Clinical trial NCT04489888: 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)
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).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Squamous Cell Carcinoma of Head and Neck
Keywords: Programmed Cell Death-1 (PD1, PD-1)
Programmed Death-Ligand 1 (PDL1, PD-L1)
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2020-07-28
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: Up to ~25 months
Secondary outcomes:
measure: Duration of Response (DOR)
timeFrame: Up to ~25 months
measure: Progression-free Survival (PFS)
timeFrame: Up to ~25 months
measure: Overall Survival (OS)
timeFrame: Up to ~25 months
measure: Percentage of Participants Who Experience an Adverse Event (AE)
timeFrame: Up to ~25 months
measure: Percentage of Participants Who Discontinued Study Treatment Due to an AE
timeFrame: Up to ~25 months
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale-New Haven Hospital-Yale Cancer Center ( Site 0265)
state: Connecticut
city: Newark
country: United States
facility: Helen F. Graham Cancer Center & Research Institute ( Site 0214)
state: Delaware
city: Jacksonville
country: United States
facility: Baptist MD Anderson Cancer Center ( Site 0215)
state: Florida
city: Orlando
country: United States
facility: Orlando Health, Inc. ( Site 0216)
state: Florida
city: Saint Paul
country: United States
facility: Regions Hospital ( Site 0227)
state: Minnesota
city: Saint Louis
country: United States
facility: Washington University School of Medicine ( Site 0240)
state: Missouri
city: Buffalo
country: United States
facility: Erie County Medical Center-Head & Neck Surgery and Plastic & Reconstructive Surgery ( Site 0268)
state: New York
city: Mineola
country: United States
facility: Perlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 0262)
state: New York
city: Charlotte
country: United States
facility: Novant Health Presbyterian ( Site 0261)
state: North Carolina
city: Winston-Salem
country: United States
facility: Novant Health Forsyth Medical Center ( Site 0266)
state: North Carolina
city: Pittsburgh
country: United States
facility: UPMC Hillman Cancer Center ( Site 0253)
state: Pennsylvania
city: Willow Grove
country: United States
facility: Abington Hospital - Asplundh Cancer Center ( Site 0229)
state: Pennsylvania
city: Charleston
country: United States
facility: Charleston Oncology ( Site 0231)
state: South Carolina
city: Richmond
country: United States
facility: Virginia Commonwealth University ( Site 0233)
state: Virginia
city: Rosario
country: Argentina
facility: Hospital Provincial del Centenario ( Site 0304)
state: Santa Fe
city: San Miguel de Tucuman
country: Argentina
facility: Centro Medico San Roque ( Site 0302)
state: Tucuman
city: Buenos Aires
country: Argentina
facility: IDIM Instituto de Diagnostico e Investigaciones Metabolicas ( Site 0303)
city: Buenos Aires
country: Argentina
facility: Fundación Respirar ( Site 0306)
city: Buenos Aires
country: Argentina
facility: Instituto Medico Especializado Alexander Fleming ( Site 0301)
city: Orange
country: Australia
facility: Orange Health Services ( Site 0106)
state: New South Wales
city: Douglas
country: Australia
facility: The Townsville Hospital ( Site 0105)
state: Queensland
city: Southport
country: Australia
facility: Gold Coast University Hospital ( Site 0103)
state: Queensland
city: Fitzroy
country: Australia
facility: St Vincents Hospital Melbourne ( Site 0101)
state: Victoria
city: Fortaleza
country: Brazil
facility: Centro Regional Integrado de Oncologia ( Site 0403)
state: Ceara
city: Belo Horizonte
country: Brazil
facility: CETUS Hospital Dia Oncologia ( Site 0400)
state: Minas Gerais
city: Natal
country: Brazil
facility: Liga Norte Riograndense Contra o Cancer ( Site 0404)
state: Rio Grande Do Norte
city: Ijui
country: Brazil
facility: ONCOSITE - Centro de Pesquisa Clinica em Oncologia ( Site 0406)
state: Rio Grande Do Sul
city: Sao Paulo
country: Brazil
facility: Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 0402)
city: Sao Paulo
country: Brazil
facility: Real e Benemerita Associacao Portuguesa de Beneficencia ( Site 0401)
city: Sao Paulo
country: Brazil
facility: A.C. Camargo Cancer Center ( Site 0405)
city: Calgary
country: Canada
facility: Tom Baker Cancer Center ( Site 0014)
state: Alberta
city: Saint John S
country: Canada
facility: Dr. H. Bliss Murphy Cancer Centre ( Site 0001)
state: Newfoundland and Labrador
city: Kingston
country: Canada
facility: Cancer Centre of Southeastern Ontario at Kingston General Hospital ( Site 0004)
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre ( Site 0005)
state: Ontario
city: Sherbrooke
country: Canada
facility: CIUSSS de l Estrie - CHUS - Centre Hosp. Univ. Sherbrooke ( Site 0003)
state: Quebec
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: 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.