Study of MEDI4736 Monotherapy and in Combination With Tremelimumab Versus Standard of Care Therapy in Patients With Head and Neck Cancer

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02369874
• Date of registration: 18/02/2015
• Prospective Registration: Yes
• Primary sponsor: AstraZeneca
• Public title: Study of MEDI4736 Monotherapy and in Combination With Tremelimumab Versus Standard of Care Therapy in Patients With Head and Neck Cancer EAGLE
• Scientific title: A Phase III Randomized, Open-Label, Multi-Center, Global Study of MEDI4736 Monotherapy and MEDI4736 in Combination With Tremelimumab Versus Standard of Care Therapy in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN)
• Date of first enrolment: September 9, 2015
• Target sample size: 736
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/show/NCT02369874
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Argentina, Australia, Belgium, Brazil, Bulgaria, Chile, Croatia, Czech Republic, Czechia, France, Georgia, Germany, Hungary, Israel, Italy, Japan, Korea, Republic of, Malaysia, Peru, Poland, Romania, Russian Federation, Serbia, Spain, Taiwan, Ukraine, United Kingdom, United States

Contacts

• Name: Nassim Morsli, MD
• Affiliation: Medical Director AstraZeneca

Key inclusion & exclusion criteria

Inclusion Criteria: - Age =18 years; - Written informed consent obtained from the
patient/legal representative; - Histologically or cytologically confirmed recurrent or
metastatic SCCHN; - Tumor progression or recurrence during or after only one palliative
systemic treatment regimen for recurrent or metastatic disease that must have contained a
platinum agent OR progression within 6 months of the last dose of platinum given as part of
multimodality therapy with curative intent; - Confirmed PD-L1-positive or -negative SCCHN
by the Ventana PD-L1 SP263 IHC assay; - WHO/Eastern Cooperative Oncology Group (ECOG)
performance status of 0 or 1; At least 1 measurable lesion, - Not previously irradiated; -
No prior exposure to immune-mediated therapy; - Adequate organ and marrow function;
Evidence of post-menopausal status or negative urinary or serum pregnancy test for female
pre-menopausal patients. Exclusion Criteria: - Histologically or cytologically confirmed
squamous cell carcinoma of any other primary anatomic location in the head and neck; -
Received more than 1 palliative systemic regimen for recurrent or metastatic disease; -Any
concurrent chemotherapy, Investigational Product, biologic, or hormonal therapy for cancer
treatment; - Receipt of any investigational anticancer therapy within 28 days or 5
half-lives; - Receipt of last dose of an approved (marketed) anticancer therapy
(chemotherapy, targeted therapy, biologic therapy, mAbs, etc) within 21 days prior to the
first dose of study treatment; - Major surgical procedure within 28 days prior to the first
dose of Investigational Product; - Any unresolved toxicity NCI CTCAE Grade =2 from previous
anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values
defined in the inclusion criterion; - Current or prior use of immunosuppressive medication
within 14 days before the first dose of their assigned Investigational Product; - History
of allogeneic organ transplantation; - Active or prior documented autoimmune or
inflammatory disorders; - Uncontrolled intercurrent illness; - Patients with a history of
brain metastases, spinal cord compression, or leptomeningeal carcinomatosis; - Mean QT
interval corrected for heart rate (QTc) =470 ms calculated from 3 electrocardiograms (ECGs)
using Fridericia's Correction; - History of active primary immunodeficiency; - Active
tuberculosis; - Active infection including hepatitis B, hepatitis C or human
immunodeficiency virus (HIV); - Receipt of live, attenuated vaccine within 30 days prior to
the first dose of Investigational Product; - Pregnant or breast-feeding female patients; -
Known allergy or hypersensitivity to Investigational Product



Age minimum: 18 Years
Age maximum: 96 Years
Gender: All

Health Condition(s) or Problem(s) studied

Recurrent or Metastatic PD-L1-positive or -Negative Squamous Cell Carcinoma of the Head and Neck SCCHN

Intervention(s)

Drug: MEDI4736 + Tremelimumab

Drug: MEDI4736

Drug: Standard of Care

Primary Outcome(s)

Overall Survival (OS) [Time Frame: September 2015 to September 2018 (36 months)]

Secondary Outcome(s)

Progression Free Survival (PFS) in PD-L1 Negative Participants [Time Frame: September 2015 to September 2018 (36 months)]

Time to Deterioration for European Organisation for Research and Treatment of Cancer 35-item Head and Neck Quality of Life Questionnaire (EORTC QLQ-H&N35) [Time Frame: September 2015 to September 2018 (36 months)]

Objective Response Rate (ORR) [Time Frame: Assessed at randomization and every 8 weeks thereafter]

Objective Response Rate (ORR) in PD-L1 Negative Participants [Time Frame: September 2015 to September 2018 (36 months)]

Duration of Response (DoR) [Time Frame: September 2015 to September 2018 (36 months)]

Percentage of Participants Alive [Time Frame: 12, 18 and 24 months]

Number of Participants Reporting One or More Adverse Events (AE) [Time Frame: First dose to last dose + 90 days or data cut off (up to 36 months)]

Time to Deterioration in European Organisation for Research and Treatment of Cancer 30-item Core Quality of Life Questionnaire, Version 3 (EORTC QLQ-C30) [Time Frame: September 2015 to September 2018 (36 months)]

Overall Survival (OS) in PD-L1 Negative Participants [Time Frame: September 2015 to September 2018 (36 months)]

Percentage of Participants Alive and Progression Free (APF) [Time Frame: Baseline up to 6 months; baseline up to 12 months]

Overall Survival (OS) in PD-L1 Positive Participants [Time Frame: September 2015 to September 2018 (36 months)]

Progression Free Survival (PFS) [Time Frame: September 2015 to September 2018 (36 months)]

Disease Control Rate (DCR) [Time Frame: Baseline up to 6 months; baseline up to 12 months]

Secondary ID(s)

D4193C00002

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 03/10/2019
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02369874