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NCT02788279 · ClinicalTrials.gov registry record · Phase 3
A Study to Investigate Efficacy and Safety of Cobimetinib Plus Atezolizumab and Atezolizumab Monotherapy Versus Regorafenib in Participants With Metastatic Colorectal Adenocarcinoma (COTEZO IMblaze370)
A Phase 3 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 3
- Development phase
- 363
- Enrollment target
NCT02788279: Completed Phase 3 study, sponsored by Hoffmann-La Roche.
NCT02788279 is a Phase 3 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 363 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (53% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02788279, a Phase 3 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 363 participants
- Enrollment target
Study Summary
This is a Phase III, multicenter, open-label, three-arm, randomized study in participants with unresectable locally advanced or metastatic colorectal cancer (CRC) who have received at least two prior regimens of cytotoxic chemotherapy for metastatic disease. The study compares regorafenib, a standard of care therapy in this setting, to cobimetinib plus atezolizumab and atezolizumab monotherapy.
Primary Outcome
Overall survival is defined as the time (in months) between the date of randomization and the date of death due to any cause. Participants who were not reported as having died at the date of analysis were censored at the date when they were last known to be alive. Participants who did not have post-baseline information were censored at the date of randomization + 1 day. Median OS was estimated by Kaplan-Meier method and 95% CI was assessed using the method of Brookmeyer and Crowley.
Interventions
- DRUG Regorafenib
- DRUG Cobimetinib
- DRUG Atezolizumab (MPDL3280A), an Engineered Anti-PDL1 Antibody
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 363 participants |
| Start Date | 2016-07-05 |
| Est. Completion | 2018-12-26 |
| Phase | Phase 3 |
What the finished NCT02788279 record still lists
NCT02788279 is an interventional study that assigns participants to a tested intervention. The registered 363 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (53% lower).
The record links to 0 conditions, and to 3 interventions - of which Regorafenib is the first listed.
NCT02788279 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02788279 about?
NCT02788279 is a clinical study titled "A Study to Investigate Efficacy and Safety of Cobimetinib Plus Atezolizumab and Atezolizumab Monotherapy Versus Regorafenib in Participants With Metastatic Colorectal Adenocarcinoma (COTEZO IMblaze370)". This is a Phase III, multicenter, open-label, three-arm, randomized study in participants with unresectable locally advanced or metastatic colorectal cancer (CRC) who have received at least two prior regimens of cytotoxic chemotherapy for metastatic disease. The study compares regorafenib, a standar...
What is the current status of trial NCT02788279?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 363 participants. The study started on 2016-07-05. Estimated completion is 2018-12-26.
What interventions are being tested in trial NCT02788279?
The interventions under investigation include: Regorafenib (DRUG), Cobimetinib (DRUG), Atezolizumab (MPDL3280A), an Engineered Anti-PDL1 Antibody (DRUG).
Who is sponsoring clinical trial NCT02788279?
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 NCT02788279's enrollment target sits among peer trials
363 1005th of 2000 higher than 994 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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