Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion
Principal Investigator
by Lawrence Fong, MD
Photo of Lawrence Fong
Lawrence Fong

Description

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

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

Details

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.

Keywords

Urothelial Carcinoma Recurrent Advanced Urothelial Carcinoma Carcinoma Carcinoma, Transitional Cell Durvalumab Vactosertib(TEW-7197)/ Durvalumab Vactosertib+Durvalumab

Eligibility

You can join if…

Open to people ages 18 years and up

  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

You CAN'T join if...

  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

Locations

  • University of California San Francisco
    San Francisco California 94158 United States
  • Roswell Park Comprehensive Cancer Center
    Buffalo New York 14263 United States

Lead Scientist at UCSF

  • Lawrence Fong, MD
    Lawrence Fong, M.D. is the Efim Guzik Distinguished Professor in Cancer Biology and leads the Cancer Immunotherapy Program at the UCSF. He also co-directs the Parker Institute of Cancer Immunotherapy at UCSF and co-leads the Cancer Immunity Program in the Helen Diller Family Comprehensive Cancer Center.

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
MedPacto, Inc.
ID
NCT04064190
Phase
Phase 2
Study Type
Interventional
Last Updated