Phase II Study of MEDI4736, Tremelimumab, and MEDI4736 in Combination w/ Tremelimumab Squamous Cell Carcinoma of the Head and Neck
|Recurrent/Metastatic Squamous Cell Carcinoma of Head & Neck||Drug: MEDI4736 Drug: Tremelimumab Drug: MEDI4736 + Tremelimumab||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
|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)|
- Objective Response Rate (ORR) [ Time Frame: after 12 month ]the number (%) of patients with a confirmed overall response of CR (complete response) or PR (partial response) and will be based on all treated patients who have measurable disease at baseline per ICR (evaluable set)
- Duration of response (DoR) [ Time Frame: after 12 month ]time from the date of first documented response until the first date of documented progression or death in the absence of disease progression
- Disease control rate (DCR) [ Time Frame: after 12 month ]percentage of patients who have a BoR (best objective response) of CR(complete response) or PR (partial response) or who have demonstrated SD (stable disease)
- Progression-free survival (PFS) [ Time Frame: after 12 month ]time from the date of randomization until the date of objective disease progression or death
- Overall survival (OS) [ Time Frame: after 12 month ]time from the date of randomization until death due to any cause
- Best objective response (BoR) [ Time Frame: after 12 month ]the best response a patient has had during their time in the study
- AEs, physical examinations, laboratory findings (including clinical chemistry, hematology, and urinalysis), vital signs (including blood pressure, pulse, and oxygen saturation), and ECGs [ Time Frame: after 12 month ]the safety and tolerability profile
|Actual Study Start Date:||April 15, 2015|
|Estimated Study Completion Date:||March 30, 2018|
|Primary Completion Date:||September 26, 2016 (Final data collection date for primary outcome measure)|
Experimental: MEDI4736 + Tremelimumab
MEDI4736 + Tremelimumab combination therapy
Drug: MEDI4736 + Tremelimumab
MEDI4736 + Tremelimumab combination therapy
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02319044
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|Study Director:||Anthony Jarkowski III||Medical Scientist AstraZeneca Anthony.Jarkowski@astrazeneca.com|
|Principal Investigator:||Lillian Siu, MD||Princess Margaret Hospital in Toronto, Ontario|