Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study of GSK3359609 With Pembrolizumab and 5-fluorouracil (5-FU)-Platinum Chemotherapy in Participants With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (INDUCE-4)

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: NCT04428333
Recruitment Status : Recruiting
First Posted : June 11, 2020
Last Update Posted : November 13, 2020
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
GlaxoSmithKline

Brief Summary:
The purpose of this study is to evaluate if the addition of GSK3359609 to pembrolizumab in combination with 5FU-platinum based chemotherapy improves the efficacy of the pembrolizumab combination with 5FU-platinum based chemotherapy in participants with recurrent or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC). This randomized, double-blinded, Phase II/III study will compare the combination of GSK3359609 with pembrolizumab and 5FU-platinum chemotherapy to placebo in combination with pembrolizumab and 5FU-platinum chemotherapy in participants with recurrent or metastatic HNSCC of the oral cavity, oropharynx, hypopharynx or larynx. Approximately 640 participants will be enrolled in the study.

Condition or disease Intervention/treatment Phase
Neoplasms, Head and Neck Drug: GSK3359609 Drug: Pembrolizumab Drug: Placebo Drug: Platinum based chemotherapy Drug: Fluorouracil (5FU) Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 640 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This will be a randomized, parallel group treatment study with eligible participants receiving either GSK3359609 in combination with pembrolizumab and 5FU-platinum chemotherapy or placebo in combination with pembrolizumab and 5FU-platinum chemotherapy.
Masking: Double (Participant, Investigator)
Masking Description: This will be a double blind study.
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Adaptive, Phase II/III Study of GSK3359609 in Combination With Pembrolizumab and 5FU-Platinum Chemotherapy Versus Placebo in Combination With Pembrolizumab Plus 5FU-Platinum Chemotherapy for First-Line Treatment of Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma
Actual Study Start Date : August 13, 2020
Estimated Primary Completion Date : March 11, 2024
Estimated Study Completion Date : March 11, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: GSK3359609 + Pembrolizumab + 5-FU-platinum chemotherapy Drug: GSK3359609
Humanized anti-inducible T cell co-stimulatory receptor (ICOS) immunoglobulin G4 [IgG4] monoclonal antibody [mAb]

Drug: Pembrolizumab
Humanized anti-PD-1 IgG4 mAb

Drug: Platinum based chemotherapy
Cisplatin/carboplatin

Drug: Fluorouracil (5FU)
5-fluorouracil

Placebo Comparator: Placebo + Pembrolizumab + 5-FU-platinum chemotherapy Drug: Pembrolizumab
Humanized anti-PD-1 IgG4 mAb

Drug: Placebo
Sterile normal saline

Drug: Platinum based chemotherapy
Cisplatin/carboplatin

Drug: Fluorouracil (5FU)
5-fluorouracil




Primary Outcome Measures :
  1. Overall Survival (OS) in total population [ Time Frame: Up to 66 months ]
    OS in the total population, defined as the time from the date of randomization until the date of death due to any cause.

  2. OS in programmed death receptor-ligand 1 (PD-L1) combined positive score (CPS) >=1 population [ Time Frame: Up to 66 months ]
    OS in the PD-L1 CPS >=1 population, defined as the time from the date of randomization until the date of death due to any cause

  3. Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1 in total population [ Time Frame: Up to 48 months ]
    PFS per RECIST v1.1 in the total population, defined as the time from the date of randomization until the date of disease progression or death due to any cause, whichever occurs first.


Secondary Outcome Measures :
  1. PFS per RECIST v1.1 in the PD-L1 CPS >=1 population [ Time Frame: Up to 48 months ]
    PFS per RECIST v1.1 in the PD-L1 CPS >= 1, defined as the time from the date of randomization until the date of disease progression or death due to any cause, whichever comes first

  2. Milestone OS rate at 12, 24 and 36 months in total population [ Time Frame: Months 12, 24 and 36 ]
    Milestone OS rate at 12, 24, and 36 months will be evaluated from survival curves.

  3. Milestone OS rate at 12, 24 and 36 months in PD-L1 CPS >=1 population [ Time Frame: Months 12, 24 and 36 ]
    Milestone OS rate at 12, 24, and 36 months will be evaluated from survival curves.

  4. Overall Response Rate (ORR) per RECIST v1.1 in total population [ Time Frame: Up to 66 months ]
    ORR is defined as the proportion of the participants who have a complete response (CR) or partial response (PR) as the best overall response per RECIST v1.1.

