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NCT04216290 · ClinicalTrials.gov registry record · Phase 2
A Study of Chemotherapy and Radiation Therapy Compared to Chemotherapy and Radiation Therapy Plus MEDI4736 (Durvalumab) Immunotherapy for Bladder Cancer Which Has Spread to the Lymph Nodes, INSPIRE Trial
A Phase 2 study of Bladder Urothelial Carcinoma and Stage III Bladder Cancer AJCC v8, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 2
- Development phase
- 95
- Enrollment target
- 20
- Study locations
NCT04216290 is a Phase 2 study of Bladder Urothelial Carcinoma and Stage III Bladder Cancer AJCC v8 that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 95 participants, below the 114-participant average among 7 other Bladder Urothelial Carcinoma trials with a reported enrollment target (17% lower). The trial reports 20 study locations across 5 states.
The verdict
NCT04216290, a Phase 2 study of Bladder Urothelial Carcinoma and Stage III Bladder Cancer AJCC v8, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 95 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase II trial studies the benefit of adding an immunotherapy drug called MEDI4736 (durvalumab) to standard chemotherapy and radiation therapy in treating bladder cancer which has spread to the lymph nodes. Drugs used in standard chemotherapy 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. Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of tumor cells. Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Immunotherapy with durvalumab may help the body's immune system attack the cancer and may interfere with the ability of tumor cells to grow and spread. Giving chemotherapy and radiation therapy with the addition of durvalumab may work better in helping tumors respond to treatment compared to chemotherapy and radiation therapy alone. Patients with limited regional lymph node involvement may benefit from attempt at bladder preservation, and use of immunotherapy and systemic chemotherapy.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- DRUG Cisplatin
- PROCEDURE Cystoscopy
- PROCEDURE Biopsy of Bladder
Study Locations (20)
Colorado
- Penrose-Saint Francis Healthcare - Colorado Springs
- Rocky Mountain Cancer Centers-Penrose - Colorado Springs
- AdventHealth Porter - Denver
- Saint Anthony Hospital - Lakewood
- AdventHealth Littleton - Littleton
- Longmont United Hospital - Longmont
- AdventHealth Parker - Parker
- Saint Mary Corwin Medical Center - Pueblo
Alaska
- Anchorage Associates in Radiation Medicine - Anchorage
- Alaska Breast Care and Surgery LLC - Anchorage
- Alaska Oncology and Hematology LLC - Anchorage
- Alaska Women's Cancer Care - Anchorage
- Anchorage Oncology Centre - Anchorage
- Katmai Oncology Group - Anchorage
- Providence Alaska Medical Center - Anchorage
Arkansas
- Mercy Hospital Fort Smith - Fort Smith
- CHI Saint Vincent Cancer Center Hot Springs - Hot Springs
California
- Providence Saint Joseph Medical Center/Disney Family Cancer Center - Burbank
- VA Palo Alto Health Care System - Palo Alto
Delaware
- Beebe South Coastal Health Campus - Millville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 95 participants |
| Start Date | 2021-03-17 |
| Est. Completion | 2026-06-30 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04216290
The ClinicalTrials.gov registry entry for NCT04216290 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 95 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 114-participant average among 7 other Bladder Urothelial Carcinoma trials with a reported enrollment target (17% lower). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Bladder Urothelial Carcinoma appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT04216290 reports 20 study locations spanning 5 distinct geographic areas - top geographies include Colorado, Alaska, Arkansas.
Frequently Asked Questions
What is clinical trial NCT04216290 about?
NCT04216290 is a clinical study titled "A Study of Chemotherapy and Radiation Therapy Compared to Chemotherapy and Radiation Therapy Plus MEDI4736 (Durvalumab) Immunotherapy for Bladder Cancer Which Has Spread to the Lymph Nodes, INSPIRE Trial". This phase II trial studies the benefit of adding an immunotherapy drug called MEDI4736 (durvalumab) to standard chemotherapy and radiation therapy in treating bladder cancer which has spread to the lymph nodes. Drugs used in standard chemotherapy work in different ways to stop the growth of tumor c...
What is the current status of trial NCT04216290?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 95 participants. The study started on 2021-03-17. Estimated completion is 2026-06-30.
What conditions does trial NCT04216290 study?
This clinical trial studies the following conditions: Bladder Urothelial Carcinoma, Stage III Bladder Cancer AJCC v8.
What interventions are being tested in trial NCT04216290?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Cisplatin (DRUG), Cystoscopy (PROCEDURE), Biopsy of Bladder (PROCEDURE).
Who is sponsoring clinical trial NCT04216290?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04216290 being conducted?
This trial has 20 study locations across Alaska, Arkansas, California, Colorado, Delaware. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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