Phase III Open Label Study of MEDI 4736 With/Without Tremelimumab Versus Standard of Care (SOC) in Recurrent/Metastatic Head and Neck Cancer
KESTREL
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
1 other identifier
interventional
823
23 countries
197
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Oct 2015
Longer than P75 for phase_3
197 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
September 9, 2015
CompletedFirst Posted
Study publicly available on registry
September 16, 2015
CompletedStudy Start
First participant enrolled
October 15, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 6, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
May 21, 2021
CompletedResults Posted
Study results publicly available
October 13, 2021
CompletedOctober 13, 2021
September 1, 2021
4.7 years
September 9, 2015
July 5, 2021
September 16, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Overall Survival (OS) Status in the PD-L1 TC/IC High Subgroup - Durvalumab Versus Standard of Care (SOC)
Number of participants with Overall Survival (OS)
From date of randomization until time of final analysis, an average of approximately 4 years
Overall Survival (OS) Median Duration in the PD-L1 TC/IC High Subgroup
Time from the date of randomization until death due to any cause (i.e., date of death or censoring - date of randomization + 1)
From date of randomization until time of final analysis, an average of approximately 4 years
Secondary Outcomes (11)
Overall Survival (OS) Status in the PD-L1 TC/IC High Subgroup - Durvalumab + Tremelimumab Versus Standard of Care (SOC)
From date of randomization until time of final analysis, an average of approximately 4 years
Percentage of Patients Alive at 12, 18 and 24 Months in the PD-L1 TC/IC High Subgroup
12, 18 and 24 months after randomization
Progression Free Survival (PFS) in the PD-L1 TC/IC High Subgroup
Tumor assessments (per RECIST 1.1) every 6 weeks for the first 24 weeks relative to the date of randomization and then every 8 weeks thereafter, up to approximately 4 years
Objective Response Rate (ORR) in the PD-L1 TC/IC High Subgroup
Tumor assessments (per RECIST 1.1) every 6 weeks for the first 24 weeks relative to the date of randomization and then every 8 weeks thereafter, up to approximately 4 years
Duration of Response (DoR) in the PD-L1 TC/IC High Subgroup
Tumor assessments (per RECIST 1.1) every 6 weeks for the first 24 weeks relative to the date of randomization and then every 8 weeks thereafter, up to approximately 4 years
- +6 more secondary outcomes
Study Arms (3)
Monotherapy
EXPERIMENTALMEDI4736 monotherapy.
Combination Therapy
EXPERIMENTALMEDI4736+Tremelimumab combination therapy
Standard of Care
ACTIVE COMPARATORStandard of Care treatment
Interventions
Eligibility Criteria
You may qualify if:
- Age ≥18 years at the time of screening
- Documented evidence of recurrent or metastatic SCCHN (oral cavity, oropharynx, hypopharynx, or larynx).
- A fresh tumor biopsy for the purpose of screening or an available archival tumor sample. Tumor lesions used for fresh biopsies should not be the same lesions used as RECIST target lesions, unless there are no other lesions suitable for biopsy.
