This is Phase 2, open label, non randomized single arm study to determine whether the administration of vactosertib with durvalumab will provide meaningful increases in the Overall Response Rate (ORR) in patients with urothelial cancers that fail to achieve a response with anti-PD-1/PD-L1 based regimens
This is a Phase 2, open-label, non-randomized, two-cohort multi center study with a safety run-in of 6 patients in Cohort 1. It is anticipated that a total of 48 patients will be enrolled. Durvalumab will be administered with the standard regimen of 1500 mg intravenously (IV) every four weeks. Vactosertib will be administered at a dose of 300 mg PO BID for 5 days per week All treatment will be administered up to two years and the trial is anticipated to be completed over a period of 36 months.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Vactosertib (PO) in combination with Durvalumab (IV) every 4 weeks
University of California San Francisco
San Francisco, California, United States
Roswell Park Comprehensive Cancer Center
Buffalo, New York, United States
Overall Response Rate
ORR by RECIST version 1.1
Time frame: 12months
Time to Tumor Response
TTR by RECIST version 1.1 and iRECIST
Time frame: Overall study period up to 3years
Best Response
Best response (percent of tumor shrinkage) by RECIST version 1.1 and iRECIST
Time frame: Overall study period up to 3years
Duration of Response
DoR by RECIST version 1.1 and iRECIST
Time frame: Overall study period up to 3years
Progression Free Survival
PFS by RECIST version 1.1 and iRECIST
Time frame: 6-month/ 12-month
Overall survival
OS by RECIST version 1.1 and iRECIST
Time frame: 12month
Tumor-specific immune responses
tumor-specific immune responses within on-therapy biopsies measured by increased T cell infiltration and increased IFN-λ signature. and the correlation with outcome as measured by ORR, TTR, DoR, PFS and OS
Time frame: Overall study period up to 3years
Incidence of Treatment-Emergent Adverse Events [Safety and tolerability]
To assess safety and tolerability of vactosertib administered concurrent with Durvalumab in patients with urothelial carcinoma failing checkpoint inhibition
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Time frame: Overall study period up to 3years