Study of MEDI4736 Monotherapy and in Combination With Tremelimumab Versus Standard of Care Therapy in Patients With Head and Neck Cancer
EAGLE
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)
1 other identifier
interventional
736
24 countries
168
Brief Summary
This is a randomized, open-label, multi-center, global, Phase III study to determine the efficacy and safety of MEDI4736 + tremelimumab combination therapy and MEDI4736 monotherapy versus SoC therapy in the target patient population.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Sep 2015
Longer than P75 for phase_3
168 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 18, 2015
CompletedFirst Posted
Study publicly available on registry
February 24, 2015
CompletedStudy Start
First participant enrolled
September 9, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 10, 2018
CompletedResults Posted
Study results publicly available
October 3, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
November 13, 2020
CompletedFebruary 10, 2021
January 1, 2021
3 years
February 18, 2015
September 10, 2019
January 21, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall Survival (OS)
OS is defined as the time from the date of randomization until death due to any cause. OS was analyzed for the full analysis set, regardless of programmed death-ligand 1 (PD-L1) status.
September 2015 to September 2018 (36 months)
Secondary Outcomes (13)
Overall Survival (OS) in PD-L1 Negative Participants
September 2015 to September 2018 (36 months)
Overall Survival (OS) in PD-L1 Positive Participants
September 2015 to September 2018 (36 months)
Progression Free Survival (PFS)
September 2015 to September 2018 (36 months)
Objective Response Rate (ORR)
Assessed at randomization and every 8 weeks thereafter
Duration of Response (DoR)
September 2015 to September 2018 (36 months)
- +8 more secondary outcomes
Study Arms (3)
MEDI4736
EXPERIMENTALMEDI4736 monotherapy
MEDI4736 + Tremelimumab
EXPERIMENTALMEDI4736 + tremelimumab combination therapy
Standard of Care
ACTIVE COMPARATORStandard of Care
Interventions
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (168)
Research Site
Tucson, Arizona, 85711, United States
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Fullerton, California, 92835-3825, United States
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Los Angeles, California, 90089, United States
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Redondo Beach, California, 90277, United States
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Stanford, California, 94305, United States
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Denver, Colorado, 80218, United States
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Newark, Delaware, 19713, United States
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Miami Beach, Florida, 33140, United States
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Orlando, Florida, 32806, United States
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Atlanta, Georgia, 30322, United States
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Evanston, Illinois, 60201-1718, United States
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Lexington, Kentucky, 40536, United States
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Boston, Massachusetts, 02215, United States
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Rochester, New York, 14621, United States
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Rochester, New York, 14642, United States
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Winston-Salem, North Carolina, 27157, United States
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Pittsburgh, Pennsylvania, 15232, United States
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Germantown, Tennessee, 38138, United States
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Nashville, Tennessee, 37232, United States
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Dallas, Texas, 75230, United States
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Dallas, Texas, 75246, United States
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McAllen, Texas, 78503, United States
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Norfolk, Virginia, 23502, United States
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CABA, C1426ANZ, Argentina
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San Miguel de Tucumán, T4000IAK, Argentina
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Adelaide, 5000, Australia
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Heidelberg, 3084, Australia
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Melbourne, 3004, Australia
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St Leonards, 2065, Australia
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Woolloongabba, 4102, Australia
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Brussels, 1090, Belgium
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Brussels, 1200, Belgium
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Charleroi, 6000, Belgium
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Kortrijk, 8500, Belgium
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Leuven, 3000, Belgium
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Namur, 5000, Belgium
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Barretos, 14784-400, Brazil
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Curitiba, 81520-060, Brazil
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Porto Alegre, 90020-090, Brazil
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Porto Alegre, 90610-000, Brazil
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Rio de Janeiro, 20231-050, Brazil
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Santo André, 09060-650, Brazil
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São José do Rio Preto, 15090-000, Brazil
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São Paulo, 03102-002, Brazil
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Shumen, 9700, Bulgaria
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Sofia, 1527, Bulgaria
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Varna, 9000, Bulgaria
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Temuco, 4810469, Chile
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Osijek, 31000, Croatia
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Zagreb, 10 000, Croatia
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Olomouc, 775 20, Czechia
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Zlín, 762 75, Czechia
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Angers, 49933, France
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Bordeaux, 33000, France
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Dijon, 21079, France
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Le Mans, 72000, France
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Lyon, 69373, France
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Montpellier, 34298, France
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Paris, 75248, France
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Plerin SUR MER, 22190, France
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Rouen, 76038, France
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Saint-Grégoire, 35768, France
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Strasbourg, 67085, France
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Villejuif, 94805, France
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Lorient Cedex, 56322, Georgia
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Berlin, 12200, Germany
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Essen, 45122, Germany
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Halle, 06120, Germany
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Hanover, 30625, Germany
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Heidelberg, 69120, Germany
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Leipzig, 04103, Germany
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München, 81377, Germany
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Potsdam, 14467, Germany
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Budapest, 1083, Hungary
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Budapest, 1122, Hungary
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Budapest, 1162, Hungary
