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NCT05137262 · ClinicalTrials.gov registry record · Phase 2
A Phase II Multicenter Study of Chemotherapy Versus Chemotherapy Plus Durvalumab (MEDI 4736) in Patients With Lymph Node Positive Urothelial Carcinoma of the Bladder
A Phase 2 study of Bladder Cancer and Urothelial Carcinoma, sponsored by M.D. Anderson Cancer Center.
- Active
- Registry status
- Phase 2
- Development phase
- 12
- Enrollment target
- 2
- Study locations
NCT05137262 is a Phase 2 study of Bladder Cancer and Urothelial Carcinoma that is active but no longer recruiting, run by M.D. Anderson Cancer Center. The registered enrollment target is 12 participants, below the 12,754-participant average among 175 other Bladder Cancer trials with a reported enrollment target (100% lower). The trial reports 2 study locations across 2 states.
The verdict
NCT05137262, a Phase 2 study of Bladder Cancer and Urothelial Carcinoma, is active but no longer recruiting, sponsored by M.D. Anderson Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 12 participants
- Enrollment target
- 2
- Study locations
Study Summary
This is a phase II randomized study of standard of care (SOC) neo-adjuvant cisplatin chemotherapy (NAC) versus NAC plus durvalumab in patients with either clinical or pathologic intra-pelvic node-positive urothelial carcinoma of the bladder. Patients with cTanyN1-3M0 via American Joint Committee on Cancer (AJCC) 8th edition staging30 will be considered tor enrollment in this trial. We plan to enroll 60 patients. Patients will be randomized 2:1 to the intervention arm with durvalumab plus NAC vs SOC NAC. In patients randomized to receive, durvalumab will be continued as maintenance every 4 weeks until either relapse or 1 year, whichever event occurs first. Tissue collection will occur as a biopsy prior to initiation of neo-adjuvant therapy via both transurethral biopsy of bladder and lymph node biopsy. Tissue will again be collected at the time of radical cystectomy or, in patients who are no longer surgical candidates, in the form of biopsy as standard of care. Blood and urine will be collected at baseline, week 2, week 6, week 16, and at the 6 week-post surgery visit for analysis of correlative studies.
Conditions Studied
Interventions
- DRUG Doxorubicin Hydrochloride
- DRUG Durvalumab
- DRUG Methotrexate
- DRUG Vinblastine
- OTHER Abiraterone acetate
Study Locations (2)
Indiana
- Indiana University - Bloomington
Texas
- M D Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2021-10-13 |
| Est. Completion | 2026-08-31 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05137262
The ClinicalTrials.gov registry entry for NCT05137262 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 12,754-participant average among 175 other Bladder Cancer trials with a reported enrollment target (100% lower). The listed sponsor is M.D. Anderson Cancer Center, which has 2,692 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Bladder Cancer appearing as the primary indexed condition, and to 5 interventions - of which Doxorubicin Hydrochloride is the first listed.
NCT05137262 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Indiana, Texas.
Frequently Asked Questions
What is clinical trial NCT05137262 about?
NCT05137262 is a clinical study titled "A Phase II Multicenter Study of Chemotherapy Versus Chemotherapy Plus Durvalumab (MEDI 4736) in Patients With Lymph Node Positive Urothelial Carcinoma of the Bladder". This is a phase II randomized study of standard of care (SOC) neo-adjuvant cisplatin chemotherapy (NAC) versus NAC plus durvalumab in patients with either clinical or pathologic intra-pelvic node-positive urothelial carcinoma of the bladder. Patients with cTanyN1-3M0 via American Joint Committee on ...
What is the current status of trial NCT05137262?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 12 participants. The study started on 2021-10-13. Estimated completion is 2026-08-31.
What conditions does trial NCT05137262 study?
This clinical trial studies the following conditions: Bladder Cancer, Urothelial Carcinoma.
What interventions are being tested in trial NCT05137262?
The interventions under investigation include: Doxorubicin Hydrochloride (DRUG), Durvalumab (DRUG), Methotrexate (DRUG), Vinblastine (DRUG), Abiraterone acetate (OTHER).
Who is sponsoring clinical trial NCT05137262?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05137262 being conducted?
This trial has 2 study locations across Indiana, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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