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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT02551159

Recruitment Status : Active, not recruiting

First Posted : September 16, 2015

Last Update Posted : December 10, 2020

Sponsor:

Information provided by (Responsible Party):

AstraZeneca

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Squamous Cell Carcinoma of the Head and Neck	Biological: MEDI4736 Biological: Tremelimumab Biological: MEDI4736+Tremelimumab Biological: Cetuximab Drug: 5-fluorouracil (5FU) Drug: Cisplatin Drug: Carboplatin	Phase 3

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.

Study Design

Layout table for study information

Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	823 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	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
Actual Study Start Date :	October 15, 2015
Actual Primary Completion Date :	July 6, 2020
Estimated Study Completion Date :	March 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Head and neck squamous cell carcinoma

MedlinePlus related topics: Head and Neck Cancer

Drug Information available for: Durvalumab

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: Monotherapy MEDI4736 monotherapy.	Biological: MEDI4736 Anti-PD-L1 antibody
Experimental: Combination Therapy MEDI4736+Tremelimumab combination therapy	Biological: Tremelimumab Anti-CTLA-4 Antibody Biological: MEDI4736+Tremelimumab
Active Comparator: Standard of Care Standard of Care treatment	Biological: Cetuximab Monoclonal Antibody Drug: 5-fluorouracil (5FU) Chemotherapy Agent Drug: Cisplatin Chemotherapy agent Drug: Carboplatin Chemotherapy Agent

Outcome Measures

Primary Outcome Measures :

To assess the efficacy of MEDI4736 monotherapy compared to Standard of Care (SoC, EXTREME) in terms of overall survival (OS) [ Time Frame: Estimated up to 2 years ]
PD-L1 TC/IC high subgroup

Secondary Outcome Measures :

