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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)

Primary Purpose

Squamous Cell Carcinoma of Head and Neck

Status
Active
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Pembrolizumab
Carboplatin
Paclitaxel
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Squamous Cell Carcinoma of Head and Neck focused on measuring Programmed Cell Death-1 (PD1, PD-1), Programmed Death-Ligand 1 (PDL1, PD-L1)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Yale-New Haven Hospital-Yale Cancer Center ( Site 0265)
  • Helen F. Graham Cancer Center & Research Institute ( Site 0214)
  • Baptist MD Anderson Cancer Center ( Site 0215)
  • Orlando Health, Inc. ( Site 0216)
  • Regions Hospital ( Site 0227)
  • Washington University School of Medicine ( Site 0240)
  • Erie County Medical Center-Head & Neck Surgery and Plastic & Reconstructive Surgery ( Site 0268)
  • Perlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 0262)
  • Novant Health Presbyterian ( Site 0261)
  • Novant Health Forsyth Medical Center ( Site 0266)
  • UPMC Hillman Cancer Center ( Site 0253)
  • Abington Hospital - Asplundh Cancer Center ( Site 0229)
  • Charleston Oncology ( Site 0231)
  • Virginia Commonwealth University ( Site 0233)
  • Hospital Provincial del Centenario ( Site 0304)
  • Centro Medico San Roque ( Site 0302)
  • IDIM Instituto de Diagnostico e Investigaciones Metabolicas ( Site 0303)
  • Fundación Respirar ( Site 0306)
  • Instituto Medico Especializado Alexander Fleming ( Site 0301)
  • Orange Health Services ( Site 0106)
  • The Townsville Hospital ( Site 0105)
  • Gold Coast University Hospital ( Site 0103)
  • St Vincents Hospital Melbourne ( Site 0101)
  • Centro Regional Integrado de Oncologia ( Site 0403)
  • CETUS Hospital Dia Oncologia ( Site 0400)
  • Liga Norte Riograndense Contra o Cancer ( Site 0404)
  • ONCOSITE - Centro de Pesquisa Clinica em Oncologia ( Site 0406)
  • Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 0402)
  • Real e Benemerita Associacao Portuguesa de Beneficencia ( Site 0401)
  • A.C. Camargo Cancer Center ( Site 0405)
  • Tom Baker Cancer Center ( Site 0014)
  • Dr. H. Bliss Murphy Cancer Centre ( Site 0001)
  • Cancer Centre of Southeastern Ontario at Kingston General Hospital ( Site 0004)
  • Princess Margaret Cancer Centre ( Site 0005)
  • CIUSSS de l Estrie - CHUS - Centre Hosp. Univ. Sherbrooke ( Site 0003)

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pembrolizumab + Carboplatin + Paclitaxel

Arm Description

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).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
Overall Survival (OS)
OS is defined as the time from first dose of study treatment to death due to any cause.
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.
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.

Full Information

First Posted
July 27, 2020
Last Updated
March 27, 2023
Sponsor
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT04489888
Brief Title
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