  5. ORR per RECIST v1.1 in PD-L1 CPS >=1 population [ Time Frame: Up to 66 months ]
    ORR is defined as the proportion of the participants who have a CR or PR as the best overall response per RECIST v1.1.

  6. Disease Control Rate (DCR) per RECIST v1.1 in total population [ Time Frame: Up to 66 months ]
    DCR is defined as the percentage of participants with a best overall response of CR or PR at any time plus stable disease (SD) meeting the minimum time of 18 weeks per RECIST v1.1.

  7. DCR per RECIST v1.1 in PD-L1 CPS >=1 population [ Time Frame: Up to 66 months ]
    DCR is defined as the percentage of participants with a best overall response of CR or PR at any time SD meeting the minimum time of 18 weeks per RECIST v1.1.

  8. Duration of Response (DoR) per RECIST v1.1 in total population [ Time Frame: Up to 66 months ]
    DoR is defined as the time from first documented evidence of CR or PR until first documented disease progression per RECIST v1.1, whichever occurs first, among participants who demonstrated CR or PR as the best overall response per RECIST v1.1.

  9. DoR per RECIST v1.1 in PD-L1 CPS >=1 population [ Time Frame: Up to 66 months ]
    DoR is defined as the time from first documented evidence of CR or PR until first documented disease progression per RECIST v1.1, whichever occurs first, among participants who demonstrated CR or PR as the best overall response per RECIST v1.1.

  10. Number of participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) in total population [ Time Frame: Up to 66 months ]
    Number of participants with any AEs and SAEs per International Council on Harmonization (ICH) definitions.

  11. Number of participants with adverse Events of Special Interest (AESI) in total population [ Time Frame: Up to 66 months ]
    AESI are defined as events of potential immunologic etiology, including immune-related (ir) AEs

  12. Number of participants with AEs and SAEs in PD-L1 CPS>=1 population [ Time Frame: Up to 66 months ]
    Number of participants with any AEs and SAEs per ICH definitions.

  13. Number of participants with AESIs in PD-L1 CPS>=1 population [ Time Frame: Up to 66 months ]
    AESI are defined as events of potential immunologic etiology, including irAEs

  14. Severity of AEs and SAEs in total population [ Time Frame: Up to 66 months ]
    Severity for each AE and SAE will be reported during the study and will assign a grade according to the National Cancer Institute - Common Toxicity Criteria for Adverse Events (NCI-CTCAE) v5.0

  15. Severity of AESIs in total population [ Time Frame: Up to 66 months ]
    Severity for each AESIs will be reported during the study and will assign a grade according to the NCI-CTCAE v5.0

  16. Severity of AEs and SAEs in PD-L1 CPS>=1 population [ Time Frame: Up to 66 months ]
    Severity for each AE and SAE will be reported during the study and will assign a grade according to the NCI-CTCAE v5.0

  17. Severity of AESI in PD-L1 CPS>=1 population [ Time Frame: Up to 66 months ]
    Severity for each AESI will be reported during the study and will assign a grade according to the NCI-CTCAE v5.0

  18. Number of participants with dose modifications in total population [ Time Frame: Up to 66 months ]
    Number of participants with dose modifications (i.e. interruptions, discontinuations) in the total populations will be reported

  19. Number of participants with dose modifications in PD-L1 CPS>=1 population [ Time Frame: Up to 66 months ]
    Number of participants with dose modifications (i.e. interruptions, discontinuations) in the PD-L1 CPS>=1 population will be reported.

  20. Time to deterioration in pain in total populations [ Time Frame: Up to 66 months ]
    Time to deterioration in pain is defined as the time from the date of randomization to the date of first definitive meaningful deterioration in score measured by structured participants questionnaire.

  21. Time to deterioration in pain in PD-L1 CPS >=1 populations [ Time Frame: Up to 66 months ]
    Time to deterioration in pain is defined as the time from the date of randomization to the date of first definitive meaningful deterioration in score measured by structured participants questionnaire.

  22. Time to deterioration in physical function in total population [ Time Frame: Up to 66 months ]
    The time to deterioration in physical function will be measured by the participant-reported outcomes measurement.

  23. Time to deterioration in physical function in PD-L1 CPS >=1 population [ Time Frame: Up to 66 months ]
    The time to deterioration in physical function will be measured by the participant-reported outcomes measurement.



