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NCT04871529 · ClinicalTrials.gov registry record · Phase 2
Testing the Addition of an Anti-Cancer Immunotherapy Drug, Avelumab, to Gemcitabine and Carboplatin Chemotherapy Prior to Surgery in Muscle Invasive Urinary Tract Cancer vs. Surgery Alone in Patients Who Are Not Able to Receive Cisplatin Therapy (SWOG GAP TRIAL)
A Phase 2 study, sponsored by SWOG Cancer Research Network.
- Terminated
- Registry status
- Phase 2
- Development phase
- 6
- Enrollment target
NCT04871529 is a Phase 2 study that was terminated before completion, run by SWOG Cancer Research Network. The registered enrollment target is 6 participants.
The verdict
NCT04871529, a Phase 2 study, was terminated before completion, sponsored by SWOG Cancer Research Network.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 6 participants
- Enrollment target
Study Summary
This phase II trial studies the effect of avelumab, gemcitabine and carboplatin before surgery compared with surgery alone in treating patients with muscle invasive bladder or upper urinary tract cancer who are not able to receive cisplatin therapy. Immunotherapy with monoclonal antibodies, such as avelumab, 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 gemcitabine and carboplatin, 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. Giving avelumab together with gemcitabine and carboplatin before surgery may work better in lowering the chance of muscle invasive urinary tract cancer growing or spreading, in patients who cannot receive cisplatin therapy compared to surgery alone.
Interventions
- DRUG Carboplatin
- PROCEDURE Therapeutic Conventional Surgery
- DRUG Avelumab
- DRUG Gemcitabine Hydrochloride
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2022-08-10 |
| Est. Completion | 2024-06-26 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04871529
The ClinicalTrials.gov registry entry for NCT04871529 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 6 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is SWOG Cancer Research Network, which has 270 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Carboplatin is the first listed.
NCT04871529 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04871529 about?
NCT04871529 is a clinical study titled "Testing the Addition of an Anti-Cancer Immunotherapy Drug, Avelumab, to Gemcitabine and Carboplatin Chemotherapy Prior to Surgery in Muscle Invasive Urinary Tract Cancer vs. Surgery Alone in Patients Who Are Not Able to Receive Cisplatin Therapy (SWOG GAP TRIAL)". This phase II trial studies the effect of avelumab, gemcitabine and carboplatin before surgery compared with surgery alone in treating patients with muscle invasive bladder or upper urinary tract cancer who are not able to receive cisplatin therapy. Immunotherapy with monoclonal antibodies, such as ...
What is the current status of trial NCT04871529?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 6 participants. The study started on 2022-08-10. Estimated completion is 2024-06-26.
What interventions are being tested in trial NCT04871529?
The interventions under investigation include: Carboplatin (DRUG), Therapeutic Conventional Surgery (PROCEDURE), Avelumab (DRUG), Gemcitabine Hydrochloride (DRUG).
Who is sponsoring clinical trial NCT04871529?
This trial is sponsored by SWOG Cancer Research Network, which has 270 total clinical trials registered on ClinicalTrials.gov.
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