Status:
WITHDRAWN
Vactosertib with Durvalumab in Urothelial Carcinoma Failing Checkpoint Inhibition
Lead Sponsor:
MedPacto, Inc.
Collaborating Sponsors:
AstraZeneca
Conditions:
Urothelial Carcinoma Recurrent
Advanced Urothelial Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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)...
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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 .
- 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
Key Trial Info
Start Date :
December 13 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2024
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04064190
Start Date
December 13 2019
End Date
December 30 2024
Last Update
December 9 2024
Active Locations (2)
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1
University of California San Francisco
San Francisco, California, United States, 94158
2
Roswell Park Comprehensive Cancer Center
Buffalo, New York, United States, 14263