About this trial
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.
Eligibility criteria
Qualifiers
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
Biopsy (gold standard, preferred) and either upper urinary tract mass on cross-sectional imaging or tumor directly visualized during upper urinary tract endoscopy
Disqualifiers
None
Trial design
Treatments tested in this trial
- Biopsy Procedure
- Biospecimen Collection
- Cisplatin
- Computed Tomography
- Doxorubicin Hydrochloride
- Durvalumab
- Gemcitabine Hydrochloride
- Magnetic Resonance Imaging
- Methotrexate
- Pegfilgrastim
- Therapeutic Conventional Surgery
- Vinblastine Sulfate