Atezolizumab and Bevacizumab in Patients With Recurrent or Metastatic Squamous-cell Carcinoma of the Head and Neck
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Head and Neck Neoplasms
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: Non-RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: The sample size calculation will use an adaptive Simon 2-stage design based on the strategy developed by Lin and Shih (Biometrics 2004). This method allows checking the result at the first stage, adjusting the power and success rate if necessary, and adapting the decision rule accordingly. A minimum of 69 patients (up to 110) will be enrolled in 2 parallel independent cohorts depending on the HPV status of their tumors: cohort A (HPV+, N = 42 to 59) and cohort B (HPV-, N = 27 to 51).Masking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
Patients will receive the combination of Atezolizumab 1200 mg and Bevacizumab 15 mg/kg by IV infusion every 3 weeks. Treatment will be continued until disease progression, unacceptable toxicity or voluntary withdrawal. In the absence of unacceptable toxicity, patients who meet criteria for disease p...
Patients will receive the combination of Atezolizumab 1200 mg and Bevacizumab 15 mg/kg by IV infusion every 3 weeks. Treatment will be continued until disease progression, unacceptable toxicity or voluntary withdrawal. In the absence of unacceptable toxicity, patients who meet criteria for disease progression per RECIST v1.1 while receiving study treatment will be permitted to continue the study treatment if they meet all of the following criteria: Evidence of clinical benefit, as determined by the investigator following a review of all available data Absence of symptoms and signs (including laboratory values, such as new or worsening hypercalcemia) indicating unequivocal progression of disease Absence of decline in ECOG Performance Status that can be attributed to disease progression Absence of tumor progression at critical anatomical sites (e.g., leptomeningeal disease) that cannot be managed by protocol-allowed medical interventions.
Tracking Information
- NCT #
- NCT03818061
- Collaborators
- Not Provided
- Investigators
- Not Provided
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