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

GlaxoSmithKline Research & Development Ltd0 sites600 target enrollmentApril 8, 2020

ConditionsRecurrent/Metastatic Head and Neck Squamous Cell Carcinoma MedDRA version: 21.1Level: LLTClassification code 10065147Term: Malignant solid tumorSystem Organ Class: 100000004864 Therapeutic area: Diseases [C] - Cancer [C04]

DrugsKEYTRUDA

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma
Sponsor: GlaxoSmithKline Research & Development Ltd
Enrollment: 600
Status: Active, not recruiting
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

April 8, 2020

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

GlaxoSmithKline Research & Development Ltd

Eligibility Criteria

Inclusion Criteria

•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

Exclusion Criteria

•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