NCT04628767 · National Cancer Institute (NCI)
Testing the Addition of MEDI4736 (Durvalumab) to Chemotherapy Before Surgery for Patients With High-Grade Upper Urinary Tract Cancer
What this study is about
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.
View original scientific description
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.
Interventions
PROCEDURE
Biopsy Procedure
Undergo tissue biopsy
PROCEDURE
Biospecimen Collection
Undergo blood sample collection
DRUG
Cisplatin
Given IV
PROCEDURE
Computed Tomography
Undergo CT
DRUG
Doxorubicin Hydrochloride
Given Iv
BIOLOGICAL
Durvalumab
Given IV
DRUG
Gemcitabine Hydrochloride
Given IV
PROCEDURE
Magnetic Resonance Imaging
Undergo MRI
DRUG
Methotrexate
Given IV
BIOLOGICAL
Pegfilgrastim
Given via injection
PROCEDURE
Therapeutic Conventional Surgery
Undergo surgery
DRUG
Vinblastine Sulfate
Given Iv
Primary outcome measures
Event-free survival (EFS) (Cisplatin eligible cohort: Arms A and B)
Time frame: From registration/randomization to the earliest of systemic recurrence outside urinary tract, cancer progression, or death from any cause, assessed up to 5 years
Disease progression prior to surgery or omission of surgery due to unresectable tumors, muscle-invasive cancer or disease recurring outside of the bladder, urethra, or contralateral upper tract are considered as events for EFS.
Pathologic complete response (pCR) (Cisplatin ineligible cohort: Arm C)
Time frame: At surgery
Will assess pathologic complete response at surgery (pCR, pT0N0/Nx) by local pathology review. Patients who drop out prior to surgery or who have unknown response status will be considered as non-responders.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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, preferred) and either upper urinary tract mass on cross-sectional imaging or
- Tumor directly visualized during upper urinary tract endoscopy
- High grade cytology and clinically estimated invasive upper urinary tract mass on cross-sectional imaging (e.g., including presence of tumor-related hydronephrosis) or tumor directly visualized during upper urinary tract endoscopy
- NOTE: Universal
Where
- Kingman, Arizona
- Fort Smith, Arkansas
- Little Rock, Arkansas
- Auburn, California
- Berkeley, California
- Duarte, California
- Fremont, California
- La Jolla, California
- Modesto, California
- Mountain View, California
- Palo Alto, California
- Roseville, California
And 189 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 8, 2026 · Source of record for eligibility and locations