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NCT05060003 · ClinicalTrials.gov registry record · Phase 2
Tiragolumab Plus Atezolizumab Versus Atezolizumab in the Treatment of Stage II Melanoma Patients Who Are ctDNA-positive Following Resection
A Phase 2 study, sponsored by Washington University School of Medicine.
- Terminated
- Registry status
- Phase 2
- Development phase
- 7
- Enrollment target
NCT05060003 is a Phase 2 study that was terminated before completion, run by Washington University School of Medicine. The registered enrollment target is 7 participants.
The verdict
NCT05060003, a Phase 2 study, was terminated before completion, sponsored by Washington University School of Medicine.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 7 participants
- Enrollment target
Study Summary
This study's hypothesis is that patients with stage II melanoma who test positive for circulating tumor DNA are at a higher risk for recurrence and therefore adjuvant treatment is justified. In this study, the blood of consenting and eligible patients will be tested for ctDNA and those patients who test positive will be randomized on a 1:1 basis to either treatment with atezolizumab and tiragolumab or atezolizumab alone during Stage 1 of the study. If at least 3 patients in the atezolizumab + tiragolumab arm are shown to be ctDNA negative at C3D1, stage 2 of the study will begin enrollment. Stage 2 consists of 25 patients all enrolled to the atezolizumab + tiragolumab arm (no randomization and no atezolizumab monotherapy arm).Patients who test negative for ctDNA will be observed off protocol.
Interventions
- DRUG Atezolizumab
- DRUG Tiragolumab
- DEVICE Signatera Assay
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2022-11-08 |
| Est. Completion | 2023-11-27 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05060003
The ClinicalTrials.gov registry entry for NCT05060003 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 7 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Washington University School of Medicine, which has 1,502 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Atezolizumab is the first listed.
NCT05060003 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05060003 about?
NCT05060003 is a clinical study titled "Tiragolumab Plus Atezolizumab Versus Atezolizumab in the Treatment of Stage II Melanoma Patients Who Are ctDNA-positive Following Resection". This study's hypothesis is that patients with stage II melanoma who test positive for circulating tumor DNA are at a higher risk for recurrence and therefore adjuvant treatment is justified. In this study, the blood of consenting and eligible patients will be tested for ctDNA and those patients who ...
What is the current status of trial NCT05060003?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 7 participants. The study started on 2022-11-08. Estimated completion is 2023-11-27.
What interventions are being tested in trial NCT05060003?
The interventions under investigation include: Atezolizumab (DRUG), Tiragolumab (DRUG), Signatera Assay (DEVICE).
Who is sponsoring clinical trial NCT05060003?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
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