Recurrent/Metastatic Squamous Cell Carcinoma of Head & Neck Clinical Trial
Official title:
A Phase II, Randomized, Open-Label, Multi-Center, Global Study of MEDI4736 Monotherapy, Tremelimumab Monotherapy, and MEDI4736 in Combination With Tremelimumab in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN)
The purpose of this study is to determine the efficacy and safety of investigational medical products (MEDI4736 monotherapy, tremelimumab monotherapy, and MEDI4736 + tremelimumab combination therapy) in the treatment of patients with recurrent or metastatic carcinoma of the head and neck who have progressed during or after treatment with a platinum containing regimen for recurrent/metastatic disease.
This is a randomized, open-label, multi-center, global, Phase II study to determine the
efficacy and safety of MEDI4736 + tremelimumab combination therapy, MEDI4736 monotherapy and
tremelimumab monotherapy in the treatment of patients with recurrent or metastatic
PD-L1-negative squamous cell carcinoma of the head and neck (SCCHN) who have progressed
during or after treatment with only 1 systemic palliative regimen for recurrent or metastatic
disease, that must have contained a platinum agent.
Patients will be randomized in a stratified manner according to prognostic factors, including
human papillomavirus (HPV) status and smoking status to achieve a balance between treatments
for each of the factors. Patients will be randomized in a 1:1:2 fashion to receive MEDI4736
monotherapy, tremelimumab monotherapy, or MEDI4736 + tremelimumab combination.
All treatments will be administered beginning on Day 0 for 12 months or until confirmed
progression of disease; unless, in the Investigator's opinion, the patient continues to
receive benefit from the treatment), initiation of alternative cancer therapy, unacceptable
toxicity, withdrawal of consent, or another discontinuation criterion is met. Patients with
confirmed progression of disease who, in the Investigator's opinion, continue to receive
benefit from their assigned investigational product and who meet the criteria for treatment
in the setting of progression of disease may continue to receive their assigned
investigational product treatment for a maximum of 12 months after consultation with the
Sponsor and at the Investigator's discretion. The monotherapy arms (tremelimumab and
MEDI4736) should be discontinued if there is confirmed progression of disease following a
previous response in target lesions (complete response or partial response).
Tumor assessments will be performed using computed tomography or magnetic resonance imaging.
Efficacy for all patients will be assessed by objective tumor assessments every 8 weeks (q8w)
for the first 48 weeks (relative to the date of the first infusion) then q12w in patients who
have disease control after 12 months until confirmed objective disease progression.
Following completion or discontinuation of treatment, patients will enter a follow-up period.
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