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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03172936
Registration number
NCT03172936
Ethics application status
Date submitted
30/05/2017
Date registered
1/06/2017
Titles & IDs
Public title
Study of the Safety and Efficacy of MIW815 With PDR001 in Patients With Advanced/Metastatic Solid Tumors or Lymphomas
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Scientific title
A Phase Ib, Open Label, Multicenter Study of the Safety and Efficacy of MIW815 (ADU-S100) Administered by Intratumoral Injection With PDR001 to Patients With Advanced/Metastatic Solid Tumors or Lymphomas
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Secondary ID [1]
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2017-000707-25
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Secondary ID [2]
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CMIW815X2102J
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Solid Tumors and Lymphomas
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Condition category
Condition code
Cancer
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Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
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Cancer
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0
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Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - MIW815
Treatment: Other - PDR001
Experimental: Dosing Schedule A - Patients were treated with MIW815 (ADU-S100) via intratumoral injection for 3 weeks followed by one week off in combination with a fixed intravenous dose of PDR001 given once per month
Experimental: Dosing Schedule B - Patients were treated with MIW815 (ADU-S100) via intratumoral injection given once a month in combination with a fixed intravenous dose of PDR001 given once per month
Treatment: Drugs: MIW815
MIW 815 (ADU-S100) is a STING agonist
Treatment: Other: PDR001
PDR001 is an anti-PD-1 antibody
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Treatment: Other
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Incidence of dose limiting toxicities (DLTs)
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Assessment method [1]
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A dose-limiting toxicity (DLT) is defined as an adverse event or abnormal laboratory value assessed as having a suspected relationship to study drug, and unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the first cycle of treatment with the combination of MIW815 (ADU-S100) and PDR001
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Timepoint [1]
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24 months
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Secondary outcome [1]
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AUC inf
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Assessment method [1]
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The area under the concentration-time curve extrapolated to infinity (mass\*time/volume)
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Timepoint [1]
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36 months
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Secondary outcome [2]
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AUC last
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Assessment method [2]
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The area under the concentration (AUC) -time curve calculated to the last quantifiable concentration point (mass\* time/volume)
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Timepoint [2]
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36 months
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Secondary outcome [3]
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AUC tau
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Assessment method [3]
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Area under the concentration-time curve calculated to the end of the dosing interval (tau) (mass\* time/volume)
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Timepoint [3]
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36 months
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Secondary outcome [4]
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Tmax
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Assessment method [4]
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The time to reach the maximum observed concentration (time)
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Timepoint [4]
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36 months
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Secondary outcome [5]
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Cmax
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Assessment method [5]
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The maximum observed concentration (Cmax) following dose administration (mass/volume)
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Timepoint [5]
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36 months
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Secondary outcome [6]
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Lambda_z
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Assessment method [6]
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Terminal elimination rate constant (1/time)
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Timepoint [6]
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36 months
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Secondary outcome [7]
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CL/F
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Assessment method [7]
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Apparent systemic clearance of drug from the plasma (volume x time -1)
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Timepoint [7]
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36 months
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Secondary outcome [8]
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T1/2
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Assessment method [8]
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Elimination half-life, determined as 0.693/Lambda_z (time)
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Timepoint [8]
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36 months
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Secondary outcome [9]
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Vz/F
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Assessment method [9]
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Apparent volume of distribution during the terminal elimination phase (volume)
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Timepoint [9]
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36 months
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Secondary outcome [10]
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Best overall response (BOR)
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Assessment method [10]
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Best overall response will be summarized
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Timepoint [10]
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36 months
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Secondary outcome [11]
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Overall response rate (ORR)
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Assessment method [11]
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Overall response rate will be summarized with accompanying 90% exact binomial confidence interval (CI).
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Timepoint [11]
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36 months
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Secondary outcome [12]
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Progression free survival (PFS)
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Assessment method [12]
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The survival function will be estimated using the Kaplan-Meier product limit method. Median duration, with a two-sided Brookmeyer-Crowley 90% confidence interval and Kaplan-Meier estimates of survival proportions will be provided at specified time points.
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Timepoint [12]
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36 months
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Secondary outcome [13]
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Disease control rate (DCR)
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Assessment method [13]
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The disease control rate is calculated as the percentage of patients with advanced or metastatic cancer who have achieved complete response, partial response and stable disease
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Timepoint [13]
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36 months
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Secondary outcome [14]
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Time to response (TTR)
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Assessment method [14]
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Time To Response is the time from first dose to first documented response (CR or PR). TTR will be summarized
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Timepoint [14]
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36 months
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Secondary outcome [15]
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Duration of Response (DOR)
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Assessment method [15]
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Duration of response is defined as the time from the date of the first documented response (CR or PR), to the date of first documented progression, or death due to study indication. Estimates will use Kaplan-Meier method
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Timepoint [15]
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36 months
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Secondary outcome [16]
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Tumor infiltrating lymphocytes (TIL)
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Assessment method [16]
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Induction of TILs in the injected lesion (local PD effect) and in a non-injected lesion (distal PD effect) will be assessed using paired tumor samples at screening and on-treatment.
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Timepoint [16]
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36 months
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Eligibility
Key inclusion criteria
ECOG = 1 Willing to undergo tumor biopsies from injected and distal lesions
Must have two biopsy accessible lesions:
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Symptomatic or untreated leptomeningeal disease. Presence of symptomatic central nervous system metastases Impaired cardiac function or clinically significant cardiac disease Active autoimmune disease or a documented history of autoimmune disease, except vitiligo or resolved childhood asthma/atopy.
Active infection requiring systemic antibiotic therapy. Known history of human immunodeficiency virus infection. Active Epstein-Barr virus, hepatitis B virus or hepatitis C virus Malignant disease, other than that being treated in this study
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Stopped early
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
8/09/2017
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
18/12/2020
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Sample size
Target
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Accrual to date
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Final
106
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Recruitment in Australia
Recruitment state(s)
NSW,VIC
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Recruitment hospital [1]
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Novartis Investigative Site - North Sydney
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Recruitment hospital [2]
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Novartis Investigative Site - Melbourne
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Recruitment postcode(s) [1]
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2060 - North Sydney
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Recruitment postcode(s) [2]
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3000 - Melbourne
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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California
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Country [2]
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United States of America
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State/province [2]
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Illinois
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Country [3]
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United States of America
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State/province [3]
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Texas
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Country [4]
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United States of America
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State/province [4]
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Washington
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Country [5]
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Canada
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State/province [5]
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Ontario
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Country [6]
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Germany
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State/province [6]
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Essen
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Country [7]
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Japan
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State/province [7]
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Tokyo
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Country [8]
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Netherlands
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State/province [8]
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Amsterdam
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Country [9]
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Spain
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State/province [9]
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Catalunya
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Country [10]
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Switzerland
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State/province [10]
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Zurich
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Novartis Pharmaceuticals
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study was to characterize the safety, tolerability, pharmacokinetics, pharmacodynamics and antitumor activity of MIW815 (ADU-S100) in combination with PDR001.
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Trial website
https://clinicaltrials.gov/study/NCT03172936
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Trial related presentations / publications
Gogoi H, Mansouri S, Jin L. The Age of Cyclic Dinucleotide Vaccine Adjuvants. Vaccines (Basel). 2020 Aug 13;8(3):453. doi: 10.3390/vaccines8030453.
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Public notes
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Contacts
Principal investigator
Name
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Nancy Lewis, MD
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Address
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Novartis
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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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 not provided in
https://clinicaltrials.gov/study/NCT03172936