A Phase II/III study of GSK3359609 in combination with pembrolizumab compared with pembrolizumab plus placebo in participants with recurrent or metastatic head and neck cancer
- Conditions
- Recurrent/Metastatic Head and Neck Squamous Cell CarcinomaMedDRA version: 21.1Level: LLTClassification code 10065147Term: Malignant solid tumorSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2019-002263-99-HU
- Lead Sponsor
- GlaxoSmithKline Research & Development Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 600
Participants are eligible to be included in the study if all of the following criteria apply:
1. Capable of giving signed informed consent
2. Male or female, age =18 years at the time consent is obtained (minimum age requirement per local regulatory requirements)
3. Histological or cytological documentation of Head and Neck Squamous Cell Carcinoma (HNSCC) that was diagnosed as recurrent or metastatic and considered incurable by local therapies
4. Primary tumor location of the oral cavity, oropharynx, hypopharynx or larynx.
5. 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)
6. Measurable disease per RECIST version 1.1 guidelines
7. ECOG Performance PS score of 0 or 1
8. Adequate organ function
9. Life expectancy of at least 12 weeks
10. Female participants: must not be pregnant, not breastfeeding, and at least one of the following conditions apply:
a. Not a woman of childbearing potential (WOCBP)
b. 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.
11. 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.
12. 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.
13. Have PD-L1 IHC CPS =1 status by central laboratory testing
14. Have results from testing of HPV status for oropharyngeal cancer
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 384
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 216
Participants are excluded from the study if any of the following criteria apply:
1. Prior therapy with an anti-PD-1/L1/L2 and/or anti-ICOS directed agent
2. Systemic approved or investigational anticancer therapy within 30 days or 5 half-lives of the drug, whichever is shorter.
3.Major surgery =28 days prior to randomization.
4. 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)
5. Received transfusion of blood products or administration of colony stimulating factors within 14 days prior to randomization
6. 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
7.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
b.Curatively treated non-melanoma skin or successfully treated in situ carcinoma
c.Low-risk early stage prostate cancer
8. Autoimmune disease (current or history) or syndrome that required systemic treatment within the past 2 years
9. 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
10. Receipt of any live vaccine within 30 days prior randomization
11. Prior allogeneic/autologous bone marrow or solid organ transplantation
12. Has current pneumonitis or history of non-infectious pneumonitis that required steroids or other immunosuppressive agents
13. Recent history (within the past 6 months) of uncontrolled symptomatic ascites, pleural or pericardial effusions
14. Recent history (within the past 6 months) of gastrointestinal obstruction that required surgery, acute diverticulitis, inflammatory bowel disease, or intra-abdominal abscess
15. Recent history of allergen desensitization therapy within 4 weeks of randomization
16. History or evidence of cardiac abnormalities within the 6 months prior to randomization
17. 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.
18. Active infection requiring systemic therapy
19.Known HIV infection, or positive test for hepatitis B active infection (presence of hepatitis B surface antigen), or hepatitis C active infection
20. History of severe hypersensitivity to monoclonal antibodies or any ingredient used in the study treatment formulations
21. Known history of active tuberculosis
22. 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method