Back to resultsPhase III Open Label Study of MEDI 4736 With/Without Tremelimumab Versus Standard of Care (SOC) in Recurrent/Metastatic Head and Neck Cancer (KESTREL)
Primary Purpose
Squamous Cell Carcinoma of the Head and Neck
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
MEDI4736
Tremelimumab
MEDI4736+Tremelimumab
Cetuximab
5-fluorouracil (5FU)
Cisplatin
Carboplatin
Sponsored by
About this trial
This is an interventional treatment trial for Squamous Cell Carcinoma of the Head and Neck focused on measuring programmed cell death ligand 1 (PD-L1), MEDI4736, Cytotoxic T-lymphocyte-associated antigen 4 {CTLA-4}, PFS, SCCHN
Eligibility 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
Sites / Locations
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Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
Monotherapy
Combination Therapy
Standard of Care
Arm Description
MEDI4736 monotherapy.
MEDI4736+Tremelimumab combination therapy
Standard of Care treatment
Outcomes
Primary Outcome Measures
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)
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)
Secondary Outcome Measures
Overall Survival (OS) Status in the PD-L1 TC/IC High Subgroup - Durvalumab + Tremelimumab Versus Standard of Care (SOC)
Number of participants with Overall Survival (OS)
Percentage of Patients Alive at 12, 18 and 24 Months in the PD-L1 TC/IC High Subgroup
Percentage of patients alive
Progression Free Survival (PFS) in the PD-L1 TC/IC High Subgroup
Time from the date of randomization until the date of objective disease progression or death (by any cause in the absence of progression). Progression is defined using Response Evaluation Criteria in Solid Tumours criteria (RECIST v1.1), as ≥20% increase in the sum of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Objective Response Rate (ORR) in the PD-L1 TC/IC High Subgroup
Number (%) of patients with at least 1 visit response of complete response (CR) or partial response (PR). Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) for target lesions (TL) and assessed by MRI or CT: CR: Disappearance of all TLs since baseline; PR: >= 30% decrease in the sum of diameters of TLs; Overall Response (OR = CR + PR)
Duration of Response (DoR) in the PD-L1 TC/IC High Subgroup
Time from the date of first documented response until the first date of documented progression or death in the absence of disease progression
Overall Survival (OS) Status in the All-comers (Full Analysis Set)
Number of participants with Overall Survival (OS)
Overall Survival (OS) Median Duration in the All-comers (Full Analysis Set)
Time from the date of randomization until death due to any cause (i.e., date of death or censoring - date of randomization + 1)
Percentage of Patients Alive at 12, 18 and 24 Months in the All-comers (Full Analysis Set)
Percentage of patients alive
Progression Free Survival (PFS) in the All-comers (Full Analysis Set)
Time from the date of randomization until the date of objective disease progression or death (by any cause in the absence of progression).
Progression is defined using Response Evaluation Criteria in Solid Tumours criteria (RECIST v1.1), as ≥20% increase in the sum of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Objective Response Rate (ORR) in the All-comers (Full Analysis Set)
Number (%) of patients with at least 1 visit response of complete response (CR) or partial response (PR). Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) for target lesions (TL) and assessed by MRI or CT: CR: Disappearance of all TLs since baseline; PR: >= 30% decrease in the sum of diameters of TLs; Overall Response (OR = CR + PR)
Duration of Response (DoR) in the All-comers (Full Analysis Set)
Time from the date of first documented response until the first date of documented progression or death in the absence of disease progression
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02551159
Brief Title
Phase III Open Label Study of MEDI 4736 With/Without Tremelimumab Versus Standard of Care (SOC) in Recurrent/Metastatic Head and Neck Cancer
Acronym
KESTREL
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
October 15, 2015 (Actual)
Primary Completion Date
July 6, 2020 (Actual)
Study Completion Date
May 21, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Squamous Cell Carcinoma of the Head and Neck
Keywords
programmed cell death ligand 1 (PD-L1), MEDI4736, Cytotoxic T-lymphocyte-associated antigen 4 {CTLA-4}, PFS, SCCHN
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
823 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Monotherapy
Arm Type
Experimental
Arm Description
MEDI4736 monotherapy.
