Trial · NCT04375527
Binimetinib and Nivolumab for the Treatment of Locally Advanced Unresectable or Metastatic BRAF V600 Wildtype Melanoma
NCT04375527, Phase 2, Terminated, Jonsson Comprehensive Cancer Center
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Binimetinib and Nivolumab for the Treatment of Locally Advanced Unresectable or Metastatic BRAF V600 Wildtype Melanoma. Trials, record NCT04375527. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04375527
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Binimetinib and Nivolumab for the Treatment of Locally Advanced Unresectable or Metastatic BRAF V600 Wildtype Melanoma
- NCT number
- NCT04375527
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 3 participants, actual
- Lead sponsor
- Jonsson Comprehensive Cancer Center
- Conditions
Clinical Stage III Cutaneous Melanoma AJCC V8, Clinical Stage IV Cutaneous Melanoma AJCC V8, Locally Advanced Cutaneous Melanoma, Metastatic Cutaneous Melanoma, Pathologic Stage III Cutaneous Melanoma AJCC V8, Pathologic Stage IIIA Cutaneous Melanoma AJCC V8, Pathologic Stage IIIB Cutaneous Melanoma AJCC V8, Pathologic Stage IIIC Cutaneous Melanoma AJCC V8, Pathologic Stage IIID Cutaneous Melanoma AJCC V8, Pathologic Stage IV Cutaneous Melanoma AJCC V8, Unresectable Cutaneous Melanoma
- Interventions
- Binimetinib, Nivolumab, Questionnaire Administration
- First posted
- 2020-05-05
- Last updated
- 2024-12-04
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective response rate | Up to 26 months | Will be defined as the total number of patients with confirmed responses of either complete response or partial response divided by the total number of subjects in the enrolled population per Response Evaluation Criteria in Solid Tumors 1.1 by investigator assessment. Will be calculated along with the corresponding exact one-sided 95% Clopper-Pearson confidence interval. |
| Secondary | Progression-free survival | From first dose of study drug to the date of progressive disease first documented disease progression or death due to any cause by investigator assessment, or the start of secondary antitumor therapy, whichever occurs first, assessed up to 26 months | Will be assessed per Response Evaluation Criteria in Solid Tumors 1.1. Will be summarized using the Kaplan Meier method. Will be summarized descriptively (mean, standard deviation, median, first and third quartiles, minimum, maximum). Figures showing the Kaplan-Meier estimates will also be presented. |
| Secondary | Clinical benefit rate | Up to 26 months | Will be defined as the proportion of response-evaluable participants who have achieved a confirmed complete response, partial response, and stable disease per Response Evaluation Criteria in Solid Tumors 1.1, as determined by the investigator assessment. Clinical benefit rate and the individual rates for complete response/partial response/stable disease will be summarized with the frequency count and the percentage of subjects in each category along with a 2-sided 95% exact confidence interval. |
| Secondary | Overall survival | From first dose of study drug and death due to any cause, assessed up to 26 months | Will be summarized using the Kaplan Meier method. The Kaplan Meier estimates for the 1 year OS rates and the 2-sided 95% confidence interval of the rates using the Greenwood's formula will be reported. Will be summarized descriptively (mean, standard deviation, median, first and third quartiles, minimum, maximum). Figures showing the Kaplan-Meier estimates will also be presented. |
| Secondary | Duration of response | From the time measurement criteria is met for complete response/partial response (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented, assessed up to 26 months | Will be summarized using the Kaplan Meier method. Will be summarized descriptively (mean, standard deviation, median, first and third quartiles, minimum, maximum). Figures showing the Kaplan-Meier estimates will also be presented. |
| Other | Pharmacodynamic marker analysis | Up to disease progression, assessed up to 26 months | Will use purely descriptive analysis to assess biomarkers (PDL1 status at baseline, baseline mutational load, presence of tumor infiltrating lymphocytes, hormone receptor status, T-cell receptor repertoire in tumor infiltrating lymphocytes and peripheral blood mononuclear cells). They will be further related to individual subject tumor responses. |
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.
Grants0
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.
None in this release.
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.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license 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/NCT04375527
GET https://conductscience.org/api/trials/v1/NCT04375527/registered