MelanomaPhase 4NCT03340506
Dabrafenib and/or Trametinib Rollover Study
A Phase 4 study testing dabrafenib and trametinib in people with Melanoma and Non Small Cell Lung Cancer, run by Novartis Pharmaceuticals at 38 sites in 15 countries.
Trial summary
This study is to provide access for patients who are receiving treatment with dabrafenib and/or trametinib in a Novartis-sponsored Oncology Global Development, Global Medical Affairs or a former GSK-sponsored study who have fulfilled the requirements for the primary objective, and who are judged by the investigator as… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Melanoma, Non Small Cell Lung Cancer, Solid Tumor
- What is being tested?
- dabrafenib and trametinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 38 sitesin 15 countries
- Study dates
- 26 Jan 2018to 28 Dec 2032
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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
- Patient is currently receiving treatment with dabrafenib/trametinib monotherapy or combination within a Novartis or former GSK sponsored study which has fulfilled the requirements for the primary objective.
- In the opinion of the Investigator would benefit from continued treatment.
Who cannot join
- Patient has been previously permanently discontinued from study treatment in the parent protocol.
- Patient's indication is commercially available and reimbursed in the local country.
- Patient currently has unresolved toxicities for which dabrafenib and/or trametinib dosing has been interrupted in the parent study.
Trial locations and contacts
38 sites in 15 countries. Contact the study team or a site near you to ask about taking part.
38 sites in 15 countries
Germany7 sites
- Active, not recruiting
Novartis Investigative Site
Augsburg, 86179
- Completed
Novartis Investigative Site
Berlin, 13353
- Active, not recruiting
Novartis Investigative Site
Essen, 45147
- Completed
Novartis Investigative Site
Hamburg, 20246
- Active, not recruiting
Novartis Investigative Site
Hamburg, 20246
- Active, not recruiting
Novartis Investigative Site
Heidelberg, 69120
- Completed
Novartis Investigative Site
Mannheim, Baden-Wurttemberg, 68305
Spain7 sites, 4 recruiting
- Recruiting
Novartis Investigative Site
Barcelona, 08035
- Recruiting
Novartis Investigative Site
Madrid, 28009
- Active, not recruiting
Novartis Investigative Site
Madrid, 28009
- Recruiting
Novartis Investigative Site
Madrid, 28040
- Completed
Novartis Investigative Site
Madrid, 28041
- Recruiting
Novartis Investigative Site
Madrid, 28050
- Active, not recruiting
Novartis Investigative Site
Valencia, 46026
France5 sites, 1 recruiting
- Active, not recruiting
Novartis Investigative Site
Lyon, 69373
- Completed
Novartis Investigative Site
Nantes, 44093
- Active, not recruiting
Novartis Investigative Site
Paris, 75231
- Completed
Novartis Investigative Site
Paris, 75970
- Recruiting
Novartis Investigative Site
Villejuif, 94800
United States4 sites
- Active, not recruiting
National Institute Of Health
Bethesda, Maryland, 20892
- Completed
James Cancer Hospital and Solove Research Institute Ohio State
Columbus, Ohio, 43210
- Completed
Mary Crowley Cancer Research
Dallas, Texas, 75251
- Active, not recruiting
Honor Health Research Institute
Scottsdale, Arizona, 85258
Czechia2 sites, 2 recruiting
- Recruiting
Novartis Investigative Site
Brno, 625 00
- Recruiting
Novartis Investigative Site
Prague, 150 06
Hungary2 sites
- Completed
Novartis Investigative Site
Budapest, 1122
- Completed
Novartis Investigative Site
Debrecen, Hajdu Bihar Megye, 4032
Japan2 sites
- Completed
Novartis Investigative Site
Chuo Ku, Tokyo, 1040045
- Completed
Novartis Investigative Site
Kashiwa, Chiba, 2778577
Netherlands2 sites
- Completed
Novartis Investigative Site
Rotterdam, South Holland, 3015 GD
- Active, not recruiting
Novartis Investigative Site
Utrecht, 3584 CX
Argentina1 site
- Completed
Novartis Investigative Site
Caba, Buenos Aires, C1121ABE
Austria1 site
- Active, not recruiting
Novartis Investigative Site
Innsbruck, Tyrol, 6020
Canada1 site, 1 recruiting
- Recruiting
Novartis Investigative Site
Toronto, Ontario, M5G 1X8
Denmark1 site
- Active, not recruiting
Novartis Investigative Site
Copenhagen, 2100
Russia1 site, 1 recruiting
- Recruiting
Novartis Investigative Site
Moscow, 117198
Thailand1 site
- Active, not recruiting
Novartis Investigative Site
Songkhla, Hat Yai, 90110
About this study
Official title: Open Label, Multi-center Roll-over Study to Assess Long Term Safety in Patients Who Have Completed a Global Novartis or GSK Sponsored Dabrafenib and/or Trametinib Study
This study is to provide access for patients who are receiving treatment with dabrafenib and/or trametinib in a Novartis-sponsored Oncology Global Development, Global Medical Affairs or a former GSK-sponsored study who have fulfilled the requirements for the primary objective, and who are judged by the investigator as benefiting from continued treatment in the parent study as judged by the Investigator at the completion of the parent study.
