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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
Date last updated
3/05/2022

Titles & IDs
Public title
Study of the Safety and Efficacy of MIW815 With PDR001 in Patients With Advanced/Metastatic Solid Tumors or Lymphomas
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
Secondary ID [1] 0 0
2017-000707-25
Secondary ID [2] 0 0
CMIW815X2102J
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Solid Tumors and Lymphomas 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of dose limiting toxicities (DLTs)
Timepoint [1] 0 0
24 months
Secondary outcome [1] 0 0
AUC inf
Timepoint [1] 0 0
36 months
Secondary outcome [2] 0 0
AUC last
Timepoint [2] 0 0
36 months
Secondary outcome [3] 0 0
AUC tau
Timepoint [3] 0 0
36 months
Secondary outcome [4] 0 0
Tmax
Timepoint [4] 0 0
36 months
Secondary outcome [5] 0 0
Cmax
Timepoint [5] 0 0
36 months
Secondary outcome [6] 0 0
Lambda_z
Timepoint [6] 0 0
36 months
Secondary outcome [7] 0 0
CL/F
Timepoint [7] 0 0
36 months
Secondary outcome [8] 0 0
T1/2
Timepoint [8] 0 0
36 months
Secondary outcome [9] 0 0
Vz/F
Timepoint [9] 0 0
36 months
Secondary outcome [10] 0 0
Best overall response (BOR)
Timepoint [10] 0 0
36 months
Secondary outcome [11] 0 0
Overall response rate (ORR)
Timepoint [11] 0 0
36 months
Secondary outcome [12] 0 0
Progression free survival (PFS)
Timepoint [12] 0 0
36 months
Secondary outcome [13] 0 0
Disease control rate (DCR)
Timepoint [13] 0 0
36 months
Secondary outcome [14] 0 0
Time to response (TTR)
Timepoint [14] 0 0
36 months
Secondary outcome [15] 0 0
Duration of Response (DOR)
Timepoint [15] 0 0
36 months
Secondary outcome [16] 0 0
Tumor infiltrating lymphocytes (TIL)
Timepoint [16] 0 0
36 months

Eligibility
Key inclusion criteria
ECOG = 1 Willing to undergo tumor biopsies from injected and distal lesions

Must have two biopsy accessible lesions:
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

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
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
8/09/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
18/12/2020
Sample size
Target
Accrual to date
Final
106
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Novartis Investigative Site - North Sydney
Recruitment hospital [2] 0 0
Novartis Investigative Site - Melbourne
Recruitment postcode(s) [1] 0 0
2060 - North Sydney
Recruitment postcode(s) [2] 0 0
3000 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Illinois
Country [3] 0 0
United States of America
State/province [3] 0 0
Texas
Country [4] 0 0
United States of America
State/province [4] 0 0
Washington
Country [5] 0 0
Canada
State/province [5] 0 0
Ontario
Country [6] 0 0
Germany
State/province [6] 0 0
Essen
Country [7] 0 0
Japan
State/province [7] 0 0
Tokyo
Country [8] 0 0
Netherlands
State/province [8] 0 0
Amsterdam
Country [9] 0 0
Spain
State/province [9] 0 0
Catalunya
Country [10] 0 0
Switzerland
State/province [10] 0 0
Zurich

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT03172936
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.
Public notes

Contacts
Principal investigator
Name 0 0
Nancy Lewis, MD
Address 0 0
Novartis
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/study/NCT03172936