The purpose of this study was to assess the safety, tolerability, and preliminary anti-tumor activity of experimental medication NZV930 alone and when combined with PDR001 and/or NIR178, in patients with advanced cancers
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
127
H Lee Moffitt Cancer Center and Research Institute Inc
Tampa, Florida, United States
University of Texas MD Anderson Cancer Center MD Anderson PSC
Houston, Texas, United States
Novartis Investigative Site
Melbourne, Victoria, Australia
Novartis Investigative Site
Toronto, Ontario, Canada
Novartis Investigative Site
Montreal, Quebec, Canada
Novartis Investigative Site
Chuo Ku, Tokyo, Japan
Novartis Investigative Site
Singapore, Singapore
Novartis Investigative Site
Valencia, Valencia, Spain
Novartis Investigative Site
Madrid, Spain
Novartis Investigative Site
Sutton, Surrey, United Kingdom
Number of participants with adverse events as a measure of safety and tolerability of the NZV930 in combination with PDR001 and/or NIR178
Incidence and severity of AEs and SAEs, incl. changes in laboratory parameters, vital signs, and ECGs Dose limiting toxicity in cycle 1 (28 days) for single agent NZV930 and NZV930 in combination with PDR001 and/or NIR178 during dose escalation phase only Tolerability: dose interruptions Tolerability: dose reductions Tolerability: dose intensity
Time frame: 3 years
Overall response rate (ORR)
Defined as the proportion of patients with best overall response of CR or PR
Time frame: 3 years
Clinical Benefit Rate (CBR)
Defined as the proportion of patients with best overall response of CR, PR or SD \>= 16 weeks
Time frame: 3 years
Progression Free Survival (PFS)
Defined as the time from the date of start of treatment to the date of the event defined as first documented progression or death due to any cause
Time frame: 3 years
Serum concentration vs. time profiles of NZV930 (free drug) and PDR001.
Serum concentration vs. time profiles of NZV930 (free drug) and PDR001.
Time frame: 3 years
Plasma concentration vs. time profiles for NIR178 and derived PK parameters
Concentration time profile of NIR178 and its metabolites
Time frame: 3 years
To assess the immunogenicity of NZV930 and PDR001
Presence and titer of anti-drug antibodies, anti-NZV930 and anti-PDR001 in (patients receiving combination with PDR001).
Time frame: 3 years
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