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Clinical Trial Summary

To determine the effect of neoadjuvant atezolizumab alone or in combination with emactuzumab, CPI-444, and other immune modulating agents on T-cell infiltration in advanced SCCHN. To determine the impact of neo-adjuvant immunotherapy on surgical outcomes.


Clinical Trial Description

PRIMARY OBJECTIVES:

I. To determine the effect of neoadjuvant atezolizumab alone or in combination with emactuzumab and other immune modulating agents on T-cell infiltration in advanced squamous cell carcinoma of the head and neck (SCCHN). (Translational) II. To determine the impact of neo-adjuvant immunotherapy on surgical outcomes. (Clinical)

SECONDARY OBJECTIVES:

I. To associate changes in CD3 infiltration with radiographic response in the surgical window. (Translational) II. To describe the changes in T-cell subtypes and other mediators of anti-tumor immune response induced by neoadjuvant atezolizumab alone or in combination with emactuzumab or other immune-modulating agents in advanced SCCHN patients. (Translational) III. To describe the impact of neoadjuvant, surgical, and adjuvant therapy on peripheral immune responses. (Translational) IV. To determine whether combined neo-adjuvant and adjuvant immune therapy improves 2-year relapse-free survival (RFS) in patients with SCCHN. (Clinical) V. To establish the safety/toxicity profile of each regimen in the perioperative and postoperative settings for patients with advanced SCCHN. (Clinical)

EXPLORATORY OBJECTIVES:

I. To establish immune-competent tumor xenograft models for future research. II. To characterize changes in the gut microbiome associated with each therapeutic combination.

OUTLINE: Patients are assigned to 1 of 2 arms.

ARM I: Patients receive atezolizumab intravenously (IV) over 30-60 minutes every 3 weeks for up to 2 courses prior to standard surgery and radiation. 16 weeks post-surgery, patients receive atezolizumab IV over 30-60 minutes every 3 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive atezolizumab IV over 30-60 minutes and emactuzumab IV over 90 minutes every 3 weeks for up to 2 courses prior to standard surgery and radiation. 16 weeks post-surgery, patients receive atezolizumab IV over 30-60 minutes every 3 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 28 days and then periodically for up to 2 years.

IV. To determine whether combined neo-adjuvant and adjuvant immune therapy improves 2-year relapse-free survival (RFS) in patients with SCCHN. (Clinical) V. To establish the safety/toxicity profile of each regimen in the perioperative and postoperative settings for patients with advanced SCCHN. (Clinical)

EXPLORATORY OBJECTIVES:

I. To establish immune-competent tumor xenograft models for future research. II. To characterize changes in the gut microbiome associated with each therapeutic combination.

OUTLINE: Patients are assigned to 1 of 2 arms.

ARM I: Patients receive atezolizumab intravenously (IV) over 30-60 minutes every 3 weeks for up to 2 courses prior to standard surgery and radiation. 16 weeks post-surgery, patients receive atezolizumab IV over 30-60 minutes every 3 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive atezolizumab IV over 30-60 minutes and emactuzumab IV over 90 minutes every 3 weeks for up to 2 courses prior to standard surgery and radiation. 16 weeks post-surgery, patients receive atezolizumab IV over 30-60 minutes every 3 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 28 days and then periodically for up to 2 years. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03708224
Study type Interventional
Source University of California, San Francisco
Contact Alain Algazi, MD
Phone 877-827-3222
Email cancertrials@ucsf.edu
Status Not yet recruiting
Phase Phase 2
Start date November 1, 2018
Completion date November 30, 2025

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