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)

June 9, 2025 updated by: Merck Sharp & Dohme LLC

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
101

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Objective Response Rate (ORR)
Time Frame: Up to ~25 months
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Duration of Response (DOR)
Time Frame: Up to ~25 months
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)
Time Frame: Up to ~25 months
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)
Time Frame: Up to ~25 months
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
Time Frame: Up to ~25 months
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)
Time Frame: Up to ~39 months
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Merck Sharp & Dohme LLC

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 27, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 20, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 28, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 27, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 27, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 28, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 19, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 9, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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