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NCT03532451 · ClinicalTrials.gov registry record · Phase 1
Phase Ib Feasibility Trial of Neoadjuvant Nivolumab/Lirilumab in Cisplatin-Ineligible Muscle-Invasive Bladder Cancer
A Phase 1 study, sponsored by PrECOG.
- Completed
- Registry status
- Phase 1
- Development phase
- 43
- Enrollment target
NCT03532451 is a Phase 1 study that has completed, run by PrECOG. The registered enrollment target is 43 participants.
The verdict
NCT03532451, a Phase 1 study, has completed, sponsored by PrECOG.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 43 participants
- Enrollment target
Study Summary
Patients with muscle-invasive bladder cancer (MIBC) who can not receive cisplatin or refuse cisplatin therapy will receive nivolumab or nivolumab/lirilumab before a planned surgical procedure called a radical cystectomy (RC) to remove the bladder. Nivolumab works by attaching to and blocking a molecule called Programmed Death-1 (PD-1). Lirilumab attaches to and blocks a group of molecules called Killer Cell Immunoglobulin-Like Receptor (KIR). PD-1 and KIR are proteins present mainly on immune system cells, and each controls part of the immune system by shutting it down. It is hoped that by binding to and inactivating these proteins, these drugs can enhance the body's ability to detect, attack and destroy cancer cells. The purpose of this research study is to see whether nivolumab alone or combination of nivolumab and lirilumab given before surgery is effective in treating people who have bladder cancer, and to examine the side effects, good and bad, associated with nivolumab and lirilumab.
Interventions
- DRUG Nivolumab
- DRUG Nivolumab/Lirilumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 43 participants |
| Start Date | 2019-03-22 |
| Est. Completion | 2022-10-05 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03532451
The ClinicalTrials.gov registry entry for NCT03532451 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 43 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is PrECOG, which has 17 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Nivolumab is the first listed.
NCT03532451 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03532451 about?
NCT03532451 is a clinical study titled "Phase Ib Feasibility Trial of Neoadjuvant Nivolumab/Lirilumab in Cisplatin-Ineligible Muscle-Invasive Bladder Cancer". Patients with muscle-invasive bladder cancer (MIBC) who can not receive cisplatin or refuse cisplatin therapy will receive nivolumab or nivolumab/lirilumab before a planned surgical procedure called a radical cystectomy (RC) to remove the bladder. Nivolumab works by attaching to and blocking a mole...
What is the current status of trial NCT03532451?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 43 participants. The study started on 2019-03-22. Estimated completion is 2022-10-05.
What interventions are being tested in trial NCT03532451?
The interventions under investigation include: Nivolumab (DRUG), Nivolumab/Lirilumab (DRUG).
Who is sponsoring clinical trial NCT03532451?
This trial is sponsored by PrECOG, which has 17 total clinical trials registered on ClinicalTrials.gov.
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