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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02000947




Registration number
NCT02000947
Ethics application status
Date submitted
27/11/2013
Date registered
4/12/2013
Date last updated
31/10/2019

Titles & IDs
Public title
A Phase 1b Study of MEDI4736 in Combination With Tremelimumab in Subjects With Advanced Non-small Cell Lung Cancer
Scientific title
A Phase 1b Open-label Study to Evaluate the Safety and Tolerability of MEDI4736 in Combination With Tremelimumab in Subjects With Advanced Non-small Cell Lung Cancer
Secondary ID [1] 0 0
2015-003715-38
Secondary ID [2] 0 0
D4190C00006
Universal Trial Number (UTN)
Trial acronym
D4190C00006
Linked study record

Health condition
Health condition(s) or problem(s) studied:
NSCLC 0 0
Non-small Cell Lung Cancer 0 0
Lung Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

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

Experimental: Dose Escalation - MEDI4736 and tremelimumab received by intravenous infusion.

Experimental: Arm A - Medi4736 and tremelimumab received by intravenous infusion

Experimental: Arm B - MEDI4736 and tremelimumab received by intravenous infusion

Experimental: Arm C - MEDI4736 and tremelimumab received by intravenous infursion


Treatment: Drugs: MEDI4736
MEDI4736 is an anti-PD-L1 monoclonal antibody (MAb).

Treatment: Drugs: Tremelimumab
Tremelimumab is an anti-CTLA4 monoclonal antibody (mAb).

Treatment: Drugs: tremelimumab
Tremelimumab is an anti-CTLA4 monoclonal antibody (mAb).

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of subjects reporting adverse events - The number of subjects reporting adverse events (AEs) and number (percentage) of subjects reporting serious adverse events (SAEs) as graded by CTCAE Version 4.03
Timepoint [1] 0 0
Screening through 90 days after the last dose of study medication
Primary outcome [2] 0 0
Objective response - Best overall response of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 as defined as the best response among all overall responses recorded from the start of treatment until progression, or the last evaluable disease assessment in the absence of progressive disease (PD) prior to the initiation of subsequent anti-cancer therapy, or discontinuation from the study, whichever occurs first.
Timepoint [2] 0 0
At least 24 weeks as compared to baseline
Primary outcome [3] 0 0
Number of subjects experiencing dose-limiting toxicities (DLTs) - The maximum tolerated dose (MTD), which is the highest dose within a cohort where no more than 1 out of 6 subjects experience DLTs or the highest protocol-defined dose for each agent in the absence of exceeding the MTD, will be evaluated using the following safety assessments: adverse events, serious advents, laboratory evaluations, vital signs, physical examinations, and electrocardiogram (ECG) results. Measurements will be aggregated to determine whether a subject has experienced a DLT as assessed by the investigator.
Timepoint [3] 0 0
Depending upon the cohort, the DLT evaluation period is from the 1st dose of study medication until (1) the 3rd dose of MEDI4736 and tremelimumab (2) the 2nd dose of MEDI4736 and tremelimumab or (3) the 3rd dose of MEDI4736 and 2nd dose of tremelimumab
Secondary outcome [1] 0 0
Immunogenicity of tremelimumab in combination with MEDI4736 - Immunogenicity of MEDI4736 and tremelimumab will include the number and percentage of subjects who develop detectable anti-drug antibodies (ADAs).
Timepoint [1] 0 0
During treatment through study completion, about 2 years
Secondary outcome [2] 0 0
Antitumor activity of tremelimumab in combination with MEDI4736 - Antitumor activity will include objective response (OR) and disease control (DC) based on RECIST Version 1.1, duration of response (DoR), progression-free survival (PFS), and overall survival (OS).
Timepoint [2] 0 0
During treatment through study completion, about 2 years
Secondary outcome [3] 0 0
Pharmacokinetic parameters - Assessment of PK of MEDI4736 and tremelimumab will include individual MEDI4736 and tremelimumab concentrations in serum, and PK parameters including peak concentration (Cmax), area under the concentration-time curve (AUC), clearance (CL), and half-life (t½).
Timepoint [3] 0 0
During treatment through study completion, about 2 years
Secondary outcome [4] 0 0
Number of subjects reporting adverse events - The number of subjects reporting adverse events (AEs) and number (percentage) of subjects reporting serious adverse events (SAEs) as graded by CTCAE Version 4.03
Timepoint [4] 0 0
Screening through 90 days after the last dose of study medication

Eligibility
Key inclusion criteria
1. Age = 18 years

2. Advanced non-small cell lung cancer

3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1

4. Adequate organ and marrow function
Minimum age
18 Years
Maximum age
101 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Any concurrent chemotherapy, immunotherapy, biologic, or hormonal therapy for cancer
treatment

2. Current or prior use of immunosuppressive medication within 14 days before the first
dose of study drugs

3. Active or prior documented autoimmune disease within the last 2 years.

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
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
Single group
Other design features
Phase
Phase 1
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Darlinghurst
Recruitment hospital [2] 0 0
Research Site - Gosford
Recruitment hospital [3] 0 0
Research Site - Kogarah
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
2250 - Gosford
Recruitment postcode(s) [3] 0 0
2217 - Kogarah
Recruitment outside Australia
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United States of America
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Alabama
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Arizona
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California
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Colorado
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Connecticut
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Delaware
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Indiana
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Maryland
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Massachusetts
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Michigan
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Missouri
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New Hampshire
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New York
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North Carolina
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Ohio
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Oregon
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Texas
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Virginia
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Washington
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West Virginia
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Belgium
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Bruxelles
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Belgium
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Gent
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Liege
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France
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Bordeaux Cedex
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France
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Dijon
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France
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La Tronche
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France
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Lille
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France
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Lyon
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France
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Marseille
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France
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Montpellier Cedex 5
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France
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Saint Herblain
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Italy
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Bologna
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Italy
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Milano
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Italy
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Rozzano
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Italy
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Saronno
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Italy
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Siena
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Italy
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Sondrio
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Korea, Republic of
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Cheongju-si
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Korea, Republic of
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Incheon
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Seongnam-si
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Seoul
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Jaen
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Sevilla
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Valencia
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Taiwan
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Tainan
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Taipei
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London
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United Kingdom
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Manchester

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
MedImmune LLC
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to determine if MEDI4736 will be adequately tolerated in
combination with tremelimumab in subjects with advanced non-small cell lung cancer (NSCLC).
Trial website
https://clinicaltrials.gov/show/NCT02000947
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
MedImmune LLC
Address 0 0
MedImmune LLC
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

Summary results
Other publications