Metastatic MelanomaPhase 2EBRAIN-MELNCT03898908
Encorafenib and Binimetinib Before Local Treatment in Patients With BRAF Mutant Melanoma Metastatic to the Brain
A Phase 2 study testing encorafenib, binimetinib and Whole brain radiation therapy in people with Metastatic Melanoma and Brain Metastases, run by Grupo Español Multidisciplinar de Melanoma at 21 sites in Spain.
Trial summary
Phase II clinical trial, with two cohorts of patients included in parallel, all with melanoma BRAF mutated and brain metastases without previous local treatment in the brain. Cohort 1 will include patients with asymptomatic brain metastases and cohort 2 will include patients with symptomatic brain metastasis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Melanoma, Brain Metastases
- What is being tested?
- encorafenib, binimetinib and Whole brain radiation therapy
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 21 sitesSpain
- Study dates
- 18 Jul 2019to 31 Jul 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent of approved by the investigator's Institutional Review Board (IRB)/Independent Ethics Committee (IEC), prior to the performance of any trial activities.
- Histologically confirmed diagnosis of unresectable metastatic cutaneous melanoma, or unknown primary melanoma with one or more brain metastasis with a diameter of 10 to 50 mm, measured by contrast enhanced MRI.
- Presence of a BRAF V600E or V600K mutation, or both, in their tumour tissue.
- Barthel Index of Activities of Daily Living > 10.
- Subjects aged ≥ 18 years.
- ECOG 0-1 in asymptomatic patients (cohort 1), 0-2 in symptomatic patients (cohort 2).
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- Adequate haematological function (Haemoglobin ≥ 9 g/dL, may have been transfused; Platelet count ≥ 100 × 109/L; Absolute neutrophil count (ANC) ≥ 1.5 × 109/L.)
- Adequate hepatic function defined by a total bilirubin level ≤ 2.0 × the upper limit of normality (ULN) and AST and ALT levels ≤ 2.5 × ULN or AST and ALT levels ≤ 5 x ULN (for subjects with documented metastatic disease to the liver).
- Serum Creatinine ≤ 2.0 x ULN or estimated creatinine clearance ≥ 30 mL/min according to the Cockcroft-Gault formula (or local institutional standard method).
- Evidence of at least one measurable lesion as detected by radiological or photographic methods according to guidelines based on Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1.
- Naïve untreated patients or patients who have progressed on or after prior first line immunotherapy for unresectable locally advanced or metastatic melanoma, but it must have ended at least 6 weeks prior to randomization; prior adjuvant therapy is permitted (e.g. IFN, IL-2 therapy, any other immunotherapy, radiotherapy or chemotherapy), BRAF or MEK inhibitors can be used in the adjuvant setting, providing the relapse does not occur during the adjuvant treatment or within 12 months after the end of it, and providing the adjuvant treatment with targeted therapy did not cause in the patient any grade 3-4 toxicity not including medically serious and reversible/controlled toxicities (ex: GGT elevation, CPK elevation, vomiting).
- Steroids or anticonvulsants are allowed if clinically needed and are not being administered in an increasing dose.
- Female subjects must either be of non-reproductive potential (ie, post-menopausal by history: ≥60 years old and no menses for ≥1 year without an alternative medical cause; OR history of hysterectomy, OR history of bilateral tubal ligation, OR history of bilateral oophorectomy) or must have a negative serum pregnancy test upon study entry.
- Normal functioning of daily living activities.
- Willingness and ability to attend scheduled visits, follow the treatment schedule and undergo clinical tests and other study procedures.
Who cannot join
- Uveal or mucosal melanoma.
- History of leptomeningeal metastases, with the exception that they are only seen in brain MRI and the patient has ECOG 0-1 and no neurological symptoms (except for cohort 2, where symptomatic patients will be allowed if ECOG is 0-2).
- Another cancer in the last five years, except for in situ carcinoma of the cervix or squamous cell carcinoma of the skin adequately treated or limited basal cell skin cancer adequately controlled.
- History of or current evidence of central serous retinopathy (CSR), retinal vein occlusion (RVO) or history of retinal degenerative disease (RDD).
- Any previous systemic chemotherapy treatment, extensive brain radiotherapy, targeted therapy for locally advanced unresectable or metastatic melanoma; Immunotherapy treatment is allowed but must have ended at least 6 weeks prior to randomization.
- History of Gilbert's syndrome.
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- Previous treatment with a BRAF or MEK inhibitor in metastatic setting. This treatment will be allowed in the adjuvant setting (see above). Previous treatments with immunotherapy will be allowed in both the metastatic and adjuvant setting.
