NCT02551159

Phase III Open Label Study of MEDI 4736 With/Without Tremelimumab Versus Standard of Care (SOC) in Recurrent/Metastatic Head and Neck Cancer

A Phase III Randomized, Open-label, Multi-center, Global Study of MEDI4736 Alone or in Combination With Tremelimumab Versus Standard of Care in the Treatment of First-line Recurrent or Metastatic Squamous Cell Head and Neck Cancer Patients

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 823 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 130 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, open-label, multi-center, 3-arm, global Phase III study to determine the efficacy and safety of MEDI4736 + tremelimumab combination or MEDI4736 monotherapy versus SoC (EXTREME regimen) in the treatment of patients with SCCHN who have not received prior systemic chemotherapy for recurrent or metastatic disease.

Detailed description

Patients will be randomized in a 2:1:1 ratio to MEDI4736 + tremelimumab combination therapy, MEDI4736 monotherapy, or SoC. Patients in all arms will continue therapy until progression. Tumor assessments will be performed on computed tomography scans or magnetic resonance imaging scans, preferably with intravenous (IV) contrast. Efficacy for all patients will be assessed by objective tumor assessments every 6 weeks for the first 24 weeks, then every 8 weeks thereafter until treatment discontinuation due to progression or toxicity. All patients will be followed every 3 months for survival after progression is confirmed.

Conditions

• Squamous Cell Carcinoma of the Head and Neck

Interventions

Type	Name	Description
BIOLOGICAL	MEDI4736	Anti-PD-L1 antibody
BIOLOGICAL	Tremelimumab	Anti-CTLA-4 Antibody
BIOLOGICAL	MEDI4736+Tremelimumab
BIOLOGICAL	Cetuximab	Monoclonal Antibody
DRUG	5-fluorouracil (5FU)	Chemotherapy Agent
DRUG	Cisplatin	Chemotherapy agent
DRUG	Carboplatin	Chemotherapy Agent

Timeline

• Start date: 2015-10-15
• Primary completion: 2020-07-06
• Completion: 2021-05-21
• First posted: 2015-09-16
• Last updated: 2021-10-13
• Results posted: 2021-10-13

Locations

197 sites across 23 countries: United States, Austria, Belgium, Brazil, Canada, France, Germany, Greece, India, Italy, Japan, Philippines, Poland, Romania, Russia, Slovakia, South Korea, Spain, Taiwan, Thailand, Ukraine, United Kingdom, Vietnam

Regulatory

• FDA-regulated drug study