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NCT04628767 · ClinicalTrials.gov registry record · Phase 2
Testing the Addition of MEDI4736 (Durvalumab) to Chemotherapy Before Surgery for Patients With High-Grade Upper Urinary Tract Cancer
A Phase 2 study of Renal Pelvis and Ureter Urothelial Carcinoma, sponsored by National Cancer Institute (NCI).
- Recruiting
- Registry status
- Phase 2
- Development phase
- 249
- Enrollment target
- 20
- Study locations
NCT04628767: Recruiting Phase 2 study of Renal Pelvis and Ureter Urothelial Carcinoma, sponsored by National Cancer Institute (NCI).
NCT04628767 is a Phase 2 study of Renal Pelvis and Ureter Urothelial Carcinoma that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 249 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (87% higher). The trial reports 20 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04628767, a Phase 2 study of Renal Pelvis and Ureter Urothelial Carcinoma, is actively recruiting participants, sponsored by National Cancer Institute (NCI).
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 249 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
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.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 249 participants |
| Start Date | 2021-11-12 |
| Est. Completion | 2027-09-30 |
| Phase | Phase 2 |
What NCT04628767 shows while recruiting
NCT04628767 is an interventional study that assigns participants to a tested intervention. The registered 249 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (87% higher).
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.
NCT04628767 names 20 study sites across 3 states, led by California, Arkansas, Arizona.
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.
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).
Who is sponsoring clinical trial NCT04628767?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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.
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Where NCT04628767's enrollment target sits among peer trials
249 233rd of 2000 higher than 1,767 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
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