The efficacy of MEDI4736 + tremelimumab combination therapy compared to SoC in terms of Overall Survival (OS) [ Time Frame: Estimated up to 2 years ]
OS in low risk of early mortality (EM) subgroup, ctDNA TMB high subgroup, all-comers and in the PD-L1 TC/IC high subgroup
The efficacy of MEDI4736 + tremelimumab combination therapy compared to SoC in terms of Objective Response Rate (ORR) [ Time Frame: Estimated up to 2 years ]
ORR in the PD-L1 TC/IC high subgroup, low risk of EM subgroup, ctDNA TMB high subgroup and all-comers using investigator assessments according to RECIST 1.1
The efficacy of MEDI4736 + tremelimumab combination therapy compared to SoC in terms of Progression Free Survival (PFS) [ Time Frame: Estimated up to 2 years ]
PFS in the PD-L1 TC/IC high subgroup, low risk of EM subgroup, ctDNA TMB high subgroup and all-comers using investigator assessments according to RECIST 1.1
The efficacy of MEDI4736 + tremelimumab combination therapy compared to SoC in terms of Second Progression (PFS2) [ Time Frame: Estimated up to 2 years ]
PFS2 using local standard clinical practice in the PD-L1 TC/IC high subgroup, and all-comers
The efficacy of MEDI4736 + tremelimumab combination therapy compared to SoC in terms of Duration of Response (DoR) [ Time Frame: Estimated up to 2 years ]
DOR using site investigator assessments according to RECIST 1.1 in the PD-L1 TC/IC high subgroup and all-comers
The efficacy of MEDI4736 + tremelimumab combination therapy compared to SoC in terms of Best Objective Response (BoR) [ Time Frame: Estimated up to 2 years ]
BoR using site investigator assessments according to RECIST 1.1 in the PD-L1 TC/IC high subgroup and all-comers.
The efficacy of MEDI4736 + tremelimumab combination therapy compared to SoC in terms of Time to Response (TTR) [ Time Frame: Estimated up to 2 years ]
TTR using site investigator assessments according to RECIST 1.1 in the PD-L1 TC/IC high subgroup and all-comers.
The efficacy of MEDI4736 + tremelimumab combination therapy compared to SoC in terms of Time to First Subsequent Therapy (TFST) [ Time Frame: Estimated up to 2 years ]
TFST in the PD-L1 TC/IC high subgroup and all-comers
The efficacy of MEDI4736 + tremelimumab combination therapy compared to SoC in terms of Time to Second Subsequent Therapy (TSST) [ Time Frame: Estimated up to 2 years ]
TSST in the PD-L1 TC/IC high subgroup and all-comers
The efficacy of MEDI4736 + tremelimumab combination therapy compared to SoC in terms of Overall Survival at 12, 18 and 24 Months (OS12, OS18, OS24) over a period of 2 years [ Time Frame: Estimated up to 2 Years ]
OS12, OS18 and OS24 in the low risk of EM subgroup, ctDNA TMB high subgroup, all-comers and in the PD-L1 TC/IC high subgroup
The efficacy of MEDI4736 + tremelimumab combination therapy compared to SoC in terms of Alive and Progression Free at 6 and 12 Months (APF6, APF12) over a period of 1 year [ Time Frame: Estimated up to 1 Year ]
APF6 and APF12 in the PD-L1 TC/IC subgroup, low risk of EM subgroup, ctDNA TMB high subgroup and all-comers using site investigator assessments according to RECIST 1.1
The efficacy of MEDI4736 monotherapy vs SoC in terms of Duration of Response(DoR) [ Time Frame: Estimated up to 2 years ]
DoR using site investigator assessments according to RECIST 1.1 in the PD-L1 TC/IC high subgroup and all-comers
The efficacy of MEDI4736 monotherapy vs SoC in terms of Time to Response (TTR) [ Time Frame: Estimated up to 2 years ]
TTR using site investigator assessments according to RECIST 1.1 in the PD-L1 TC/IC high subgroup and all-comers
The efficacy of MEDI4736 monotherapy vs SoC in terms of Time to First Subsequent Therapy(TFST) [ Time Frame: Estimated up to 2 years ]
TFST in the PD-L1 TC/IC high subgroup and all-comers
The efficacy of MEDI4736 monotherapy vs SoC in terms of Time to Second Subsequent Therapy(TSST) [ Time Frame: Estimated up to 2 years ]
TSST in the PD-L1 TC/IC high subgroup and all-comers
The efficacy of MEDI4736 monotherapy vs SoC in terms of Best Objective Response (BoR) [ Time Frame: Estimated up to 2 Years ]
BoR using site investigator assessments according to RECIST 1.1 in the PD-L1 TC/IC high subgroup and all-comers
The efficacy of MEDI4736 monotherapy vs SoC in terms of proportion of patients Alive and Progression Free at 6 and 12 Months (APF6, APF12) over a period of 1 year [ Time Frame: Estimated up to 1 year ]
APF6 and APF12 using site investigator assessments according to RECIST 1.1 in the PD-L1 TC/IC high subgroup, low risk of EM subgroup, ctDNA TMB high subgroup and all-comers
The efficacy of MEDI4736 monotherapy compared to SoC in terms of Progression Free Survival (PFS) and Second Progression (PFS2) [ Time Frame: Estimated up to 2 years ]
PFS using site investigator assessments according to RECIST 1.1 in the PD-L1 TC/IC high subgroup, low risk of EM subgroup, ctDNA TMB high subgroup and all-comers

PFS2 using local standard clinical practice in the PD-L1 TC/IC high subgroup and all-comers
The efficacy of MEDI4736 monotherapy compared to SoC in terms of Overall Survival (OS) and Overall Survival at 12, 18 and 24 months (OS12, OS18, OS24) [ Time Frame: Estimated up to 2 Years ]
OS in low risk of EM subgroup, ctDNA TMB high subgroup and all-comers