Arm Title
Combination Therapy
Arm Type
Experimental
Arm Description
MEDI4736+Tremelimumab combination therapy
Arm Title
Standard of Care
Arm Type
Active Comparator
Arm Description
Standard of Care treatment
Intervention Type
Biological
Intervention Name(s)
MEDI4736
Intervention Description
Anti-PD-L1 antibody
Intervention Type
Biological
Intervention Name(s)
Tremelimumab
Intervention Description
Anti-CTLA-4 Antibody
Intervention Type
Biological
Intervention Name(s)
MEDI4736+Tremelimumab
Intervention Type
Biological
Intervention Name(s)
Cetuximab
Intervention Description
Monoclonal Antibody
Intervention Type
Drug
Intervention Name(s)
5-fluorouracil (5FU)
Intervention Description
Chemotherapy Agent
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
Chemotherapy agent
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Intervention Description
Chemotherapy Agent
Primary Outcome Measure Information:
Title
Overall Survival (OS) Status in the PD-L1 TC/IC High Subgroup - Durvalumab Versus Standard of Care (SOC)
Description
Number of participants with Overall Survival (OS)
Time Frame
From date of randomization until time of final analysis, an average of approximately 4 years
Title
Overall Survival (OS) Median Duration in the PD-L1 TC/IC High Subgroup
Description
Time from the date of randomization until death due to any cause (i.e., date of death or censoring - date of randomization + 1)
Time Frame
From date of randomization until time of final analysis, an average of approximately 4 years
Secondary Outcome Measure Information:
Title
Overall Survival (OS) Status in the PD-L1 TC/IC High Subgroup - Durvalumab + Tremelimumab Versus Standard of Care (SOC)
Description
Number of participants with Overall Survival (OS)
Time Frame
From date of randomization until time of final analysis, an average of approximately 4 years
Title
Percentage of Patients Alive at 12, 18 and 24 Months in the PD-L1 TC/IC High Subgroup
Description
Percentage of patients alive
Time Frame
12, 18 and 24 months after randomization
Title
Progression Free Survival (PFS) in the PD-L1 TC/IC High Subgroup
Description
Time from the date of randomization until the date of objective disease progression or death (by any cause in the absence of progression). Progression is defined using Response Evaluation Criteria in Solid Tumours criteria (RECIST v1.1), as ≥20% increase in the sum of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Time Frame
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
Title
Objective Response Rate (ORR) in the PD-L1 TC/IC High Subgroup
Description
Number (%) of patients with at least 1 visit response of complete response (CR) or partial response (PR). Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) for target lesions (TL) and assessed by MRI or CT: CR: Disappearance of all TLs since baseline; PR: >= 30% decrease in the sum of diameters of TLs; Overall Response (OR = CR + PR)
Time Frame
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
Title
Duration of Response (DoR) in the PD-L1 TC/IC High Subgroup
Description
Time from the date of first documented response until the first date of documented progression or death in the absence of disease progression
Time Frame
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
Title
Overall Survival (OS) Status in the All-comers (Full Analysis Set)
Description
Number of participants with Overall Survival (OS)
Time Frame
From date of randomization until time of final analysis, an average of approximately 4 years
Title
Overall Survival (OS) Median Duration in the All-comers (Full Analysis Set)
Description
Time from the date of randomization until death due to any cause (i.e., date of death or censoring - date of randomization + 1)
Time Frame
From date of randomization until time of final analysis, an average of approximately 4 years
Title
Percentage of Patients Alive at 12, 18 and 24 Months in the All-comers (Full Analysis Set)
Description
Percentage of patients alive
Time Frame
12, 18 and 24 months after randomization
Title
Progression Free Survival (PFS) in the All-comers (Full Analysis Set)
Description
Time from the date of randomization until the date of objective disease progression or death (by any cause in the absence of progression).
Progression is defined using Response Evaluation Criteria in Solid Tumours criteria (RECIST v1.1), as ≥20% increase in the sum of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Time Frame
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
Title
Objective Response Rate (ORR) in the All-comers (Full Analysis Set)
Description
Number (%) of patients with at least 1 visit response of complete response (CR) or partial response (PR). Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) for target lesions (TL) and assessed by MRI or CT: CR: Disappearance of all TLs since baseline; PR: >= 30% decrease in the sum of diameters of TLs; Overall Response (OR = CR + PR)
Time Frame
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
Title
Duration of Response (DoR) in the All-comers (Full Analysis Set)
Description
Time from the date of first documented response until the first date of documented progression or death in the absence of disease progression
Time Frame
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
130 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Olsson
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Tanguy Seiwert
Organizational Affiliation
The University of Chicago, 5841 S Maryland Ave, Chicago, IL 60637
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Site
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Research Site
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Research Site
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33916
Country
United States
Facility Name
Research Site
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33705
Country
United States
Facility Name
Research Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Research Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Research Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Research Site
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Research Site
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231
Country
United States
Facility Name
Research Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Research Site
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07960
Country
United States
Facility Name
Research Site
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Research Site
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Research Site
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Research Site
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Research Site
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Research Site
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44115
Country
United States
Facility Name
Research Site
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Research Site
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Research Site
City
Graz
ZIP/Postal Code
8036
Country
Austria
Facility Name
Research Site
City
Innsbruck
ZIP/Postal Code
6020
Country
Austria
Facility Name
Research Site
City
Linz
ZIP/Postal Code
4010
Country
Austria
Facility Name
Research Site
City
Wien
ZIP/Postal Code
1140
Country
Austria
Facility Name
Research Site
City
Brussels
ZIP/Postal Code
1000
Country
Belgium
Facility Name
Research Site
City
Brussels
ZIP/Postal Code
1090
Country
Belgium
Facility Name
Research Site
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Research Site
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Research Site
City
Namur
ZIP/Postal Code
5000
Country
Belgium
Facility Name
Research Site
City
Barretos
ZIP/Postal Code
14784-400
Country
Brazil
Facility Name
Research Site
City
Curitiba
ZIP/Postal Code
81520-060
Country
Brazil
Facility Name
Research Site
City
Florianópolis
ZIP/Postal Code
88034-000
Country
Brazil
Facility Name
Research Site
City
Ijui
ZIP/Postal Code
98700-000
Country
Brazil
Facility Name
Research Site
City
Porto Alegre
ZIP/Postal Code
90035-003
Country
Brazil
Facility Name
Research Site
City
Porto Alegre
ZIP/Postal Code
90619-900
Country
Brazil
Facility Name
Research Site
City
Porto Alegre
ZIP/Postal Code
91350-200
Country
Brazil
Facility Name
Research Site
City
Recife
ZIP/Postal Code
50040-000
Country
Brazil
Facility Name
Research Site
City
Rio de Janeiro
ZIP/Postal Code
22793-080
Country
Brazil
Facility Name
Research Site
City
Santo Andre
ZIP/Postal Code
09080-110
Country
Brazil
Facility Name
Research Site
City
Santo André
ZIP/Postal Code
09060-650
Country
Brazil
Facility Name
Research Site
City
São José do Rio Preto
ZIP/Postal Code
15090-000
Country
Brazil
Facility Name
Research Site
City
São Paulo
