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

  • STATUS
    Recruiting
  • End date
    Mar 11, 2024
  • participants needed
    640
  • sponsor
    GlaxoSmithKline
Updated on 15 April 2021
measurable disease
carcinoma
fluorouracil
squamous cell carcinoma
dental caries
carboplatin
pembrolizumab
primary tumor
squamous cell carcinoma of head and neck
oropharyngeal
human papillomavirus
carcinoma of oropharynx
metastatic head and neck squamous cell carcinoma
gsk3359609

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.

Details
Condition head and neck cancer
Treatment Placebo, Pembrolizumab, GSK3359609, Platinum Based Chemotherapy, Fluorouracil (5FU), feladilimab
Clinical Study IdentifierNCT04428333
SponsorGlaxoSmithKline
Last Modified on15 April 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Do you have any of these conditions: Do you have head and neck cancer??
Do you have any of these conditions: Do you have head and neck cancer??
Do you have any of these conditions: Do you have head and neck cancer??
Do you have any of these conditions: Do you have head and neck cancer??
Do you have any of these conditions: Do you have head and neck cancer??
Do you have any of these conditions: Do you have head and neck cancer??
Do you have any of these conditions: Do you have head and neck cancer??
Do you have any of these conditions: Do you have head and neck cancer??
Do you have any of these conditions: Do you have head and neck cancer??
Do you have any of these conditions: Do you have head and neck cancer??
Do you have any of these conditions: Do you have head and neck cancer??
Is your age greater than or equal to 18 yrs?
Do you have any of these conditions: Do you have head and neck cancer??
Do you have any of these conditions: Do you have head and neck cancer??
Do you have any of these conditions: Do you have head and neck cancer??
Do you have any of these conditions: Do you have head and neck cancer??
Do you have any of these conditions: Do you have head and neck cancer??
Do you have any of these conditions: Do you have head and neck cancer??
Do you have any of these conditions: Do you have head and neck cancer??
Do you have any of these conditions: Do you have head and neck cancer??
Do you have head and neck cancer?
Gender: Male or Female
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
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