Evidence map›Paper›PMID 39038265›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2024

Pembrolizumab Plus Carboplatin and Paclitaxel as First-Line Therapy for Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (KEYNOTE-B10): A Single-Arm Phase IV Trial.

Marcin Dzienis, Juan Cundom, Christian Sebastian Fuentes, Anna Spreafico, Melanie Nordlinger, Andrea Viviana Pastor, Erin Alesi, Anterpreet Neki, Andrea S Fung, Iane Pinto Figueiredo Lima and 12 more

Registry-linked trialAbstract readClinical Trial, Phase IVMulticenter Study
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04489888 (A Phase 4, Single-arm, Open-label Clinical Study of Pembrolizumab), which is not on this map. Cited by 33 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
33citing papers in PubMed, 2 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.

NCT04489888 phase4completednot on this map

A Phase 4, Single-arm, Open-label Clinical Study of Pembrolizumab (MK-3475) to Evaluate the Efficacy and Safety of MK-3475 Plus Carboplatin and Paclitaxel as First-line Treatment of Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (KEYNOTE B10).

TypeinterventionalSponsorMerck Sharp & Dohme LLCRan2020 to 2024Enrolled101ConditionsSquamous Cell Carcinoma of Head and NeckArmsPembrolizumab, Carboplatin, Paclitaxel
3 · Its place in the literature

Who cites it

33 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Trial
  5. Trial
  6. Review
  7. Article
  8. Weight loss despite nutritional support predicts poor outcomes after postoperative chemoradiotherapy for high-risk head and neck cancer.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2026
    Article
  9. Article
  10. Article
  11. Review
  12. Article
  13. Article
  14. Article
  15. Review
  16. Article
  17. Review
  18. Article
  19. Review
  20. [Application of neoadjuvant immunotherapy in head and neck squamous cell carcinoma: From mechanisms to clinical practice].Zhong nan da xue xue bao. Yi xue ban = Journal of Central South University. Medical sciences · 2025
    Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

22 authors.

Marcin DzienisCancer Department, Gold Coast University Hospital, Southport, QLD, Australia.ORCID 0000-0002-8475-3282
Juan CundomDepartment of Oncology, IDIM Instituto de Diagnóstico e Investigaciones Metabólicas, Buenos Aires, Argentina.
Christian Sebastian FuentesDepartment of Oncology, Fundación Respirar, Buenos Aires, Argentina.
Anna SpreaficoDivision of Medical Oncology and Hematology, Princess Margaret Cancer Center, Toronto, ON, Canada.ORCID 0000-0002-3034-3042
Melanie NordlingerDepartment of Medical Oncology, Sidney Kimmel Cancer Center at Jefferson-Abington Hospital, Philadelphia, PA.
Andrea Viviana PastorDepartment of Oncology, Hospital Provincial del Centenario, Rosario, Argentina.
Erin AlesiDepartment of Hematology/Oncology and Palliative Medicine, VCU Massey Cancer Center, Richmond, VA.ORCID 0000-0001-7985-6108
Anterpreet NekiDepartment of Hematology/Oncology, UC Davis Medical Center, Sacramento, CA.
Andrea S FungDepartment of Oncology, Cancer Centre of Southeastern Ontario at Kingston General Hospital, Kingston, ON, Canada.ORCID 0000-0002-2031-6921
Iane Pinto Figueiredo LimaDepartment of Oncology, Centro Regional Integrado de Oncologia, Fortaleza, Brazil.
Peter OppeltDepartment of Oncology, Washington University School of Medicine, St Louis, MO.
Geraldo Felicio da Cunha JuniorDepartment of Oncology, CETUS Oncologia, Belo Horizonte, Brazil.ORCID 0000-0003-1602-7745
Barbara BurtnessYale University School of Medicine and Yale Cancer Center, New Haven, CT.ORCID 0000-0003-4660-1859
Fabio Andre FrankeDepartment of Oncology, Oncosite Centro de Pesquisa Clínica em Oncologia, Ijuí, Brazil.
Jennifer E TsengDepartment of Hematology and Oncology, Orlando Health Cancer Institute, Orlando, FL.
Abhishek JoshiDepartment of Medical Oncology, The Townsville University Hospital, Douglas, QLD, Australia.ORCID 0000-0003-2632-0646
Joy McCarthyDr. H. Bliss Murphy Cancer Centre, St John's, NL, Canada.
Ramona SwabyMerck & Co, Inc, Rahway, NJ.
Yulia SidiMerck & Co, Inc, Rahway, NJ.
Burak GumuscuMerck & Co, Inc, Rahway, NJ.
Niroshini NaickerOncology European Clinical Development, MSD (UK) Limited, London, United Kingdom.
Gilberto de CastroClinical Oncology, Instituto do Câncer do Estado de São Paulo-ICESP, São Paulo, Brazil.ORCID 0000-0001-8765-3044

Funding

Yale Clinical and Translational Science Award (U Component)UL1TR001863 · NCATS · YALE UNIVERSITY · PI John H. Krystal, LUCILA OHNO-MACHADO · 2016 to 2026
$102.9M
NCATS NIH HHS UL1 TR001863
6 · The paper itself

Abstract

purposeStandard-of-care first-line treatment for recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC) is pembrolizumab plus platinum and fluorouracil (FU). However, FU is associated with potential challenges (continuous 4-day infusion, high administration costs, and cardiovascular and gastrointestinal toxicities), creating a clinical need for alternative chemotherapy combinations. We evaluated the efficacy and safety of first-line pembrolizumab plus carboplatin and paclitaxel for R/M HNSCC in the open-label, single-arm, phase IV KEYNOTE-B10 study (ClinicalTrials.gov identifier: NCT04489888).

methodsEligible adults had previously untreated, histologically or cytologically confirmed R/M HNSCC regardless of PD-L1 status, measurable disease per RECIST v1.1 by blinded independent central review (BICR), and an Eastern Cooperative Oncology Group performance status of 0 or 1. Patients received pembrolizumab 200 mg intravenously once every 3 weeks for ≤35 cycles and carboplatin AUC 5 mg/mL/min intravenously once every 3 weeks for ≤6 cycles and investigator's choice of paclitaxel 100 mg/m

resultsBetween October 27, 2020, and April 29, 2022, 149 patients were screened and 101 received treatment. As of February 20, 2023, the median follow-up was 18.9 months (range, 9.1-27.0). At this final analysis, 49 (49%) of 101 patients had an objective response (95% CI, 38.4 to 58.7), including seven patients (7%) with a confirmed complete response. Of the 101 treated patients, grade 3-5 and serious treatment-related adverse events occurred in 76 (75%) and 27 (27%), respectively. There were no new safety signals.

conclusionPembrolizumab plus carboplatin and paclitaxel showed promising antitumor activity and a manageable safety profile in first-line R/M HNSCC, suggesting this combination may be an alternative option for this patient population.

Indexed as

Antibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsCarboplatinHead and Neck NeoplasmsNeoplasm Recurrence, LocalPaclitaxelSquamous Cell Carcinoma of Head and NeckAdultAgedFemaleHumansMaleMiddle AgedAntibodies, Monoclonal, HumanizedCarboplatinPaclitaxelpembrolizumab

Identifiers

PMID39038265
PMCPMC11361359

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

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.