Clinical Trials /

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)

NCT04489888

Description:

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.

Related Conditions:
  • Head and Neck Squamous Cell Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 4

Trial Eligibility

Document

Title

  • 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).

Clinical Trial IDs

  • ORG STUDY ID: 3475-B10
  • SECONDARY ID: MK-3475-B10
  • NCT ID: NCT04489888

Conditions

  • Squamous Cell Carcinoma of Head and Neck

Interventions

DrugSynonymsArms
PembrolizumabMK-3475, KEYTRUDA®Pembrolizumab + Carboplatin + Paclitaxel
CarboplatinPARAPLATIN®Pembrolizumab + Carboplatin + Paclitaxel
PaclitaxelTAXOL®, ONXAL®Pembrolizumab + Carboplatin + Paclitaxel

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
Pembrolizumab + Carboplatin + PaclitaxelExperimentalParticipants 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).
  • Pembrolizumab
  • Carboplatin
  • Paclitaxel

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 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 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
      
Maximum Eligible Age:120 Years
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Objective Response Rate (ORR)
Time Frame:Up to ~20 months
Safety Issue:
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.

Secondary Outcome Measures

Measure:Duration of Response (DOR)
Time Frame:Up to ~47 months
Safety Issue:
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.
Measure:Progression-free Survival (PFS)
Time Frame:Up to ~47 months
Safety Issue:
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.
Measure:Overall Survival (OS)
Time Frame:Up to ~47 months
Safety Issue:
Description:OS is defined as the time from first dose of study treatment to death due to any cause.
Measure:Percentage of Participants who Experience an Adverse Event (AE)
Time Frame:Up to ~27 months
Safety Issue:
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.
Measure:Percentage of Participants who Discontinue Study Treatment due to an AE
Time Frame:Up to ~24 months
Safety Issue:
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.

Details

Phase:Phase 4
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Merck Sharp & Dohme Corp.

Trial Keywords

  • Programmed Cell Death-1 (PD1, PD-1)
  • Programmed Death-Ligand 1 (PDL1, PD-L1)

Last Updated

September 10, 2020