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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02319044




Registration number
NCT02319044
Ethics application status
Date submitted
12/12/2014
Date registered
18/12/2014

Titles & IDs
Public title
Phase II Study of MEDI4736, Tremelimumab, and MEDI4736 in Combination w/ Tremelimumab Squamous Cell Carcinoma of the Head and Neck
Scientific title
A Phase II, Randomized, Open-Label, Multi-Center, Global Study of MEDI4736 Monotherapy, Tremelimumab Monotherapy, and MEDI4736 in Combination With Tremelimumab in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN)
Secondary ID [1] 0 0
D4193C00003
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Recurrent/Metastatic Squamous Cell Carcinoma of Head & Neck 0 0
Condition category
Condition code
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney
Cancer 0 0 0 0
Head and neck

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - MEDI4736
Treatment: Drugs - Tremelimumab
Treatment: Drugs - MEDI4736 + Tremelimumab

Experimental: MEDI4736 - MEDI4736 monotherapy

Experimental: Tremelimumab - Tremelimumab monotherapy

Experimental: MEDI4736 + Tremelimumab - MEDI4736 + Tremelimumab combination therapy


Treatment: Drugs: MEDI4736
MEDI4736 monotherapy

Treatment: Drugs: Tremelimumab
Tremelimumab monotherapy

Treatment: Drugs: MEDI4736 + Tremelimumab
MEDI4736 + Tremelimumab combination therapy
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Objective Response Rate at 6 Months
Timepoint [1] 0 0
After 6 months
Primary outcome [2] 0 0
Objective Response Rate at 12 Months
Timepoint [2] 0 0
After 12 months
Secondary outcome [1] 0 0
Best Objective Response
Timepoint [1] 0 0
After 12 months
Secondary outcome [2] 0 0
Duration of Response - Participants Remaining in Response
Timepoint [2] 0 0
After 12 months
Secondary outcome [3] 0 0
Time to Response
Timepoint [3] 0 0
After 12 months
Secondary outcome [4] 0 0
Time to Onset of Response From First Dose
Timepoint [4] 0 0
After 12 months
Secondary outcome [5] 0 0
Disease Control Rate (DCR)
Timepoint [5] 0 0
After 6 months
Secondary outcome [6] 0 0
Disease Control Rate (DCR)
Timepoint [6] 0 0
After 12 months
Secondary outcome [7] 0 0
Progression-free Survival (PFS)
Timepoint [7] 0 0
After 6 months
Secondary outcome [8] 0 0
Progression-free Survival (PFS)
Timepoint [8] 0 0
After 12 months
Secondary outcome [9] 0 0
Overall Survival
Timepoint [9] 0 0
After 12 months
Secondary outcome [10] 0 0
Quality of Life
Timepoint [10] 0 0
After 12 months
Secondary outcome [11] 0 0
Duration of Response
Timepoint [11] 0 0
After 12 months

Eligibility
Key inclusion criteria
* Age =18 years;
* Written informed consent obtained from the patient/legal representative;
* Histologically confirmed recurrent or metastatic SCCHN; tumor progression or recurrence during or after treatment with only 1 systemic palliative regimen for recurrent or metastatic disease that must have contained a platinum agent; Patients who have only received chemo-radiation with curative intent for treatment of their locally advanced disease or recurrent disease are not eligible. Patients who received concurrent chemo-radiation as part of treatment of their recurrent disease are also not eligible.
* Written consent to provide newly acquired tumor tissue (preferred) or archival tissue for the purpose of establishing PD-L1 status.
* Confirmed PD-L1-negative SCCHN by Ventana SP263;
* WHO/ECOG performance status of 0 or 1;
* At least 1 measurable lesion at baseline;
* No prior exposure to immune-mediated therapy;
* Adequate organ and marrow function; Evidence of post-menopausal status or negative urinary or serum pregnancy test.
Minimum age
18 Years
Maximum age
96 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Histologically confirmed squamous cell carcinoma of any other primary anatomic location in the head and neck;
* Received more than 1 regimen for recurrent or metastatic disease
* Any concurrent chemotherapy, Investigational Product, biologic, or hormonal therapy for cancer treatment;
* Receipt of any investigational anticancer therapy within 28 days or 5 half-lives;
* Receipt of last dose of an approved (marketed) anticancer therapy (chemotherapy, targeted therapy, biologic therapy, mAbs, etc) within 21 days prior to the first dose of study treatment;
* Major surgical procedure within 28 days prior to the first dose of Investigational Product;
* Any unresolved toxicity NCI CTCAE Grade =2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criterion;
* Current or prior use of immunosuppressive medication within 14 days before the first dose of their assigned Investigational Product;
* History of allogeneic organ transplantation;
* Active or prior documented autoimmune or inflammatory disorders;
* Uncontrolled intercurrent illness;
* another primary malignancy
* Patients with history of brain metastases, spinal cord compression, or a history of leptomeningeal carcinomatosis;
* History of active primary immunodeficiency;
* Known history of previous tuberculosis;
* Active infection including hepatitis B, hepatitis C or human immunodeficiency virus (HIV);
* Receipt of live, attenuated vaccine within 30 days prior to the first dose of Investigational Product;
* Pregnant or breast-feeding female patients;
* Mean QT interval corrected for heart rate (QTc) =470 ms calculated from 3 electrocardiograms (ECGs) using Fridericia's Correction
* Known allergy or hypersensitivity to Investigational Product.
* Any condition that, in the opinion of the Investigator, would interfere with evaluation of the IP or interpretation of patient safety or study results

