Window of Opportunity Study of Preoperative Immunotherapy With Atezolizumab in Local SCCHN

Sponsor
University Hospital, Essen
Study ID
NCT04939480
Phase
PHASE2
Status
Completed

Conditions

  • Squamous Cell Carcinoma of Head and Neck

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Atezolizumab — DRUG
    Atezolizumab 1200 mg intravenous solution

Study Details

Targeting the PD-L1 pathway with atezolizumab has demonstrated objective responses across a broad range of malignancies including head and neck squamous cell carcinoma (SCCHN). MO39839 is a window of opportunity study investigating the feasibility, safety and postoperative complication rates of preoperative short time immunotherapy with atezolizumab in patients with local SCCHN. In the scope of MO39839 a comprehensive translational research program will be conducted to assess the potential effect of atezolizumab on dynamics in tumor immunity, and to identify and validate potential predictive and prognostic biomarkers.

Key Dates

Start date
Oct 6, 2021
Status verified
Aug 2023
Primary completion
Mar 14, 2024
Completion
Mar 14, 2024

Study Design

Enrollment
20 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Atezolizumab
    Pre-operative administration of atezolizumab 1200 mg followed by definitive resection of the tumor, followed by standard of care radiotherapy or radio-chemotherapy.

Primary Outcome Measure

Effect of atezolizumab on tumor-infiltrating immune cells in resectable SCCHN [ Time Frame: 4 weeks ]

Related Studies