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 |
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.
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
Houston, Texas 77030
Principal Investigator: Funda Meric-Bernstam, MD
Phone: 713-563-2690
Click here to add this to my saved trials
Aurora, Colorado 80045
Principal Investigator: Wells Messersmith, MD FACP
Phone: 720-848-0755
Click here to add this to my saved trials
Click here to add this to my saved trials
450 Brookline Ave
Boston, Massachusetts 2215
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...
Click here to add this to my saved trials
5841 S Maryland Ave
Chicago, Illinois 60637
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...
Click here to add this to my saved trials
New York, New York 10032
Principal Investigator: Matthew Ingham, MD
Phone: 212-304-5571
Click here to add this to my saved trials
Salt Lake City, Utah 84112
Principal Investigator: Wallace Akerley, MD
Phone: 801-587-5598
Click here to add this to my saved trials