Study of the Safety and Efficacy of MIW815 With PDR001 in Patients With Advanced/Metastatic Solid Tumors or Lymphomas
Solid Tumors and Lymphomas
About this trial
This is an interventional treatment trial for Solid Tumors and Lymphomas focused on measuring injected lesion, distal lesion, abscopal activity, intratumoral, checkpoint inhibitor, cyclic dinucleotide, programmed cell death
Eligibility Criteria
Inclusion Criteria:
ECOG ≤ 1 Willing to undergo tumor biopsies from injected and distal lesions
Must have two biopsy accessible lesions:
Exclusion Criteria:
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
Sites / Locations
- The Angeles Clinic and Research Institute
- Novartis Investigative Site
- MD Anderson Cancer Center
- Seattle Cancer Care Alliance
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Dosing Schedule A
Dosing Schedule B
Patients were treated with MIW815 (ADU-S100) via intratumoral injection for 3 weeks followed by one week off in combination with a fixed intravenous dose of PDR001 given once per month
Patients were treated with MIW815 (ADU-S100) via intratumoral injection given once a month in combination with a fixed intravenous dose of PDR001 given once per month