Trial · NCT02587650
Capmatinib, Ceritinib, Regorafenib, or Entrectinib in Treating Patients With BRAF/NRAS Wild-Type Stage III-IV Melanoma
NCT02587650, Phase 2, Terminated, University of California, San Francisco; results first posted 2020-01-27
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Capmatinib, Ceritinib, Regorafenib, or Entrectinib in Treating Patients With BRAF/NRAS Wild-Type Stage III-IV Melanoma. Trials, record NCT02587650. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02587650
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Capmatinib, Ceritinib, Regorafenib, or Entrectinib in Treating Patients With BRAF/NRAS Wild-Type Stage III-IV Melanoma
- NCT number
- NCT02587650
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 1 participants, actual
- Lead sponsor
- University of California, San Francisco
- Conditions
ALK Fusion Protein Expression, BRAF wt Allele, Invasive Skin Melanoma, MET Fusion Gene Positive, NRAS wt Allele, NTRK1 Fusion Positive, NTRK2 Fusion Positive, NTRK3 Fusion Positive, RET Fusion Positive, ROS1 Fusion Positive, Stage III Cutaneous Melanoma, Stage IIIA Cutaneous Melanoma, Stage IIIB Cutaneous Melanoma, Stage IIIC Cutaneous Melanoma, Stage IV Cutaneous Melanoma
- Interventions
- Capmatinib, Ceritinib, Entrectinib, Laboratory Biomarker Analysis, Regorafenib
- First posted
- 2015-10-27
- Last updated
- 2020-01-27
- Results first posted
- 2020-01-27
- Limitations and caveats
- Only 1 participant was enrolled on this study to Arm C (regorafenib) based on the participants mutation profile. The study was terminated after one accrual due to lack of funding.
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Confirmed Overall Response Rate (ORR) | 24 weeks | Defined as a complete or partial response as per Response Evaluation Criteria in Solid Tumors version 1.1 criteria with confirmatory measurements a minimum of 4 weeks after the response-defining determination. Analysis of study results will include ORR estimations of ALK, NTRK, ROS1, RET, MET, and BRAF rearrangement-positive patients. |
| Secondary | Clinical Benefit Rate (CBR) | Up to 2 years | Clinical benefit rate is defined as the proportion of patients achieving a complete response (CR) or partial response (PR) or stable disease (SD) for \> 24 weeks using the same RECIST 1.1 decision matrix used to calculate ORR. The CBR will be estimated for each arm along with a 95% confidence interval |
| Secondary | Overall Survival | From treatment start to death, assessed up to 2 years | Overall defined as the time from treatment start to the progression or death and overall survival defined as the time from treatment start to death will be estimated using Kaplan-Meier methodology. |
| Secondary | Progression Free Survival | up to 2 years | Progression free survival (PFS) defined as the time from treatment start to the progression or death and overall survival defined as the time from treatment start to death will be estimated using Kaplan-Meier methodology |
| Secondary | Evaluation of the Adverse Effect Profile of Each Kinase Inhibitor | Up to 2 years | Frequencies of toxicities will be tabulated according to CTCAE v4.03 to assess drug safety and tolerability |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Confirmed Overall Response Rate (ORR) | 24 weeks | Evaluable participants would be those with baseline staging, treatment for at least 8 weeks, and at least one post-baseline staging scan while on treatment. No participants meet the criteria to be considered evaluable for this analysis. | ||
| SECONDARY | Clinical Benefit Rate (CBR) | Up to 2 years | Evaluable patients would be those with baseline staging, treatment for at least 8 weeks, and at least one post-baseline staging scan while on treatment. No participants meet the criteria to be considered evaluable for this analysis. | ||
| SECONDARY | Overall Survival | From treatment start to death, assessed up to 2 years | Evaluable patients would be those with baseline staging, treatment for at least 8 weeks, and at least one post-baseline staging scan while on treatment. No participants meet the criteria to be considered evaluable for this analysis. | ||
| SECONDARY | Progression Free Survival | up to 2 years | Evaluable patients would be those with baseline staging, treatment for at least 8 weeks, and at least one post-baseline staging scan while on treatment. No participants meet the criteria to be considered evaluable for this analysis. | ||
| SECONDARY | Evaluation of the Adverse Effect Profile of Each Kinase Inhibitor | Up to 2 years | Evaluable patients would be those with baseline staging, treatment for at least 8 weeks, and at least one post-baseline staging scan while on treatment. No participants meet the criteria to be considered evaluable for this analysis. |
Source ClinicalTrials.gov
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm A (Capmatinib) | 0 | |
| Overall Study | STARTED | Arm B (Ceritinib) | 0 | |
| Overall Study | STARTED | Arm C (Regorafenib) | 1 | |
| Overall Study | STARTED | Arm D (Entrectinib) | 0 | |
| Overall Study | COMPLETED | Arm A (Capmatinib) | 0 | |
| Overall Study | COMPLETED | Arm B (Ceritinib) | 0 | |
| Overall Study | COMPLETED | Arm C (Regorafenib) | 1 | |
| Overall Study | COMPLETED | Arm D (Entrectinib) | 0 | |
| Overall Study | NOT COMPLETED | Arm A (Capmatinib) | 0 | |
| Overall Study | NOT COMPLETED | Arm B (Ceritinib) | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events10
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diarrhea | Gastrointestinal disorders | Arm C (Regorafenib) | 1 | 1 | 2 |
| other | Nausea | Gastrointestinal disorders | Arm C (Regorafenib) | 1 | 1 | 1 |
| other | Chills | General disorders | Arm C (Regorafenib) | 1 | 1 | 1 |
| other | Skin infection | Infections and infestations | Arm C (Regorafenib) | 1 | 1 | 1 |
| other | Anorexia | Metabolism and nutrition disorders | Arm C (Regorafenib) | 1 | 1 | 1 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Arm C (Regorafenib) | 1 | 1 | 1 |
| other | Dyspnea | Respiratory, thoracic and mediastinal disorders | Arm C (Regorafenib) | 1 | 1 | 1 |
| other | Hot flashes | Vascular disorders | Arm C (Regorafenib) | 1 | 1 | 1 |
| other | Hypertension | Vascular disorders | Arm C (Regorafenib) | 1 | 1 | 3 |
| serious | Sepsis | Infections and infestations | Arm C (Regorafenib) | 1 | 1 | 1 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm C (Regorafenib) | 1 | 1 |
| Total, other adverse events | Arm C (Regorafenib) | 1 | 1 |
| Total, serious adverse events | Arm C (Regorafenib) | 1 | 1 |
Source ClinicalTrials.gov
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/NCT02587650
GET https://conductscience.org/api/trials/v1/NCT02587650/registered