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Clinical Trial Summary

This is a phase 1b/2 study to evaluate the safety and efficacy of metronomic combination therapy in subjects with melanoma who have progressed on or after chemotherapy and anti-PD-1/PD-L1 therapy.


Clinical Trial Description

Treatment will be administered in two phases. Subjects will continue treatment for up to 1 year or until they experience progressive disease (PD) or experience unacceptable toxicity (not correctable with dose reduction), withdraw consent, or if the Investigator feels it is no longer in the subject's best interest to continue treatment. Those who have a complete response (CR) in the induction phase will enter phase 2 of the study. Subjects may remain on phase 2 of the study for up to 1 year. Treatment will continue in phase 2 until the subject experiences PD or unacceptable toxicity (not correctable with dose reduction), withdraws consent, or if the Investigator feels it is no longer in the subject's best interest to continue treatment. The maximum time on study treatment, including both phases, is up to 2 years. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03167177
Study type Interventional
Source ImmunityBio, Inc.
Contact
Status Withdrawn
Phase Phase 1/Phase 2
Start date December 2017
Completion date March 2019

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