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
15/04/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
6/07/2020
Sample size
Target
Accrual to date
Final
267
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Adelaide
Recruitment hospital [2] 0 0
Research Site - Darlinghurst
Recruitment hospital [3] 0 0
Research Site - Tweed Heads
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [3] 0 0
2485 - Tweed Heads
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Arkansas
Country [4] 0 0
United States of America
State/province [4] 0 0
California
Country [5] 0 0
United States of America
State/province [5] 0 0
Colorado
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Georgia
Country [8] 0 0
United States of America
State/province [8] 0 0
Illinois
Country [9] 0 0
United States of America
State/province [9] 0 0
Kentucky
Country [10] 0 0
United States of America
State/province [10] 0 0
Maryland
Country [11] 0 0
United States of America
State/province [11] 0 0
Massachusetts
Country [12] 0 0
United States of America
State/province [12] 0 0
Michigan
Country [13] 0 0
United States of America
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Minnesota
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United States of America
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Missouri
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United States of America
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New Hampshire
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United States of America
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New York
Country [17] 0 0
United States of America
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North Carolina
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United States of America
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Oregon
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United States of America
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Pennsylvania
Country [20] 0 0
United States of America
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South Carolina
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United States of America
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Tennessee
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United States of America
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Texas
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United States of America
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West Virginia
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United States of America
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Wisconsin
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Belgium
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Brussels
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Belgium
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Charleroi
Country [27] 0 0
Belgium
State/province [27] 0 0
Kortrijk
Country [28] 0 0
Belgium
State/province [28] 0 0
Leuven
Country [29] 0 0
Belgium
State/province [29] 0 0
Namur
Country [30] 0 0
Canada
State/province [30] 0 0
Alberta
Country [31] 0 0
Canada
State/province [31] 0 0
New Brunswick
Country [32] 0 0
Canada
State/province [32] 0 0
Ontario
Country [33] 0 0
Canada
State/province [33] 0 0
Quebec
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Czechia
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Olomouc
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Czechia
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Zlin
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France
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Angers
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France
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Bordeaux
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France
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Brest
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France
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Dijon
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France
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Le Mans
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France
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Lille cedex
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France
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Lorient cedex
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France
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Lyon Cedex 08
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France
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Montpellier
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France
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Nice
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France
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Rouen
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France
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Saint Brieuc
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France
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St Grégoire
Country [49] 0 0
France
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Strasbourg Cedex
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France
State/province [50] 0 0
Toulouse Cedex 9
Country [51] 0 0
France
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Villejuif Cedex
Country [52] 0 0
Georgia
State/province [52] 0 0
Batumi
Country [53] 0 0
Georgia
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Tbilisi
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Germany
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Berlin
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Germany
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Halle
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Germany
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Hannover
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Germany
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Heidelberg
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Germany
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Leipzig
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Germany
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München
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Hungary
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Budapest
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Hungary
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Gyula
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Hungary
State/province [62] 0 0
Györ
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Hungary
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Kecskemét
Country [64] 0 0
Hungary
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Miskolc
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Hungary
State/province [65] 0 0
Zalaegerszeg
Country [66] 0 0
Israel
State/province [66] 0 0
Haifa
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Israel
State/province [67] 0 0
Petach-Tikva
Country [68] 0 0
Israel
State/province [68] 0 0
Tel Hashomer
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Korea, Republic of
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Daegu
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Korea, Republic of
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Goyang-si
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Korea, Republic of
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Suwon
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Malaysia
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Kuala Lumpur
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Malaysia
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Kuching
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Spain
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Barakaldo
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Spain
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Barcelona
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Gerona
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Spain
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Granada
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Spain
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Jaén
Country [79] 0 0
Spain
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Madrid
Country [80] 0 0
Spain
State/province [80] 0 0
Malaga
Country [81] 0 0
Spain
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Marbella (Málaga)
Country [82] 0 0
Spain
State/province [82] 0 0
Valencia
Country [83] 0 0
Spain
State/province [83] 0 0
Zaragoza
Country [84] 0 0
Taiwan
State/province [84] 0 0
Taipei
Country [85] 0 0
United Kingdom
State/province [85] 0 0
Aberdeen
Country [86] 0 0
United Kingdom
State/province [86] 0 0
Birmingham
Country [87] 0 0
United Kingdom
State/province [87] 0 0
Glasgow
Country [88] 0 0
United Kingdom
State/province [88] 0 0
London
Country [89] 0 0
United Kingdom
State/province [89] 0 0
Manchester
Country [90] 0 0
United Kingdom
State/province [90] 0 0
Wirral

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AstraZeneca
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
PRA Health Sciences
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Magdalena Wrona
Address 0 0
Medical Scientist AstraZeneca Magdalena.Wrona@astrazeneca.com
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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

Supporting document/s available: Study protocol, Statistical analysis plan (SAP)
When will data be available (start and end dates)?
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
Available to whom?
When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://astrazenecagroup-dt.pharmacm.com/DT/Home


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT02319044