- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02369874
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)
Study Overview
Status
Intervention / Treatment
Detailed Description
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.
The main objectives of the study are to:
- assess the efficacy of MEDI4736 + tremelimumab combination therapy versus SoC in patients with squamous cell carcinoma of the head and neck (SCCHN), in terms of overall survival (OS), regardless of PDL-1 status
- assess the efficacy of MEDI4736 monotherapy versus SOC in patients with SCCHN, in terms of OS, regardless of PDL-1 status
Patients will undergo a screening assessment on their tumor tissue sample to determine PD-L1 expression per a pre-specified cut-off level. Patients with ≥25% of tumor cells with membrane staining will be considered PD-L1 positive while those with 0% to 24% of tumor cells with membrane staining will be considered PD-L1 negative. Based on the underlying PD-L1 status, patients will be randomized in a 1:1:1 ratio to receive treatment with MEDI4736 monotherapy, MEDI4736 + tremelimumab combination therapy, or SoC therapy. Patients who discontinue treatment in 1 treatment group may not switch to treatment in a different group.
Stratification factors include PD-L1 status, human papillomavirus status, (in patients with oropharyngeal cancer only), and smoking status.
Tumor assessments will be performed every 8 weeks until objective tumor response by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1).
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Caba, Argentina, C1426ANZ
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San Miguel de Tucuman, Argentina, T4000IAK
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Adelaide, Australia, 5000
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Heidelberg, Australia, 3084
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Melbourne, Australia, 3004
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St Leonards, Australia, 2065
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Woolloongabba, Australia, 4102
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Brussels, Belgium, 1090
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Bruxelles, Belgium, 1200
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Charleroi, Belgium, 6000
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Kortrijk, Belgium, 8500
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Leuven, Belgium, 3000
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Namur, Belgium, 5000
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Barretos, Brazil, 14784-400
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Curitiba, Brazil, 81520-060
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Porto Alegre, Brazil, 90610-000
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Porto Alegre, Brazil, 90020-090
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Rio de Janeiro, Brazil, 20231-050
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Santo Andre, Brazil, 09060-650
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São José do Rio Preto, Brazil, 15090-000
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São Paulo, Brazil, 03102-002
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Shumen, Bulgaria, 9700
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Sofia, Bulgaria, 1527
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Varna, Bulgaria, 9000
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Temuco, Chile, 4810469
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Osijek, Croatia, 31000
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Zagreb, Croatia, 10 000
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Olomouc, Czechia, 775 20
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Zlin, Czechia, 762 75
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Angers, France, 49933
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Bordeaux, France, 33000
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Dijon, France, 21079
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Le Mans, France, 72000
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Lyon Cedex 08, France, 69373
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Montpellier Cedex 5, France, 34298
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Paris Cedex 5, France, 75248
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Plerin SUR MER, France, 22190
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Rouen, France, 76038
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St Grégoire, France, 35768
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Strasbourg Cedex, France, 67085
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Villejuif Cedex, France, 94805
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Lorient Cedex, Georgia, 56322
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Berlin, Germany, 12200
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Essen, Germany, 45122
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Halle, Germany, 06120
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Hannover, Germany, 30625
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Heidelberg, Germany, 69120
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Leipzig, Germany, 04103
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München, Germany, 81377
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Potsdam, Germany, 14467
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Budapest, Hungary, 1083
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Budapest, Hungary, 1122
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Budapest, Hungary, 1162
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Gyor, Hungary, 9024
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Kecskemét, Hungary, 6000
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Haifa, Israel, 31096
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Jerusalem, Israel, 91120
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Petach-Tikva, Israel, 49100
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Tel Aviv, Israel, 6423906
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Tel Hashomer, Israel, 52621
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Aosta, Italy, 11100
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Bologna, Italy, 40138
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Gallarate, Italy, 21013
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Legnago, Italy, 37045
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Milano, Italy, 20133
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Napoli, Italy, 80131