- Known positive serology for human immunodeficiency virus, or an active hepatitis B or hepatitis C infection, or both.
- Impaired cardiovascular function or clinically significant cardiovascular diseases "Clinically significant (i.e., active) cardiovascular disease: cerebrovascular accident/stroke (< 6 months prior to enrolment), myocardial infarction (< 6 months prior to enrolment), unstable angina, congestive heart failure (≥ New York Heart Association Classification Class II), a LVEF < 50% evaluated by MUGA or echocardiography, or serious cardiac arrhythmia requiring medication or a triplicate average baseline QTc interval > 500 ms."
- Uncontrolled arterial hypertension despite medical treatment.
- Moderate (Child Pugh Class B) or severe (Child Pugh Class C) hepatic impairment.
- Impairment of gastrointestinal function.
- Neuromuscular disorders associated with high concentrations of creatine kinase.
- Pregnant or nursing (lactating) women.
- Medical, psychiatric, cognitive or other conditions that may compromise the patient's ability to understand the patient information, give informed consent, comply with the study protocol or complete the study.
- Known hypersensitivity to encorafenib, binimetinib or their components.
- Persisting toxicity related to prior therapy of Grade >1 NCI-CTCAE v 4.03; however, alopecia and sensory neuropathy Grade ≤ 2 is acceptable.
- Female patients who are pregnant or breastfeeding or male or female patients of reproductive potential who are not willing to employ highly effective birth control from screening to 180 days after the last dose of study treatment.
- Known alcohol or drug abuse.
- Inability to swallow tablets or capsules.
- Total lactase deficiency or glucose-galactose malabsorption.
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
Spain21 sites
Institut Català d'Oncología Hospitalet
Barcelona, Barcelona, Spain, 08908
Hospital Universitario Quirón Dexeus
Barcelona, Catalonia
Hospital Universitari Vall d'Hebron
Barcelona, 08035
Hospital Clínic de Barcelona
Barcelona
Hospital del Mar
Barcelona
Hospital Universitario Reina Sofía
Córdoba
Hospital Clínico Universitario Virgen de la Arrixaca
El Palmar, Murcia, 30120
Complejo Hospitalario Universitario Insular de Canarias
Las Palmas de Gran Canaria, Las Palmas
Hospital Lucus Augusti
Lugo, 27003
Hospital Universitario Ramón y Cajal
Madrid, 28034
H. U. Gregorio Marañón
Madrid
Hospital Clínico San Carlos
Madrid
Hospital Universitario La Paz
Madrid
Hospital Regional Universitario de Málaga
Málaga
Hospital Universitario Son Espases
Palma de Mallorca, Balearic Islands
Clínica Universidad de Navarra
Pamplona
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria
Hospital Universitario Virgen Macarena
Seville
Hospital General Universitario de Valencia
Valencia
Hospital Universitario y Politécnico La Fe
Valencia
Hospital Miguel Servet
Zaragoza
About this study
Official title: Phase II, Multicentre Clinical Trial to Evaluate the Activity of Encorafenib and Binimetinib Administered Before Local Treatment in Patients With BRAF Mutant Melanoma Metastatic to the Brain
Phase II clinical trial, with two cohorts of patients included in parallel, all with melanoma BRAF mutated and brain metastases without previous local treatment in the brain. Cohort 1 will include patients with asymptomatic brain metastases and cohort 2 will include patients with symptomatic brain metastasis.
- Conditions
- Metastatic Melanoma, Brain Metastases
- Being tested
- encorafenib, binimetinib, Whole brain radiation therapy, Radiosurgery/stereotactic radiosurgery
- Keywords
- metastases, melanoma, encorafenib, binimetinib
- Medical subject headings
- Melanoma, Brain Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
encorafenibDrug
Also called Braftovi
Encorafenib 75mg and 50mg (capsules) for a 450mg daily for oral administration during 56 days and after local radiation treatment.
If no progression of disease progression (PD) is reported, treatment will continue until PD, unacceptable toxicity or death.
binimetinibDrug
Also called Mektovi
Binimetinib 15mg (tablets) for a 45mg/12 hours for oral administration during 56 days and after local radiation treatment.
Whole brain radiation therapyRadiation
The whole brain planning target volume (PTV) will receive 30 Gy in 10 fractions.
Treatment will be delivered once daily, 5 fractions per week, over 2 to 2.5 weeks.
Radiosurgery/stereotactic radiosurgeryRadiation
Dose selection must be based on previously published Radiation Therapy Oncology Group (RTOG) data, with dose modification left up to the treating physician. The total dose will depend on the size of the metastatic lesion(s) and proximity to critical structures.
