A Randomized, Double-blind, Adaptive, Phase II/III Study of GSK3359609 or Placebo in Combination with Pembrolizumab for First-Line Treatment of PD-L1 Positive Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma

Overview

No summary available.

Registry

who.int

Start Date

March 30, 2020

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•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 (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

•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\.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)
•NOTE: Principal investigator should consult the GSK Medical Monitors to confirm eligibility of patients with disease features that may confer a high risk of tumor associated hemorrhage.
•4\.Active tumor bleeding
•5\.Grade 3 or Grade 4 hypercalcemia
•6\.Major surgery \=28 days prior to randomization.
•7\. 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\)
•8\. Received transfusion of blood products or administration of colony stimulating factors within 14 days prior to randomization