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



Status:Recruiting
Conditions:Lymphoma
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:9/28/2018
Start Date:March 2016
End Date:December 2020
Contact:Novartis Pharmaceuticals
Phone:1-888-669-6682

Use our guide to learn which trials are right for you!

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

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.


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.
We found this trial at
7
sites
Salt Lake City, Utah 84112
Principal Investigator: Wallace Akerley, MD
Phone: 801-587-5598
?
mi
from
Salt Lake City, UT
Click here to add this to my saved trials
Aurora, Colorado 80045
Principal Investigator: Wells Messersmith, MD FACP
Phone: 720-848-0755
?
mi
from
Aurora, CO
Click here to add this to my saved trials
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Principal Investigator: Frank Hodi, MD
Phone: 617-724-4000
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
?
mi
from
Boston, MA
Click here to add this to my saved trials
5841 S Maryland Ave
Chicago, Illinois 60637
(773) 702-1000
Principal Investigator: Jason Luke, MD
Phone: 773-702-1835
University of Chicago Medical Center The University of Chicago Medicine has been at the forefront...
?
mi
from
Chicago, IL
Click here to add this to my saved trials
Houston, Texas 77030
Principal Investigator: Funda Meric-Bernstam, MD
Phone: 713-563-2690
?
mi
from
Houston, TX
Click here to add this to my saved trials
New York, New York 10032
Principal Investigator: Matthew Ingham, MD
Phone: 212-304-5571
?
mi
from
New York, NY
Click here to add this to my saved trials