Trial · NCT05388877
E6201 and Dabrafenib for the Treatment of Central Nervous System Metastases From BRAF V600 Mutated Metastatic Melanoma
NCT05388877, Phase 1, Terminated, Mayo Clinic
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. E6201 and Dabrafenib for the Treatment of Central Nervous System Metastases From BRAF V600 Mutated Metastatic Melanoma. Trials, record NCT05388877. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05388877
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- E6201 and Dabrafenib for the Treatment of Central Nervous System Metastases From BRAF V600 Mutated Metastatic Melanoma
- NCT number
- NCT05388877
- Status
- Terminated
- Phases
- Phase 1
- Enrollment
- 13 participants, actual
- Lead sponsor
- Mayo Clinic
- Conditions
- Clinical Stage IV Cutaneous Melanoma AJCC v8, Metastatic Malignant Neoplasm in the Brain, Metastatic Malignant Neoplasm in the Central Nervous System, Metastatic Melanoma
- Interventions
- Dabrafenib, MEK-1/MEKK-1 Inhibitor E6201, Biospecimen Collection, Computed Tomography, Magnetic Resonance Imaging
- First posted
- 2022-05-24
- Last updated
- 2025-08-19
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum tolerated dose | Up to end of cycle 1 (1 cycle = 28 days) | |
| Secondary | Overall intracranial response rate | Up to 2 years | Defined as the number of patients who have achieved CR or PR per Response Assessment in Neuro-oncology (RANO) for brain metastases criteria during treatment with E6201 plus dabrafenib divided by total number of evaluable patients. Responses will be summarized by simple descriptive summary statistics delineating complete and partial responses as well as stable and progressive disease in this patient population. |
| Secondary | Overall extracranial response rate | Up to 2 years | Defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Systemic response by RECIST 1.1 criteria for extracranial disease will be estimated using systemic response rate (SRR) - where SRR is defined as the number of evaluable patients achieving a response (partial response or complete response per RECIST 1.1) during treatment with study therapy divided by the total number of evaluable patients. Responses will be summarized by simple descriptive summary statistics delineating complete and partial responses as well as stable and progressive disease in this patient population. |
| Secondary | Incidence of adverse events | Up to 2 years | The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine patterns. Additionally, the relationship of the adverse event(s) to the study treatment will be taken into consideration. |
| Secondary | Time to first progression | Up to 2 years | Will be summarized descriptively. |
| Secondary | Overall survival | Up to 2 years | Will be summarized descriptively. |
| Other | BRAF mutational status | Up to 2 years | Correlations between BRAF mutational status (e.g., type, heterozygosity or homozygosity) and other outcome measures like response, and dose levels will be carried out in an exploratory manner. Descriptive statistics will form the basis of presentation of these data. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| P30CA015083 | Mayo Clinic Comprehensive Cancer Center Support Grant | WILLMAN, CHERYL LYNN | MAYO CLINIC ROCHESTER | NATIONAL CANCER INSTITUTE | 1985 to 2025 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05388877
GET https://conductscience.org/api/trials/v1/NCT05388877/registered