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Pavia, Italy, 27100
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Roma, Italy, 00144
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Siena, Italy, 53100
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Chuo-ku, Japan, 104-0045
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Fukuoka-shi, Japan, 811-1395
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Hirakata-shi, Japan, 573-1191
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Isehara-shi, Japan, 259-1193
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Kashiwa, Japan, 277-8577
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Kitaadachi-gun, Japan, 362-0806
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Kobe-shi, Japan, 650-0017
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Koto-ku, Japan, 135-8550
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Matsuyama-shi, Japan, 791-0280
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Nagoya, Japan, 464-8681
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Natori-shi, Japan, 981-1293
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Okayama, Japan, 700-8558
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Osaka, Japan, 541-8567
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Osakasayama, Japan, 589-8511
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Sapporo, Japan, 060-8648
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Sapporo, Japan, 003-0804
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Shimotsuke-shi, Japan, 329-0498
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Sunto-gun, Japan, 411-8777
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Takatsuki-shi, Japan, 569-8686
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Yokohama, Japan, 236-0004
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Yokohama-shi, Japan, 241-8515
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Daegu, Korea, Republic of, 42601
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Goyang-si, Korea, Republic of, 10408
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Seoul, Korea, Republic of, 05505
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Seoul, Korea, Republic of, 03080
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Suwon, Korea, Republic of, 16247
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Kraków, Poland, 31-108
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Poznań, Poland, 60-780
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Łódź, Poland, 93-513
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Baia Mare, Romania, 430031
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Brasov, Romania, 500152
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Cluj, Romania, 400058
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Cluj-Napoca, Romania, 400015
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Craiova, Romania, 200347
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Arkhangelsk, Russian Federation, 163045
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Chelyabinsk, Russian Federation, 454087
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Kursk, Russian Federation, 305524
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Moscow, Russian Federation, 125367
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Moscow, Russian Federation, 111123
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Moscow, Russian Federation, 143423
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Moscow, Russian Federation, 125284
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Moscow, Russian Federation, 105229
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Nizhniy Novgorod, Russian Federation, 603081
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Omsk, Russian Federation, 644013
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Pyatigorsk, Russian Federation, 357502
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Saint Petersburg, Russian Federation, 198255
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Saint-Petersburg, Russian Federation, 197758
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Sankt-Peterburg, Russian Federation, 197785
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Sochi, Russian Federation, 354057
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Ufa, Russian Federation, 450054
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Vladimir, Russian Federation, 600020
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Belgrad, Serbia, 11000
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Belgrade, Serbia, 11000
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Kragujevac, Serbia, 34000
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Nis, Serbia, 18000
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Sremska Kamenica, Serbia, 21204
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Barcelona, Spain, 08035
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Barcelona, Spain, 08036
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L'Hospitalet de Llobregat, Spain, 08908
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Madrid, Spain, 28046
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Madrid, Spain, 28041
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Madrid, Spain, 28050
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Malaga, Spain, 29010
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Marbella, Spain, 29600
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Pamplona, Spain, 31008
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Valencia, Spain, 46026
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Valencia, Spain, 46014
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Zaragoza, Spain, 50009
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Kaohsiung, Taiwan, 833
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Taipei, Taiwan, 100
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Taipei, Taiwan, 10449
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Taoynan, Taiwan, 33305
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Dnipro, Ukraine, 49102
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Kyiv, Ukraine, 03115
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Sumy, Ukraine, 40022
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Uzhhorod, Ukraine, 88014
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Zaporizhzhia, Ukraine, 69040
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Arizona
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Tucson, Arizona, United States, 85711
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California
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Fullerton, California, United States, 92835-3825
