A Study of Pembrolizumab (MK-3475) Plus Carboplatin and Paclitaxel as First-line Treatment of Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (MK-3475-B10/KEYNOTE B10)

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).

The goal of this study is to evaluate the efficacy and safety of pembrolizumab combined with carboplatin and paclitaxel as first-line treatment in participants with recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC). No statistical hypothesis will be tested in this study.

Study Overview

• Status: Completed
• Conditions: Squamous Cell Carcinoma of Head and Neck
• Intervention / Treatment: Drug: Pembrolizumab; Drug: Carboplatin; Drug: Paclitaxel

• Study Type: Interventional
• Enrollment (Actual): 101
• Phase: Phase 4

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1012AAR
    • IDIM Instituto de Diagnostico e Investigaciones Metabolicas ( Site 0303)
  • Buenos Aires, Argentina, C1426ABP
    • Fundación Respirar ( Site 0306)
  • Buenos Aires, Argentina, C1426ANZ
    • Instituto Medico Especializado Alexander Fleming ( Site 0301)
  • Santa Fe
    • Rosario, Santa Fe, Argentina, 2000
      • Hospital Provincial del Centenario ( Site 0304)
  • Tucuman
    • San Miguel de Tucuman, Tucuman, Argentina, T4000IAK
      • Centro Medico San Roque ( Site 0302)
• Australia
  • New South Wales
    • Orange, New South Wales, Australia, 2800
      • Orange Health Services ( Site 0106)
  • Queensland
    • Douglas, Queensland, Australia, 4814
      • The Townsville Hospital ( Site 0105)
    • Southport, Queensland, Australia, 4215
      • Gold Coast University Hospital ( Site 0103)
  • Victoria
    • Fitzroy, Victoria, Australia, 3065
      • St Vincents Hospital Melbourne ( Site 0101)
• Brazil
  • Sao Paulo, Brazil, 01246-000
    • Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 0402)
  • Sao Paulo, Brazil, 01321-001
    • Real e Benemerita Associacao Portuguesa de Beneficencia ( Site 0401)
  • Sao Paulo, Brazil, 01509-900
    • A.C. Camargo Cancer Center ( Site 0405)
  • Ceara
    • Fortaleza, Ceara, Brazil, 60336-232
      • Centro Regional Integrado de Oncologia ( Site 0403)
  • Minas Gerais
    • Belo Horizonte, Minas Gerais, Brazil, 30110-022
      • CETUS Hospital Dia Oncologia ( Site 0400)
  • Rio Grande Do Norte
    • Natal, Rio Grande Do Norte, Brazil, 59075-740
      • Liga Norte Riograndense Contra o Cancer ( Site 0404)
  • Rio Grande Do Sul
    • Ijui, Rio Grande Do Sul, Brazil, 98700-000
      • ONCOSITE - Centro de Pesquisa Clinica em Oncologia ( Site 0406)
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 4N2
      • Tom Baker Cancer Center ( Site 0014)
  • Newfoundland and Labrador
    • Saint John S, Newfoundland and Labrador, Canada, A1B 3V6
      • Dr. H. Bliss Murphy Cancer Centre ( Site 0001)
  • Ontario
    • Kingston, Ontario, Canada, K7L 2V7
      • Cancer Centre of Southeastern Ontario at Kingston General Hospital ( Site 0004)
    • Toronto, Ontario, Canada, M5G 2M9
      • Princess Margaret Cancer Centre ( Site 0005)
  • Quebec
    • Sherbrooke, Quebec, Canada, J1H 5N4
      • CIUSSS de l Estrie - CHUS - Centre Hosp. Univ. Sherbrooke ( Site 0003)
• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Yale-New Haven Hospital-Yale Cancer Center ( Site 0265)
  • Delaware
    • Newark, Delaware, United States, 19718
      • Helen F. Graham Cancer Center & Research Institute ( Site 0214)
  • Florida
    • Jacksonville, Florida, United States, 32207
      • Baptist MD Anderson Cancer Center ( Site 0215)
    • Orlando, Florida, United States, 32806
      • Orlando Health, Inc. ( Site 0216)
  • Minnesota
    • Saint Paul, Minnesota, United States, 55101
      • Regions Hospital ( Site 0227)
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University School of Medicine ( Site 0240)
  • New York
    • Buffalo, New York, United States, 14215
      • Erie County Medical Center-Head & Neck Surgery and Plastic & Reconstructive Surgery ( Site 0268)
    • Mineola, New York, United States, 11501
      • Perlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 0262)
  • North Carolina
    • Charlotte, North Carolina, United States, 28204
      • Novant Health Presbyterian ( Site 0261)
    • Winston-Salem, North Carolina, United States, 27103
      • Novant Health Forsyth Medical Center ( Site 0266)
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15232
      • UPMC Hillman Cancer Center ( Site 0253)
    • Willow Grove, Pennsylvania, United States, 19090
      • Abington Hospital - Asplundh Cancer Center ( Site 0229)
  • South Carolina
    • Charleston, South Carolina, United States, 29414
      • Charleston Oncology ( Site 0231)
  • Virginia
    • Richmond, Virginia, United States, 23219
      • Virginia Commonwealth University ( Site 0233)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Has histologically or cytologically-confirmed diagnosis of R/M HNSCC that is considered incurable by local therapies
• Male participants refrain from donating sperm plus are abstinent from heterosexual intercourse or agree to use contraception during the intervention period and for at least 95 days after carboplatin/paclitaxel
• Female participants are not pregnant or breastfeeding and are either not a woman of child-bearing potential (WOCBP) or use a contraceptive method that is highly effective or are abstinent from heterosexual intercourse during the intervention period and for at least 120 days after pembrolizumab or 30 days after paclitaxel or 6 months after carboplatin whichever occurs last, and agree not to donate or freeze eggs during this period
• Has adequate organ function

