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NCT03554083 · ClinicalTrials.gov registry record · Phase 2
Vemurafenib, Cobimetinib, Atezolizumab, and Tiragolumab in Treating Patients With High-Risk Stage III Melanoma
A Phase 2 study of Clinical Stage III Cutaneous Melanoma AJCC v8 and Pathologic Stage IIIC Cutaneous Melanoma AJCC v8, sponsored by Mayo Clinic.
- Active
- Registry status
- Phase 2
- Development phase
- 59
- Enrollment target
- 3
- Study locations
NCT03554083: Active Phase 2 study of Clinical Stage III Cutaneous Melanoma AJCC v8 and Pathologic Stage IIIC Cutaneous Melanoma AJCC v8, sponsored by Mayo Clinic.
NCT03554083 is a Phase 2 study of Clinical Stage III Cutaneous Melanoma AJCC v8 and Pathologic Stage IIIC Cutaneous Melanoma AJCC v8 that is active but no longer recruiting, run by Mayo Clinic. The registered enrollment target is 59 participants, below the 240-participant average among 23 other Clinical Stage III Cutaneous Melanoma AJCC v8 trials with a reported enrollment target (75% lower). The trial reports 3 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03554083, a Phase 2 study of Clinical Stage III Cutaneous Melanoma AJCC v8 and Pathologic Stage IIIC Cutaneous Melanoma AJCC v8, is active but no longer recruiting, sponsored by Mayo Clinic.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 59 participants
- Enrollment target
- 3
- Study locations
Study Summary
This trial studies how well vemurafenib, cobimetinib, and atezolizumab work in treating patients with high-risk stage III melanoma. Vemurafenib and cobimetinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as atezolizumab and tiragolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving vemurafenib, cobimetinib, and atezolizumab may work better in treating high-risk stage III melanoma. Giving atezolizumab and tiragolumab together may also work better in treating high-risk stage III melanoma.
Primary Outcome
Pathologic complete response rate defined as the percentage of patients with no residual disease found in the surgical specimen among the patients who began neo-adjuvant protocol treatment.
Conditions Studied
Interventions
- DRUG Atezolizumab
- DRUG Vemurafenib
- DRUG Cobimetinib
- BIOLOGICAL Tiragolumab
Study Locations (3)
Minnesota
- University of Minnesota/Masonic Cancer Center - Minneapolis
- Mayo Clinic in Rochester - Rochester
Florida
- Mayo Clinic in Florida - Jacksonville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 59 participants |
| Start Date | 2018-10-05 |
| Est. Completion | 2027-11-30 |
| Phase | Phase 2 |
What the registry record for NCT03554083 still lists
NCT03554083 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 59 participants, a relatively small participant target, below the 240-participant average among 23 other Clinical Stage III Cutaneous Melanoma AJCC v8 trials with a reported enrollment target (75% lower).
The record links to 6 conditions, with Clinical Stage III Cutaneous Melanoma AJCC v8 appearing as the primary indexed condition, and to 4 interventions - of which Atezolizumab is the first listed.
NCT03554083 reports a single indexed study location in Minnesota, Florida.
Frequently Asked Questions
What is clinical trial NCT03554083 about?
NCT03554083 is a clinical study titled "Vemurafenib, Cobimetinib, Atezolizumab, and Tiragolumab in Treating Patients With High-Risk Stage III Melanoma". This trial studies how well vemurafenib, cobimetinib, and atezolizumab work in treating patients with high-risk stage III melanoma. Vemurafenib and cobimetinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as...
What is the current status of trial NCT03554083?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 59 participants. The study started on 2018-10-05. Estimated completion is 2027-11-30.
What conditions does trial NCT03554083 study?
This clinical trial studies the following conditions: Clinical Stage III Cutaneous Melanoma AJCC v8, Pathologic Stage IIIC Cutaneous Melanoma AJCC v8, Pathologic Stage IIIB Cutaneous Melanoma AJCC v8, Pathologic Stage IIID Cutaneous Melanoma AJCC v8, Pathologic Stage III Cutaneous Melanoma AJCC v8.
What interventions are being tested in trial NCT03554083?
The interventions under investigation include: Atezolizumab (DRUG), Vemurafenib (DRUG), Cobimetinib (DRUG), Tiragolumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT03554083?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03554083 being conducted?
This trial has 3 study locations across Florida, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03554083's enrollment target sits among peer trials
59 15th of 23 higher than 9 of 23 other Clinical Stage III Cutaneous Melanoma AJCC v8 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Clinical Stage III Cutaneous Melanoma AJCC v8 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.
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