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Los Angeles, California, United States, 90089
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Redondo Beach, California, United States, 90277
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Stanford, California, United States, 94305
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Colorado
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Denver, Colorado, United States, 80218
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Delaware
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Newark, Delaware, United States, 19713
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Florida
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Miami Beach, Florida, United States, 33140
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Orlando, Florida, United States, 32806
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Georgia
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Atlanta, Georgia, United States, 30322
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Illinois
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Evanston, Illinois, United States, 60201-1718
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Kentucky
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Lexington, Kentucky, United States, 40536
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Massachusetts
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Boston, Massachusetts, United States, 02215
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New York
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Rochester, New York, United States, 14642
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Rochester, New York, United States, 14621
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North Carolina
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Winston-Salem, North Carolina, United States, 27157
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15232
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Tennessee
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Germantown, Tennessee, United States, 38138
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Nashville, Tennessee, United States, 37232
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Texas
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Dallas, Texas, United States, 75246
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Dallas, Texas, United States, 75230
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McAllen, Texas, United States, 78503
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Virginia
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Norfolk, Virginia, United States, 23502
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: MEDI4736
MEDI4736 monotherapy
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MEDI4736 Monotherapy
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Experimental: MEDI4736 + Tremelimumab
MEDI4736 + tremelimumab combination therapy
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MEDI4736 + Tremelimumab combination therapy
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Active Comparator: Standard of Care
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Standard of Care
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall Survival (OS)
Time Frame: September 2015 to September 2018 (36 months)
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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.
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September 2015 to September 2018 (36 months)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall Survival (OS) in PD-L1 Negative Participants
Time Frame: September 2015 to September 2018 (36 months)
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OS is defined as the time from the date of randomization until death due to any cause.
PD-L1 negative was defined as <25% of tumor cells with membrane staining for PD-L1 at any intensity.
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September 2015 to September 2018 (36 months)
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Overall Survival (OS) in PD-L1 Positive Participants
Time Frame: September 2015 to September 2018 (36 months)
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OS is defined as the time from the date of randomization until death due to any cause.
PD-L1 positive was defined as ≥25% of tumor cells with membrane staining for PD-L1 at any intensity.
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September 2015 to September 2018 (36 months)
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Progression Free Survival (PFS)
Time Frame: September 2015 to September 2018 (36 months)
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PFS was defined as the time from the date of randomization until the date of objective disease progression or death based on investigator assessments, according to response evaluation criteria in solid tumors 1.1 (RECIST1.1).
Objective disease progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study).
In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
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September 2015 to September 2018 (36 months)
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Objective Response Rate (ORR)
Time Frame: Assessed at randomization and every 8 weeks thereafter
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The percentage of participants who experienced an objective response (complete response [CR] or partial response [PR]), based on investigator assessments according to response evaluation criteria in solid tumors 1.1 (RECIST1.1).
A CR was defined as the disappearance of all target lesions (TLs) since baseline.
Any pathological lymph nodes selected as TLs must have a reduction in short axis to <10 mm.
A PR was defined as at least a 30% decrease in the sum of the diameters of TLs, taking as reference the baseline sum of diameters.
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Assessed at randomization and every 8 weeks thereafter
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Duration of Response (DoR)
Time Frame: September 2015 to September 2018 (36 months)
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Median DoR, in months, based on investigator assessments, according to response evaluation criteria in solid tumors 1.1 (RECIST1.1).
A complete response was defined as the disappearance of all target lesions (TLs) since baseline.
Any pathological lymph nodes selected as TLs must have a reduction in short axis to <10 mm.
A partial response was defined as at least a 30% decrease in the sum of the diameters of TLs, taking as reference the baseline sum of diameters.