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 27, 2020 (Actual)
Primary Completion Date
February 20, 2023 (Actual)
Study Completion Date
July 25, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Squamous Cell Carcinoma of Head and Neck
Keywords
Programmed Cell Death-1 (PD1, PD-1), Programmed Death-Ligand 1 (PDL1, PD-L1)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
101 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pembrolizumab + Carboplatin + Paclitaxel
Arm Type
Experimental
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
Pembrolizumab
Other Intervention Name(s)
MK-3475, KEYTRUDA®
Intervention Description
Pembrolizumab 200 mg IV infusion given on Day 1 of each 21-day cycle
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Other Intervention Name(s)
PARAPLATIN®
Intervention Description
Carboplatin AUC 5 mg/mL/minute IV infusion given on Day 1 of each 21-day cycle
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Other Intervention Name(s)
TAXOL®, ONXAL®
Intervention Description
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
Primary Outcome Measure Information:
Title
Objective Response Rate (ORR)
Description
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.
Time Frame
Up to ~20 months
Secondary Outcome Measure Information:
Title
Duration of Response (DOR)
Description
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.
Time Frame
Up to ~47 months
Title
Progression-free Survival (PFS)
Description
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.
Time Frame
Up to ~47 months
Title
Overall Survival (OS)
Description
OS is defined as the time from first dose of study treatment to death due to any cause.
Time Frame
Up to ~47 months
Title
Percentage of Participants who Experience an Adverse Event (AE)
Description
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.
Time Frame
Up to ~27 months
Title
Percentage of Participants who Discontinue Study Treatment due to an AE
Description
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.
Time Frame
Up to ~24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
Facility Information:
Facility Name
Yale-New Haven Hospital-Yale Cancer Center ( Site 0265)
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
Helen F. Graham Cancer Center & Research Institute ( Site 0214)
City
Newark
State/Province
Delaware
ZIP/Postal Code
19718
Country
United States
Facility Name
Baptist MD Anderson Cancer Center ( Site 0215)
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Facility Name
Orlando Health, Inc. ( Site 0216)
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Regions Hospital ( Site 0227)
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55101
Country
United States
Facility Name
Washington University School of Medicine ( Site 0240)
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Erie County Medical Center-Head & Neck Surgery and Plastic & Reconstructive Surgery ( Site 0268)
City
Buffalo
State/Province
New York
ZIP/Postal Code
14215
Country
United States
Facility Name
Perlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 0262)
City
Mineola
State/Province
New York
ZIP/Postal Code
11501
Country
United States
Facility Name
Novant Health Presbyterian ( Site 0261)
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Novant Health Forsyth Medical Center ( Site 0266)
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
UPMC Hillman Cancer Center ( Site 0253)
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
Abington Hospital - Asplundh Cancer Center ( Site 0229)
City
Willow Grove
State/Province
Pennsylvania
ZIP/Postal Code
19090
Country
United States
Facility Name
Charleston Oncology ( Site 0231)
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29414
Country
United States
Facility Name
Virginia Commonwealth University ( Site 0233)
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23219
Country
United States
Facility Name
Hospital Provincial del Centenario ( Site 0304)
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
2000
Country
Argentina
Facility Name
Centro Medico San Roque ( Site 0302)
City
San Miguel de Tucuman
State/Province
Tucuman
ZIP/Postal Code
T4000IAK
Country
Argentina
Facility Name
IDIM Instituto de Diagnostico e Investigaciones Metabolicas ( Site 0303)
City
Buenos Aires
ZIP/Postal Code
C1012AAR
Country
Argentina
Facility Name
Fundación Respirar ( Site 0306)
City
Buenos Aires
ZIP/Postal Code
C1426ABP
Country
Argentina
Facility Name
Instituto Medico Especializado Alexander Fleming ( Site 0301)
City
Buenos Aires
ZIP/Postal Code
C1426ANZ
Country
Argentina
Facility Name
Orange Health Services ( Site 0106)
City
Orange
State/Province
New South Wales
ZIP/Postal Code
2800
Country
Australia
Facility Name
The Townsville Hospital ( Site 0105)
City
Douglas
State/Province
Queensland
ZIP/Postal Code
4814
Country
Australia
Facility Name
Gold Coast University Hospital ( Site 0103)
City
Southport
State/Province
Queensland
ZIP/Postal Code
4215
Country
Australia
Facility Name
St Vincents Hospital Melbourne ( Site 0101)
City
Fitzroy
State/Province
Victoria
ZIP/Postal Code
3065
Country
Australia
Facility Name
Centro Regional Integrado de Oncologia ( Site 0403)
City
Fortaleza
State/Province
Ceara
ZIP/Postal Code
60336-232
Country
Brazil
Facility Name
CETUS Hospital Dia Oncologia ( Site 0400)
City
Belo Horizonte
State/Province
Minas Gerais
ZIP/Postal Code
30110-022
Country
Brazil
Facility Name
Liga Norte Riograndense Contra o Cancer ( Site 0404)
City
Natal
State/Province
Rio Grande Do Norte
ZIP/Postal Code
59075-740
Country
Brazil
Facility Name
ONCOSITE - Centro de Pesquisa Clinica em Oncologia ( Site 0406)
City
Ijui
State/Province
Rio Grande Do Sul
ZIP/Postal Code
98700-000
Country
Brazil
Facility Name
Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 0402)
City
Sao Paulo
ZIP/Postal Code
01246-000
Country
Brazil
Facility Name
Real e Benemerita Associacao Portuguesa de Beneficencia ( Site 0401)
City
Sao Paulo
ZIP/Postal Code
01321-001
Country
Brazil
Facility Name
A.C. Camargo Cancer Center ( Site 0405)
City
Sao Paulo
ZIP/Postal Code
01509-900
Country
Brazil
Facility Name
Tom Baker Cancer Center ( Site 0014)
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N2
Country
Canada
Facility Name
Dr. H. Bliss Murphy Cancer Centre ( Site 0001)
City
Saint John S
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1B 3V6
Country
Canada
Facility Name
Cancer Centre of Southeastern Ontario at Kingston General Hospital ( Site 0004)
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 2V7
Country
Canada
Facility Name
Princess Margaret Cancer Centre ( Site 0005)
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
CIUSSS de l Estrie - CHUS - Centre Hosp. Univ. Sherbrooke ( Site 0003)
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
IPD Sharing URL
http://engagezone.msd.com/ds_documentation.php
Links:
URL
http://merckoncologyclinicaltrials.com
Description
Merck Oncology Clinical Trials Information

Learn more about this trial

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)

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