ZIP/Postal Code
03102-002
Country
Brazil
Facility Name
Research Site
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N2
Country
Canada
Facility Name
Research Site
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3E 0V9
Country
Canada
Facility Name
Research Site
City
Moncton
State/Province
New Brunswick
ZIP/Postal Code
E1C 8X3
Country
Canada
Facility Name
Research Site
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 1V7
Country
Canada
Facility Name
Research Site
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V 5C2
Country
Canada
Facility Name
Research Site
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4L6
Country
Canada
Facility Name
Research Site
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Facility Name
Research Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
Research Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4A 3J1
Country
Canada
Facility Name
Research Site
City
Bordeaux
ZIP/Postal Code
33000
Country
France
Facility Name
Research Site
City
Brest
ZIP/Postal Code
29200
Country
France
Facility Name
Research Site
City
Dijon
ZIP/Postal Code
21079
Country
France
Facility Name
Research Site
City
Lyon Cedex 08
ZIP/Postal Code
69373
Country
France
Facility Name
Research Site
City
Nice
ZIP/Postal Code
06100
Country
France
Facility Name
Research Site
City
Paris
ZIP/Postal Code
75015
Country
France
Facility Name
Research Site
City
Poitiers Cedex
ZIP/Postal Code
86021
Country
France
Facility Name
Research Site
City
Toulouse Cedex
ZIP/Postal Code
31059
Country
France
Facility Name
Research Site
City
Vandoeuvre les Nancy
ZIP/Postal Code
54519
Country
France
Facility Name
Research Site
City
Villejuif
ZIP/Postal Code
94800
Country
France
Facility Name
Research Site
City
Berlin
ZIP/Postal Code
12203
Country
Germany
Facility Name
Research Site
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Facility Name
Research Site
City
Essen
ZIP/Postal Code
45147
Country
Germany
Facility Name
Research Site
City
Frankfurt am Main
ZIP/Postal Code
60590
Country
Germany
Facility Name
Research Site
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Facility Name
Research Site
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Research Site
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Research Site
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Research Site
City
Tübingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Research Site
City
Würzburg
ZIP/Postal Code
97070
Country
Germany
Facility Name
Research Site
City
Athens
ZIP/Postal Code
115 22
Country
Greece
Facility Name
Research Site
City
Athens
ZIP/Postal Code
11527
Country
Greece
Facility Name
Research Site
City
Athens
ZIP/Postal Code
124 61
Country
Greece
Facility Name
Research Site
City
Athens
ZIP/Postal Code
18547
Country
Greece
Facility Name
Research Site
City
Heraklion
ZIP/Postal Code
711 11
Country
Greece
Facility Name
Research Site
City
Thessaloniki
ZIP/Postal Code
54645
Country
Greece
Facility Name
Research Site
City
Bangalore
ZIP/Postal Code
560027
Country
India
Facility Name
Research Site
City
Bangalore
ZIP/Postal Code
560076
Country
India
Facility Name
Research Site
City
Bengaluru
ZIP/Postal Code
560076
Country
India
Facility Name
Research Site
City
Gurgaon
ZIP/Postal Code
122001
Country
India
Facility Name
Research Site
City
Karamsad
ZIP/Postal Code
388325
Country
India
Facility Name
Research Site
City
Madurai
ZIP/Postal Code
625107
Country
India
Facility Name
Research Site
City
Pune
ZIP/Postal Code
411001
Country
India
Facility Name
Research Site
City
Cona
ZIP/Postal Code
44124
Country
Italy
Facility Name
Research Site
City
Firenze
ZIP/Postal Code
50134
Country
Italy
Facility Name
Research Site
City
Messina
ZIP/Postal Code
98158
Country
Italy
Facility Name
Research Site
City
Milano
ZIP/Postal Code
20133
Country
Italy
Facility Name
Research Site
City
Padova
ZIP/Postal Code
35128
Country
Italy
Facility Name
Research Site
City
Palermo
ZIP/Postal Code
90127
Country
Italy
Facility Name
Research Site
City
Salerno
ZIP/Postal Code
84131
Country
Italy
Facility Name
Research Site
City
Siena
ZIP/Postal Code
53100
Country
Italy
Facility Name
Research Site
City
Torino
ZIP/Postal Code
10126
Country
Italy
Facility Name
Research Site
City
Akashi-shi
ZIP/Postal Code
673-8558
Country
Japan
Facility Name
Research Site
City
Chiba-shi
ZIP/Postal Code
260-8717
Country
Japan
Facility Name
Research Site
City
Fukuoka-shi
ZIP/Postal Code
811-1347
Country
Japan
Facility Name
Research Site
City
Hirakata-shi
ZIP/Postal Code
