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

JRCT ID: jRCT2011200012

Registered date:03/12/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Head and Neck SCC
• Date of first enrollment: 19/01/2021
• Target sample size: 640
• Countries of recruitment: Argentina,Japan,Australia,Japan,Belgium,Japan,Brazil,Japan,Canada,Japan,Denmark,Japan,France,Japan,Germany,Japan,Ireland,Japan,Italy,Japan,Korea,Japan,Republic of Poland,Japan,Romania,Japan,Russian Federation,Japan,Spain,Japan,Sweden,Japan,United Kingdom,Japan,United States,Japan
• Study type: Interventional

Intervention(s)

Arm :
Experimental: GSK3359609 + Pembrolizumab + 5-FU-platinum chemotherapy

Intervention:
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

Arm:
Placebo Comparator: Placebo + Pembrolizumab + 5-FU-platinum chemotherapy

Intervention:
Drug: Pembrolizumab
Humanized anti-PD-1 IgG4 mAb

Drug: Placebo
Sterile normal saline

Drug: Platinum based chemotherapy
Cisplatin/carboplatin

Drug: Fluorouracil (5FU)
5-fluorouracil

Outcome(s)

Primary Outcome

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.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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."

Exclude 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.

Related Information

• Primary Sponsor: Ishibashi Hideyasu
• Secondary ID(s): NCT04428333