Exclusion Criteria:

• Has disease that is suitable for local therapy administered with curative intent
• Has a life expectancy of less than 3 months and/or has rapidly progressive disease
• Has a diagnosed and/or treated additional malignancy within 5 years prior to allocation with the exception of curatively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, curatively resected in situ cervical cancer and curatively resected in situ breast cancer
• Has received a live or live-attenuated vaccine within 30 days prior to the first dose of study intervention
• Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study intervention
• Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
• Has a history of or current non-infectious pneumonitis/interstitial lung disease that requires steroids
• Has an active infection requiring systemic therapy
• Has a known history of human immunodeficiency virus (HIV) infection
• Has a known history of Hepatitis B or Hepatitis C virus infection
• Has had an allogenic tissue/solid organ transplant

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Pembrolizumab + Carboplatin + Paclitaxel; Participants will receive pembrolizumab plus carboplatin plus paclitaxel. Pembrolizumab will be administered via intravenous (IV) infusion at a dose of 200 mg on Day 1 of each 21-day cycle for up to 35 cycles (up to ~2 years). Carboplatin will be administered via IV infusion at area under curve (AUC) 5 mg/mL/minute on Day 1 of each 21-day cycle for up to 6 cycles (up to ~4 months). At investigator's choice, paclitaxel will be administered via IV infusion at a dose of 100 mg/m^2 on Day 1 and Day 8 of each 21-day cycle for up to 6 cycles (up to ~4 months) or at a dose of 175 mg/m^2 on Day 1 of each 21-day cycle for up to 6 cycles (up to ~4 months).

Drug: Pembrolizumab; Pembrolizumab 200 mg IV infusion given on Day 1 of each 21-day cycle; Other Names: MK-3475; KEYTRUDA®; Drug: Carboplatin; Carboplatin AUC 5 mg/mL/minute IV infusion given on Day 1 of each 21-day cycle; Other Names: PARAPLATIN®; Drug: Paclitaxel; At investigator's choice, paclitaxel 100 mg/m^2 IV infusion given on Day 1 and Day 8 of each 21-day cycle or paclitaxel 175 mg/m^2 IV infusion given on Day 1 of each 21-day cycle; Other Names: TAXOL®; ONXAL®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Response Rate (ORR)	ORR was defined as the percentage of participants who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters) per Response Evaluation Criteria in Solid Tumors Update and Clarification 1.1 (RECIST 1.1) which was adjusted for this study to include a maximum of 10 target lesions and a maximum of 5 target lesions per organ. The percentage of participants who experienced a CR or PR as assessed by blinded independent central review based on RECIST 1.1 was presented.	Up to ~25 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of Response (DOR)	For participants who demonstrated a confirmed Complete Response (CR: Disappearance of all target lesions) or confirmed Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters) per RECIST 1.1, DOR was defined as the time from first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurred first. RECIST 1.1 was adjusted for this study to include a maximum of 10 target lesions and a maximum of 5 target lesions per organ. The DOR as assessed by blinded independent central review based on RECIST 1.1 was presented.	Up to ~25 months
Progression-free Survival (PFS)	PFS was defined as the time from first dose of study treatment to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. RECIST 1.1 was been adjusted for this study to include a maximum of 10 target lesions and a maximum of 5 target lesions per organ. PFS as assessed by blinded independent central review based on RECIST 1.1 was from product-limit (Kaplan-Meier) method for censored data.	Up to ~25 months
Overall Survival (OS)	OS was defined as the time from first dose of study treatment to death due to any cause. PFS as assessed by blinded independent central review based on RECIST 1.1 was from product-limit (Kaplan-Meier) method for censored data.	Up to ~25 months
Percentage of Participants Who Discontinued Study Treatment Due to an AE	An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants who discontinued study treatment due to an AE was reported.	Up to ~25 months
Percentage of Participants Who Experienced an Adverse Event (AE)	An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants who experienced an AE was reported.	Up to ~39 months

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC
• Investigators: Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

General Publications

• Dzienis M, Cundom J, Fuentes CS, Spreafico A, Nordlinger M, Pastor AV, Alesi E, Neki A, Fung AS, Figueiredo Lima IP, Oppelt P, da Cunha Junior GF, Burtness B, Franke FA, Tseng JE, Joshi A, McCarthy J, Swaby R, Sidi Y, Gumuscu B, Naicker N, de Castro G Jr. 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. J Clin Oncol. 2024 Sep 1;42(25):2989-2999. doi: 10.1200/JCO.23.02625. Epub 2024 Jul 22.

Helpful Links

• Merck Oncology Clinical Trials Information

Study record dates

Study Major Dates

• Study Start (Actual): October 27, 2020
• Primary Completion (Actual): February 20, 2023
• Study Completion (Actual): June 28, 2024

Study Registration Dates

• First Submitted: July 27, 2020
• First Submitted That Met QC Criteria: July 27, 2020
• First Posted (Actual): July 28, 2020

Study Record Updates

• Last Update Posted (Actual): June 19, 2025
• Last Update Submitted That Met QC Criteria: June 9, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Programmed Cell Death-1 (PD1, PD-1); Programmed Death-Ligand 1 (PDL1, PD-L1)
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Head and Neck Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Squamous Cell; Squamous Cell Carcinoma of Head and Neck; Carcinoma; Carcinoma, Squamous Cell; Antineoplastic Agents, Immunological; Immune Checkpoint Inhibitors; Antineoplastic Agents; Molecular Mechanisms of Pharmacological Action; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Carboplatin; Pembrolizumab; Paclitaxel
• Other Study ID Numbers: 3475-B10; MK-3475-B10 (Other Identifier: MSD)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No