NCT04064190

Vactosertib with Durvalumab in Urothelial Carcinoma Failing Checkpoint Inhibition

A Phase 2 Study of TGF-β Inhibition (Vactosertib) with Anti-PD-L1 (Durvalumab) in Patients with Advanced or Recurrent Urothelial Carcinoma Failing to Achieve Response with Checkpoint Inhibition

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: MedPacto, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Urothelial Carcinoma Recurrent
• Advanced Urothelial Carcinoma

Interventions

Type	Name	Description
DRUG	Vactosertib(TEW-7197)/ Durvalumab	Vactosertib (PO) in combination with Durvalumab (IV) every 4 weeks

Timeline

• Start date: 2019-12-13
• Primary completion: 2023-12-30
• Completion: 2024-12-30
• First posted: 2019-08-21
• Last updated: 2024-12-09

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study