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NCT03178851 · ClinicalTrials.gov registry record · Phase 1
Cobimetinib (Targeted Therapy) Plus Atezolizumab (Immunotherapy) in Participants With Advanced Melanoma Whose Cancer Has Worsened During or After Treatment With Previous Immunotherapy and Atezolizumab Monotherapy in Participants With Previously Untreated Advanced Melanoma
A Phase 1 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 1
- Development phase
- 155
- Enrollment target
NCT03178851: Completed Phase 1 study, sponsored by Hoffmann-La Roche.
NCT03178851 is a Phase 1 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 155 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (158% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03178851, a Phase 1 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 155 participants
- Enrollment target
Study Summary
This study will evaluate the preliminary efficacy, safety, and pharmacokinetics of cobimetinib and atezolizumab in participants with advanced BRAF V600-wild type (WT), metastatic, or unresectable locally advanced melanoma who have progressed on prior anti-PD-1 therapy. In addition, this study will evaluate the efficacy, safety, and pharmacokinetics of atezolizumab monotherapy in participants with BRAFV600-WT metastatic or unresectable locally advanced melanoma, who have not been previously treated.
Primary Outcome
ORR is defined as the percentage of participants with confirmed objective response (OR). Confirmed OR is defined as complete response (CR) or partial response (PR) on two consecutive occasions ≥ 4 weeks apart, as determined by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. CR is defined as disappearance of all target lesions. PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diame
Interventions
- BIOLOGICAL Atezolizumab
- DRUG Cobimetinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 155 participants |
| Start Date | 2017-06-20 |
| Est. Completion | 2020-09-21 |
| Phase | Phase 1 |
What the finished NCT03178851 record still lists
NCT03178851 is an interventional study that assigns participants to a tested intervention. The registered 155 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (158% higher).
The record links to 0 conditions, and to 2 interventions - of which Atezolizumab is the first listed.
NCT03178851 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03178851 about?
NCT03178851 is a clinical study titled "Cobimetinib (Targeted Therapy) Plus Atezolizumab (Immunotherapy) in Participants With Advanced Melanoma Whose Cancer Has Worsened During or After Treatment With Previous Immunotherapy and Atezolizumab Monotherapy in Participants With Previously Untreated Advanced Melanoma". This study will evaluate the preliminary efficacy, safety, and pharmacokinetics of cobimetinib and atezolizumab in participants with advanced BRAF V600-wild type (WT), metastatic, or unresectable locally advanced melanoma who have progressed on prior anti-PD-1 therapy. In addition, this study will e...
What is the current status of trial NCT03178851?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 155 participants. The study started on 2017-06-20. Estimated completion is 2020-09-21.
What interventions are being tested in trial NCT03178851?
The interventions under investigation include: Atezolizumab (BIOLOGICAL), Cobimetinib (DRUG).
Who is sponsoring clinical trial NCT03178851?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03178851's enrollment target sits among peer trials
155 352nd of 2000 higher than 1,645 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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