OS12, OS18 and OS24 in the low risk of EM subgroup, ctDNA TMB high subgroup all-comers and PD-L1 TC/IC high subgroup
The efficacy of MEDI4736 monotherapy compared to SoC in terms of Objective Response Rate (ORR) [ Time Frame: Estimated up to 2 years ]
ORR using site investigator assessments according to RECIST 1.1 in the PD-L1 TC/IC high subgroup, low risk of EM subgroup, ctDNA TMB high subgroup and all-comers
The efficacy of MEDI4736 + tremelimumab combination therapy compared to MEDI4736 monotherapy in terms of Progression Free Survival (PFS) [ Time Frame: Estimated up to 2 years ]
PFS using site investigator assessments according to RECIST 1.1 in the low risk of EM subgroup, ctDNA TMB high subgroup, PD-L1 TC/IC high subgroup and all-comers
The efficacy of MEDI4736 + tremelimumab combination therapy compared to MEDI4736 monotherapy in terms of Objective Response Rate (ORR) [ Time Frame: Estimated up to 2 years ]
ORR using site investigator assessments according to RECIST 1.1 in the low risk of EM subgroup, ctDNA TMB high subgroup, PD-L1 TC/IC high subgroup and all-comers
The efficacy of MEDI4736 + tremelimumab combination therapy compared to MEDI4736 monotherapy in terms of Overall Survival (OS) [ Time Frame: Estimated up to 2 years ]
OS in the low risk of EM subgroup, ctDNA TMB high subgroup, PD-L1 TC/IC high subgroup and all-comers
The pharmacokinetics (PK) analysis of MEDI4736 and Tremelimumab using Area Under the Curve (AUC) [ Time Frame: Estimated up to 6 months ]
After the first and steady-state doses: peak and trough concentrations of MEDI4736 and Tremelimumab will be determined.
The immunogenicity of MEDI4736 and tremelimumab [ Time Frame: Estimated up to 2 years ]
Serum will be tested for the presence of anti-drug antibodies.
HRQoL in patients treated with MEDI4736 + tremelimumab or MEDI4736 compared to SoC using the European Organization for Research and Treatment of Cancer Core Quality of Life (EORTC QLQ-C30) module [ Time Frame: Estimated up to 2 years ]
EORTC QLQ-C30: global health QoL, functioning (physical) and symptoms (fatigue) in the PD-L1 TC/IC high subgroup and all-comers
HRQoL in patients treated with MEDI4736 + tremelimumab or MEDI4736 compared to SoC using the European Organization for Research and Treatment of Cancer Head and Neck Quality of Life (EORTC QLQ-H&N35) module [ Time Frame: Estimated up to 2 years ]
EORTC QLQ-H&N35: symptoms (pain, swallowing) in the primary analysis population, and all-comers Changes in WHO/ECOG performance status in the PD-L1 TC/IC high subgroup and all-comers
The pharmacokinetics (PK) analysis of MEDI4736 and Tremelimumab using Maximum Plasma Concentration (Cmax) [ Time Frame: Estimated up to 6 months ]
After the first and steady-state doses: peak and trough concentrations of MEDI4736 and Tremelimumab will be determined.

Other Outcome Measures:

Safety and tolerability profile of MEDI4736 + tremelimumab combination therapy and MEDI4736 monotherapy compared to SoC (EXTREME) in the first-line setting for treatment of SCCHN-Adverse Events [ Time Frame: Estimated up to 2 years ]
Adverse Events in PD-L1 TC/IC high subgroup, low risk of EM subgroup and all-comers
Safety and tolerability profile of MEDI4736 + tremelimumab combination therapy and MEDI4736 monotherapy compared to SoC (EXTREME) in the first-line setting for treatment of SCCHN-Physical Examination [ Time Frame: Estimated up to 2 years ]
Incidence of abnormal physical examination findings in PD-L1 TC/IC high subgroup, low risk of EM subgroup and all-comers
Safety and tolerability profile of MEDI4736 + tremelimumab combination therapy and MEDI4736 monotherapy compared to SoC (EXTREME) in the first-line setting for treatment of SCCHN-Clinical Chemistry [ Time Frame: Estimated up to 2 years ]
Incidence of abnormal clinical chemistry test results in PD-L1 TC/IC high subgroup, low risk of EM subgroup and all-comers
Safety and tolerability profile of MEDI4736 + tremelimumab combination therapy and MEDI4736 monotherapy compared to SoC (EXTREME) in the first-line setting for treatment of SCCHN-Hematology [ Time Frame: Estimated up to 2 years ]
Incidence of abnormal hematology test results in PD-L1 TC/IC high subgroup, low risk of EM subgroup and all-comers
Safety and tolerability profile of MEDI4736 + tremelimumab combination therapy and MEDI4736 monotherapy compared to SoC (EXTREME) in the first-line setting for treatment of SCCHN-Urinalysis [ Time Frame: Estimated up to 2 years ]
Incidence of abnormal urinalysis test results in PD-L1 TC/IC high subgroup, low risk of EM subgroup and all-comers
Safety and tolerability profile of MEDI4736 + tremelimumab combination therapy and MEDI4736 monotherapy compared to SoC (EXTREME) in the first-line setting for treatment of SCCHN-Blood Pressure [ Time Frame: Estimated up to 2 years ]
Incidence of abnormal vital signs (systolic and diastolic blood pressure) in PD-L1 TC/IC high subgroup, low risk of EM subgroup and all-comers
Safety and tolerability profile of MEDI4736 + tremelimumab combination therapy and MEDI4736 monotherapy compared to SoC (EXTREME) in the first-line setting for treatment of SCCHN-Pulse [ Time Frame: Estimated up to 2 years ]
Vital signs (pulse) in PD-L1 TC/IC high subgroup, low risk of EM subgroup and all-comers
Safety and tolerability profile of MEDI4736 + tremelimumab combination therapy and MEDI4736 monotherapy compared to SoC (EXTREME) in the first-line setting for treatment of SCCHN-ECG [ Time Frame: Estimated up to 2 years ]
Incidence of abnormal ECG (QTcF) findings in PD-L1 TC/IC high subgroup, low risk of EM subgroup and all-comers

