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-IT
- Lead Sponsor
- GLAXOSMITHKLINE RESEARCH AND DEVELOPMENT
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- 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 orlarynx.
5. 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 systemic treatment with curative intent)
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 date of 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
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
dd or 5 half-lives of the drug, whichever is shorter.
3.Has high risk of bleeding (examples include but not limited to tumors
encasing or infiltrating a major vessel [i.e. carotid, jugular, bronchial
artery) and/or exhibits other high-risk features such as an arteriovenous
fistula)
4.Active tumor bleeding
5.G3 or G4 hypercalcemia
6.Major surgery =28 dd prior to random
7. Toxicity from previous anticancer treatment that includes toxicity
related to prior treatment that has not resolved to = G1 (except
alopecia, hearing loss, endocrinopathy managed with replacement
therapy, and peripheral neuropathy which must be = G2)
8. Received transfusion of blood products or administration of colony
stimulating factors within 14 dd prior to randomization
9. 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 dd
prior to random
10.Invasive malignancy or history of invasive malignancy other than
disease under study within the last 3 yy, except as noted below:
a.Any other invasive malignancy for which the participant was
definitively treated, has been disease-free for =3 yy and in the
opinion of the principal investigator and GSK MM 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
11. Autoimmune disease or syndrome that required
systemic treatment within the past 2 yy
12. Has a diagnosis of immunodeficiency or is receiving systemic
steroids (=10 mg oral prednisone per day or equivalent) or other
immunosuppressive agents within 7 dd prior to randomization
13. Receipt of any live vaccine within 30 dd prior randomization
14. Prior allogeneic/autologous bone marrow or solid organ
transplantation
15. Has current pneumonitis or history of non-infectious pneumonitis
that required steroids or other immunosuppressive agents
16. Recent history (within the past 6 mm) of uncontrolled
symptomatic ascites, pleural or pericardial effusions
17. Recent history (within the past 6 mm) of gastrointestinal
obstruction that required surgery, acute diverticulitis, inflammatory
bowel disease, or intra-abdominal abscess
18. Recent history of allergen desensitization therapy within 4 ww of
random
19. History or evidence of cardiac abnormalities within the 6 mm
prior to random
20. 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
21. Active infection requiring systemic therapy
22.Known HIV infection, or positive test for hepatitis B active infection
(presence of hepatitis B surface antigen), or hepatitis C active infection
23. History of severe hypersensitivity to monoclonal antibodies or any
ingredient used in the study treatment formulations
24. Known history of active tuberculosis
25. Any serious (=G3) and/or unstable pre-existing medical
condition (aside from malignancy)
26. Any psychiatric disorder, or other condition that could interfere with
participant's safety, obtaining informed consent, or compliance to the
study procedures in the o
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