Study of the Safety and Efficacy of MIW815 With PDR001 in Patients With Advanced/Metastatic Solid Tumors or Lymphomas
Stopped early · Phase 1
Conditions studied: Solid Tumors and Lymphomas
In brief
The purpose of this study was to characterize the safety, tolerability, pharmacokinetics, pharmacodynamics and antitumor activity of MIW815 (ADU-S100) in combination with PDR001.
Key facts
- Study ID
- NCT03172936
- Run by
- Novartis Pharmaceuticals
- People needed
- 106
- Starts
- 2017-09-08
- Expected to finish
- 2020-12-18
- Last updated by the study team
- 2022-05-03
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- ECOG ≤ 1 Willing to undergo tumor biopsies from injected and distal lesions
- Must have two biopsy accessible lesions:
You may not qualify if…
- 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
Where it is running
- The Angeles Clinic and Research Institute — Los Angeles, California, United States
- Novartis Investigative Site — Chicago, Illinois, United States
- MD Anderson Cancer Center — Houston, Texas, United States
- Seattle Cancer Care Alliance — Seattle, Washington, United States
- Novartis Investigative Site — North Sydney, New South Wales, Australia
- Novartis Investigative Site — Melbourne, Victoria, Australia
- Novartis Investigative Site — Toronto, Ontario, Canada
- Novartis Investigative Site — Essen, Germany
- Novartis Investigative Site — Chuo Ku, Tokyo, Japan
- Novartis Investigative Site — Amsterdam, Netherlands
- Novartis Investigative Site — L'Hospitalet de Llobregat, Catalonia, Spain
- Novartis Investigative Site — Zurich, Switzerland
Full record on ClinicalTrials.gov
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