Phase 2 / Phase 3: testing Cisplatin for Renal Pelvis and Ureter Urothelial Carcinoma
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.
Official registry: https://clinicaltrials.gov/study/NCT04628767 · National Cancer Institute (NCI) · enrollment listed as 131
What this phase means
Phase 2/3: earlier tests looked promising enough to expand. This stage asks, in a larger group, whether the treatment really works and is safe enough to seek approval.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are Biopsy Procedure, Biospecimen Collection, or Cisplatin. The registry lists allocation as randomized. 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.
They plan to enroll about 131 people at 258 sites. Taking part typically means taking a study drug (or dummy pill), an infusion or injection of a biologic, a procedure as part of the study plus check-ins.
Official title (unrewritten)
A Phase II/III Trial of Durvalumab and Chemotherapy for Patients With High Grade Upper Tract Urothelial Cancer Prior to Nephroureterectomy
Interventions: Biopsy Procedure, Biospecimen Collection, Cisplatin, Computed Tomography, Doxorubicin Hydrochloride, Durvalumab, Gemcitabine Hydrochloride, Magnetic Resonance Imaging, Methotrexate, Pegfilgrastim, Therapeutic Conventional Surgery, Vinblastine Sulfate
Primary outcome (registry wording): Event-free survival (EFS) (Cisplatin eligible cohort: Arms A and B)
Who it is for (from inclusion criteria)
- Ages 18 Years to any
- STEP 1 REGISTRATION AND RANDOMIZATION
- Patients must be \>= 18 years of age
- 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
- Due to the anatomy of upper urinary tract and lack of muscularis propria, pathologic evidence of cT2 on biopsy is usually not possible
- Patients must not have any component of small cell/neuroendocrine carcinoma. Other histologic subtypes (variants) are permitted provided the half or predominant (\>= 50%) subtype is conventional urothelial carcinoma
Who the registry excludes
- People the protocol lists as excluded — the study team must confirm.
Contact
No central phone on the registry card. Use the official listing to reach a site.
Sites listed on ClinicalTrials.gov
258 listed- Kingman Regional Medical Center — Kingman, Arizona (recruiting)
- Mercy Hospital Fort Smith — Fort Smith, Arkansas (suspended)
- University of Arkansas for Medical Sciences — Little Rock, Arkansas (active_not_recruiting)
- Sutter Auburn Faith Hospital — Auburn, California (active_not_recruiting)
- Alta Bates Summit Medical Center-Herrick Campus — Berkeley, California (active_not_recruiting)
- City of Hope Comprehensive Cancer Center — Duarte, California (active_not_recruiting)
- Palo Alto Medical Foundation-Fremont — Fremont, California (active_not_recruiting)
- UC San Diego Moores Cancer Center — La Jolla, California (recruiting)
- Memorial Medical Center — Modesto, California (active_not_recruiting)
- Palo Alto Medical Foundation-Camino Division — Mountain View, California (active_not_recruiting)
- Palo Alto Medical Foundation Health Care — Palo Alto, California (active_not_recruiting)
- Stanford Cancer Institute Palo Alto — Palo Alto, California (recruiting)
FAQ about this NCT record
Is NCT04628767 still recruiting?
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT04628767?
Phase 2 / Phase 3. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT04628767?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
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