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information

Ages Eligible for Study:	18 Years to 130 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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,

Exclusion Criteria:

Histologically or cytologically confirmed head and neck cancer of any other primary anatomic location in the head and neck not specified in the inclusion criteria including patients with SCCHN of unknown primary or non-squamous histologies (eg, nasopharynx or salivary gland)
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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02551159

Locations

Show 198 study locations

Layout table for location information

United States, Colorado
Research Site
Aurora, Colorado, United States, 80045
United States, District of Columbia
Research Site
Washington, District of Columbia, United States, 20007
United States, Florida
Research Site
Fort Myers, Florida, United States, 33916
Research Site
Saint Petersburg, Florida, United States, 33705
Research Site
Tampa, Florida, United States, 33612
United States, Georgia
Research Site
Atlanta, Georgia, United States, 30322
United States, Illinois
Research Site
Chicago, Illinois, United States, 60637
United States, Maryland
Research Site
Baltimore, Maryland, United States, 21201
Research Site
Baltimore, Maryland, United States, 21231
United States, Massachusetts
Research Site
Boston, Massachusetts, United States, 02215
United States, New Jersey
Research Site
Morristown, New Jersey, United States, 07960
United States, New York
Research Site
New York, New York, United States, 10029
Research Site
New York, New York, United States, 10065
United States, North Carolina
Research Site
Chapel Hill, North Carolina, United States, 27599
Research Site
Charlotte, North Carolina, United States, 28204
Research Site
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
Research Site
Cleveland, Ohio, United States, 44106
Research Site
Columbus, Ohio, United States, 43210
United States, Tennessee
Research Site
Nashville, Tennessee, United States, 37203
Austria
Research Site
Graz, Austria, 8036
Research Site
Innsbruck, Austria, 6020
Research Site
Linz, Austria, 4010
Research Site
Wien, Austria, 1140
Belgium
Research Site
Brussels, Belgium, 1000
Research Site
Brussels, Belgium, 1090
Research Site
Bruxelles, Belgium, 1200
Research Site
Leuven, Belgium, 3000
Research Site
Namur, Belgium, 5000
Brazil
Research Site
Barretos, Brazil, 14784-400
Research Site
Curitiba, Brazil, 81520-060
Research Site
Florianópolis, Brazil, 88034-000
Research Site
Ijui, Brazil, 98700-000
Research Site
Porto Alegre, Brazil, 90035-003
Research Site
Porto Alegre, Brazil, 90619-900
Research Site
Porto Alegre, Brazil, 91350-200
Research Site
Recife, Brazil, 50040-000
Research Site
Rio de Janeiro, Brazil, 22793-080
Research Site
Santo Andre, Brazil, 09080-110
Research Site
Santo André, Brazil, 09060-650
Research Site
São José do Rio Preto, Brazil, 15090-000
Research Site
São Paulo, Brazil, 03102-002
Canada, Alberta
Research Site
Calgary, Alberta, Canada, T2N 4N2
Canada, Manitoba
Research Site
Winnipeg, Manitoba, Canada, R3E 0V9
Canada, New Brunswick
Research Site
Moncton, New Brunswick, Canada, E1C 8X3
Canada, Nova Scotia
Research Site
Halifax, Nova Scotia, Canada, B3H 1V7
Canada, Ontario
Research Site
Hamilton, Ontario, Canada, L8V 5C2
Research Site
London, Ontario, Canada, N6A 4L6
Research Site
Ottawa, Ontario, Canada, K1H 8L6
Research Site
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
Research Site
Montreal, Quebec, Canada, H4A 3J1
France
Research Site
Bordeaux Cedex, France, 33075
Research Site
Brest, France, 29200
Research Site
Dijon, France, 21079
Research Site
Lyon Cedex 08, France, 69373
Research Site
Nice, France, 06100
Research Site
Paris, France, 75015
Research Site
Poitiers Cedex, France, 86021
Research Site
Toulouse Cedex, France, 31059
Research Site
Vandoeuvre les Nancy, France, 54519
Research Site
Villejuif, France, 94800
Germany
Research Site
Berlin, Germany, 12203
Research Site
Erlangen, Germany, 91054
Research Site
Essen, Germany, 45147
Research Site
Frankfurt am Main, Germany, 60590
Research Site
Freiburg, Germany, 79106
Research Site
Hamburg, Germany, 20246
Research Site
Heidelberg, Germany, 69120
Research Site
Mainz, Germany, 55131
Research Site
Tübingen, Germany, 72076
Research Site
Würzburg, Germany, 97070
Greece
Research Site
Athens, Greece, 115 22
Research Site
Athens, Greece, 11527
Research Site
Athens, Greece, 124 61
Research Site
Athens, Greece, 18547
Research Site
Heraklion, Greece, 711 11
Research Site
Thessaloniki, Greece, 54645
India
Research Site
Bangalore, India, 560027
Research Site
Bangalore, India, 560076
Research Site
Bengaluru, India, 560076
Research Site
Gurgaon, India, 122001
Research Site
Karamsad, India, 388325
Research Site
Madurai, India, 625107
Research Site
Pune, India, 411001
Italy
Research Site
Cona, Italy, 44124
Research Site
Firenze, Italy, 50141
Research Site
Messina, Italy, 98158
Research Site
Milano, Italy, 20133
Research Site
Padova, Italy, 35128
Research Site
Palermo, Italy, 90127
Research Site
Salerno, Italy, 84131
Research Site
Siena, Italy, 53100
Research Site
Torino, Italy, 10126
Japan
Research Site
Akashi-shi, Japan, 673-8558
Research Site
Chiba-shi, Japan, 260-8717
Research Site
Fukuoka-shi, Japan, 811-1347
Research Site
Hirakata-shi, Japan, 573-1191
Research Site
Isehara-shi, Japan, 259-1193
Research Site
Kagoshima-shi, Japan, 890-8520
Research Site
Kanazawa-shi, Japan, 920-8650
Research Site
Kitaadachi-gun, Japan, 362-0806
Research Site
Kobe-shi, Japan, 650-0017
Research Site
Koto-ku, Japan, 135-8550
Research Site
Natori-shi, Japan, 981-1293
Research Site
Okayama-shi, Japan, 700-8558
Research Site
Osaka-shi, Japan, 541-8567
Research Site
Osakasayama, Japan, 589-8511
Research Site
Sapporo-shi, Japan, 003-0804
Research Site
Sapporo, Japan, 060-8648
Research Site
Sunto-gun, Japan, 411-8777
Research Site
Takatsuki-shi, Japan, 569-8686
Research Site
Toyoake-shi, Japan, 470-1192
Research Site
Yokohama-shi, Japan, 241-8515
Korea, Republic of
Research Site
Cheongju-si, Korea, Republic of, 28644
Research Site
Hwasun-gun, Korea, Republic of, 58128
Research Site
Incheon, Korea, Republic of, 21565
Research Site
Seo-Gu, Korea, Republic of, 49241
Research Site
Seongnam-si, Korea, Republic of, 13620
Research Site
Seoul, Korea, Republic of, 03080
Research Site
Seoul, Korea, Republic of, 03722
Research Site
Seoul, Korea, Republic of, 05505
Research Site
Seoul, Korea, Republic of, 135-710
Research Site
Suwon-si, Korea, Republic of, 16499
Philippines
Research Site
Cebu City, Philippines, 6000
Research Site
Las Pinas, Philippines, 1740
Research Site
Manila, Philippines, 1000
Research Site
Pasay City, Philippines
Research Site
Quezon City, Philippines, 1112
Poland
Research Site
Białystok, Poland, 15-027
Research Site
Bielsko-Biała, Poland, 43-300
Research Site
Gdańsk, Poland, 80-214
Research Site
Gdynia, Poland, 81-519
Research Site
Lublin, Poland, 20-090
Research Site
Poznan, Poland, 60-780
Research Site
Poznan, Poland, 61-866
Research Site
Szczecin, Poland, 71-730
Research Site
Warszawa, Poland, 02-781
Research Site
Łódź, Poland, 93-513
Romania
Research Site
Suceava, Romania, 720237
Russian Federation
Research Site
Arkhangelsk, Russian Federation, 163045
Research Site
Ekaterinburg, Russian Federation, 620905
Research Site
Krasnodar, Russian Federation, 350040
Research Site
Moscow, Russian Federation, 125367
Research Site
Obninsk, Russian Federation, 249036
Research Site
Omsk, Russian Federation, 644013
Research Site
Saint Petersburg, Russian Federation, 195271
Research Site
Saint Petersburg, Russian Federation, 198255
Research Site
Saint-Petersburg, Russian Federation, 197758
Research Site
Sochi, Russian Federation, 354057
Research Site
St.Petersburg, Russian Federation, 191014
Research Site
Ufa, Russian Federation, 450054
Slovakia
Research Site
Bratislava, Slovakia, 833 01
Research Site
Kosice, Slovakia, 041 91
Spain
Research Site
Badajoz, Spain, 06008
Research Site
Barcelona, Spain, 08035
Research Site
Barcelona, Spain, 08036
Research Site
Jaén, Spain, 23007
Research Site
L'Hospitalet de Llobregat, Spain, 08907
Research Site
Madrid, Spain, 28007
Research Site
Madrid, Spain, 28034
Research Site
Madrid, Spain, 28040
Research Site
Madrid, Spain, 28050
Research Site
Marbella, Spain, 29600
Research Site
Málaga, Spain, 29010
Research Site
Valencia, Spain, 46026
Research Site
Zaragoza, Spain, 50009
Taiwan
Research Site
Kaohsiung, Taiwan
Research Site
Taichung, Taiwan, 40447
Research Site
Taichung, Taiwan, 40705
Research Site
Taipei, Taiwan, 100
Research Site
Taipei, Taiwan, 10449
Research Site
Taipei, Taiwan, 11217
Thailand
Research Site
Bangkok, Thailand, 10330
Research Site
Bangkok, Thailand, 10700
Research Site
Chiang Mai, Thailand, 50200
Research Site
Pathumthani, Thailand, 12120
Research Site
Songkla, Thailand, 90110
Ukraine
Research Site
Dnipro, Ukraine, 49102
Research Site
Ivano-Frankivsk, Ukraine, 76018
Research Site
Kapitanivka Village, Ukraine, 08111
Research Site
Kharkiv Region, Ukraine, 61070
Research Site
Kirovohrad, Ukraine, 25006
Research Site
Kryvyi Rih, Ukraine, 50048
Research Site
Kyiv, Ukraine, 03022
Research Site
Kyiv, Ukraine, 03115
Research Site
Odesa, Ukraine, 65055
Research Site
Sumy, Ukraine, 40022
Research Site
Vinnytsia, Ukraine, 21029
United Kingdom
Research Site
Bebington, United Kingdom, CH63 4JY
Research Site
Birmingham, United Kingdom, B15 2TT
Research Site
London, United Kingdom, EC1A 7BE
Research Site
London, United Kingdom, SW3 6JJ
Research Site
Manchester, United Kingdom, M20 4BX
Research Site
Sutton, United Kingdom, SM2 5PT
Research Site
Taunton, United Kingdom, TA1 5DA
Vietnam
Research Site
Ha Noi, Vietnam, 100000
Research Site
Hanoi, Vietnam, 100000
Research Site
Hanoi, Vietnam
Research Site
Ho Chi Minh city, Vietnam, 700000

