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NCT02812420 · ClinicalTrials.gov registry record · Early Phase 1
Durvalumab and Tremelimumab in Treating Patients With Muscle-Invasive, High-Risk Urothelial Cancer That Cannot Be Treated With Cisplatin-Based Therapy Before Surgery
A Early Phase 1 study of Stage II Bladder Urothelial Carcinoma AJCC v6 and v7 and Hydronephrosis, sponsored by M.D. Anderson Cancer Center.
- Active
- Registry status
- Early Phase 1
- Development phase
- 54
- Enrollment target
- 1
- Study location
NCT02812420: Active Early Phase 1 study of Stage II Bladder Urothelial Carcinoma AJCC v6 and v7 and Hydronephrosis, sponsored by M.D. Anderson Cancer Center.
NCT02812420 is a Early Phase 1 study of Stage II Bladder Urothelial Carcinoma AJCC v6 and v7 and Hydronephrosis that is active but no longer recruiting, run by M.D. Anderson Cancer Center. The registered enrollment target is 54 participants, below the 584-participant average among 3 other Stage II Bladder Urothelial Carcinoma AJCC v6 and v7 trials with a reported enrollment target (91% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02812420, a Early Phase 1 study of Stage II Bladder Urothelial Carcinoma AJCC v6 and v7 and Hydronephrosis, is active but no longer recruiting, sponsored by M.D. Anderson Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 54 participants
- Enrollment target
- 1
- Study location
Study Summary
This pilot phase I trial studies the side effects of durvalumab and tremelimumab in treating patients with muscle-invasive, high-risk urothelial cancer that cannot be treated with cisplatin-based therapy before surgery. Immunotherapy with monoclonal antibodies, such as durvalumab and tremelimumab, may induce changes in the body's immune system and may interfere with the ability of tumor cells to grow and spread.
Conditions Studied
Interventions
- BIOLOGICAL Durvalumab
- PROCEDURE Therapeutic Conventional Surgery
- BIOLOGICAL Tremelimumab
Study Locations (1)
Texas
- M D Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 54 participants |
| Start Date | 2017-03-07 |
| Est. Completion | 2027-12-31 |
| Phase | Early Phase 1 |
What the registry record for NCT02812420 still lists
NCT02812420 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 54 participants, a relatively small participant target, below the 584-participant average among 3 other Stage II Bladder Urothelial Carcinoma AJCC v6 and v7 trials with a reported enrollment target (91% lower).
The record links to 10 conditions, with Stage II Bladder Urothelial Carcinoma AJCC v6 and v7 appearing as the primary indexed condition, and to 3 interventions - of which Durvalumab is the first listed.
NCT02812420 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT02812420 about?
NCT02812420 is a clinical study titled "Durvalumab and Tremelimumab in Treating Patients With Muscle-Invasive, High-Risk Urothelial Cancer That Cannot Be Treated With Cisplatin-Based Therapy Before Surgery". This pilot phase I trial studies the side effects of durvalumab and tremelimumab in treating patients with muscle-invasive, high-risk urothelial cancer that cannot be treated with cisplatin-based therapy before surgery. Immunotherapy with monoclonal antibodies, such as durvalumab and tremelimumab, m...
What is the current status of trial NCT02812420?
This trial is currently active not recruiting. It is a Early Phase 1 study. The enrollment target is 54 participants. The study started on 2017-03-07. Estimated completion is 2027-12-31.
What conditions does trial NCT02812420 study?
This clinical trial studies the following conditions: Stage II Bladder Urothelial Carcinoma AJCC v6 and v7, Hydronephrosis, Stage II Ureter Cancer AJCC v7, Infiltrating Bladder Urothelial Carcinoma Sarcomatoid Variant, Infiltrating Bladder Urothelial Carcinoma, Micropapillary Variant.
What interventions are being tested in trial NCT02812420?
The interventions under investigation include: Durvalumab (BIOLOGICAL), Therapeutic Conventional Surgery (PROCEDURE), Tremelimumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT02812420?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02812420 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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