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September 2015 to September 2018 (36 months)
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Disease Control Rate (DCR)
Time Frame: Baseline up to 6 months; baseline up to 12 months
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6 Months: The percentage of participants who had a best objective response of complete response (CR) or partial response (PR) in the first 6 months or had demonstrated stable disease (SD) for a minimum interval of 24 weeks following randomization. 12 Months: The percentage of participants who had a best objective response of CR or PR within 12 months or had demonstrated SD for a minimum interval of 48 weeks following randomization. Objective response was based on investigator assessments, according to response evaluation criteria in solid tumors 1.1 (RECIST1.1). A CR was defined as the disappearance of all target lesions (TLs) since baseline. Any pathological lymph nodes selected as TLs must have a reduction in short axis to <10 mm. A PR was defined as at least a 30% decrease in the sum of the diameters of TLs, taking as reference the baseline sum of diameters. |
Baseline up to 6 months; baseline up to 12 months
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Percentage of Participants Alive and Progression Free (APF)
Time Frame: Baseline up to 6 months; baseline up to 12 months
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APF is defined as the percentage of participants who are alive and progression free at 6 months and 12 months after randomization.
Estimates of progression free survival were based on investigator assessments according to response evaluation criteria in solid tumors 1.1 (RECIST1.1).
Objective disease progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study).
In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
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Baseline up to 6 months; baseline up to 12 months
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Percentage of Participants Alive
Time Frame: 12, 18 and 24 months
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Percentage of participants alive at 12, 18 and 24 months using a Kaplan Meier estimate.
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12, 18 and 24 months
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Progression Free Survival (PFS) in PD-L1 Negative Participants
Time Frame: September 2015 to September 2018 (36 months)
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Number of participants with confirmed objective disease progression (PD) at the time of the participant's last evaluable response evaluation criteria in solid tumors 1.1 (RECIST1.1)
assessment.
PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study).
In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
PD-L1 negative was defined as <25% of tumor cells with membrane staining for PD-L1 at any intensity.
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September 2015 to September 2018 (36 months)
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Objective Response Rate (ORR) in PD-L1 Negative Participants
Time Frame: September 2015 to September 2018 (36 months)
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The percentage of PD-L1 negative participants who experienced an objective response (complete response [CR] or partial response [PR]), based on investigator assessments according to response evaluation criteria in solid tumors 1.1 (RECIST1.1).
A CR was defined as the disappearance of all target lesions (TLs) since baseline.
Any pathological lymph nodes selected as TLs must have a reduction in short axis to <10 mm.
A PR was defined as at least a 30% decrease in the sum of the diameters of TLs, taking as reference the baseline sum of diameters.
PD-L1 negative was defined as <25% of tumor cells with membrane staining for PD-L1 at any intensity.
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September 2015 to September 2018 (36 months)
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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)
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The EORTC QLQ-C30 consists of 30 questions that can be combined to produce functional scales (e.g.
physical), symptom scales (e.g.
fatigue), and a global measure of health status.
Each of the scales are measured from 0 to 100.
Deterioration was defined as a 10-point decrease from baseline in a functioning or global health status/ quality of life score or a 10-point increase from baseline in a symptom score.
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September 2015 to September 2018 (36 months)
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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)
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The EORTC QLQ-H&N35 comprises of 35 questions to assess head and neck cancer symptoms (e.g.
pain, swallowing).
Deterioration was defined as a 10-point increase from baseline in the symptom score.
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September 2015 to September 2018 (36 months)
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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)
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An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment.
Inclusive of AEs and serious AEs.
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First dose to last dose + 90 days or data cut off (up to 36 months)
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Nassim Morsli, MD, Medical Director AstraZeneca
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Head and Neck Neoplasms
- Neoplasms, Squamous Cell
- Carcinoma
- Carcinoma, Squamous Cell
- Squamous Cell Carcinoma of Head and Neck
- Physiological Effects of Drugs
- Antineoplastic Agents
- Immunologic Factors
- Antineoplastic Agents, Immunological
- Durvalumab
- Tremelimumab
- Antibodies, Monoclonal
Other Study ID Numbers
- D4193C00002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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AstraZenecaPRA Health SciencesCompletedRecurrent or Metastatic PD-L1-positive Squamous Cell Carcinoma of the Head and NeckUnited States, Belgium, Canada, France, Spain, Korea, Republic of, Hungary, Malaysia, United Kingdom, Taiwan, Germany, Georgia, Israel, Czechia
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