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)

NCT04489888 | Completed Phase 4 Results FDA Drug

• 2 other identifiers: 3475-B10MK-3475-B10
• Study Type: interventional
• Target: 101
• Locations: 5 countries
• Sites: 35

Brief 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.

Conditions

Squamous Cell Carcinoma of Head and Neck

Keywords

Programmed Cell Death-1 (PD1, PD-1); Programmed Death-Ligand 1 (PDL1, PD-L1)

Outcome Measures

Primary Outcomes (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.

  Up to ~25 months

Secondary Outcomes (5)

• Duration of Response (DOR)

  Up to ~25 months

• Progression-free Survival (PFS)

  Up to ~25 months

• Overall Survival (OS)

  Up to ~25 months

• Percentage of Participants Who Experienced an Adverse Event (AE)

  Up to ~39 months

• Percentage of Participants Who Discontinued Study Treatment Due to an AE

  Up to ~25 months

Study Arms (1)

Pembrolizumab + Carboplatin + Paclitaxel

EXPERIMENTAL

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; Drug: Carboplatin; Drug: Paclitaxel

Interventions

Pembrolizumab DRUG

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

Also known as: MK-3475, KEYTRUDA®

Pembrolizumab + Carboplatin + Paclitaxel

Carboplatin DRUG

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

Also known as: PARAPLATIN®

Pembrolizumab + Carboplatin + Paclitaxel

Paclitaxel DRUG

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

Also known as: TAXOL®, ONXAL®

Pembrolizumab + Carboplatin + Paclitaxel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (35)

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

New Haven, Connecticut, 06510, United States

Location

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

Newark, Delaware, 19718, United States

Location

Baptist MD Anderson Cancer Center ( Site 0215)

Jacksonville, Florida, 32207, United States

Location

Orlando Health, Inc. ( Site 0216)

Orlando, Florida, 32806, United States

Location

Regions Hospital ( Site 0227)

Saint Paul, Minnesota, 55101, United States

Location

Washington University School of Medicine ( Site 0240)

St Louis, Missouri, 63110, United States

Location

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

Buffalo, New York, 14215, United States

Location

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

Mineola, New York, 11501, United States

Location

Novant Health Presbyterian ( Site 0261)

Charlotte, North Carolina, 28204, United States

Location

Novant Health Forsyth Medical Center ( Site 0266)

Winston-Salem, North Carolina, 27103, United States

Location

UPMC Hillman Cancer Center ( Site 0253)

Pittsburgh, Pennsylvania, 15232, United States

Location

Abington Hospital - Asplundh Cancer Center ( Site 0229)

Willow Grove, Pennsylvania, 19090, United States

Location

Charleston Oncology ( Site 0231)

Charleston, South Carolina, 29414, United States

Location

Virginia Commonwealth University ( Site 0233)

Richmond, Virginia, 23219, United States

Location

Hospital Provincial del Centenario ( Site 0304)

Rosario, Santa Fe Province, 2000, Argentina

Location

Centro Medico San Roque ( Site 0302)

San Miguel de Tucumán, Tucumán Province, T4000IAK, Argentina

Location

IDIM Instituto de Diagnostico e Investigaciones Metabolicas ( Site 0303)

Buenos Aires, C1012AAR, Argentina

Location

Fundación Respirar ( Site 0306)

Buenos Aires, C1426ABP, Argentina

Location

Instituto Medico Especializado Alexander Fleming ( Site 0301)

Buenos Aires, C1426ANZ, Argentina

Location

Orange Health Services ( Site 0106)

Orange, New South Wales, 2800, Australia

Location

The Townsville Hospital ( Site 0105)

Douglas, Queensland, 4814, Australia

Location

Gold Coast University Hospital ( Site 0103)

Southport, Queensland, 4215, Australia

Location

St Vincents Hospital Melbourne ( Site 0101)

Fitzroy, Victoria, 3065, Australia

Location

Centro Regional Integrado de Oncologia ( Site 0403)

Fortaleza, Ceará, 60336-232, Brazil

Location

CETUS Hospital Dia Oncologia ( Site 0400)

Belo Horizonte, Minas Gerais, 30110-022, Brazil

Location

Liga Norte Riograndense Contra o Cancer ( Site 0404)

Natal, Rio Grande do Norte, 59075-740, Brazil

Location

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

Ijuí, Rio Grande do Sul, 98700-000, Brazil

Location

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

São Paulo, 01246-000, Brazil

Location

Real e Benemerita Associacao Portuguesa de Beneficencia ( Site 0401)

São Paulo, 01321-001, Brazil

Location

A.C. Camargo Cancer Center ( Site 0405)

São Paulo, 01509-900, Brazil

Location

Tom Baker Cancer Center ( Site 0014)

Calgary, Alberta, T2N 4N2, Canada

Location

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

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

Location

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

Kingston, Ontario, K7L 2V7, Canada

Location

Princess Margaret Cancer Centre ( Site 0005)

Toronto, Ontario, M5G 2M9, Canada

Location

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

Sherbrooke, Quebec, J1H 5N4, Canada

Location

Related Publications (1)

• 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.

  PMID: 39038265 RESULT

Related Links

• Merck Oncology Clinical Trials Information

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck; Parkinson Disease 4, Autosomal Dominant Lewy Body

Interventions

pembrolizumab; Carboplatin; Paclitaxel

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme LLC

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2020
• First Posted: July 28, 2020
• Study Start: October 27, 2020
• Primary Completion: February 20, 2023
• Study Completion: June 28, 2024
• Last Updated: June 19, 2025
• Results First Posted: May 9, 2024

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share

Locations

BR (7); US (14); CA (5); AR (5); AU (4)