Vactosertib With Durvalumab in Urothelial Carcinoma Failing Checkpoint Inhibition
- 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
- 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
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.
Trial Phase Phase II
Trial Type Treatment
- Primary ID MP-VAC-202 (ION-03)
- Secondary IDs NCI-2020-05654
- Clinicaltrials.gov ID NCT04064190