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
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...
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Aurora, Colorado 80045
Principal Investigator: Wells Messersmith, MD FACP
Phone: 720-848-0755
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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...
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Houston, Texas 77030
Principal Investigator: Funda Meric-Bernstam, MD
Phone: 713-563-2690
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New York, New York 10032
Principal Investigator: Matthew Ingham, MD
Phone: 212-304-5571
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Salt Lake City, Utah 84112
Principal Investigator: Wallace Akerley, MD
Phone: 801-587-5598
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