Suggested doses are as follow: 1 fraction x 15-25 Gy; 3 fractions x 9-11 Gy; 5 fractions x 6-7 Gy; or 6 fractions x 5-6 Gy.
For GTV > 20 mm hypofractionated stereotactic radiotherapy could be preferred. Treatment will be delivered once daily, alternate-day, 3 fractions per week.
| Study group | Role | What they receive |
|---|---|---|
| COMBO450 | Experimental | Encorafenib - Orally, 75 mg and 50 mg capsules Binimetinib - Orally, 15 mg tablets
In each cohort, patients will be treated with encorafenib 450 mg once daily and binimetinib 45 mg twice daily until PD or death. Receives: Drug: encorafenib; Drug: binimetinib; Radiation: Whole brain radiation therapy; Radiation: Radiosurgery/stereotactic radiosurgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intracranial Objective Response (iORR) by Modified RECIST 1.1 Before Local Radiotherapy Treatment in Full Dataset
iORR calculated as the proportion of patient with a best overall intracranial response of complete response (CR) or partial response (PR) before local treatment according to modified RECIST 1.1.
Modified RECIST 1.1 consists of:
Up to 5 intracranial lesions could be selected as target lesions Target lesions might have a longest diameter ≥ 5 mm when evaluated by contrast-enhanced MRI
This endpoint was also independently reported in patients with symptomatic and asymptomatic brain metastasis.
Measured: 24 months after start of treatment
Secondary outcomes (10)
Duration of Intracranial Response
Calculated as the time from the date of first documented CR or PR to the first documented intracranial progression or death due to underlying cancer accoridng to modified RECIST 1.1, in patients with documented intracranial CR or PR before local treatment.
Measured: Throughout the study period, up to approximately 24 months
Intracranial Progression-free Survival (iPFS) by RECIST 1.1
Defined as the time from the date of inclusion to the date of the first documented intracranial disease progression or death due to any cause, whichever occurs first. PFS was determined based on tumor assessment (modified RECIST version 1.1 criteria). The local Investigator's assessments was used for analyses. Those patients who were alive and had not progressed at the last follow-up, date of progression was censored at the date of the last follow-up. Patients with no additional image test other than baseline were censored the day after inclusion.
Measured: Throughout the study period, up to approximately 24 months
Extracranial Progression-free Survival (ePFS) in Both Cohorts
Defined as the time from the date of inclusion to the date of the first documented extracranial disease progression or death due to any cause, whichever occurs first. PFS was determined based on tumor assessment (RECIST version 1.1 criteria). The local Investigator's assessments was used for analyses. Those patients who were alive and had not progressed at the last follow-up, date of progression was censored at the date of the last follow-up. Patients with no additional image test other than baseline were censored the day after inclusion.
Measured: Throughout the study period, up to approximately 24 months
Intracranial Progression-free Rates
Proportion of patients free of intracranial progression assessed by modified RECIST at 6 months (week 24), 12 months (week 48) and 24-month (week 96) considering date of inclusion estimated through Kaplan-Meier method
Measured: at 6 months (week 24), 12 months (week 48) and 24-month (week 96)
Overall Survival
Calculated as the time from date of inclusion to date of death due to any cause.
Measured: Throughout the study period, up to approximately 24 months
Overall Survival Rates
Proportion of of patients alive at 6 months, 12 month and 24-month considering date of inclusion estimated using Kaplan-Meier.
Patients alive at the moment of the analysis were censored on the date of their last follow-up.
Measured: at 6 months, 12 month and 24-month
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0
Number of patients experiencing treatment related adverse events. These events were graded accrding to CTCAE, a scale that ranges from 0 (less intense; no event) to 5 (death) .
Here we report the number of patients experiencing any grade toxicities and the number of patients experiencing high grade (grade 3-5) toxicities.
Measured: Throughout the study period, up to approximately 24 months
Change on Quality of Life at Week 8 in Both Cohorts Based on the EORTC QLQ 30 Scale
The EORTC QLQ-C30 questionnaire is validated for cancer. It is composed of 30 questions or items that assess QoL. The questionnaire is structured in 5 functional scales physical functioning, daily activities, emotional functioning, cognitive functioning and social functioning), 3 symptom scales (fatigue, pain and nausea, vomiting), 1 global health status scale, and 6 independent items (dyspnea, insomnia, anorexia, constipation, diarrhea and economic impact). Values between 1 and 4 (1: not at all, 2: a little, 3: quite, 4: a lot) are assigned according to the patient's responses to the item, only in items 29 and 30 are they evaluated with a score of 1 to 7 (1: dreadful, 7: excellent).
