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NCT03815058 · ClinicalTrials.gov registry record · Phase 2
A Study to Evaluate the Efficacy and Safety of Autogene Cevumeran (RO7198457) in Combination With Pembrolizumab Versus Pembrolizumab Alone in Participants With Previously Untreated Advanced Melanoma.
A Phase 2 study, sponsored by Genentech.
- Completed
- Registry status
- Phase 2
- Development phase
- 131
- Enrollment target
NCT03815058: Completed Phase 2 study, sponsored by Genentech.
NCT03815058 is a Phase 2 study that has completed, run by Genentech. The registered enrollment target is 131 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03815058, a Phase 2 study, has completed, sponsored by Genentech.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 131 participants
- Enrollment target
Study Summary
This study will evaluate the efficacy, safety, pharmacokinetics, and patient-reported outcomes (PROs) of autogene cevumeran (RO7198457) plus pembrolizumab compared with pembrolizumab alone in patients with previously untreated advanced melanoma.
Primary Outcome
PFS was defined as the time from randomization to the first documented PD as determined by the investigator according to RECIST v1.1 or death from any cause, whichever occurred first. PD was defined as at least a 20% increase in the sum of diameters (SOD) of target lesions, taking as reference the smallest sum on study (nadir), including baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeters (mm). Kaplan-Meier (KM) meth
Interventions
- DRUG Pembrolizumab
- BIOLOGICAL Autogene cevumeran
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 131 participants |
| Start Date | 2018-12-21 |
| Est. Completion | 2025-01-21 |
| Phase | Phase 2 |
What the finished NCT03815058 record still lists
NCT03815058 is an interventional study that assigns participants to a tested intervention. The registered 131 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Pembrolizumab is the first listed.
NCT03815058 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03815058 about?
NCT03815058 is a clinical study titled "A Study to Evaluate the Efficacy and Safety of Autogene Cevumeran (RO7198457) in Combination With Pembrolizumab Versus Pembrolizumab Alone in Participants With Previously Untreated Advanced Melanoma.". This study will evaluate the efficacy, safety, pharmacokinetics, and patient-reported outcomes (PROs) of autogene cevumeran (RO7198457) plus pembrolizumab compared with pembrolizumab alone in patients with previously untreated advanced melanoma.
What is the current status of trial NCT03815058?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 131 participants. The study started on 2018-12-21. Estimated completion is 2025-01-21.
What interventions are being tested in trial NCT03815058?
The interventions under investigation include: Pembrolizumab (DRUG), Autogene cevumeran (BIOLOGICAL).
Who is sponsoring clinical trial NCT03815058?
This trial is sponsored by Genentech, which has 332 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03815058's enrollment target sits among peer trials
131 541st of 2000 higher than 1,458 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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