A Study of Pharmacodynamics of RO5083945 in Patients With Head and Neck Squamous Cell Carcinoma

Hoffmann-La Roche62 enrolled

Overview

This open-label study will assess the pharmacodynamics, safety and efficacy of RO5083945 as compared to cetuximab in patients with head and neck squamous cell carcinoma. Patients will receive at least 2 infusions of either RO5083945 or cetuximab. Anticipated time on study treatment is up to 3 months, and target sample size is \<50.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Head and Neck Cancer

Interventions

RO5083945DRUG

700mg iv weekly

cetuximabDRUG

400mg/m2 iv 1st dose, 250mg/m2 iv subsequent weekly doses

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * adult patients, \>/=18 years of age * squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx Exclusion Criteria: * carcinoma of nasal cavity, paranasal sinus and nasopharynx * recurrent squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx * known positivity for HIV, hepatitis B and/or hepatitis C infection

Locations (7)

Unnamed facility

Toulouse, France

Unnamed facility

Villejuif, France

Unnamed facility

Milan, Lombardy, Italy

Unnamed facility

Nijmegen, Netherlands

Unnamed facility

Outcomes

Primary Outcomes

immune cell infiltration head and neck squamous cell cancer (HNSCC)

Time frame: through study completion or early study discontinuation

Secondary Outcomes

pharmacodynamics: T lymphocytes, B lymphocytes, NK cells, plasma cytokine levels

Time frame: through study completion or early study discontinuation

safety and efficacy: AEs, laboratory parameters, tumour assessments

Time frame: through study completion or early study discontinuation

Data from ClinicalTrials.gov

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