A Phase II/III Trial of Durvalumab and Chemotherapy for Patients With High Grade Upper Tract Urothelial Cancer Prior to Nephroureterectomy
National Cancer Institute (NCI)
Summary
This phase II/III trial compares the effect of adding durvalumab to chemotherapy versus chemotherapy alone before surgery in treating patients with upper urinary tract cancer. Immunotherapy with monoclonal antibodies, such as durvalumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as methotrexate, vinblastine, doxorubicin, cisplatin, and gemcitabine work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Durvalumab in combination with chemotherapy before surgery may enhance the shrinking of the tumor compared to chemotherapy alone.
Description
PRIMARY OBJECTIVES: I. To compare event-free survival (EFS) between patients with upper tract urothelial cancer (UTUC) randomized to neoadjuvant accelerated methotrexate, vinblastine, adriamycin, cisplatin (aMVAC) alone or in combination with durvalumab. (Cisplatin eligible patients \[Arms A and B\]) II. Evaluation of pathologic complete response at radical nephroureterectomy (RNU) (pathologic complete response \[pCR\], ypT0N0/ Nx). (Cisplatin ineligible patients \[Arm C\]). SECONDARY OBJECTIVES: I. To assess pathologic complete response (pCR) at surgery. (Cisplatin eligible cohort) II. Eve…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * STEP 1 REGISTRATION AND RANDOMIZATION * Patients must be \>= 18 years of age * Patient must have the ability to understand and the willingness to sign a written informed consent document. Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and/or family member available will also be considered eligible * Patient must have a diagnosis of high grade upper tract urothelial carcinoma expected within 14 weeks (98 days) prior to registration/randomization with one of the following: * Biopsy (gold standard, p…
Interventions
- ProcedureBiopsy Procedure
Undergo tissue biopsy
- ProcedureBiospecimen Collection
Undergo blood sample collection
- DrugCisplatin
Given IV
- ProcedureComputed Tomography
Undergo CT
- DrugDoxorubicin Hydrochloride
Given Iv
- BiologicalDurvalumab
Given IV
- DrugGemcitabine Hydrochloride
Given IV
Locations (258)
- Kingman Regional Medical CenterKingman, Arizona
- Mercy Hospital Fort SmithFort Smith, Arkansas
- University of Arkansas for Medical SciencesLittle Rock, Arkansas
- Sutter Auburn Faith HospitalAuburn, California
- Alta Bates Summit Medical Center-Herrick CampusBerkeley, California
- City of Hope Comprehensive Cancer CenterDuarte, California