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NCT04310397 · ClinicalTrials.gov registry record · Phase 2
Dabrafenib, Trametinib, and Spartalizumab for the Treatment of BRAF V600E or V600K Mutation Positive Stage IIIB/C/D Melanoma
A Phase 2 study, sponsored by M.D. Anderson Cancer Center.
- Terminated
- Registry status
- Phase 2
- Development phase
- 4
- Enrollment target
NCT04310397: Clinical Trial Phase 2 study, sponsored by M.D. Anderson Cancer Center.
NCT04310397 is a Phase 2 study that was terminated before completion, run by M.D. Anderson Cancer Center. The registered enrollment target is 4 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04310397, a Phase 2 study, was terminated before completion, sponsored by M.D. Anderson Cancer Center.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 4 participants
- Enrollment target
Study Summary
This phase II trial studies how well dabrafenib, trametinib, and spartalizumab works in treating patients with BRAF V600E or V600K mutation positive stage IIIB/C/D melanoma, who do not achieve a pathologic complete response after 8 weeks of dabrafenib and trametinib treatment. Patients who achieve a pathologic complete response after 8 weeks of neoadjuvant dabrafenib and trametinib will receive adjuvant dabrafenib and trametinib. Dabrafenib and trametinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as spartalizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving dabrafenib, trametinib, and spartalizumab may help to control melanoma.
Interventions
- PROCEDURE Therapeutic Conventional Surgery
- DRUG Trametinib
- DRUG Dabrafenib
- BIOLOGICAL Spartalizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2020-01-29 |
| Est. Completion | 2023-10-09 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04310397
The ClinicalTrials.gov registry entry for NCT04310397 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 4 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is M.D. Anderson Cancer Center, which has 2,692 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Therapeutic Conventional Surgery is the first listed.
NCT04310397 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04310397 about?
NCT04310397 is a clinical study titled "Dabrafenib, Trametinib, and Spartalizumab for the Treatment of BRAF V600E or V600K Mutation Positive Stage IIIB/C/D Melanoma". This phase II trial studies how well dabrafenib, trametinib, and spartalizumab works in treating patients with BRAF V600E or V600K mutation positive stage IIIB/C/D melanoma, who do not achieve a pathologic complete response after 8 weeks of dabrafenib and trametinib treatment. Patients who achieve a...
What is the current status of trial NCT04310397?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 4 participants. The study started on 2020-01-29. Estimated completion is 2023-10-09.
What interventions are being tested in trial NCT04310397?
The interventions under investigation include: Therapeutic Conventional Surgery (PROCEDURE), Trametinib (DRUG), Dabrafenib (DRUG), Spartalizumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT04310397?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
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