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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: Clinical Trial Phase 2 study, sponsored by Washington University School of Medicine.
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, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
-Defined as the proportion of ctDNA-positive participants having a ctDNA-negative test at Cycle 3 Day 1
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 |
Why NCT05060003 stopped before completion
NCT05060003 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 7 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 3 interventions - of which Atezolizumab is the first listed.
NCT05060003 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05060003's enrollment target sits among peer trials
7 1996th of 2000 higher than 5 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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