573-1191
Country
Japan
Facility Name
Research Site
City
Isehara-shi
ZIP/Postal Code
259-1193
Country
Japan
Facility Name
Research Site
City
Kagoshima-shi
ZIP/Postal Code
890-8520
Country
Japan
Facility Name
Research Site
City
Kanazawa-shi
ZIP/Postal Code
920-8650
Country
Japan
Facility Name
Research Site
City
Kitaadachi-gun
ZIP/Postal Code
362-0806
Country
Japan
Facility Name
Research Site
City
Kobe-shi
ZIP/Postal Code
650-0017
Country
Japan
Facility Name
Research Site
City
Koto-ku
ZIP/Postal Code
135-8550
Country
Japan
Facility Name
Research Site
City
Natori-shi
ZIP/Postal Code
981-1293
Country
Japan
Facility Name
Research Site
City
Okayama-shi
ZIP/Postal Code
700-8558
Country
Japan
Facility Name
Research Site
City
Osaka-shi
ZIP/Postal Code
541-8567
Country
Japan
Facility Name
Research Site
City
Osakasayama
ZIP/Postal Code
589-8511
Country
Japan
Facility Name
Research Site
City
Sapporo-shi
ZIP/Postal Code
003-0804
Country
Japan
Facility Name
Research Site
City
Sapporo
ZIP/Postal Code
060-8648
Country
Japan
Facility Name
Research Site
City
Sunto-gun
ZIP/Postal Code
411-8777
Country
Japan
Facility Name
Research Site
City
Takatsuki-shi
ZIP/Postal Code
569-8686
Country
Japan
Facility Name
Research Site
City
Toyoake-shi
ZIP/Postal Code
470-1192
Country
Japan
Facility Name
Research Site
City
Yokohama-shi
ZIP/Postal Code
241-8515
Country
Japan
Facility Name
Research Site
City
Cheongju-si
ZIP/Postal Code
28644
Country
Korea, Republic of
Facility Name
Research Site
City
Hwasun-gun
ZIP/Postal Code
58128
Country
Korea, Republic of
Facility Name
Research Site
City
Incheon
ZIP/Postal Code
21565
Country
Korea, Republic of
Facility Name
Research Site
City
Seo-Gu
ZIP/Postal Code
49241
Country
Korea, Republic of
Facility Name
Research Site
City
Seongnam-si
ZIP/Postal Code
13620
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Facility Name
Research Site
City
Suwon-si
ZIP/Postal Code
16499
Country
Korea, Republic of
Facility Name
Research Site
City
Cebu City
ZIP/Postal Code
6000
Country
Philippines
Facility Name
Research Site
City
Las Pinas
ZIP/Postal Code
1740
Country
Philippines
Facility Name
Research Site
City
Quezon City
ZIP/Postal Code
1112
Country
Philippines
Facility Name
Research Site
City
Białystok
ZIP/Postal Code
15-027
Country
Poland
Facility Name
Research Site
City
Bielsko-Biała
ZIP/Postal Code
43-300
Country
Poland
Facility Name
Research Site
City
Gdańsk
ZIP/Postal Code
80-214
Country
Poland
Facility Name
Research Site
City
Gdynia
ZIP/Postal Code
81-519
Country
Poland
Facility Name
Research Site
City
Lublin
ZIP/Postal Code
20-090
Country
Poland
Facility Name
Research Site
City
Poznan
ZIP/Postal Code
60-780
Country
Poland
Facility Name
Research Site
City
Poznan
ZIP/Postal Code
61-866
Country
Poland
Facility Name
Research Site
City
Szczecin
ZIP/Postal Code
71-730
Country
Poland
Facility Name
Research Site
City
Warszawa
ZIP/Postal Code
02-781
Country
Poland
Facility Name
Research Site
City
Łódź
ZIP/Postal Code
93-513
Country
Poland
Facility Name
Research Site
City
Suceava
ZIP/Postal Code
720237
Country
Romania
Facility Name
Research Site
City
Arkhangelsk
ZIP/Postal Code
163045
Country
Russian Federation
Facility Name
Research Site
City
Ekaterinburg
ZIP/Postal Code
620905
Country
Russian Federation
Facility Name
Research Site
City
Krasnodar
ZIP/Postal Code
350040
Country
Russian Federation
Facility Name
Research Site
City
Moscow
ZIP/Postal Code
125367
Country
Russian Federation
Facility Name
Research Site
City
Obninsk
ZIP/Postal Code
249036
Country
Russian Federation
Facility Name
Research Site
City
Omsk
ZIP/Postal Code
644013
Country
Russian Federation
Facility Name
Research Site
City
Saint Petersburg
ZIP/Postal Code
195271
Country
Russian Federation
Facility Name
Research Site
City
Saint Petersburg
ZIP/Postal Code
198255
Country
Russian Federation
Facility Name
Research Site
City
Saint-Petersburg
ZIP/Postal Code
197758
Country
Russian Federation
Facility Name
Research Site
City
Sochi
ZIP/Postal Code
354057
Country
Russian Federation
Facility Name
Research Site
City
St.Petersburg
ZIP/Postal Code
191014
Country
Russian Federation
Facility Name
Research Site
City
Ufa
ZIP/Postal Code
450054
Country
Russian Federation
Facility Name
Research Site
City
Bratislava
ZIP/Postal Code
833 01
Country
Slovakia
Facility Name
Research Site
City
Kosice
ZIP/Postal Code
041 91
Country
Slovakia
Facility Name
Research Site
City
Badajoz
ZIP/Postal Code
06008
Country
Spain
Facility Name
Research Site
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Research Site
