A clinical trial to compare the effects, of atezolizumab versus placebo on patients with locally advanced cancer of the head and neck region.
- Conditions
- Health Condition 1: null- high-risk, Locally advanced squamous cell Carcinoma of the head and neckHealth Condition 2: C00-D49- Neoplasms
- Registration Number
- CTRI/2018/05/014028
- Lead Sponsor
- F HoffmannLa Roche Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Other (Terminated)
- Sex
- Not specified
- Target Recruitment
- 16
1. Histologically or cytologically confirmed SCCHN
2. HPV status as determined locally by p16 IHC
3.Completed definitive local therapy
4.Absence of metastatic disease
5.Recovered from acute toxicities
6. ECOG PS of 0 or 1
7.Life expectancy = 12 weeks
8. Adequate hematologic and end-organ function
1.Patients who have received surgery alone as definitive local therapy
2.HPV-negative patients who have a T1/T2 or N0/N1 tumor
3.HPV-positive oropharyngeal carcinoma patients who have a clinical N0/N1/N2 or pathological N0/N1 nodal stage
4.Patients, other than laryngeal cancer patients, who have persistent disease at the primary site and require salvage resection of primary tumor post CRT
5.Squamous cell carcinoma of the nasopharynx
6.Evidence of disease progression or metastatic disease during or following definitive local therapy documented in the 10- to 12-week post-definitive local therapy scans
7.Uncontrolled or symptomatic hypercalcemia (ionized calcium > 1.5 mmol/L, calcium > 12 mg/dL or corrected serum calcium > ULN)
8.Active or history of autoimmune disease or immune deficiency.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.IRF-assessed EFS, or disease progression or death from any cause, whichever occurs first <br/ ><br>2.OS after randomization, defined as the time from randomization to death from any cause <br/ ><br>Timepoint: disease progression or death from any cause, whichever occurs first <br/ ><br>
- Secondary Outcome Measures
Name Time Method 1.Investigator-assessed EFS <br/ ><br>2.IRF-assessed EFS and investigator-assessed EFS at 1 and 2 years <br/ ><br>3.OS at 1, 2, and 3 years <br/ ><br>Timepoint: OS at 1, 2, and 3 years