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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04489888
Recruitment Status : Recruiting
First Posted : July 28, 2020
Last Update Posted : November 26, 2020
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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.

Condition or disease Intervention/treatment Phase
Squamous Cell Carcinoma of Head and Neck Drug: Pembrolizumab Drug: Carboplatin Drug: Paclitaxel Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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).
Actual Study Start Date : October 27, 2020
Estimated Primary Completion Date : September 23, 2023
Estimated Study Completion Date : July 25, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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).
Drug: Pembrolizumab
Pembrolizumab 200 mg IV infusion given on Day 1 of each 21-day cycle
Other Names:
  • MK-3475
  • KEYTRUDA®

Drug: Carboplatin
Carboplatin AUC 5 mg/mL/minute IV infusion given on Day 1 of each 21-day cycle
Other Name: PARAPLATIN®

Drug: 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
Other Names:
  • TAXOL®
  • ONXAL®




Primary Outcome Measures :
  1. Objective Response Rate (ORR) [ Time Frame: Up to ~20 months ]
    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 :
  1. Duration of Response (DOR) [ Time Frame: Up to ~47 months ]
    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.

  2. Progression-free Survival (PFS) [ Time Frame: Up to ~47 months ]
    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.

  3. Overall Survival (OS) [ Time Frame: Up to ~47 months ]
    OS is defined as the time from first dose of study treatment to death due to any cause.

  4. Percentage of Participants who Experience an Adverse Event (AE) [ Time Frame: Up to ~27 months ]
    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.

  5. Percentage of Participants who Discontinue Study Treatment due to an AE [ Time Frame: Up to ~24 months ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04489888


Contacts
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Contact: Toll Free Number 1-888-577-8839 Trialsites@merck.com

Locations
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United States, Florida
Baptist MD Anderson Cancer Center ( Site 0215) Recruiting
Jacksonville, Florida, United States, 32207
Contact: Study Coordinator    904-202-7300      
Orlando Health, Inc. ( Site 0216) Recruiting
Orlando, Florida, United States, 32806
Contact: Study Coordinator    321-841-1869      
United States, Missouri
Washington University School of Medicine ( Site 0240) Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Study Coordinator    314-747-8378      
United States, Pennsylvania
UPMC Hillman Cancer Center ( Site 0253) Recruiting
Pittsburgh, Pennsylvania, United States, 15232
Contact: Study Coordinator    412-692-4724      
United States, South Carolina
Charleston Oncology ( Site 0231) Recruiting
Charleston, South Carolina, United States, 29414
Contact: Study Coordinator    8435776957x291      
Argentina
IDIM Instituto de Diagnostico e Investigaciones Metabolicas ( Site 0303) Recruiting
Buenos Aires, Argentina, C1012AAR
Contact: Study Coordinator    +541150319779      
Canada, Ontario
Cancer Centre of Southeastern Ontario at Kingston General Hospital ( Site 0004) Recruiting
Kingston, Ontario, Canada, K7L 2V7
Contact: Study Coordinator    6135496666 x4502      
Princess Margaret Cancer Centre ( Site 0005) Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Study Coordinator    41694645015634      
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
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Study Director: Medical Director Merck Sharp & Dohme Corp.
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Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT04489888    
Other Study ID Numbers: 3475-B10
MK-3475-B10 ( Other Identifier: Merck )
First Posted: July 28, 2020    Key Record Dates
Last Update Posted: November 26, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
URL: http://engagezone.msd.com/ds_documentation.php

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Merck Sharp & Dohme Corp.:
Programmed Cell Death-1 (PD1, PD-1)
Programmed Death-Ligand 1 (PDL1, PD-L1)
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Head and Neck Neoplasms
Neoplasms by Site
Paclitaxel
Carboplatin
Pembrolizumab
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological