MelanomaPhase 2Match MelNCT02645149
Molecular Profiling and Matched Targeted Therapy for Patients With Unresectable Advanced or Metastatic Melanoma
A Phase 2 study testing Standard therapy or clinical trial, Matched targeted therapy and Trametinib and / or supportive care in people with Melanoma, run by Melanoma Institute Australia at 2 sites in Australia.
Trial summary
This is a patient oriented translational research project aiming to improve clinical outcomes for patients with BRAF and NRAS wild-type unresectable Stage III or Stage IV metastatic melanoma who have progressed on, or are unable to receive standard therapy (in general, immunotherapy). Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Melanoma
- What is being tested?
- Standard therapy or clinical trial, Matched targeted therapy and Trametinib and / or supportive care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 216 participants
- Where
- 2 sitesAustralia
- Study dates
- 22 Nov 2021to 6 Mar 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent for Part 1
- Newly diagnosed, histologically confirmedand , unresectable Stage IIIB, IIIC or Stage IV melanoma including cutaneous (including acral, ungual subtypes), ocular (including uveal and extra-uveal), mucosal, and unknown primary).
- Treatment-naïve for unresectable advanced orf metastatic melanoma (systemic treatment given in the neoadjuvant and adjuvant settings are acceptable).
- Tumour tissue available from advanced or metastatic disease. Archival tissue from primary or regional recurrent melanoma may be considered if no recent sample is available.
- Male or female patients aged 18 or over.
- Standard of care molecular tumour testing which has identified NRAS wild type, and either BRAF wild type or non-V600 BRAF mutant melanoma.
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- Adequate tissue available for the Molecular Testing Platform.
- Eligibility Criteria for NGS Molecular Testing Platform (Part 1)
- Standard of care molecular tumour testing which has identified non V600 BRAF or BRAF wild type, or NRAS wild type melanoma (NRAS mutant patients are eligible for Part 2, but will not undergo NGS testing).
- Adequate tissue available per NGS specimen preparation instructions.
- Written informed consent to receive targeted therapy (if applicable) and clinical follow up.
- Patient has undergone NGS tumour testing or has NRAS or ALKati mutant melanoma on routine testing
- Histologically confirmed melanoma of any sub type with measurable disease per RECIST criteria.
- Received available standard therapies or clinical trial agents for unrectable metastatic melanoma that has progressed, unable to tolerate standard therapy, or standard therapy is contraindicated.
- Patient has an 'actionable' genetic aberration and matched targeted therapy is available. Patients with no genetic aberration or where no matched targeted therapy is available, patients will be offered trametinib
- ECOG status 0 - 2.
- Adequate haematological, hepatic and renal organ function as defined by:
- White cell count ≥ 2.0 × 109/L
- Neutrophil count ≥ 1.5 × 109/L
- Haemoglobin ≥ 90 g/L
- Platelet count ≥ 100 x 109/L
- Total bilirubin ≤ 3.0 x ULN
- Alanine transaminase ≤ 3.0 x ULN
- Aspartate aminotransferase ≤ 3.0 x ULN
- Serum creatinine ≤ 1.5 x the upper limit of normal (ULN).
- Life expectancy > 30 days.
- Women of child bearing potential (WOCBP) to use contraception to avoid pregnancy.
- Non sterile men with female partners of CBP to use contraception to avoid pregnancy.
Who cannot join
- An expectation for the need for concurrent radiotherapy (unless safety has been established with the matched drug regimen and is directed at one anatomical region for symptom control).
- Any clinically significant gastrointestinal abnormalities which may impair intake or absorption of the study drug.
- Any investigational drug or other systemic drug therapy for melanoma within 14 days or 5 half-lives from baseline, whichever is shorter.
- Pregnant or breast feeding females.
- Drug specific exclusions as detailed in the TGA Product Information for each drug.
Trial locations and contacts
2 sites in 1 country.
Australia2 sites
Westmead Hospital
Westmead, New South Wales, 2145
Melanoma Institute Australia
Wollstonecraft, New South Wales, 2260
About this study
This is a patient oriented translational research project aiming to improve clinical outcomes for patients with BRAF and NRAS wild-type unresectable Stage III or Stage IV metastatic melanoma who have progressed on, or are unable to receive standard therapy (in general, immunotherapy). Consecutive patients seen at three major clinics and fitting the broad eligibility criteria will be invited to participate.
The approach is designed to test the impact of different targeted drugs on different mutations in a single type of cancer. In this project, patients will have tumour tissue genetically profiled to determine which mutation(s) are present, and will then be assigned to receive a matched drug expected to target the mutation(s) in the tumour. Where multiple targets are identified in one patient, or where multiple potential therapies would be appropriate for a single tumour mutation, the treating clinician may determine the appropriate therapeutic approach after consultation with the study team, using the latest version of library of matched therapies.
Read the detailed description
Current standard of care testing covers mutations in the BRAF and NRAS genes. The comprehensive gene testing platform to be used in this project is designed to interrogate the entire coding sequence of 315 cancer-related genes plus introns from 28 genes often rearranged or altered in cancer. These genes are known to be somatically altered in solid cancers based on recent scientific and clinical literature. The test panel will be used on melanoma tissue from patients pre-screened as having BRAF and NRAS wild-type melanoma. The extent of testing will be updated to reflect new discoveries in melanoma tumourigenesis and availability of new therapies as the project proceeds. Testing will be performed on formalin-fixed and paraffin-embedded samples of metastatic tissue. Archival tissue from primary or regional recurrent melanoma may be considered if no recent sample is available or possible.
All new patients with unresectable Stage III or IV melanoma seen at each participating site will be invited to participate. Following written consent, all patients will undergo the standard testing for BRAF and NRAS mutations. Patients found to have mutations in either gene will receive standard treatment with dabrafenib and / or trametinib and no further molecular testing.
Patients with wild type versions of BRAF and NRAS genes will have tumour tissue sent for the extended gene testing platform. These patients will first receive standard of care therapy for wild type BRAF / NRAS melanoma, where possible. Once standard therapies have been exhausted (because of disease progression or intolerable adverse events), patients will then receive a targeted therapy matched for their genetic result, if applicable. The selection of targeted therapy will be based on clinical evidence of activity in other solid tumours harbouring similar mutations and / or in at least Phase I testing in melanoma. The table of matched therapies will be modified and extended as new findings from clinical research become available. Patients may be included in specific clinical trials of targeted therapies if available, e.g. a MEK inhibitor combined with an MDM2 inhibitor (AMG232) for BRAF and TP53 wild-type melanoma or a MEK inhibitor combined with a CDK4/6 inhibitor for BRAF wild-type melanoma.
The extensive molecular profiling platform is fully validated and will be conducted by an external provider accredited by an authority with the responsibility to award Laboratory Accreditation at private and public facilities.
- Conditions
- Melanoma
- Being tested
- Standard therapy or clinical trial, Matched targeted therapy, Trametinib and / or supportive care, CDK4/6 and MEK inhibitor, Compassionate Access Targeted Therapy
- Keywords
- Metastatic Melanoma, Molecular Testing, Targeted Therapy
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard therapy or clinical trialDrug
Also called Immunotherapy, Biological agent
Patients with BRAF V600 mutations detected by standard of care tumour testing will be treated with standard approved therapies or on clinical trials.
Matched targeted therapyDrug
Also called ALK - Ceritinib, BRAF fusion - Trametinib, CCND1 - Ribociclib + Trametinib, CDK4/6 - Ribociclib + Trametinib
Patients with tumour found to be non-V600 BRAF, BRAF wildtype and NRAS wildtype melanoma will have tumour tested further using the extended molecular testing platform designed for this project. Patients will first receive standard therapy(ies) for non-V600 BRAF, wildtype and NRAS wildtype melanoma until disease progression or intolerable drug toxicities. Followed by a targeted therapy matched to the genetic aberration detected in their tumour on NGS testing.
Trametinib and / or supportive careDrug
Also called Trametinib, Supportive care
Patients with non-V600 BRAF, BRAF wildtype and NRAS wildtype melanoma for whom there is no actionable genetic aberration found on extended molecular testing, may receive trametinib (if not already administered as part of standard care) and/or supportive care.
CDK4/6 and MEK inhibitorDrug
Also called Ribociclib + Trametinib
Patients mucosal melanoma and any genetic aberration on NGS testing may receive ribociclib + trametinib initially. After failure of trametinib and ribociclib, actionable genetic aberrations from the NGS testing will be reviewed for the opportunity to use a further targeted therapy off label.
Patients with an NRAS mutation on standard of care tumour testing will also receive ribociclib + trametinib.
Compassionate Access Targeted TherapyDrug
Also called Off label use of a matched targeted therapy currently unavailable to the study
Patients with non-V600 BRAF, BRAF wildtype and NRAS wildtype melanoma may have an actionable aberration(s) for which there is no current study-specific drug supply. In this scenario, access will be sought for compassionate use of the off label use of the relevant regulatory approved targeted therapy
| Study group | Role | What they receive |
|---|---|---|
| A1. Non-V600 BRAF, BRAF wildtype, NRAS wildtype. Actionable gene mutation, matched drug available | Experimental | Patients will receive targeted drug matched to the actionable gene mutation detected on NGS testing. If a patient cannot receive the matched targeted therapy because of the existence of one or more drug specific exclusion criteria, an alternative matched therapy may be assigned, or trametinib, or clinical trials if available. Receives: Drug: Matched targeted therapy |
| A2. Non-V600 BRAF, BRAF wildtype, NRAS wildtype. Actionable gene mutation, no matched drug available | Experimental | Patients may have an actionable aberration for which there is no current study-specific drug supply available. In this scenario, access will be sought for compassionate use of the relevant approved targeted therapy. Receives: Drug: Compassionate Access Targeted Therapy |
| A3. Non-V600 BRAF, BRAF wild type and NRAS wild type melanoma - no actionable genetic aberration | Experimental | Patients for whom there is no actionable genetic aberration will receive trametinib, based upon the known MAPK excess activity in the majority of melanomas that may be inhibited by a MEK inhibitor Receives: Drug: Trametinib and / or supportive care |
| B. Mucosal melanoma | Experimental | Patients will receive combined trametinib and ribociclib based on evidence to suggest that combined MEK inhibition and CDK4/6 inhibition may be effective. After failure of trametinib and ribociclib, actionable genetic aberrations from the NGS testing will be reviewed for the opportunity to use a further targeted therapy off label. Receives: Drug: CDK4/6 and MEK inhibitor |
| C. NRAS mutant melanoma | Experimental | Patients with an NRAS mutation detected on standard gene testing only will receive combined trametinib and ribociclib based on evidence that combining MEK inhibition and CDK4/6 inhibition is a viable treatment option. Receives: Drug: CDK4/6 and MEK inhibitor |
| D. BRAF V600 mutant melanoma | Other | Patients will receive standard of care treatment only. Receives: Drug: Standard therapy or clinical trial |
What is being measured
The primary outcome is the main question the study is designed to answer.
Type and frequency of genetic aberrations in BRAF/NRAS wild-type metastatic melanoma
Genetic aberrations detected by extended molecular profiling in patients with BRAF / NRAS wild type metastatic melanoma.
Measured: For the duration of the study, estimated at 5 years.
Proportion of patients with BRAS/NRAS wild-type melanoma receiving targeted therapy
Patients able to receive matched targeted therapy as a result of genetic aberrations detected with extended molecular profiling, from a pool of all BRAF / NRAS wild type patients.
Measured: For the duration of the study, estimated at 5 years.
Secondary outcomes (9)
Proportion of patients who have BRAF/NRAS wild type melanoma
From consecutive patients with metastatic melanoma tested for common BRAF / NRAS mutations as part of standard care.
Measured: For the duration of the study, estimated at 5 years.
Proportion of patients with complete (CR) or partial (PR) response.
Proportion of patients who received matched targeted therapy as a result of genetic aberrations detected with extended molecular profiling who had a complete (CR) or partial (PR) response.
Measured: From date of targeted therapy commencement until the date of first documented objective partial or complete response per RECIST, assessed up to 60 months.
Duration of response
For patients experiencing a complete or partial response to study treatment, the amount of time from this outcome to the time that disease progression or death occurs
Measured: From date of first objective partial or complete response to disease progression or death, which ever is sooner, assessed up to 60 months.
Progression free survival
The period of time from study entry to progression of disease or death
Measured: From date of targeted therapy commencement to date of objective disease progression per RECIST, assessed up to 60 months.
Overall survival
The proportion of patients alive from the time of study entry
Measured: From date of targeted therapy commencement to date of death from any cause, assessed up to 60 months.
Correlation of genetic aberration detected in tumour tissue with clinical response and disease progression
Identify genetic predictors of response and progression using the extended molecular testing platform.
Measured: From date of targeted therapy commencement to date of to partial or complete response or disease progression, assessed up to 60 months.
Correlation of with genetic aberration detected in tumour tissue with age at diagnosis, site of primary tumour, chronic sun damaged skin.
Identify clinicopathological correlates (e.g. age at diagnosis, site of primary tumour, chronic sun damaged skin etc.) of molecular subtypes of melanoma at baseline.
Measured: At baseline
Correlation of genetic aberration detected in tumour tissue with site of metastases, nodular or superficial spreading disease.
Identify the differences in disease behaviour (e.g. site of metastases, nodular or superficial spreading disease) based on molecular subtypes of melanoma.
Measured: At baseline
Adverse events in patients receiving matched targeted therapy.
Characterisation of adverse events by type, frequency and severity using CTCAE version 5.0
Measured: From date of the start of targeted therapy to 30 days from discontinuation of targeted therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2016 (estimated)
- Study start22 Nov 2021
- Primary completion1 Nov 2025
- Study completion6 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 216 participants (actual)
Sponsor and investigators
- Lead sponsor
- Melanoma Institute Australia
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis
- Responsible party
- Sponsor
- Investigators
- Alex Menzies, Study chair, Melanoma Institute Australia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02645149
- Sponsor's protocol ID
- MIA2015/174
- Acronym
- Match Mel
- Status last verified
- Feb 2026
- First submitted
- 27 Dec 2015
- Last updated
- 29 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nassar KW, Hintzsche JD, Bagby SM, Espinoza V, Langouet-Astrie C, Amato CM, Chimed TS, Fujita M, Robinson W, Tan AC, Schweppe RE. Targeting CDK4/6 Represents a Therapeutic Vulnerability in Acquired BRAF/MEK Inhibitor-Resistant Melanoma. Mol Cancer Ther. 2021 Oct;20(10):2049-2060. doi: 10.1158/1535-7163.MCT-20-1126. Epub 2021 Aug 10.
PubMed 34376578
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Profiling and Matched Targeted Therapy for Patients With Unresectable Advanced or Metastatic Melanoma
- ClinicalTrials.gov ID
- NCT02645149
- Acronym / sponsor ID
- Match Mel / MIA2015/174
- Conditions
- Melanoma
- Keywords
- Metastatic Melanoma, Molecular Testing, Targeted Therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 216 participants (actual)
- Lead sponsor
- Melanoma Institute AustraliaUniversity, hospital or other
- Collaborators
- Novartis
- Study start
- 22 Nov 2021 (actual)
- Primary completion
- 1 Nov 2025 (actual)
- Study completion
- 6 Mar 2026 (actual)
- First posted
- 1 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a patient oriented translational research project aiming to improve clinical outcomes for patients with BRAF and NRAS wild-type unresectable Stage III or Stage IV metastatic melanoma who have progressed on, or are unable to receive standard therapy (in general, immunotherapy). Consecutive patients seen at three major clinics and fitting the broad eligibility criteria will be invited to participate.
The approach is designed to test the impact of different targeted drugs on different mutations in a single type of cancer. In this project, patients will have tumour tissue genetically profiled to determine which mutation(s) are present, and will then be assigned to receive a matched drug expected to target the mutation(s) in the tumour. Where multiple targets are identified in one patient, or where multiple potential therapies would be appropriate for a single tumour mutation, the treating clinician may determine the appropriate therapeutic approach after consultation with the study team, using the latest version of library of matched therapies.
Detailed description
Current standard of care testing covers mutations in the BRAF and NRAS genes. The comprehensive gene testing platform to be used in this project is designed to interrogate the entire coding sequence of 315 cancer-related genes plus introns from 28 genes often rearranged or altered in cancer. These genes are known to be somatically altered in solid cancers based on recent scientific and clinical literature. The test panel will be used on melanoma tissue from patients pre-screened as having BRAF and NRAS wild-type melanoma. The extent of testing will be updated to reflect new discoveries in melanoma tumourigenesis and availability of new therapies as the project proceeds. Testing will be performed on formalin-fixed and paraffin-embedded samples of metastatic tissue. Archival tissue from primary or regional recurrent melanoma may be considered if no recent sample is available or possible.
All new patients with unresectable Stage III or IV melanoma seen at each participating site will be invited to participate. Following written consent, all patients will undergo the standard testing for BRAF and NRAS mutations. Patients found to have mutations in either gene will receive standard treatment with dabrafenib and / or trametinib and no further molecular testing.
Patients with wild type versions of BRAF and NRAS genes will have tumour tissue sent for the extended gene testing platform. These patients will first receive standard of care therapy for wild type BRAF / NRAS melanoma, where possible. Once standard therapies have been exhausted (because of disease progression or intolerable adverse events), patients will then receive a targeted therapy matched for their genetic result, if applicable. The selection of targeted therapy will be based on clinical evidence of activity in other solid tumours harbouring similar mutations and / or in at least Phase I testing in melanoma. The table of matched therapies will be modified and extended as new findings from clinical research become available. Patients may be included in specific clinical trials of targeted therapies if available, e.g. a MEK inhibitor combined with an MDM2 inhibitor (AMG232) for BRAF and TP53 wild-type melanoma or a MEK inhibitor combined with a CDK4/6 inhibitor for BRAF wild-type melanoma.
The extensive molecular profiling platform is fully validated and will be conducted by an external provider accredited by an authority with the responsibility to award Laboratory Accreditation at private and public facilities.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| A1. Non-V600 BRAF, BRAF wildtype, NRAS wildtype. Actionable gene mutation, matched drug available | Experimental | Drug: Matched targeted therapyPatients will receive targeted drug matched to the actionable gene mutation detected on NGS testing. If a patient cannot receive the matched targeted therapy because of the existence of one or more drug specific exclusion criteria, an alternative matched therapy may be assigned, or trametinib, or clinical trials if available. |
| A2. Non-V600 BRAF, BRAF wildtype, NRAS wildtype. Actionable gene mutation, no matched drug available | Experimental | Drug: Compassionate Access Targeted TherapyPatients may have an actionable aberration for which there is no current study-specific drug supply available. In this scenario, access will be sought for compassionate use of the relevant approved targeted therapy. |
| A3. Non-V600 BRAF, BRAF wild type and NRAS wild type melanoma - no actionable genetic aberration | Experimental | Drug: Trametinib and / or supportive carePatients for whom there is no actionable genetic aberration will receive trametinib, based upon the known MAPK excess activity in the majority of melanomas that may be inhibited by a MEK inhibitor |
| B. Mucosal melanoma | Experimental | Drug: CDK4/6 and MEK inhibitorPatients will receive combined trametinib and ribociclib based on evidence to suggest that combined MEK inhibition and CDK4/6 inhibition may be effective. After failure of trametinib and ribociclib, actionable genetic aberrations from the NGS testing will be reviewed for the opportunity to use a further targeted therapy off label. |
| C. NRAS mutant melanoma | Experimental | Drug: CDK4/6 and MEK inhibitorPatients with an NRAS mutation detected on standard gene testing only will receive combined trametinib and ribociclib based on evidence that combining MEK inhibition and CDK4/6 inhibition is a viable treatment option. |
| D. BRAF V600 mutant melanoma | Other | Drug: Standard therapy or clinical trialPatients will receive standard of care treatment only. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (28 listed)
- Written informed consent for Part 1
- Newly diagnosed, histologically confirmedand , unresectable Stage IIIB, IIIC or Stage IV melanoma including cutaneous (including acral, ungual subtypes), ocular (including uveal and extra-uveal), mucosal, and unknown primary).
- Treatment-naïve for unresectable advanced orf metastatic melanoma (systemic treatment given in the neoadjuvant and adjuvant settings are acceptable).
- Tumour tissue available from advanced or metastatic disease. Archival tissue from primary or regional recurrent melanoma may be considered if no recent sample is available.
- Male or female patients aged 18 or over.
Key exclusion criteria (5 listed)
- An expectation for the need for concurrent radiotherapy (unless safety has been established with the matched drug regimen and is directed at one anatomical region for symptom control).
- Any clinically significant gastrointestinal abnormalities which may impair intake or absorption of the study drug.
- Any investigational drug or other systemic drug therapy for melanoma within 14 days or 5 half-lives from baseline, whichever is shorter.
- Pregnant or breast feeding females.
- Drug specific exclusions as detailed in the TGA Product Information for each drug.
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 |
|---|---|---|
| Standard therapy or clinical trialAlso: Immunotherapy, Biological agentPatients with BRAF V600 mutations detected by standard of care tumour testing will be treated with standard approved therapies or on clinical trials. | Drug | D. BRAF V600 mutant melanoma |
| Matched targeted therapyAlso: ALK - Ceritinib, BRAF fusion - Trametinib, CCND1 - Ribociclib + Trametinib, CDK4/6 - Ribociclib + TrametinibPatients with tumour found to be non-V600 BRAF, BRAF wildtype and NRAS wildtype melanoma will have tumour tested further using the extended molecular testing platform designed for this project. Patients will first receive standard therapy(ies) for non-V600 BRAF, wildtype and NRAS wildtype melanoma until disease progression or intolerable drug toxicities. Followed by a targeted therapy matched to the genetic aberration detected in their tumour on NGS testing. | Drug | A1. Non-V600 BRAF, BRAF wildtype, NRAS wildtype. Actionable gene mutation, matched drug available |
| Trametinib and / or supportive careAlso: Trametinib, Supportive carePatients with non-V600 BRAF, BRAF wildtype and NRAS wildtype melanoma for whom there is no actionable genetic aberration found on extended molecular testing, may receive trametinib (if not already administered as part of standard care) and/or supportive care. | Drug | A3. Non-V600 BRAF, BRAF wild type and NRAS wild type melanoma - no actionable genetic aberration |
| CDK4/6 and MEK inhibitorAlso: Ribociclib + TrametinibPatients mucosal melanoma and any genetic aberration on NGS testing may receive ribociclib + trametinib initially. After failure of trametinib and ribociclib, actionable genetic aberrations from the NGS testing will be reviewed for the opportunity to use a further targeted therapy off label. Patients with an NRAS mutation on standard of care tumour testing will also receive ribociclib + trametinib. | Drug | B. Mucosal melanoma, C. NRAS mutant melanoma |
| Compassionate Access Targeted TherapyAlso: Off label use of a matched targeted therapy currently unavailable to the studyPatients with non-V600 BRAF, BRAF wildtype and NRAS wildtype melanoma may have an actionable aberration(s) for which there is no current study-specific drug supply. In this scenario, access will be sought for compassionate use of the off label use of the relevant regulatory approved targeted therapy | Drug | A2. Non-V600 BRAF, BRAF wildtype, NRAS wildtype. Actionable gene mutation, no matched drug available |
Primary outcome
Type and frequency of genetic aberrations in BRAF/NRAS wild-type metastatic melanoma
Time frame: For the duration of the study, estimated at 5 years.
Genetic aberrations detected by extended molecular profiling in patients with BRAF / NRAS wild type metastatic melanoma.
Proportion of patients with BRAS/NRAS wild-type melanoma receiving targeted therapy
Time frame: For the duration of the study, estimated at 5 years.
Patients able to receive matched targeted therapy as a result of genetic aberrations detected with extended molecular profiling, from a pool of all BRAF / NRAS wild type patients.
9 secondary outcomes
Proportion of patients who have BRAF/NRAS wild type melanoma
Time frame: For the duration of the study, estimated at 5 years.
Proportion of patients with complete (CR) or partial (PR) response.
Time frame: From date of targeted therapy commencement until the date of first documented objective partial or complete response per RECIST, assessed up to 60 months.
Duration of response
Time frame: From date of first objective partial or complete response to disease progression or death, which ever is sooner, assessed up to 60 months.
Progression free survival
Time frame: From date of targeted therapy commencement to date of objective disease progression per RECIST, assessed up to 60 months.
Overall survival
Time frame: From date of targeted therapy commencement to date of death from any cause, assessed up to 60 months.
Correlation of genetic aberration detected in tumour tissue with clinical response and disease progression
Time frame: From date of targeted therapy commencement to date of to partial or complete response or disease progression, assessed up to 60 months.
Correlation of with genetic aberration detected in tumour tissue with age at diagnosis, site of primary tumour, chronic sun damaged skin.
Time frame: At baseline
Correlation of genetic aberration detected in tumour tissue with site of metastases, nodular or superficial spreading disease.
Time frame: At baseline
Adverse events in patients receiving matched targeted therapy.
Time frame: From date of the start of targeted therapy to 30 days from discontinuation of targeted therapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
- Derived from this study: PubMed 34376578Nassar KW, Hintzsche JD, Bagby SM, Espinoza V, Langouet-Astrie C, Amato CM, Chimed TS, Fujita M, Robinson W, Tan AC, Schweppe RE. Targeting CDK4/6 Represents a Therapeutic Vulnerability in Acquired BRAF/MEK Inhibitor-Resistant Melanoma. Mol Cancer Ther. 2021 Oct;20(10):2049-2060. doi: 10.1158/1535-7163.MCT-20-1126. Epub 2021 Aug 10.
- Individual participant dataSharing planned: No
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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.
Alex Menzies study chair
Melanoma Institute Australia
2 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 Standard therapy or clinical trial, Matched targeted therapy and Trametinib and / or supportive care in people with Melanoma, run by Melanoma Institute Australia at 2 sites in Australia.
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 28 inclusion and 5 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 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Type and frequency of genetic aberrations in BRAF/NRAS wild-type metastatic melanoma (time frame: For the duration of the study, estimated at 5 years.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02645149, which also lists 1 linked publication.
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 29 May 2026.