Study To Compare Avelumab In Combination With Standard of Care Chemoradiotherapy (SoC CRT) Versus SoC CRT for Definitive Treatment In Patients With Locally Advanced Squamous Cell Carcinoma Of The Head And Neck (JAVELIN HEAD AND NECK 100)

Official Title

A Randomized Double-blind Phase 3 Study Of Avelumab In Combination With Standard Of Care Chemoradiotherapy (Cisplatin Plus Definitive Radiation Therapy) Versus Standard Of Care Chemoradiotherapy In The Front-line Treatment Of Patients With Locally Advanced Squamous Cell Carcinoma Of The Head And Neck

Summary:

This is a phase 3 randomized, placebo controlled study to evaluate the safety and anti-tumour activity of Avelumab in combination with standard of care chemoradiation (SoC CRT) versus SoC CRT alone in front-line treatment of patients with locally advanced head and neck cancer.

Trial Description

Primary Outcome:

  • Progression Free Survival (PFS)
Secondary Outcome:
  • Overall Survival (OS)
  • Trough plasma concentration (Ctrough) of avelumab
  • Percentage of patients with positive anti-drug antibodies (ADA) and neutralizing antibodies
  • Tumour tissue biomarker status
  • Maximum plasma concentration (Cmax) of Avelumab
  • Area under the concentration-time curve extrapolated to infinity (AUCinf) for cisplatin
  • Cmax of Cisplatin
  • Clearance (CL) of cisplatin
  • Time to maximum plasma concentration (Tmax) and elimination half-life (t1/2)for cisplatin
  • Volume of distribution (Vz) for cisplatin (total and free)
  • Change from Baseline in the EuroQoL Group 5-Dimension 5- Level Self-Report Questionnaire (EQ-5D-5L)
  • Change from baseline in National Cancer Comprehensive Network (NCCN) Head and Neck Symptom Index-22 items (FHNSI-22)
  • Rate of pathologic complete response
  • Locoregional tumour control
  • Distant metastatic failure
  • Objective Response Rate - Percentage of Participants With Objective Response
  • Duration of response
  • The incidence of pathologically-positive neck dissection versus the incidence of pathologically-negative neck dissection

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society