A 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
Reason given: Decision to terminate the study as its primary endpoint of investigator-assessed event free survival (INV-EFS) was not met at its final EFS analysis. No new safety signals were identified.
Key facts
- Where
- Aichi, Chiba, Fukuoka, Hokkaido, Hyōgo, Miyagi, Okayama, Osaka, Shizuoka, and Tokyo, JapanSee the 14 sites
- Phase
- Phase 3
Where in Japan
- Aichi Cancer Center HospitalAichi, JapanNo longer taking part
- National Cancer Center Hospital EastChiba, JapanNo longer taking part
- National Hospital Organization Kyushu Cancer CenterFukuoka, JapanNo longer taking part
- Hokkaido University HospitalHokkaido, JapanNo longer taking part
- Kobe University HospitalHyōgo, JapanNo longer taking part
- Miyagi Cancer CenterMiyagi, JapanNo longer taking part
- Okayama University HospitalOkayama, JapanNo longer taking part
- Osaka International Cancer InstituteOsaka, JapanNo longer taking part
- Shizuoka Cancer CenterShizuoka, JapanNo longer taking part
- National Cancer Center HospitalTokyo, JapanNo longer taking part
- The Cancer Institute Hospital of JFCRTokyo, JapanNo longer taking part
- The Jikei University HospitalTokyo, JapanNo longer taking part
- Tokyo Medical and Dental University HospitalTokyo, JapanNo longer taking part
- Tokyo Medical University HospitalTokyo, JapanNo longer taking part
Trial details
- Who runs it
- Hoffmann-La Roche
- Trial code
- NCT03452137
- Record updated
- 9 October 2024
- Original description
This study will evaluate the efficacy and safety of atezolizumab compared with placebo as adjuvant therapy after definitive local therapy in patients with high-risk locally advanced squamous cell carcinoma of the head and neck (SCCHN)Read full original descriptionShow less
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
This study will evaluate the efficacy and safety of atezolizumab compared with placebo as adjuvant therapy after definitive local therapy in patients with high-risk locally advanced squamous cell carcinoma of the head and neck (SCCHN)
Inclusion: Histologically or cytologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN); Human Papilloma Virus (HPV) status; Completed definitive local therapy; Absence of metastatic disease as documented by radiographic scans; Adequate hematologic and end-organ function; For patients receiving therapeutic anticoagulation: stable anticoagulant regimen; For women of childbearing potential: agreement to remain abstinent or use contraceptive methods with a failure rate of < 1% per year during the treatment period and for 5 months after the last dose of study treatment. Women must refrain from donating eggs during this same period; Confirmed response of Complete Response (CR), Partial Response (PR), or Stable Disease (SD) to definitive local therapy documented by CT with contrast or MRI with contract to head and neck region done >= 8 weeks after completion of definitive local therapy and within 28 days prior to initiation of study drug.
Exclusion: Patients who have received surgery alone or radiotherapy alone as definitive local therapy; Prior allogeneic stem cell or solid organ transplantation; Current treatment with anti-viral therapy for Hepatitis B Virus (HBV); Treatment with systemic immunostimulatory agents; Treatment with systemic immunosuppressive medication; Any systemic therapies after permitted definitive local therapies; Evidence of disease progression or metastatic disease during or following definitive local therapy documented in post-definitive local therapy screening scans; Active or history of autoimmune disease or immune deficiency; Active tuberculosis; Significant cardiovascular disease; History of malignancy, including prior SCCHN primary tumors within 5 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death; History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins; Patients who have received a non-FDA or non-EMA approved anti-EGFR agent or any other non-FDA or non-EMA, approved agent as part of definitive local therapy, unless the unapproved agent was given in addition to an approved agent; Squamous cell carcinoma of the nasopharynx or paranasal sinuses or non-squamous histology; Uncontrolled or symptomatic hypercalcemia; Pregnancy or breastfeeding, or intention of becoming pregnant during study treatment or within 5 months after the last dose of study treatment.