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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT03089645




Registration number
NCT03089645
Ethics application status
Date submitted
19/01/2017
Date registered
24/03/2017
Date last updated
27/07/2020

Titles & IDs
Public title
MEDI5083 Alone and in Combination With Durvalumab, Tremelimumab, and/or Docetaxel.
Scientific title
A Phase 1 First Time in Human Study to Evaluate the Safety, Pharmacokinetics and Immunogenicity of MEDI5083 Alone or in Combination With Durvalumab, Tremelimumab, and/or Docetaxel in Advanced Solid Tumors
Secondary ID [1] 0 0
D6840C00001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Solid Tumors 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - MEDI5083 monotherapy
Other interventions - MEID5083 with Durvalumab or Tremelimumab
Other interventions - Medi5083 with Durvalumab and Docetaxel

Experimental: Part 1 - MEDI5083 monotherapy followed by Durvalumab monotherapy in subjects with advanced solid tumors

Experimental: Part 2 - Sequential MEDI5083 with concurrent Durvalumab or Tremelimumab, and intermittent Medi5083 with concurrent Durvalumab in subjects with advanced solid tumors.

Experimental: Part 3 - Medi5083 with concurrent Durvalumab and Docetaxel randomized against Durvalumab and Docetaxel in subjects with IO refractory/relapsed 2/3L in NSCLC


Other interventions: MEDI5083 monotherapy
Dose-escalation MEDI5083 monotherapy followed by monotherapy with Durvalumab

Other interventions: MEID5083 with Durvalumab or Tremelimumab
Sequential Medi5083 with concurrent Durvalumab or Tremelimumab, and intermittent Medi5083 with concurrent Durvalumab

Other interventions: Medi5083 with Durvalumab and Docetaxel
Medi5083 with concurrent Durvalumab and Docetaxel randomized against Durvalumab and Docetaxel
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of participants with Adverse Events (AEs) as a measure of safety
Timepoint [1] 0 0
From the time of consent through 120 days after last treatment
Primary outcome [2] 0 0
Number of participants with Serious Adverse Events (SAEs) as a measure of safety
Timepoint [2] 0 0
From the time of consent through 120 days after last treatment
Primary outcome [3] 0 0
Number of participants with Dose Limiting Toxicities (DLTs) as a measure of safety
Timepoint [3] 0 0
From the time of first dose through 28 days thereafter
Primary outcome [4] 0 0
The Maximum Tolerated Dose (MTD) or Highest Protocol-Defined Dose
Timepoint [4] 0 0
From the time of first dose through end of study (2 years after last subject enrolled or earlier at sponsor discretion)
Primary outcome [5] 0 0
Discontinuation of investigational products due to toxicity
Timepoint [5] 0 0
From the time of first dose through end of study (2 years after last subject enrolled or earlier at sponsor discretion)
Primary outcome [6] 0 0
Clinically significant alterations in vital signs, laboratory parameters, physical examination, and electrocardiogram (ECG) results.
Timepoint [6] 0 0
From the time of first dose through end of study (2 years after last subject enrolled or earlier at sponsor discretion)
Primary outcome [7] 0 0
Antitumor activity endpoints OR, based on RECIST v1.1
Timepoint [7] 0 0
Part 3
Secondary outcome [1] 0 0
Serum MEDI5083 concentration levels
Timepoint [1] 0 0
From the time of first dose through 57 days after first treatment
Secondary outcome [2] 0 0
Reduction in peripheral blood CD19+ B cells
Timepoint [2] 0 0
From the time of first dose through 57 days after first treatment
Secondary outcome [3] 0 0
Incidence of anti-drug antibody (ADA) responses to MEDI5083
Timepoint [3] 0 0
From the time of first dose through 2 years after last treatment
Secondary outcome [4] 0 0
Objective Response Rate (ORR)
Timepoint [4] 0 0
From the time of consent through end of study (2 years after last subject enrolled or earlier at sponsor discretion)
Secondary outcome [5] 0 0
Progression Free Survival (PFS) at 6 months (PFS-6)
Timepoint [5] 0 0
From the time of first dose until 6 months after the last subject is dosed
Secondary outcome [6] 0 0
Overall Survival (OS)
Timepoint [6] 0 0
From the time of consent through end of study (2 years after last subject enrolled or earlier at sponsor discretion)
Secondary outcome [7] 0 0
Disease Control Rate (DCR)
Timepoint [7] 0 0
From the time of consent through end of study (2 years after last subject enrolled or earlier at sponsor discretion)
Secondary outcome [8] 0 0
Duration of Response (DoR)
Timepoint [8] 0 0
From the time of consent through end of study (2 years after last subject enrolled or earlier at sponsor discretion)
Secondary outcome [9] 0 0
Serum Durvalumab concentration levels collected over time
Timepoint [9] 0 0
From the time of first dose through 29 days after first treatment
Secondary outcome [10] 0 0
Incidence of anti-drug antibody (ADA) responses to Durvalumab
Timepoint [10] 0 0
From the time of first dose through 2 years after last treatment
Secondary outcome [11] 0 0
Incidence of anti-drug antibody (ADA) responses to tremelilumab
Timepoint [11] 0 0
From the time of first dose through 2 years after last treatment
Secondary outcome [12] 0 0
Serum tremelimumab concentration levels collected over time
Timepoint [12] 0 0
From the time of first dose through 57 days after first treatment
Secondary outcome [13] 0 0
PD of MEDI5083 alone and in combination with Durvalumab and tremelimumab
Timepoint [13] 0 0
From the time of first dose through 57 days after first treatment
Secondary outcome [14] 0 0
Safety and tolerability of MEDI5083 with durvalumamb and docetaxel and in subjects with IO relapsed/refractory 2/3L NSCLC
Timepoint [14] 0 0
From the time of first dose through 57 days after first treatment

