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Vactosertib with Durvalumab in Urothelial Carcinoma Failing Checkpoint Inhibition

NCT ID: NCT04064190

Last Updated: 2024-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-13

Study Completion Date

2024-12-30

Brief Summary

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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

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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

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Urothelial Carcinoma Recurrent Advanced Urothelial Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Phase 2, open label, non randomized single arm study with two cohorts and a safety run-in for first six patients
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Vactosertib+Durvalumab

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

Group Type EXPERIMENTAL

Vactosertib(TEW-7197)/ Durvalumab

Intervention Type DRUG

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

Interventions

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Vactosertib(TEW-7197)/ Durvalumab

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role collaborator

MedPacto, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lawrence Fong, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

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University of California San Francisco

San Francisco, California, United States

Site Status

Roswell Park Comprehensive Cancer Center

Buffalo, New York, United States

Site Status

Countries

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United States

Other Identifiers

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MP-VAC-202

Identifier Type: -

Identifier Source: org_study_id