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Squamous Cell Carcinoma of Head and NeckPhase 4NCT04489888

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 study testing Pembrolizumab, Carboplatin and Paclitaxel in people with Squamous Cell Carcinoma of Head and Neck, run by Merck Sharp & Dohme LLC at 35 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Squamous Cell Carcinoma of Head and Neck
What is being tested?
Pembrolizumab, Carboplatin and Paclitaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
101 participants
Where
35 sitesin 5 countries
Study dates
27 Oct 2020to 28 Jun 2024
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 11Show fewer
  • 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

Trial locations and contacts

35 sites in 5 countries.

35 sites in 5 countries

United States14 sites

  • Erie County Medical Center-Head & Neck Surgery and Plastic & Reconstructive Surgery ( Site 0268)

    Buffalo, New York, 14215

  • Charleston Oncology ( Site 0231)

    Charleston, South Carolina, 29414

  • Novant Health Presbyterian ( Site 0261)

    Charlotte, North Carolina, 28204

  • Baptist MD Anderson Cancer Center ( Site 0215)

    Jacksonville, Florida, 32207

  • Perlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 0262)

    Mineola, New York, 11501

  • Yale-New Haven Hospital-Yale Cancer Center ( Site 0265)

    New Haven, Connecticut, 06510

  • Helen F. Graham Cancer Center & Research Institute ( Site 0214)

    Newark, Delaware, 19718

  • Orlando Health, Inc. ( Site 0216)

    Orlando, Florida, 32806

  • UPMC Hillman Cancer Center ( Site 0253)

    Pittsburgh, Pennsylvania, 15232

  • Virginia Commonwealth University ( Site 0233)

    Richmond, Virginia, 23219

  • Regions Hospital ( Site 0227)

    Saint Paul, Minnesota, 55101

  • Washington University School of Medicine ( Site 0240)

    St Louis, Missouri, 63110

  • Abington Hospital - Asplundh Cancer Center ( Site 0229)

    Willow Grove, Pennsylvania, 19090

  • Novant Health Forsyth Medical Center ( Site 0266)

    Winston-Salem, North Carolina, 27103

Other trials in United States

Brazil7 sites

  • CETUS Hospital Dia Oncologia ( Site 0400)

    Belo Horizonte, Minas Gerais, 30110-022

  • Centro Regional Integrado de Oncologia ( Site 0403)

    Fortaleza, Ceará, 60336-232

  • ONCOSITE - Centro de Pesquisa Clinica em Oncologia ( Site 0406)

    Ijuí, Rio Grande do Sul, 98700-000

  • Liga Norte Riograndense Contra o Cancer ( Site 0404)

    Natal, Rio Grande do Norte, 59075-740

  • Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 0402)

    São Paulo, 01246-000

  • Real e Benemerita Associacao Portuguesa de Beneficencia ( Site 0401)

    São Paulo, 01321-001

  • A.C. Camargo Cancer Center ( Site 0405)

    São Paulo, 01509-900

Other trials in Brazil

Argentina5 sites

  • IDIM Instituto de Diagnostico e Investigaciones Metabolicas ( Site 0303)

    Buenos Aires, C1012AAR

  • Fundación Respirar ( Site 0306)

    Buenos Aires, C1426ABP

  • Instituto Medico Especializado Alexander Fleming ( Site 0301)

    Buenos Aires, C1426ANZ

  • Hospital Provincial del Centenario ( Site 0304)

    Rosario, Santa Fe Province, 2000

  • Centro Medico San Roque ( Site 0302)

    San Miguel de Tucumán, Tucumán Province, T4000IAK

Other trials in Argentina

Canada5 sites

  • Tom Baker Cancer Center ( Site 0014)

    Calgary, Alberta, T2N 4N2

  • Cancer Centre of Southeastern Ontario at Kingston General Hospital ( Site 0004)

    Kingston, Ontario, K7L 2V7

  • CIUSSS de l Estrie - CHUS - Centre Hosp. Univ. Sherbrooke ( Site 0003)

    Sherbrooke, Quebec, J1H 5N4

  • Dr. H. Bliss Murphy Cancer Centre ( Site 0001)

    St. John's, Newfoundland and Labrador, A1B 3V6

  • Princess Margaret Cancer Centre ( Site 0005)

    Toronto, Ontario, M5G 2M9

Other trials in Canada

Australia4 sites

  • The Townsville Hospital ( Site 0105)

    Douglas, Queensland, 4814

  • St Vincents Hospital Melbourne ( Site 0101)

    Fitzroy, Victoria, 3065

  • Orange Health Services ( Site 0106)

    Orange, New South Wales, 2800

  • Gold Coast University Hospital ( Site 0103)

    Southport, Queensland, 4215

Other trials in Australia

About this study

Official title: 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.

Keywords
Programmed Cell Death-1 (PD1, PD-1), Programmed Death-Ligand 1 (PDL1, PD-L1)
Medical subject headings
Squamous Cell Carcinoma of Head and Neck, Parkinson Disease 4, Autosomal Dominant Lewy Body

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PembrolizumabDrug

    Also called MK-3475, KEYTRUDA®

    Pembrolizumab 200 mg IV infusion given on Day 1 of each 21-day cycle

  • CarboplatinDrug

    Also called PARAPLATIN®

    Carboplatin AUC 5 mg/mL/minute IV infusion given on Day 1 of each 21-day cycle

  • PaclitaxelDrug

    Also called TAXOL®, ONXAL®

    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

Study groups in NCT04489888
Study groupRoleWhat they receive
Pembrolizumab + Carboplatin + PaclitaxelExperimentalParticipants 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).
Receives: Drug: Pembrolizumab; Drug: Carboplatin; Drug: Paclitaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to ~25 months

Secondary outcomes (5)

  1. 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.

    Measured: Up to ~25 months

  2. 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.

    Measured: Up to ~25 months

  3. 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.

    Measured: Up to ~25 months

  4. 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.

    Measured: Up to ~39 months

  5. 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.

    Measured: Up to ~25 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jul 2020
  2. Study start27 Oct 2020
  3. Primary completion20 Feb 2023
  4. Study completion28 Jun 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
101 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04489888
Sponsor's protocol ID
3475-B10
Other IDs
MK-3475-B10
Status last verified
Jun 2025
First submitted
27 Jul 2020
Last updated
19 Jun 2025
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

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.

    PubMed 39038265

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Pembrolizumab, Carboplatin and Paclitaxel in people with Squamous Cell Carcinoma of Head and Neck, run by Merck Sharp & Dohme LLC at 35 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 35 sites in United States, Brazil, Argentina, Canada, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) (time frame: Up to ~25 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04489888, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2025.

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