Brief Title
Vactosertib With Durvalumab in Urothelial Carcinoma Failing Checkpoint Inhibition
Official Title
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
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
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.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Overall Response Rate
Secondary Outcome
Time to Tumor Response
Condition
Urothelial Carcinoma Recurrent
Intervention
Vactosertib(TEW-7197)/ Durvalumab
Study Arms / Comparison Groups
Vactosertib+Durvalumab
Description: Vactosertib will be administered in combination with standard dose of durvalumab every four weeks.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
48
Start Date
October 15, 2021
Completion Date
December 30, 2024
Primary Completion Date
December 30, 2023
Eligibility Criteria
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 .
8. Any unresolved toxicity NCI CTCAE Grade ≥ 2 from previous anticancer therapy with the
exception of alopecia, vitiligo, and the laboratory values defined in the inclusion
criteria
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Lawrence Fong, MD, +82 2 6938 0206, [email protected]
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT04064190
Organization ID
MP-VAC-202
Responsible Party
Sponsor
Study Sponsor
MedPacto, Inc.
Collaborators
AstraZeneca
Study Sponsor
Lawrence Fong, MD, Principal Investigator, University of California, San Francisco
Verification Date
September 2021