Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT02675439
Previous Study | Return to List | Next Study

Safety and Efficacy of MIW815 (ADU-S100) +/- Ipilimumab in Patients With Advanced/Metastatic Solid Tumors or Lymphomas

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02675439
Recruitment Status : Recruiting
First Posted : February 5, 2016
Last Update Posted : September 26, 2018
Sponsor:
Collaborator:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Aduro Biotech, Inc.

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The purpose of this study is to characterize the safety, tolerability, pharmacokinetics, pharmacodynamics and antitumor activity of MIW815 (ADU-S100) administered via intratumoral injection as a single agent and in combination with ipilimumab.

Condition or disease Intervention/treatment Phase
Advanced/Metastatic Solid Tumors or Lymphomas Drug: ADU-S100 Biological: ipilimumab Phase 1

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I, Open Label, Multicenter Study of the Safety and Efficacy of MIW815 (ADU-S100) Administered by Intratumoral Injection to Patients With Advanced/Metastatic Solid Tumors or Lymphomas
Study Start Date : March 2016
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
Drug Information available for: Ipilimumab

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Dose escalation monotherapy
ADU-S100 administered intratumorally on Days 1, 8 and 15 of each 28-day cycle until unacceptable toxicity, progressive disease and/or treatment is discontinued; starting dose 50 micrograms
 Drug: ADU-S100
Other Name: MIW815
Experimental: Dose escalation combination
ADU-S100 administered intratumorally on Days 1 and 8 of each 21-day cycle (starting dose 200 micrograms) and ipilimumab, i.v., (3 mg/kg) on day 1 of each 21-day cycle for the first 4 cycles. Dosing is continued until unacceptable toxicity, progressive disease and/or treatment is discontinued
 Drug: ADU-S100
Other Name: MIW815

Biological: ipilimumab


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Safety: Number of patients reporting treatment-related adverse events that qualify as dose-limiting toxicities [ Time Frame: 6 months from study start ]
    Number of patients reporting treatment-related adverse events that qualify as dose-limiting toxicities

  2. Recommended dose [ Time Frame: 6 months from study start ]
    Using maximum tolerated dose to identify the recommended dose for future studies


Secondary Outcome Measures :
  1. Pharmacokinetics measured through plasma concentrations [ Time Frame: 6 months from study start ]
    measured through plasma concentrations

  2. measurement of CD8-TIL counts [ Time Frame: 6 months from study start ]
  3. RNA expression analysis of IFN gamma and immunomodulatory genes [ Time Frame: 6 months from study start ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ECOG ≤ 1
  • Willing to undergo tumor biopsies from injected and distal lesions

  • Must have two biopsy accessible lesions:

    • * one lesion must be ≥10 mm and <100 mm in longest diameter, accessible for repeated intratumoral (IT) injection and accessible for baseline and on-treatment biopsies.

      • a second (distal) lesion must be accessible for baseline and on-treatment biopsy and must be distinct from the injected lesion.
      • tumors encasing major vascular structures (i.e., carotid artery or tumors close to other vital organs), are not considered appropriate

Exclusion Criteria:

  • Patients who require local palliative measures such as XRT or surgery
  • Symptomatic or untreated leptomeningeal disease.
  • Presence of symptomatic central nervous system (CNS) 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 (HIV) infection.
  • Active Epstein-Barr virus (EBV), hepatitis B virus (HBV) or hepatitis C virus (HCV)
  • Malignant disease, other than that being treated in this study.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02675439


Contacts
Layout table for location contacts
Contact: Novartis Pharmaceuticals 1-888-669-6682

Locations
Layout table for location information
United States, Colorado
University of Colorado School of Medicine Recruiting
Aurora, Colorado, United States, 80045
Contact: Tara Wells    720-848-0755    Tara.Wells@ucdenver.edu   
Principal Investigator: Wells Messersmith, MD FACP         
United States, Illinois
University of Chicago Medical Center Recruiting
Chicago, Illinois, United States, 60637
Contact: Matthew Weist    773-702-1835    mweist@medicine.bsd.uchicago.edu   
Principal Investigator: Jason Luke, MD         
United States, Maryland
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center Active, not recruiting
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Dana-Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: Amanda Stroiney    617-724-4000    Amanda_Stroiney@dfci.harvard.edu   
Principal Investigator: Frank Hodi, MD         
United States, New York
Columbia University Medical Center-Herbert Irving Pavilion Recruiting
New York, New York, United States, 10032
Contact: Alex Liu    212-304-5571    awl2132@cumc.columbia.edu   
Principal Investigator: Matthew Ingham, MD         
United States, Texas
University of Texas/MD Anderson Cancer Center MD Anderson PSC Recruiting
Houston, Texas, United States, 77030-4009
Contact: Krystle Luna    713-563-2690    KALuna@mdanderson.org   
Principal Investigator: Funda Meric-Bernstam, MD         
United States, Utah
University of Utah Huntsman Cancer Institute Recruiting
Salt Lake City, Utah, United States, 84112
Contact: Cherie Peterson    801-587-5598    cherie.peterson@hci.utah.edu   
Principal Investigator: Wallace Akerley, MD         
Sponsors and Collaborators
Aduro Biotech, Inc.
Novartis Pharmaceuticals
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for additonal information
Responsible Party: Aduro Biotech, Inc.
ClinicalTrials.gov Identifier: NCT02675439     History of Changes
Other Study ID Numbers: ADU-CL-07
First Posted: February 5, 2016    Key Record Dates
Last Update Posted: September 26, 2018
Last Verified: September 2018

Additional relevant MeSH terms:
Layout table for MeSH terms
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
 Immunoproliferative Disorders
Immune System Diseases
Ipilimumab
Antineoplastic Agents, Immunological
Antineoplastic Agents