- No prior systemic chemotherapy for recurrent or metastatic disease
- World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at enrollment
- No prior exposure to immune-mediated therapy,
You may not qualify if:
- Tumor progression or recurrence within 6 months of last dose of platinum therapy in the primary treatment setting
- Receipt of any radiotherapy or hormonal therapy for cancer treatment within 30 days prior to first dose of study treatment
- Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease \[eg, colitis, Crohn's disease\], diverticulitis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (197)
Research Site
Aurora, Colorado, 80045, United States
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Washington D.C., District of Columbia, 20007, United States
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Fort Myers, Florida, 33916, United States
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St. Petersburg, Florida, 33705, United States
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Tampa, Florida, 33612, United States
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Atlanta, Georgia, 30322, United States
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Chicago, Illinois, 60637, United States
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Baltimore, Maryland, 21201, United States
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Baltimore, Maryland, 21231, United States
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Boston, Massachusetts, 02215, United States
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Morristown, New Jersey, 07960, United States
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New York, New York, 10029, United States
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New York, New York, 10065, United States
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Chapel Hill, North Carolina, 27599, United States
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Charlotte, North Carolina, 28204, United States
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Winston-Salem, North Carolina, 27157, United States
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Cleveland, Ohio, 44115, United States
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Columbus, Ohio, 43210, United States
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Nashville, Tennessee, 37203, United States
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Graz, 8036, Austria
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Innsbruck, 6020, Austria
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Linz, 4010, Austria
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Vienna, 1140, Austria
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Brussels, 1000, Belgium
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Brussels, 1090, Belgium
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Brussels, 1200, 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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Florianópolis, 88034-000, Brazil
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Ijuí, 98700-000, Brazil
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Porto Alegre, 90035-003, Brazil
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Porto Alegre, 90619-900, Brazil
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Porto Alegre, 91350-200, Brazil
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Recife, 50040-000, Brazil
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Rio de Janeiro, 22793-080, Brazil
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Santo André, 09060-650, Brazil
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Santo André, 09080-110, 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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Calgary, Alberta, T2N 4N2, Canada
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Winnipeg, Manitoba, R3E 0V9, Canada
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Moncton, New Brunswick, E1C 8X3, Canada
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Halifax, Nova Scotia, B3H 1V7, Canada
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Hamilton, Ontario, L8V 5C2, Canada
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London, Ontario, N6A 4L6, Canada
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Ottawa, Ontario, K1H 8L6, Canada
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Toronto, Ontario, M5G 2M9, Canada
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Montreal, Quebec, H4A 3J1, Canada
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Bordeaux, 33000, France
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Brest, 29200, France
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Dijon, 21079, France
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Lyon, 69373, France
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Nice, 06100, France
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Paris, 75015, France
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Poitiers, 86021, France
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Toulouse, 31059, France
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Vandœuvre-lès-Nancy, 54519, France
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Villejuif, 94800, France
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Berlin, 12203, Germany
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Erlangen, 91054, Germany
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Essen, 45147, Germany
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Frankfurt am Main, 60590, Germany
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Freiburg im Breisgau, 79106, Germany
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Hamburg, 20246, Germany
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Heidelberg, 69120, Germany
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Mainz, 55131, Germany
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Tübingen, 72076, Germany
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Würzburg, 97070, Germany
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Athens, 115 22, Greece
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Athens, 11527, Greece
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Athens, 124 61, Greece
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Athens, 18547, Greece
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Heraklion, 711 11, Greece
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Thessaloniki, 54645, Greece
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Bangalore, 560027, India
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Bangalore, 560076, India
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Bengaluru, 560076, India
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Gūrgaon, 122001, India
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Karamsad, 388325, India
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Madurai, 625107, India
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Pune, 411001, India
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Cona, 44124, Italy
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Florence, 50134, Italy
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Messina, 98158, Italy
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Milan, 20133, Italy
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Padua, 35128, Italy
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Palermo, 90127, Italy
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Salerno, 84131, Italy
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Siena, 53100, Italy
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Torino, 10126, Italy
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Akashi-shi, 673-8558, Japan
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Chiba, 260-8717, Japan
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Fukuoka, 811-1347, Japan
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Hirakata-shi, 573-1191, Japan
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Isehara-shi, 259-1193, Japan
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Kagoshima, 890-8520, Japan