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.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histological or cytological documentation of HNSCC that was diagnosed as recurrent or metastatic and considered incurable by local therapies.
  • Primary tumor location of the oral cavity, oropharynx, hypopharynx or larynx.
  • No prior systemic therapy administered in the recurrent or metastatic setting (with the exception of systemic therapy completed > 6 months prior if given as part of multimodal treatment for locally advanced disease and no disease progression/recurrence within 6 months of the completion of curatively intended systemic treatment).
  • Measurable disease.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 or 1.
  • Adequate organ function.
  • Life expectancy of at least 12 weeks.
  • Female participants: must not be pregnant, not breastfeeding, and be either not a woman of childbearing potential (WOCBP); or be a WOCBP who agrees to use a highly effective method of birth control from 30 days prior to randomization and for at least 120 days after the last dose of study treatment.
  • Male participants with female partners of child-bearing potential: must agree to use a highly effective contraception while receiving study treatment and for at least 120 days after the last dose of study treatment and refrain from donating sperm during this periods.
  • Provide tumor tissue from excisional or core biopsy (fine needle aspirates and bone biopsies are not acceptable) acquired within 2 years prior to randomization for PD-L1 immunohistochemistry (IHC) testing by central laboratory.
  • Have PD-L1 IHC CPS status by central laboratory testing.
  • Have results from testing of human papilloma virus (HPV) status for oropharyngeal cancer.

Exclusion Criteria:

  • Prior therapy with an anti-PD-1/L1/L2, anti-Inducible T Cell Co-Stimulatory Receptor (ICOS ) directed agent.
  • Systemic approved or investigational anticancer therapy within 30 days or 5 half lives of the drug, whichever is shorter.
  • Has high risk of bleeding.
  • Active tumor bleeding
  • Grade 3 or Grade 4 hypercalcemia.
  • Major surgery <=28 days prior to randomization.
  • Toxicity from previous anticancer treatment that includes: a. Grade 3/Grade 4 toxicity related to prior immunotherapy and that led to treatment discontinuation and toxicity related to prior treatment that has not resolved to <=Grade 1 (except alopecia, hearing loss, endocrinopathy managed with replacement therapy, and peripheral neuropathy which must be <=Grade 2).
  • Received transfusion of blood products or administration of colony stimulating factors within 14 days prior to randomization.
  • Central nervous system (CNS) metastases, with the following exception: Participants with asymptomatic CNS metastases who are clinically stable and have no requirement for steroids for at least 14 days prior to randomization.
  • Invasive malignancy or history of invasive malignancy other than disease under study within the last 3 years with the exception of any other invasive malignancy for which the participant was definitively treated, has been disease-free for <=3 years, curatively treated non-melanoma skin cancer or successfully treated in situ carcinoma and/or low-risk early stage prostate cancer.
  • Autoimmune disease or syndrome that required systemic treatment within the past 2 years.
  • Has a diagnosis of immunodeficiency or is receiving systemic steroids (>10 milligram (mg) oral prednisone or equivalent) or other immunosuppressive agents within 7 days prior to randomization.
  • Receipt of any live vaccine within 30 days prior randomization.
  • Prior allogeneic/autologous bone marrow or solid organ transplantation.
  • Has current pneumonitis or history of non-infectious pneumonitis that required steroids or other immunosuppressive agents.
  • Recent history (within the past 6 months) of uncontrolled symptomatic ascites, pleural or pericardial effusions .
  • Recent history (within the past 6 months) of gastrointestinal obstruction that required surgery, acute diverticulitis, inflammatory bowel disease, or intra-abdominal abscess.
  • Recent history of allergen desensitization therapy within 4 weeks of randomization.
  • History or evidence of cardiac abnormalities within the 6 months prior to randomization which include.
  • Current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice, or cirrhosis.
  • Active infection requiring systemic therapy.
  • Known human immunodeficiency virus (HIV) infection, or positive test for hepatitis B active infection (presence of hepatitis B surface antigen), or hepatitis C active infection.
  • History of severe hypersensitivity to monoclonal antibodies or to the chemotherapies under investigation including any ingredient used in the formulation.
  • Known history of active tuberculosis.
  • Any serious and/or unstable pre-existing medical condition (aside from malignancy).
  • Any psychiatric disorder, or other condition that could interfere with participant's safety, obtaining informed consent, or compliance to the study procedures in the opinion of the investigator.
  • Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the date of randomization.

