Testing the Addition of MEDI4736 (Durvalumab) to Chemotherapy Before Surgery for Patients With High-Grade Upper Urinary Tract Cancer

Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorNational Cancer Institute (NCI)

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

Treatment groups

131 Participants
are divided into 3 treatment groups