Sponsors and Collaborators

AstraZeneca

Investigators

Layout table for investigator information

Study Director:	Richard Olsson
Principal Investigator:	Tanguy Seiwert	The University of Chicago, 5841 S Maryland Ave, Chicago, IL 60637

More Information

Layout table for additonal information

Responsible Party:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT02551159
Other Study ID Numbers:	D419LC00001
First Posted:	September 16, 2015 Key Record Dates
Last Update Posted:	December 10, 2020
Last Verified:	December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Yes
Plan Description:	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.
Supporting Materials:	Study Protocol Statistical Analysis Plan (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.
URL:	https://astrazenecagroup-dt.pharmacm.com/DT/Home

Layout table for additional information

Studies a U.S. FDA-regulated Drug Product:	Yes
Studies a U.S. FDA-regulated Device Product:	No

Keywords provided by AstraZeneca:


programmed cell death ligand 1 (PD-L1), MEDI4736, Cytotoxic T-lymphocyte-associated antigen 4 {CTLA-4}, PFS, SCCHN

Additional relevant MeSH terms:

Layout table for MeSH terms

Head and Neck Neoplasms Squamous Cell Carcinoma of Head and Neck Carcinoma, Squamous Cell Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms by Site Cisplatin Carboplatin Fluorouracil Cetuximab	Durvalumab Tremelimumab Antibodies, Monoclonal Antineoplastic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Antimetabolites, Antineoplastic Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antineoplastic Agents, Immunological

To Top