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RECRUITING Phase 2

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

NCT04628767 · View on ClinicalTrials.gov ↗

Study 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.

Interventions

  • PROCEDURE Biospecimen Collection
  • PROCEDURE Computed Tomography
  • DRUG Cisplatin
  • PROCEDURE Biopsy Procedure
  • DRUG Doxorubicin Hydrochloride

Study Locations (20)

California

  • Sutter Auburn Faith Hospital — Auburn
  • Alta Bates Summit Medical Center-Herrick Campus — Berkeley
  • City of Hope Comprehensive Cancer Center — Duarte
  • Palo Alto Medical Foundation-Fremont — Fremont
  • UC San Diego Moores Cancer Center — La Jolla
  • Memorial Medical Center — Modesto
  • Palo Alto Medical Foundation-Camino Division — Mountain View
  • Palo Alto Medical Foundation Health Care — Palo Alto
  • Stanford Cancer Institute Palo Alto — Palo Alto
  • Sutter Roseville Medical Center — Roseville
  • Sutter Medical Center Sacramento — Sacramento
  • UC San Diego Medical Center - Hillcrest — San Diego
  • California Pacific Medical Center-Pacific Campus — San Francisco
  • Palo Alto Medical Foundation-Santa Cruz — Santa Cruz
  • Sutter Pacific Medical Foundation — Santa Rosa
  • Palo Alto Medical Foundation-Sunnyvale — Sunnyvale
  • Sutter Solano Medical Center/Cancer Center — Vallejo

Arkansas

  • Mercy Hospital Fort Smith — Fort Smith
  • University of Arkansas for Medical Sciences — Little Rock

Arizona

  • Kingman Regional Medical Center — Kingman

Trial Details

FieldValue
Enrollment Target 249 participants
Start Date 2021-11-12
Est. Completion 2027-09-30
Phase Phase 2

Sponsor

National Cancer Institute (NCI)

2,390 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04628767

The ClinicalTrials.gov registry entry for NCT04628767 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 249 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 2,390 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Renal Pelvis and Ureter Urothelial Carcinoma appearing as the primary indexed condition, and to 5 interventions — of which Biospecimen Collection is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04628767 reports 20 study locations spanning 3 distinct geographic areas — top geographies include California, Arkansas, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT04628767 about?

NCT04628767 is a clinical study titled "Testing the Addition of MEDI4736 (Durvalumab) to Chemotherapy Before Surgery for Patients With High-Grade Upper Urinary Tract Cancer". 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 i...

What is the current status of trial NCT04628767?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 249 participants. The study started on 2021-11-12. Estimated completion is 2027-09-30.

What conditions does trial NCT04628767 study?

This clinical trial studies the following conditions: Renal Pelvis and Ureter Urothelial Carcinoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04628767?

The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Cisplatin (DRUG), Biopsy Procedure (PROCEDURE), Doxorubicin Hydrochloride (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04628767?

This trial is sponsored by National Cancer Institute (NCI), which has 2,390 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT04628767 being conducted?

This trial has 20 study locations across Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial