A Randomized, Double-Blind, Adaptive, Phase II/III Study of GSK3359609 in Combination with Pembrolizumab and 5FU-Platinum Chemotherapy versus Placebo in Combination with Pembrolizumab plus 5FU-Platinum Chemotherapy for First-Line Treatment of Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma - INDUCE-4

GlaxoSmithKline Research & Development Ltd0 sites116 target enrollmentSeptember 10, 2020

Overview

No summary available.

Registry

who.int

Start Date

September 10, 2020

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•1\. Capable of giving signed informed consent/assent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol
•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 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 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)
•6\. Measurable disease per response evaluation criteria in solid tumors (RECIST) version 1\.1 guidelines
•7\. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 or 1
•8\. Adequate organ function as defined in Table 3 of the study protocol
•9\. Life expectancy of at least 12 weeks
•10\. Female participants: must not be pregnant (as confirmed by a negative serum beta\-human chorionic gonadotrophin \[ß\-hCG] test in females of reproductive potential; for further details refer to Section 10\.4\), not breastfeeding, and at least one of the following conditions apply:
•a) Not a woman of childbearing potential (WOCBP) as defined in Section 10\.4\.1\. of the study protocol

•1\. Prior therapy with an anti\-PD\-1/L1/L2, anti\-ICOS directed agent
•2\. Systemic approved or investigational anticancer therapy within 30 days or 5 half lives of the drug, whichever is shorter. At least 14 days must have elapsed between the last dose of prior anticancer agent and the date of randomization
•3\. Has high risk of bleeding (examples include but are 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 a fistula, significant cavitary lesions, prior history of hemorrhage \[60 days])
•NOTE: following principal investigator consultation with the GSK Medical Monitor, certain cases may be approved by the GSK Medical Monitor upon review of the case (this review may include a requirement to provide images)
•4\. Active tumor bleeding
•5\. Grade 3 or Grade 4 hypercalcemia
•6\. Major surgery 28 days prior to randomization. Participants must have also fully recovered from any surgery (major or minor) and/or its complications before randomization
•7\. Toxicity from previous anticancer treatment that includes:
•a. Grade 3/Grade 4 toxicity considered related to prior immunotherapy and that led to treatment discontinuation
•b. 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\)