A clinical trial to compare the effects, of atezolizumab versus placebo on patients with locally advanced cancer of the head and neck region.

A phase III, multicenter, randomized, Double-blind, placebo-controlled study of Atezolizumab (anti-pd-l1 antibody) as Adjuvant therapy after definitive local Therapy in patients with high-risk Locally advanced squamous cell Carcinoma of the head and neck

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2018/05/014028

Enrollment

400

Registered

2018-05-21

Start date

Unknown

Completion date

Unknown

Last updated

2024-11-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- high-risk, Locally advanced squamous cell Carcinoma of the head and neck Health Condition 2: C00-D49- Neoplasms

Interventions

Intervention1: Atezolizumab: 1200 mg IV Q3W x 16 doses or 1 year, whichever is first Control Intervention1: Placebo: 1200 mg IV Q3Wx 16 doses or 1 year, whichever is first

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
1.IRF-assessed EFS, or disease progression or death from any cause, whichever occurs first 2.OS after randomization, defined as the time from randomization to death from any cause Timepoint: disease progression or death from any cause, whichever occurs first	—

Secondary

Measure	Time frame
1.Investigator-assessed EFS 2.IRF-assessed EFS and investigator-assessed EFS at 1 and 2 years 3.OS at 1, 2, and 3 years Timepoint: OS at 1, 2, and 3 years	—

Countries

Australia, Brazil, Canada, China, France, Germany, India, Italy, Poland, Russian Federation, South Africa, Spain, Taiwan, Ukraine, United Kingdom, United States of America

Contacts

Public ContactAmol Pawar

Roche Products (India) Pvt. Ltd.

viraj.suvarna@roche.com9820006317

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026