Vactosertib with Durvalumab in Urothelial Carcinoma Failing Checkpoint Inhibition

NCT04064190 | Withdrawn Phase 2 FDA Drug

• 1 other identifier: MP-VAC-202
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief 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

Conditions

Urothelial Carcinoma Recurrent; Advanced Urothelial Carcinoma

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate

  ORR by RECIST version 1.1

  12months

Secondary Outcomes (7)

• Time to Tumor Response

  Overall study period up to 3years

• Best Response

  Overall study period up to 3years

• Duration of Response

  Overall study period up to 3years

• Progression Free Survival

  6-month/ 12-month

• Overall survival

  12month

Study Arms (1)

Vactosertib+Durvalumab

EXPERIMENTAL

Vactosertib will be administered in combination with standard dose of durvalumab every four weeks.

Drug: Vactosertib(TEW-7197)/ Durvalumab

Interventions

Vactosertib(TEW-7197)/ Durvalumab DRUG

Vactosertib (PO) in combination with Durvalumab (IV) every 4 weeks

Vactosertib+Durvalumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 at enrollment
• Histologically or cytologically documented locally advanced/inoperable or metastatic urothelial bladder carcinoma (UBC), including renal pelvis, ureters, urinary bladder, and urethra.
• Prior anti-PD-(L)1 treatment.
• Measurable disease per RECIST 1.1 assessed by computed tomography (CT) scan or MRI.
• Recurrent disease after any prior platinum-based chemotherapy regimen or ineligible for platinum therapy.
• Adequate organ and marrow function as defined
• Must have a life expectancy of at least 12 weeks.
• Body weight \> 30 kg

You may not qualify if:

• History of allogeneic organ transplantation.
• Active or prior documented autoimmune or inflammatory disorders
• Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure .
• History of another primary malignancy
• History of leptomeningeal carcinomatosis.
• History of active primary immunodeficiency.
• Active infection including tuberculosis, hepatitis B (known positive HBV surface antigen \[HBsAg\] result), hepatitis C, or human immunodeficiency virus .

Sponsors & Collaborators

• MedPacto, Inc.: lead
• AstraZeneca: collaborator

Study Sites (2)

University of California San Francisco

San Francisco, California, 94158, United States

Location

Roswell Park Comprehensive Cancer Center

Buffalo, New York, 14263, United States

Location

MeSH Terms

Interventions

durvalumab

Study Officials

• Lawrence Fong, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Phase 2, open label, non randomized single arm study with two cohorts and a safety run-in for first six patients

Study Record Dates

• First Submitted: August 15, 2019
• First Posted: August 21, 2019
• Study Start: December 13, 2019
• Primary Completion: December 30, 2023
• Study Completion: December 30, 2024
• Last Updated: December 9, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)