Eligibility
Key inclusion criteria
1. Age = 18 years at the time of screening or age of consent according to local law

2. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1

3. Histologically or cytologically confirmed metastatic or recurrent tumor types

4. Subjects who have received prior immunotherapy may be eligible

5. Subjects must have at least one measurable lesion

6. Consent to provide archival tumor tissue and pre/on-treatment biopsies

7. Adequate organ and marrow function

8. Consent to use one highly effective method of contraception
Minimum age
18 Years
Maximum age
101 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Receipt of any systemic anticancer therapy within 28 days prior to the first dose of
MEDI5083

2. Concurrent enrollment in another clinical study

3. Active/prior autoimmune of inflammatory disorders

4. History of immunodeficiency, solid organ transplant, or tuberculosis

5. Known allergy/hypersensitivity to drug or components

6. Untreated central nervous system (CNS) metastatic disease, leptomeningeal disease, or
cord compression

7. Current or prior use of immunosuppressive medication within 14 days prior to the first
dose of MEDI5083

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Other
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
21/03/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
23/06/2020
Sample size
Target
Accrual to date
Final
39
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Clayton
Recruitment hospital [2] 0 0
Research Site - Melbourne
Recruitment hospital [3] 0 0
Research Site - Randwick
Recruitment postcode(s) [1] 0 0
3168 - Clayton
Recruitment postcode(s) [2] 0 0
3000 - Melbourne
Recruitment postcode(s) [3] 0 0
3004 - Melbourne
Recruitment postcode(s) [4] 0 0
2031 - Randwick
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
New Jersey
Country [2] 0 0
United States of America
State/province [2] 0 0
Rhode Island
Country [3] 0 0
United States of America
State/province [3] 0 0
Tennessee
Country [4] 0 0
United States of America
State/province [4] 0 0
Utah

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 evaluate the safety, pharmacokinetics and Immunogenicity of
Medi5083 alone or in combination with Durvalumab,Tremelimumab, and/or Docetaxel in adult
subjects with advanced solid tumors.
Trial website
https://clinicaltrials.gov/ct2/show/NCT03089645
Trial related presentations / publications
Public notes

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

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT03089645