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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04489888
Registration number
NCT04489888
Ethics application status
Date submitted
27/07/2020
Date registered
28/07/2020
Date last updated
9/05/2024
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)
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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).
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Secondary ID [1]
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MK-3475-B10
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Secondary ID [2]
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3475-B10
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Squamous Cell Carcinoma of Head and Neck
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Condition category
Condition code
Cancer
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Non melanoma skin cancer
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Cancer
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Kidney
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Cancer
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Head and neck
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Objective Response Rate (ORR)
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Assessment method [1]
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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.
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Timepoint [1]
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Up to ~25 months
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Secondary outcome [1]
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Duration of Response (DOR)
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Assessment method [1]
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For participants who demonstrated 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 was defined as the time from first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurred first. RECIST 1.1 was 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 was presented.
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Timepoint [1]
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Up to ~25 months
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Secondary outcome [2]
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Progression-free Survival (PFS)
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Assessment method [2]
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PFS was defined as the time from first dose of study treatment to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as =20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of =5 mm. The appearance of one or more new lesions was also considered PD. RECIST 1.1 was 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 was from product-limit (Kaplan-Meier) method for censored data.
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Timepoint [2]
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Up to ~25 months
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Secondary outcome [3]
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Overall Survival (OS)
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Assessment method [3]
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OS was defined as the time from first dose of study treatment to death due to any cause. PFS as assessed by blinded independent central review based on RECIST 1.1 was from product-limit (Kaplan-Meier) method for censored data.
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Timepoint [3]
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Up to ~25 months
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Secondary outcome [4]
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Percentage of Participants Who Experience an Adverse Event (AE)
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Assessment method [4]
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An AE was 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 experienced an AE was reported.
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Timepoint [4]
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Up to ~25 months
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Secondary outcome [5]
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Percentage of Participants Who Discontinued Study Treatment Due to an AE
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Assessment method [5]
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An AE was 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 discontinued study treatment due to an AE was reported.
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Timepoint [5]
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Up to ~25 months
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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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
N/A
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 4
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
27/10/2020
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
25/07/2024
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Actual
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Sample size
Target
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Accrual to date
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Final
101
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
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Recruitment hospital [1]
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Orange Health Services ( Site 0106) - Orange
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Recruitment hospital [2]
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The Townsville Hospital ( Site 0105) - Douglas
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Recruitment hospital [3]
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Gold Coast University Hospital ( Site 0103) - Southport
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Recruitment hospital [4]
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St Vincents Hospital Melbourne ( Site 0101) - Fitzroy
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Recruitment postcode(s) [1]
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2800 - Orange
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Recruitment postcode(s) [2]
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4814 - Douglas
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Recruitment postcode(s) [3]
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4215 - Southport
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Recruitment postcode(s) [4]
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3065 - Fitzroy
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Connecticut
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Country [2]
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United States of America
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State/province [2]
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Delaware
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United States of America
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State/province [3]
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Florida
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United States of America
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State/province [4]
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Minnesota
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Country [5]
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United States of America
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State/province [5]
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Missouri
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Country [6]
0
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United States of America
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State/province [6]
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New York
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Country [7]
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United States of America
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State/province [7]
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North Carolina
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Country [8]
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United States of America
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State/province [8]
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Pennsylvania
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Country [9]
0
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United States of America
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State/province [9]
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South Carolina
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Country [10]
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United States of America
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State/province [10]
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Virginia
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Country [11]
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Argentina
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State/province [11]
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Santa Fe
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Country [12]
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Argentina
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State/province [12]
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Tucuman
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Country [13]
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Argentina
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State/province [13]
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Buenos Aires
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Country [14]
0
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Brazil
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State/province [14]
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Ceara
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Country [15]
0
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Brazil
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State/province [15]
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Minas Gerais
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Country [16]
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Brazil
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State/province [16]
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Rio Grande Do Norte
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Country [17]
0
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Brazil
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State/province [17]
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Rio Grande Do Sul
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Country [18]
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Brazil
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State/province [18]
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Sao Paulo
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Country [19]
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Canada
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State/province [19]
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Alberta
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Country [20]
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Canada
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State/province [20]
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Newfoundland and Labrador
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Country [21]
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Canada
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State/province [21]
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Ontario
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Country [22]
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Canada
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State/province [22]
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Quebec
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Merck Sharp & Dohme LLC
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04489888
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Medical Director
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Address
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Merck Sharp & Dohme LLC
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04489888
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