Squamous Cell Carcinoma of Head and Neck Clinical Trial
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).
| Verified date | March 2023 |
| Source | Merck Sharp & Dohme LLC |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Active, not recruiting |
| Enrollment | 101 |
| Est. completion date | July 25, 2024 |
| Est. primary completion date | February 20, 2023 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Argentina | Fundación Respirar ( Site 0306) | Buenos Aires | |
| Argentina | IDIM Instituto de Diagnostico e Investigaciones Metabolicas ( Site 0303) | Buenos Aires | |
| Argentina | Instituto Medico Especializado Alexander Fleming ( Site 0301) | Buenos Aires | |
| Argentina | Hospital Provincial del Centenario ( Site 0304) | Rosario | Santa Fe |
| Argentina | Centro Medico San Roque ( Site 0302) | San Miguel de Tucuman | Tucuman |
| Australia | The Townsville Hospital ( Site 0105) | Douglas | Queensland |
| Australia | St Vincents Hospital Melbourne ( Site 0101) | Fitzroy | Victoria |
| Australia | Orange Health Services ( Site 0106) | Orange | New South Wales |
| Australia | Gold Coast University Hospital ( Site 0103) | Southport | Queensland |
| Brazil | CETUS Hospital Dia Oncologia ( Site 0400) | Belo Horizonte | Minas Gerais |
| Brazil | Centro Regional Integrado de Oncologia ( Site 0403) | Fortaleza | Ceara |
| Brazil | ONCOSITE - Centro de Pesquisa Clinica em Oncologia ( Site 0406) | Ijui | Rio Grande Do Sul |
| Brazil | Liga Norte Riograndense Contra o Cancer ( Site 0404) | Natal | Rio Grande Do Norte |
| Brazil | A.C. Camargo Cancer Center ( Site 0405) | Sao Paulo | |
| Brazil | Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 0402) | Sao Paulo | |
| Brazil | Real e Benemerita Associacao Portuguesa de Beneficencia ( Site 0401) | Sao Paulo | |
| Canada | Tom Baker Cancer Center ( Site 0014) | Calgary | Alberta |
| Canada | Cancer Centre of Southeastern Ontario at Kingston General Hospital ( Site 0004) | Kingston | Ontario |
| Canada | Dr. H. Bliss Murphy Cancer Centre ( Site 0001) | Saint John S | Newfoundland and Labrador |
| Canada | CIUSSS de l Estrie - CHUS - Centre Hosp. Univ. Sherbrooke ( Site 0003) | Sherbrooke | Quebec |
| Canada | Princess Margaret Cancer Centre ( Site 0005) | Toronto | Ontario |
| United States | Erie County Medical Center-Head & Neck Surgery and Plastic & Reconstructive Surgery ( Site 0268) | Buffalo | New York |
| United States | Charleston Oncology ( Site 0231) | Charleston | South Carolina |
| United States | Novant Health Presbyterian ( Site 0261) | Charlotte | North Carolina |
| United States | Baptist MD Anderson Cancer Center ( Site 0215) | Jacksonville | Florida |
| United States | Perlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 0262) | Mineola | New York |
| United States | Yale-New Haven Hospital-Yale Cancer Center ( Site 0265) | New Haven | Connecticut |
| United States | Helen F. Graham Cancer Center & Research Institute ( Site 0214) | Newark | Delaware |
| United States | Orlando Health, Inc. ( Site 0216) | Orlando | Florida |
| United States | UPMC Hillman Cancer Center ( Site 0253) | Pittsburgh | Pennsylvania |
| United States | Virginia Commonwealth University ( Site 0233) | Richmond | Virginia |
| United States | Washington University School of Medicine ( Site 0240) | Saint Louis | Missouri |
| United States | Regions Hospital ( Site 0227) | Saint Paul | Minnesota |
| United States | Abington Hospital - Asplundh Cancer Center ( Site 0229) | Willow Grove | Pennsylvania |
| United States | Novant Health Forsyth Medical Center ( Site 0266) | Winston-Salem | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| Merck Sharp & Dohme LLC |
United States, Argentina, Australia, Brazil, Canada,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Objective Response Rate (ORR) | ORR is defined as the percentage of participants who have 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 has been 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 experience a CR or PR as assessed by blinded independent central review based on RECIST 1.1 will be presented. | Up to ~20 months | |
| Secondary | Duration of Response (DOR) | For participants who demonstrate 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 is defined as the time from first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurs first. RECIST 1.1 has been 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 will be presented. | Up to ~47 months | |
| Secondary | Progression-free Survival (PFS) | PFS is defined as the time from first dose of study treatment to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as =20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of =5 mm. The appearance of one or more new lesions is also considered PD. RECIST 1.1 has 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 will be presented. | Up to ~47 months | |
| Secondary | Overall Survival (OS) | OS is defined as the time from first dose of study treatment to death due to any cause. | Up to ~47 months | |
| Secondary | Percentage of Participants who Experience an Adverse Event (AE) | An AE is 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 experience an AE will be reported. | Up to ~27 months | |
| Secondary | Percentage of Participants who Discontinue Study Treatment due to an AE | An AE is 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 discontinue study treatment due to an AE will be reported. | Up to ~24 months |
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