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QUILT-3.048: NANT Urothelial Cancer Vaccine: Combination Immunotherapy in Subjects With Urothelial Cancer Who Have Progressed on or After Chemotherapy and PD-1/PD-L1 Therapy

Urothelial Carcinoma Clinical Trial

Official title:
QUILT-3.048: NANT Urothelial Cancer Vaccine: Combination Immunotherapy in Subjects With Urothelial Cancer Who Have Progressed on or After Chemotherapy and Anti-programmed Cell Death Protein 1 (PD-1)/Programmed Death-ligand 1 (PD-L1) Therapy

Clinical Trial Summary

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

Clinical Trial Description

The initial 3 subjects will be enrolled in a staggered fashion, with a 21-day interval between each subject to enable the assessment of any acute and subacute toxicities, unless data are available from other NANT cancer vaccine studies suggesting the combination therapy is tolerable. Treatment will be administered in 2 phases, an induction and a maintenance phase, as described below. Subjects will continue induction treatment for up to 1 year. Treatment in the study will be discontinued if the subject experiences progressive disease (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. Those who have a complete response (CR) in the induction phase will enter the maintenance phase of the study. Subjects may remain on the maintenance phase of the study for up to 1 year. Treatment will continue in the maintenance phase 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03197571
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Status Withdrawn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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