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): NCT04428333


Contacts
Layout table for location contacts
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com
Contact: EU GSK Clinical Trials Call Center +44 (0) 20 89904466 GSKClinicalSupportHD@gsk.com

Locations
Layout table for location information
United States, California
GSK Investigational Site Recruiting
Duarte, California, United States, 91010
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Erminia Massarelli         
Argentina
GSK Investigational Site Recruiting
Ciudad Autonoma de Buenos Aires, Argentina, 1012
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Margarita Sonia Alfie         
GSK Investigational Site Recruiting
Ciudad Autónoma de Buenos Aires, Argentina, C1426ABP
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Christian Sebastián Fuentes         
Australia, Queensland
GSK Investigational Site Recruiting
Woolloongabba, Queensland, Australia, 4102
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Rahul Ladwa         
Australia, Victoria
GSK Investigational Site Recruiting
Melbourne, Victoria, Australia, 3000
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Annette Lim         
Canada, Alberta
GSK Investigational Site Recruiting
Edmonton, Alberta, Canada, T6G 1Z2
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Neil Sun Chua         
Canada, Ontario
GSK Investigational Site Recruiting
Toronto, Ontario, Canada, M4N 3M5
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Martin Smoragiewicz         
GSK Investigational Site Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Anna Spreafico         
Italy
GSK Investigational Site Recruiting
Brescia, Lombardia, Italy, 25123
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Paolo Bossi         
Korea, Republic of
GSK Investigational Site Recruiting
Daegu-si, Korea, Republic of, 42601
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Keon Uk Park         
GSK Investigational Site Recruiting
Gyeonggi-do, Korea, Republic of, 10408
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Tak Yun         
GSK Investigational Site Recruiting
Hwasun-gun, Jeollanam-do, Korea, Republic of, 58128
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Sang Hee Cho         
GSK Investigational Site Recruiting
Incheon, Korea, Republic of, 21565
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Hee Kyung Ahn         
GSK Investigational Site Recruiting
Seoul, Korea, Republic of, 05505
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Sung-Bae Kim         
GSK Investigational Site Recruiting
Seoul, Korea, Republic of, 137-701
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Jin-Hyoung Kang         
Poland
GSK Investigational Site Recruiting
Bydgoszcz, Poland, 85-796
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Bogdan Zurawski         
GSK Investigational Site Recruiting
Gdynia, Poland, 81-519
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Joanna Pikiel         
GSK Investigational Site Recruiting
Warszawa, Poland, 02-781
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Andrzej Kawecki         
Romania
GSK Investigational Site Recruiting
Bucuresti, Romania, 021389
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Ingrid Iordan         
GSK Investigational Site Recruiting
Cluj Napoca, Romania, 400015
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Calin Ioan Cainap         
GSK Investigational Site Recruiting
Craiova, Romania, 200347
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Michael Schenker         
GSK Investigational Site Recruiting
Floresti, Romania, 407280
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Andrei Ungureanu         
GSK Investigational Site Recruiting
Iasi, Romania, 700106
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Constantin Volovat         
GSK Investigational Site Recruiting
Otopeni, Romania, 075100
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Elena Ciubotaru         
GSK Investigational Site Recruiting
Suceava, Romania, 720284
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Doina Elena Ganea         
GSK Investigational Site Recruiting
Targu Mures, Romania, 540156
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Ingrid Oana Mesinschi         
Russian Federation
GSK Investigational Site Recruiting
Pushkin, Russian Federation, 196603
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Konstantin D Penkov         
Spain
GSK Investigational Site Recruiting
Madrid, Spain, 28046
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Beatriz Castelo Fernández         
Sweden
GSK Investigational Site Recruiting
Stockholm, Sweden, SE-171 64
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Gun Wickart Johansson         
Sponsors and Collaborators
GlaxoSmithKline
Merck Sharp & Dohme Corp.
Investigators
Layout table for investigator information
Study Director: GSK Clinical Trials GlaxoSmithKline
Layout table for additonal information
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT04428333    
Other Study ID Numbers: 209227
First Posted: June 11, 2020    Key Record Dates
Last Update Posted: November 13, 2020
Last Verified: November 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by GlaxoSmithKline:
GSK3359609
Pembrolizumab
Programmed cell death receptor 1
Inducible T cell co-stimulatory receptor
Keynote-A02
Phase II/III
Platinum-based chemotherapy
5FU
Head and neck squamous cell carcinoma
Additional relevant MeSH terms:
Layout table for MeSH terms
Carcinoma
Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
Head and Neck Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Neoplasms by Site
Fluorouracil
Pembrolizumab
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Immunological