Phase II Study of MEDI4736, Tremelimumab, and MEDI4736 in Combination w/ Tremelimumab Squamous Cell Carcinoma of the Head and Neck
Condition: Recurrent/Metastatic Squamous Cell Carcinoma of Head & Neck
MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck
Study type: Interventional
Phase: Phase 2

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): MEDI4736; Tremelimumab; MEDI4736 + Tremelimumab
Intervention type(s): Drug; Drug; Drug
Intervention description(s): MEDI4736 monotherapy; Tremelimumab monotherapy; MEDI4736 + Tremelimumab combination therapy
Intervention MeSH terms: Durvalumab; Tremelimumab; Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Head and neck cancer; SCCHN