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Győr, 9024, Hungary
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Kecskemét, 6000, Hungary
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Haifa, 31096, Israel
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Jerusalem, 91120, Israel
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Petah Tikva, 49100, Israel
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Tel Aviv, 6423906, Israel
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Tel Litwinsky, 52621, Israel
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Aosta, 11100, Italy
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Bologna, 40138, Italy
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Gallarate, 21013, Italy
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Legnago, 37045, Italy
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Milan, 20133, Italy
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Napoli, 80131, Italy
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Pavia, 27100, Italy
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Roma, 00144, Italy
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Siena, 53100, Italy
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Chūōku, 104-0045, Japan
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Fukuoka, 811-1395, Japan
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Hirakata-shi, 573-1191, Japan
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Isehara-shi, 259-1193, Japan
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Kashiwa, 277-8577, Japan
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Kitaadachi-gun, 362-0806, Japan
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Kobe, 650-0017, Japan
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Kōtoku, 135-8550, Japan
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Matsuyama, 791-0280, Japan
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Nagoya, 464-8681, Japan
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Natori-shi, 981-1293, Japan
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Okayama, 700-8558, Japan
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Osaka, 541-8567, Japan
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Sapporo, 003-0804, Japan
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Sapporo, 060-8648, Japan
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Sayama, 589-8511, Japan
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Shimotsuke-shi, 329-0498, Japan
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Sunto-gun, 411-8777, Japan
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Takatsuki-shi, 569-8686, Japan
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Yokohama, 236-0004, Japan
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Yokohama, 241-8515, Japan
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Krakow, 31-108, Poland
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Lodz, 93-513, Poland
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Poznan, 60-780, Poland
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Baia Mare, 430031, Romania
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Brasov, 500152, Romania
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Cluj-Napoca, 400015, Romania
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Cluj-Napoca, 400058, Romania
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Craiova, 200347, Romania
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Arkhangelsk, 163045, Russia
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Chelyabinsk, 454087, Russia
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Kursk, 305524, Russia
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Moscow, 105229, Russia
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Moscow, 111123, Russia
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Moscow, 125284, Russia
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Moscow, 125367, Russia
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Moscow, 143423, Russia
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Nizhny Novgorod, 603081, Russia
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Omsk, 644013, Russia
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Pyatigorsk, 357502, Russia
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Saint Petersburg, 197758, Russia
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Saint Petersburg, 197785, Russia
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Saint Petersburg, 198255, Russia
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Sochi, 354057, Russia
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Ufa, 450054, Russia
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Vladimir, 600020, Russia
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Belgrade, 11000, Serbia
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Kamenitz, 21204, Serbia
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Kragujevac, 34000, Serbia
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Niš, 18000, Serbia
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Daegu, 42601, South Korea
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Goyang-si, 10408, South Korea
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Seoul, 03080, South Korea
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Seoul, 05505, South Korea
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Suwon, 16247, South Korea
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Barcelona, 08035, Spain
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Barcelona, 08036, Spain
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L'Hospitalet de Llobregat, 08908, Spain
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Madrid, 28041, Spain
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Madrid, 28046, Spain
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Madrid, 28050, Spain
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Marbella, 29600, Spain
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Málaga, 29010, Spain
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Pamplona, 31008, Spain
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Valencia, 46014, Spain
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Valencia, 46026, Spain
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Zaragoza, 50009, Spain
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Kaohsiung City, 833, Taiwan
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Taipei, 100, Taiwan
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Taipei, 10449, Taiwan
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Taoynan, 33305, Taiwan
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Dnipro, 49102, Ukraine
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Kyiv, 03115, Ukraine
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Sumy, 40022, Ukraine
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Uzhhorod, 88014, Ukraine
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Zaporizhzhia, 69040, Ukraine
Related Publications (1)
Ferris RL, Haddad R, Even C, Tahara M, Dvorkin M, Ciuleanu TE, Clement PM, Mesia R, Kutukova S, Zholudeva L, Daste A, Caballero-Daroqui J, Keam B, Vynnychenko I, Lafond C, Shetty J, Mann H, Fan J, Wildsmith S, Morsli N, Fayette J, Licitra L. Durvalumab with or without tremelimumab in patients with recurrent or metastatic head and neck squamous cell carcinoma: EAGLE, a randomized, open-label phase III study. Ann Oncol. 2020 Jul;31(7):942-950. doi: 10.1016/j.annonc.2020.04.001. Epub 2020 Apr 12.
PMID: 32294530DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Multiple testing was performed for OS analysis in the intent-to-treat (ITT) population and OS analysis in the PD-L1 negative population for durvalumab + tremelimumab versus SoC only.
Results Point of Contact
- Title
- Nassim Morsli
- Organization
- AstraZeneca
Study Officials
- STUDY DIRECTOR
Nassim Morsli, MD
Medical Director AstraZeneca
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 18, 2015
First Posted
February 24, 2015
Study Start
September 9, 2015
Primary Completion
September 10, 2018
Study Completion
November 13, 2020
Last Updated
February 10, 2021
Results First Posted
October 3, 2019
Record last verified: 2021-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.