This is an open label multi center trial to determine the safety and efficacy of ceritinib in combination with nivolumab in ALK-positive NSCLC patients
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
57
Mayo Clinic - Arizona
Scottsdale, Arizona, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Massachusetts General Hospital Thoracic Oncolgoy
Boston, Massachusetts, United States
Maximum Tolerated Dose (MTD) and/or Recommended Dose for Expansion
Time frame: Study Day 42 (6 weeks)
Overall response rate (ORR)
ORR (complete response (CR)+ partial response (PR)) per RECIST 1.1 as assessed by investigator
Time frame: 24 Weeks
Duration of Response (DOR)
Time frame: 24 weeks
Disease Control Rate (DCR)
Time frame: 24 weeks
Time to Response (TTR)
Time frame: 24 weeks
Progression Free Survival (PFS)
Time frame: 24 weeks
Overall survival (OS)
Time frame: 24 weeks
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Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
Novartis Investigative Site
Heidelberg, Victoria, Australia
Novartis Investigative Site
Leuven, Vlaams Brabant, Belgium
Novartis Investigative Site
Toronto, Ontario, Canada
Novartis Investigative Site
Hong Kong, Hong Kong
Novartis Investigative Site
Milan, MI, Italy
Novartis Investigative Site
Modena, MO, Italy
...and 2 more locations