The scores obtained are standardized and a score between 0 and 100 is obtained, which determines the level of impact of the cancer on the patient on each of the scales. Higher values indicate better performance
Measured: 8 weeks
Change on Quality of Life at Week 24 in Both Cohorts Based on the EORTC QLQ 30 Scale
The EORTC QLQ-C30 questionnaire is validated for cancer. It is composed of 30 questions or items that assess QoL. The questionnaire is structured in 5 functional scales physical functioning, daily activities, emotional functioning, cognitive functioning and social functioning), 3 symptom scales (fatigue, pain and nausea, vomiting), 1 global health status scale, and 6 independent items (dyspnea, insomnia, anorexia, constipation, diarrhea and economic impact). Values between 1 and 4 (1: not at all, 2: a little, 3: quite, 4: a lot) are assigned according to the patient's responses to the item, only in items 29 and 30 are they evaluated with a score of 1 to 7 (1: dreadful, 7: excellent).
The scores obtained are standardized and a score between 0 and 100 is obtained, which determines the level of impact of the cancer on the patient on each of the scales. Higher values indicate better performance
Measured: 24 weeks
Extracranial Progression-free Rates
Proportion of patients free of extracranial progression assessed by modified RECIST at 6 months (week 24), 12 months (week 48) and 24-month (week 96) considering date of inclusion estimated through Kaplan-Meier method
Measured: at 6 months (week 24), 12 months (week 48) and 24-month (week 96)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2019
- Study start18 Jul 2019
- Primary completion10 Oct 2022
- Study completion31 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Metastatic MelanomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Cohort 1 will include patients with asymptomatic brain metastases and without previous local treatment in the brain (N=48), while cohort 2 will include patients with symptomatic brain metastasis and without previous local treatment in the brain (N=15).
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Grupo Español Multidisciplinar de Melanoma
- Sponsor type
- University, hospital or other
- Collaborators
- Pierre Fabre Medicament, MFAR
- Responsible party
- Sponsor
- Investigators
- Iván Márquez Rodaz, M.D., Study chair, Hospital General Universitario Gregorio MarañonAlfonso Berrocal Jaime, M.D., Study chair, Hospital Universitario General de Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03898908
- Sponsor's protocol ID
- GEM-1802
- Other IDs
- 2018-002530-20, 2018
- Acronym
- EBRAIN-MEL
- Status last verified
- May 2025
- First submitted
- 27 Mar 2019
- Last updated
- 21 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II, Multicentre Clinical Trial to Evaluate the Activity of Encorafenib and Binimetinib Administered Before Local Treatment in Patients With BRAF Mutant Melanoma Metastatic to the Brain
- ClinicalTrials.gov ID
- NCT03898908
- Acronym / sponsor ID
- EBRAIN-MEL / GEM-1802
- Conditions
- Metastatic Melanoma, Brain Metastases
- Keywords
- metastases, melanoma, encorafenib, binimetinib
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Grupo Español Multidisciplinar de MelanomaUniversity, hospital or other
- Collaborators
- Pierre Fabre Medicament, MFAR
- Study start
- 18 Jul 2019 (actual)
- Primary completion
- 10 Oct 2022 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 2 Apr 2019 (actual)
- Results
- Posted 13 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Phase II clinical trial, with two cohorts of patients included in parallel, all with melanoma BRAF mutated and brain metastases without previous local treatment in the brain. Cohort 1 will include patients with asymptomatic brain metastases and cohort 2 will include patients with symptomatic brain metastasis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Cohort 1 will include patients with asymptomatic brain metastases and without previous local treatment in the brain (N=48), while cohort 2 will include patients with symptomatic brain metastasis and without previous local treatment in the brain (N=15).
| Arm | Type | Receives |
|---|---|---|
| COMBO450 | Experimental | Drug: encorafenib, Drug: binimetinib, Radiation: Whole brain radiation therapy, Radiation: Radiosurgery/stereotactic radiosurgeryEncorafenib - Orally, 75 mg and 50 mg capsules Binimetinib - Orally, 15 mg tablets In each cohort, patients will be treated with encorafenib 450 mg once daily and binimetinib 45 mg twice daily until PD or death. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Written informed consent of approved by the investigator's Institutional Review Board (IRB)/Independent Ethics Committee (IEC), prior to the performance of any trial activities.
- Histologically confirmed diagnosis of unresectable metastatic cutaneous melanoma, or unknown primary melanoma with one or more brain metastasis with a diameter of 10 to 50 mm, measured by contrast enhanced MRI.
