastatic (R/M) cutaneous squamous cell carcinoma (cSCC); mortality rates exceed 70% in patients with distant metastases. Here, we present the first interim analysis of the R/M cSCC cohort from the 2-cohort-locally advanced and R/M-phase II KEYNOTE-629 study. PATIENTS AND

methodsPatients with R/M cSCC not amenable to surgery or radiation received pembrolizumab 200 mg every 3 weeks. The primary end point was objective response rate per RECIST v1.1. Secondary end points were duration of response, disease control rate, progression-free survival, overall survival, and safety.

resultsAt data cutoff (April 8, 2019), median follow-up of 105 enrolled patients in the R/M cohort was 11.4 months (range, 0.4 to 16.3 months). Objective response rate was 34.3% (95% CI, 25.3% to 44.2%; 4 complete responses, 32 partial responses), and disease control rate was 52.4% (95% CI, 42.4% to 62.2%). Median duration of response was not reached (range, 2.7 to 13.1+ months; '+' refers to ongoing response at data cutoff). Median progression-free survival was 6.9 months (95% CI, 3.1 months to 8.5 months). Median overall survival was not reached (95% CI, 10.7 months to not reached). Treatment-related adverse events occurred in 66.7% of patients (n = 70), the most common of which were pruritus (n = 15; 14.3%), asthenia (n = 14; 13.3%), and fatigue (n = 13; 12.4%). Grade 3 to 5 treatment-related adverse events occurred in 5.7% (n = 6) of patients. One patient died of treatment-related cranial nerve neuropathy.

conclusionPembrolizumab demonstrated effective antitumor activity; clinically meaningful, durable responses; and acceptable safety in primarily elderly patients with R/M cSCC, supporting its use in clinical practice. Pembrolizumab adverse events in this study were consistent with its established safety profile.

Indexed as

AdultAgedAged, 80 and overAntibodies, Monoclonal, HumanizedAntineoplastic Agents, ImmunologicalCarcinoma, Squamous CellCohort StudiesFemaleHumansMaleMiddle AgedProgrammed Cell Death 1 ReceptorProgression-Free SurvivalSkin NeoplasmsAntibodies, Monoclonal, HumanizedAntineoplastic Agents, ImmunologicalPDCD1 protein, humanpembrolizumabProgrammed Cell Death 1 Receptor

Identifiers

PMID32673170
PMCPMC7460151
OpenAlexW3043252982

What OpenQuestion holds

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LicenceCC BY-NC-ND
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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.