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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04489888




Registration number
NCT04489888
Ethics application status
Date submitted
27/07/2020
Date registered
28/07/2020

Titles & IDs
Public 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)
Scientific 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).
Secondary ID [1] 0 0
MK-3475-B10
Secondary ID [2] 0 0
3475-B10
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Squamous Cell Carcinoma of Head and Neck 0 0
Condition category
Condition code
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney
Cancer 0 0 0 0
Head and neck

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Pembrolizumab
Treatment: Drugs - Carboplatin
Treatment: Drugs - Paclitaxel

Experimental: Pembrolizumab + Carboplatin + Paclitaxel - 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).


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

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

Treatment: Drugs: Paclitaxel
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Objective Response Rate (ORR)
Timepoint [1] 0 0
Up to ~25 months
Secondary outcome [1] 0 0
Duration of Response (DOR)
Timepoint [1] 0 0
Up to ~25 months
Secondary outcome [2] 0 0
Progression-free Survival (PFS)
Timepoint [2] 0 0
Up to ~25 months
Secondary outcome [3] 0 0
Overall Survival (OS)
Timepoint [3] 0 0
Up to ~25 months
Secondary outcome [4] 0 0
Percentage of Participants Who Experience an Adverse Event (AE)
Timepoint [4] 0 0
Up to ~25 months
Secondary outcome [5] 0 0
Percentage of Participants Who Discontinued Study Treatment Due to an AE
Timepoint [5] 0 0
Up to ~25 months

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
27/10/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
28/06/2024
Sample size
Target
Accrual to date
Final
101
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Orange Health Services ( Site 0106) - Orange
Recruitment hospital [2] 0 0
The Townsville Hospital ( Site 0105) - Douglas
Recruitment hospital [3] 0 0
Gold Coast University Hospital ( Site 0103) - Southport
Recruitment hospital [4] 0 0
St Vincents Hospital Melbourne ( Site 0101) - Fitzroy
Recruitment postcode(s) [1] 0 0
2800 - Orange
Recruitment postcode(s) [2] 0 0
4814 - Douglas
Recruitment postcode(s) [3] 0 0
4215 - Southport
Recruitment postcode(s) [4] 0 0
3065 - Fitzroy
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Connecticut
Country [2] 0 0
United States of America
State/province [2] 0 0
Delaware
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Minnesota
Country [5] 0 0
United States of America
State/province [5] 0 0
Missouri
Country [6] 0 0
United States of America
State/province [6] 0 0
New York
Country [7] 0 0
United States of America
State/province [7] 0 0
North Carolina
Country [8] 0 0
United States of America
State/province [8] 0 0
Pennsylvania
Country [9] 0 0
United States of America
State/province [9] 0 0
South Carolina
Country [10] 0 0
United States of America
State/province [10] 0 0
Virginia
Country [11] 0 0
Argentina
State/province [11] 0 0
Santa Fe
Country [12] 0 0
Argentina
State/province [12] 0 0
Tucuman
Country [13] 0 0
Argentina
State/province [13] 0 0
Buenos Aires
Country [14] 0 0
Brazil
State/province [14] 0 0
Ceara
Country [15] 0 0
Brazil
State/province [15] 0 0
Minas Gerais
Country [16] 0 0
Brazil
State/province [16] 0 0
Rio Grande Do Norte
Country [17] 0 0
Brazil
State/province [17] 0 0
Rio Grande Do Sul
Country [18] 0 0
Brazil
State/province [18] 0 0
Sao Paulo
Country [19] 0 0
Canada
State/province [19] 0 0
Alberta
Country [20] 0 0
Canada
State/province [20] 0 0
Newfoundland and Labrador
Country [21] 0 0
Canada
State/province [21] 0 0
Ontario
Country [22] 0 0
Canada
State/province [22] 0 0
Quebec

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Merck Sharp & Dohme LLC
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Director
Address 0 0
Merck Sharp & Dohme LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: http://engagezone.msd.com/ds_documentation.php


What supporting documents are/will be available?




Results publications and other study-related documents

TypeCitations or Other Details
Journal Dzienis M, Cundom J, Fuentes CS, Spreafico A, Nord... [More Details]


Results are available at https://clinicaltrials.gov/study/NCT04489888