Eligibility Details:
Inclusion Criteria:
- Capable of giving signed informed consent
- Male or female, age >=18 years
- Histological or cytological documentation of Head and Neck Squamous Cell Carcinoma
(HNSCC) that is 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 (except
for systemic therapy given as part of multimodal treatment for locally advanced
disease)
- Measurable disease per RECIST version 1.1 guidelines
- ECOG Performance 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 at least one of the
following conditions apply:
1. Not a woman of childbearing potential (WOCBP)
2. A WOCBP who agrees to use a 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 period.
- 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 1 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 and/or anti-ICOS directed agent
- Systemic approved or investigational anticancer therapy within 30 days or 5 half-lives
of the drug, whichever is shorter.
- Major surgery 28 days prior to randomization.
- Toxicity from previous anticancer treatment that includes 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, except as noted below:
a. Any other invasive malignancy for which the participant was definitively treated,
has been disease-free for 3 years and in the opinion of the principal investigator and
GSK Medical Monitor will not affect the evaluation of the effects of the study
treatment on the currently targeted malignancy, may be included in this clinical study
- Autoimmune disease or syndrome that required systemic treatment within the past 2
years
- Has a diagnosis of immunodeficiency or is receiving systemic steroids (≥10 mg oral
prednisone per day 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.
- Cirrhosis or current unstable liver or biliary disease per investigator assessment
defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia,
esophageal or gastric varices, or persistent jaundice.
- Active infection requiring systemic therapy
- Known 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 any ingredient used in
the study treatment formulations
- Known history of active tuberculosis
- Any serious and/or unstable pre-existing medical (aside from malignancy), 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 (unless in follow-up phase and 4 weeks have elapsed from
last dose of prior investigational agent), or has participated in a study of an
investigational agent or has used an investigational device within 4 weeks prior to
date of randomization
common.study.methods.has-drugs-yes
common.study.methods.is-healthy-yes