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Research Site
City
Jaén
ZIP/Postal Code
23007
Country
Spain
Facility Name
Research Site
City
L'Hospitalet de Llobregat
ZIP/Postal Code
08907
Country
Spain
Facility Name
Research Site
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Research Site
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Research Site
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Research Site
City
Madrid
ZIP/Postal Code
28050
Country
Spain
Facility Name
Research Site
City
Marbella
ZIP/Postal Code
29600
Country
Spain
Facility Name
Research Site
City
Málaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Research Site
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Research Site
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Facility Name
Research Site
City
Kaohsiung
Country
Taiwan
Facility Name
Research Site
City
Taichung
ZIP/Postal Code
40447
Country
Taiwan
Facility Name
Research Site
City
Taichung
ZIP/Postal Code
40705
Country
Taiwan
Facility Name
Research Site
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
Facility Name
Research Site
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Facility Name
Research Site
City
Taipei
ZIP/Postal Code
10449
Country
Taiwan
Facility Name
Research Site
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan
Facility Name
Research Site
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand
Facility Name
Research Site
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
Facility Name
Research Site
City
Chiang Mai
ZIP/Postal Code
50200
Country
Thailand
Facility Name
Research Site
City
Hat Yai
ZIP/Postal Code
90110
Country
Thailand
Facility Name
Research Site
City
Pathumthani
ZIP/Postal Code
12120
Country
Thailand
Facility Name
Research Site
City
Dnipro
ZIP/Postal Code
49102
Country
Ukraine
Facility Name
Research Site
City
Ivano-Frankivsk
ZIP/Postal Code
76018
Country
Ukraine
Facility Name
Research Site
City
Kapitanivka Village
ZIP/Postal Code
08111
Country
Ukraine
Facility Name
Research Site
City
Kharkiv Region
ZIP/Postal Code
61070
Country
Ukraine
Facility Name
Research Site
City
Kirovohrad
ZIP/Postal Code
25006
Country
Ukraine
Facility Name
Research Site
City
Kryvyi Rih
ZIP/Postal Code
50048
Country
Ukraine
Facility Name
Research Site
City
Kyiv
ZIP/Postal Code
03022
Country
Ukraine
Facility Name
Research Site
City
Kyiv
ZIP/Postal Code
03115
Country
Ukraine
Facility Name
Research Site
City
Odesa
ZIP/Postal Code
65055
Country
Ukraine
Facility Name
Research Site
City
Sumy
ZIP/Postal Code
40022
Country
Ukraine
Facility Name
Research Site
City
Vinnytsia
ZIP/Postal Code
21029
Country
Ukraine
Facility Name
Research Site
City
Bebington
ZIP/Postal Code
CH63 4JY
Country
United Kingdom
Facility Name
Research Site
City
Birmingham
ZIP/Postal Code
B15 2TT
Country
United Kingdom
Facility Name
Research Site
City
London
ZIP/Postal Code
EC1A 7BE
Country
United Kingdom
Facility Name
Research Site
City
London
ZIP/Postal Code
SW3 6JJ
Country
United Kingdom
Facility Name
Research Site
City
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Facility Name
Research Site
City
Sutton
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Facility Name
Research Site
City
Taunton
ZIP/Postal Code
TA1 5DA
Country
United Kingdom
Facility Name
Research Site
City
Ha Noi
ZIP/Postal Code
100000
Country
Vietnam
Facility Name
Research Site
City
Hanoi
ZIP/Postal Code
100000
Country
Vietnam
Facility Name
Research Site
City
Hanoi
Country
Vietnam
Facility Name
Research Site
City
Ho Chi Minh city
ZIP/Postal Code
700000
Country
Vietnam
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
IPD Sharing 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.
IPD Sharing 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.
IPD Sharing URL
https://astrazenecagroup-dt.pharmacm.com/DT/Home
Citations:
PubMed Identifier
33684371
Citation
Hwang 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. Erratum In: Lancet Oncol. 2021 Apr;22(4):e134.
Results Reference
derived
Links:
URL
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URL
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URL
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Description
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Learn more about this trial
Phase III Open Label Study of MEDI 4736 With/Without Tremelimumab Versus Standard of Care (SOC) in Recurrent/Metastatic Head and Neck Cancer
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