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Kanazawa, 920-8650, 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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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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Sunto-gun, 411-8777, Japan
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Takatsuki-shi, 569-8686, Japan
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Toyoake-shi, 470-1192, Japan
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Yokohama, 241-8515, Japan
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Cebu City, 6000, Philippines
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Las Piñas, 1740, Philippines
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Quezon City, 1112, Philippines
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Bialystok, 15-027, Poland
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Bielsko-Biala, 43-300, Poland
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Gdansk, 80-214, Poland
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Gdynia, 81-519, Poland
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Lodz, 93-513, Poland
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Lublin, 20-090, Poland
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Poznan, 60-780, Poland
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Poznan, 61-866, Poland
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Szczecin, 71-730, Poland
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Warsaw, 02-781, Poland
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Suceava, 720237, Romania
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Arkhangelsk, 163045, Russia
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Krasnodar, 350040, Russia
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Moscow, 125367, Russia
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Obninsk, 249036, Russia
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Omsk, 644013, Russia
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Saint Petersburg, 191014, Russia
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Saint Petersburg, 195271, Russia
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Saint Petersburg, 197758, 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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Yekaterinburg, 620905, Russia
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Bratislava, 833 01, Slovakia
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Košice, 041 91, Slovakia
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Cheongju-si, 28644, South Korea
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Hwasun-gun, 58128, South Korea
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Incheon, 21565, South Korea
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Seogu, 49241, South Korea
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Seongnam-si, 13620, South Korea
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Seoul, 03080, South Korea
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Seoul, 03722, South Korea
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Seoul, 05505, South Korea
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Seoul, 135-710, South Korea
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Suwon, 16499, South Korea
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Badajoz, 06008, Spain
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Barcelona, 08035, Spain
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Barcelona, 08036, Spain
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Jaén, 23007, Spain
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L'Hospitalet de Llobregat, 08907, Spain
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Madrid, 28007, Spain
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Madrid, 28034, Spain
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Madrid, 28040, 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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Valencia, 46026, Spain
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Zaragoza, 50009, Spain
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Kaohsiung City, Taiwan
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Taichung, 40447, Taiwan
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Taichung, 40705, Taiwan
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Tainan, 704, Taiwan
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Taipei, 100, Taiwan
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Taipei, 10449, Taiwan
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Taipei, 11217, Taiwan
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Bangkok, 10330, Thailand
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Bangkok, 10700, Thailand
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Chiang Mai, 50200, Thailand
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Hat Yai, 90110, Thailand
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Pathum Thani, 12120, Thailand
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Dnipro, 49102, Ukraine
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Ivano-Frankivsk, 76018, Ukraine
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Kapitanivka Village, 08111, Ukraine
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Kharkiv Region, 61070, Ukraine
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Kirovohrad, 25006, Ukraine
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Kryvyi Rih, 50048, Ukraine
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Kyiv, 03022, Ukraine
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Kyiv, 03115, Ukraine
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Odesa, 65055, Ukraine
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Sumy, 40022, Ukraine
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Vinnytsia, 21029, Ukraine
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Bebington, CH63 4JY, United Kingdom
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Birmingham, B15 2TT, United Kingdom
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London, EC1A 7BE, United Kingdom
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London, SW3 6JJ, United Kingdom
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Manchester, M20 4BX, United Kingdom
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Sutton, SM2 5PT, United Kingdom
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Taunton, TA1 5DA, United Kingdom
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Hanoi, 100000, Vietnam
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Hanoi, Vietnam
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Hà Nội, 100000, Vietnam
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Ho Chi Minh City, 700000, Vietnam
Related Publications (2)
Seiwert TY, Wildsmith S, Fayette J, Harrington K, Gillison M, Ahn MJ, Takahashi S, Weiss J, Machiels JP, Baxi S, Baker V, Evans B, Morsli N, Jill Walker, Real K, L'Hernault A, Psyrri A. Outcomes in biomarker-selected subgroups from the KESTREL study of durvalumab and tremelimumab in recurrent or metastatic head and neck squamous cell carcinoma. Cancer Immunol Immunother. 2024 Mar 2;73(4):70. doi: 10.1007/s00262-024-03643-3.
PMID: 38430375DERIVEDHwang M, Seiwert TY. Are taxanes the future for head and neck cancer? Pragmatism in the immunotherapy era. Lancet Oncol. 2021 Apr;22(4):413-415. doi: 10.1016/S1470-2045(21)00121-2. Epub 2021 Mar 5. No abstract available.
PMID: 33684371DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Global Clinical Lead
- Organization
- AstraZeneca Clinical Study Information Center
Study Officials
- STUDY DIRECTOR
Richard Olsson
- PRINCIPAL INVESTIGATOR
Tanguy Seiwert
The University of Chicago, 5841 S Maryland Ave, Chicago, IL 60637
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
September 9, 2015
First Posted
September 16, 2015
Study Start
October 15, 2015
Primary Completion
July 6, 2020
Study Completion
May 21, 2021
Last Updated
October 13, 2021
Results First Posted
October 13, 2021
Record last verified: 2021-09
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 deidentified 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. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.