Axelopran and Nivolumab in PD-1-Refractory Metastatic Melanoma
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- John M Kirkwood, MD · PRINCIPAL_INVESTIGATOR · UPMC Hillman Cancer Center
Who to contact
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What this trial measures
- Adverse Events Related to TreatmentUp to 30 days post end of treatment
Adverse events (AEs), serious adverse events (SAEs), AEs leading to discontinuation or death, and severity of AEs as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0) determined to be possibly, probably or definitely related to study treatment.
- Best objective response rate (BORR)Up to 3 years
The proportion of subjects with a confirmed best objective response of Complete Response (CR) or Partial Response (PR) based on RECIST v1.1. CR: Disappearance of all target lesions. Pathological lymph nodes must decrease to a short axis of \< 10 mm. All non-target lesions must have disappeared, and tumor markers must have normalized. PR: At least a 30% decrease in the sum of diameters of target lesions, using baseline measurements as a reference.