- Presence of a BRAF V600E or V600K mutation, or both, in their tumour tissue.
- Barthel Index of Activities of Daily Living > 10.
- Subjects aged ≥ 18 years.
Key exclusion criteria (21 listed)
- Uveal or mucosal melanoma.
- History of leptomeningeal metastases, with the exception that they are only seen in brain MRI and the patient has ECOG 0-1 and no neurological symptoms (except for cohort 2, where symptomatic patients will be allowed if ECOG is 0-2).
- Another cancer in the last five years, except for in situ carcinoma of the cervix or squamous cell carcinoma of the skin adequately treated or limited basal cell skin cancer adequately controlled.
- History of or current evidence of central serous retinopathy (CSR), retinal vein occlusion (RVO) or history of retinal degenerative disease (RDD).
- Any previous systemic chemotherapy treatment, extensive brain radiotherapy, targeted therapy for locally advanced unresectable or metastatic melanoma; Immunotherapy treatment is allowed but must have ended at least 6 weeks prior to randomization.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| encorafenibAlso: BraftoviEncorafenib 75mg and 50mg (capsules) for a 450mg daily for oral administration during 56 days and after local radiation treatment. If no progression of disease progression (PD) is reported, treatment will continue until PD, unacceptable toxicity or death. | Drug | COMBO450 |
| binimetinibAlso: MektoviBinimetinib 15mg (tablets) for a 45mg/12 hours for oral administration during 56 days and after local radiation treatment. | Drug | COMBO450 |
| Whole brain radiation therapyThe whole brain planning target volume (PTV) will receive 30 Gy in 10 fractions. Treatment will be delivered once daily, 5 fractions per week, over 2 to 2.5 weeks. | Radiation | COMBO450 |
| Radiosurgery/stereotactic radiosurgeryDose selection must be based on previously published Radiation Therapy Oncology Group (RTOG) data, with dose modification left up to the treating physician. The total dose will depend on the size of the metastatic lesion(s) and proximity to critical structures. Suggested doses are as follow: 1 fraction x 15-25 Gy; 3 fractions x 9-11 Gy; 5 fractions x 6-7 Gy; or 6 fractions x 5-6 Gy. For GTV > 20 mm hypofractionated stereotactic radiotherapy could be preferred. Treatment will be delivered once daily, alternate-day, 3 fractions per week. | Radiation | COMBO450 |
Primary outcome
Intracranial Objective Response (iORR) by Modified RECIST 1.1 Before Local Radiotherapy Treatment in Full Dataset
Time frame: 24 months after start of treatment
iORR calculated as the proportion of patient with a best overall intracranial response of complete response (CR) or partial response (PR) before local treatment according to modified RECIST 1.1. Modified RECIST 1.1 consists of: Up to 5 intracranial lesions could be selected as target lesions Target lesions might have a longest diameter ≥ 5 mm when evaluated by contrast-enhanced MRI This endpoint was also independently reported in patients with symptomatic and asymptomatic brain metastasis.
10 secondary outcomes
Duration of Intracranial Response
Time frame: Throughout the study period, up to approximately 24 months
Intracranial Progression-free Survival (iPFS) by RECIST 1.1
Time frame: Throughout the study period, up to approximately 24 months
Extracranial Progression-free Survival (ePFS) in Both Cohorts
Time frame: Throughout the study period, up to approximately 24 months
Intracranial Progression-free Rates
Time frame: at 6 months (week 24), 12 months (week 48) and 24-month (week 96)
Overall Survival
Time frame: Throughout the study period, up to approximately 24 months
Overall Survival Rates
Time frame: at 6 months, 12 month and 24-month
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0
Time frame: Throughout the study period, up to approximately 24 months
Change on Quality of Life at Week 8 in Both Cohorts Based on the EORTC QLQ 30 Scale
Time frame: 8 weeks
Change on Quality of Life at Week 24 in Both Cohorts Based on the EORTC QLQ 30 Scale
Time frame: 24 weeks
Extracranial Progression-free Rates
Time frame: at 6 months (week 24), 12 months (week 48) and 24-month (week 96)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Iván Márquez Rodaz, M.D. study chair
Hospital General Universitario Gregorio Marañon
Alfonso Berrocal Jaime, M.D. study chair
Hospital Universitario General de Valencia
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing encorafenib, binimetinib and Whole brain radiation therapy in people with Metastatic Melanoma and Brain Metastases, run by Grupo Español Multidisciplinar de Melanoma at 21 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intracranial Objective Response (iORR) by Modified RECIST 1.1 Before Local Radiotherapy Treatment in Full Dataset (time frame: 24 months after start of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2025.