Trial from ClinicalTrials.gov

For full trial details, please see the original record at



Trial ID
NCT02319044
Ethics application status
Date submitted
12/12/2014
Date registered
12/12/2014
Date last updated
28/04/2017

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 (ORR) - the number (%) of patients with a confirmed overall response of CR (complete response) or PR (partial response) and will be based on all treated patients who have measurable disease at baseline per ICR (evaluable set)
Timepoint [1] 0 0
after 12 month
Secondary outcome [1] 0 0
Duration of response (DoR) - time from the date of first documented response until the first date of documented progression or death in the absence of disease progression
Timepoint [1] 0 0
after 12 month
Secondary outcome [2] 0 0
Disease control rate (DCR) - percentage of patients who have a BoR (best objective response) of CR(complete response) or PR (partial response) or who have demonstrated SD (stable disease)
Timepoint [2] 0 0
after 12 month
Secondary outcome [3] 0 0
Progression-free survival (PFS) - time from the date of randomization until the date of objective disease progression or death
Timepoint [3] 0 0
after 12 month
Secondary outcome [4] 0 0
Overall survival (OS) - time from the date of randomization until death due to any cause
Timepoint [4] 0 0
after 12 month
Secondary outcome [5] 0 0
Best objective response (BoR) - the best response a patient has had during their time in the study
Timepoint [5] 0 0
after 12 month

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
Gender
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
Blinded (masking 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
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Current
Final
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
- Adelaide
Recruitment postcode(s) [2] 0 0
- Darlinghurst
Recruitment postcode(s) [3] 0 0
- 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
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United States of America
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Arkansas
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United States of America
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California
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United States of America
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Colorado
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United States of America
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Florida
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United States of America
State/province [7] 0 0
Georgia
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United States of America
State/province [8] 0 0
Illinois
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United States of America
State/province [9] 0 0
Kentucky
Country [10] 0 0
United States of America
State/province [10] 0 0
Maryland
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United States of America
State/province [11] 0 0
Massachusetts
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United States of America
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Michigan
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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
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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
State/province [19] 0 0
Pennsylvania
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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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Washington
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United States of America
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Wisconsin
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Belgium
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Brussels (Jette)
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Belgium
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Charleroi
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Belgium
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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
Country [34] 0 0
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 Cedex 05
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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
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France
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Strasbourg Cedex
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France
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Toulouse Cedex 9
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France
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Villejuif
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Georgia
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Batumi
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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
Country [60] 0 0
Hungary
State/province [60] 0 0
Budapest
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Hungary
State/province [61] 0 0
Gyula
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Hungary
State/province [62] 0 0
Györ
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Hungary
State/province [63] 0 0
Kecskemét
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Hungary
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Miskolc
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Hungary
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Zalaegerszeg
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Israel
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Haifa
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Israel
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Petach-Tikva
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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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Spain
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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
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Spain
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L'Hospitalet de Llobregat
Country [80] 0 0
Spain
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Madrid
Country [81] 0 0
Spain
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Málaga
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Spain
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Valencia
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Spain
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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
Bebington
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United Kingdom
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Birmingham
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United Kingdom
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Glasgow
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United Kingdom
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London
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United Kingdom
State/province [90] 0 0
Manchester
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United Kingdom
State/province [91] 0 0
Nottingham

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
The purpose of this study is to determine the efficacy and safety of investigational medical
products (MEDI4736 monotherapy, tremelimumab monotherapy, and MEDI4736 + tremelimumab
combination therapy) in the treatment of patients with recurrent or metastatic carcinoma of
the head and neck who have progressed during or after treatment with a platinum containing
regimen for recurrent/metastatic disease.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Anthony Jarkowski III
Address 0 0
Medical Scientist AstraZeneca Anthony.Jarkowski@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
Contact person responsible for updating information