- Being tested
- dabrafenib, trametinib
- Keywords
- Tafinlar, Mekinist, Dabrafenib, Trametinib, Adult, Melanoma, Melanoma Stage IV, Metastatic Melanoma, Advanced Melanoma, Lung Cancer, NSLC, Non Small Cell Lung Cancer, BRAF V600 Mutation, BRAF Gene Mutation, Solid tumor, Rare cancers, High Grade Glioma
- Medical subject headings
- Melanoma, Carcinoma, Non-Small-Cell Lung, Glioma, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dabrafenibDrug
dabrafenib is available in capsules (50mg and 75mg) taken twice a day
trametinibDrug
trametinib is available in tablets (0.5mg, 2mg dose)
| Study group | Role | What they receive |
|---|---|---|
| dabrafenib monotherapy | Experimental | Patients in this study may receive:
- monotherapy of dabrafenib Receives: Drug: dabrafenib |
| trametinib monotherapy | Experimental | Patients in this study may receive:
- monotherapy of trametinib Receives: Drug: trametinib |
| Combination therapy (dabrafenib & trametinib) | Experimental | Patients in this study may receive:
- the combination of dabrafenib and trametinib Receives: Drug: dabrafenib; Drug: trametinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurences of adverse events to evaluate long term safety and tolerability of dabrafenib, trametinib or combination
Clinical and laboratory assessments should be completed based on the local standard of care and physician practice for routine safety monitoring. More frequent examinations may be performed at the Investigator's discretion if medically indicated. Any abnormalities considered clinically significant, induce clinical signs or symptoms, or require changes in treatment constitute an adverse event.
Measured: Baseline up to approximately 10 years after the first subject's first visit, or will remain open until treatment becomes commercially available and reimbursed, or another access program becomes available, whichever comes first.
Secondary outcomes (1)
Clinical Benefit Assessment by investigator
To evaluate clinical benefit as assessed by the Investigator
Measured: Baseline up to approximately 10 years after the first subject's first visit, or will remain open until treatment becomes commercially available and reimbursed, or another access program becomes available, whichever comes first.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2017
- Study start26 Jan 2018
- Primary completion28 Dec 2032 (estimated)
- Study completion28 Dec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03340506
- Sponsor's protocol ID
- CDRB436X2X02B
- Other IDs
- 2023-509318-13-00, 2023
- Status last verified
- Oct 2026
- First submitted
- 8 Nov 2017
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label, Multi-center Roll-over Study to Assess Long Term Safety in Patients Who Have Completed a Global Novartis or GSK Sponsored Dabrafenib and/or Trametinib Study
- ClinicalTrials.gov ID
- NCT03340506
- Acronym / sponsor ID
- CDRB436X2X02B
- Keywords
- Tafinlar, Mekinist, Dabrafenib, Trametinib, Adult, Melanoma, Melanoma Stage IV, Metastatic Melanoma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 26 Jan 2018 (actual)
- Primary completion
- 28 Dec 2032 (estimated)
- Study completion
- 28 Dec 2032 (estimated)
- First posted
- 13 Nov 2017 (actual)
- 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 study is to provide access for patients who are receiving treatment with dabrafenib and/or trametinib in a Novartis-sponsored Oncology Global Development, Global Medical Affairs or a former GSK-sponsored study who have fulfilled the requirements for the primary objective, and who are judged by the investigator as benefiting from continued treatment in the parent study as judged by the Investigator at the completion of the parent study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| dabrafenib monotherapy | Experimental | Drug: dabrafenibPatients in this study may receive: - monotherapy of dabrafenib |
| trametinib monotherapy | Experimental | Drug: trametinibPatients in this study may receive: - monotherapy of trametinib |
| Combination therapy (dabrafenib & trametinib) | Experimental | Drug: dabrafenib, Drug: trametinibPatients in this study may receive: - the combination of dabrafenib and trametinib |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient is currently receiving treatment with dabrafenib/trametinib monotherapy or combination within a Novartis or former GSK sponsored study which has fulfilled the requirements for the primary objective.
- In the opinion of the Investigator would benefit from continued treatment.
Key exclusion criteria (3 listed)
- Patient has been previously permanently discontinued from study treatment in the parent protocol.
- Patient's indication is commercially available and reimbursed in the local country.
- Patient currently has unresolved toxicities for which dabrafenib and/or trametinib dosing has been interrupted in the parent study.
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 |
|---|---|---|
| dabrafenibdabrafenib is available in capsules (50mg and 75mg) taken twice a day | Drug | Combination therapy (dabrafenib & trametinib), dabrafenib monotherapy |
| trametinibtrametinib is available in tablets (0.5mg, 2mg dose) | Drug | Combination therapy (dabrafenib & trametinib), trametinib monotherapy |
Primary outcome
Occurences of adverse events to evaluate long term safety and tolerability of dabrafenib, trametinib or combination
Time frame: Baseline up to approximately 10 years after the first subject's first visit, or will remain open until treatment becomes commercially available and reimbursed, or another access program becomes available, whichever comes first.
Clinical and laboratory assessments should be completed based on the local standard of care and physician practice for routine safety monitoring. More frequent examinations may be performed at the Investigator's discretion if medically indicated. Any abnormalities considered clinically significant, induce clinical signs or symptoms, or require changes in treatment constitute an adverse event.
1 secondary outcome
Clinical Benefit Assessment by investigator
Time frame: Baseline up to approximately 10 years after the first subject's first visit, or will remain open until treatment becomes commercially available and reimbursed, or another access program becomes available, whichever comes first.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- Individual participant dataSharing planned: Yes. Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
38 sites in 15 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing dabrafenib and trametinib in people with Melanoma and Non Small Cell Lung Cancer, run by Novartis Pharmaceuticals at 38 sites in 15 countries.
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 2 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 38 sites in Germany, Spain, France, United States, Czechia and 10 more countries. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Novartis Pharmaceuticals (1-888-669-6682, novartis.email@novartis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurences of adverse events to evaluate long term safety and tolerability of dabrafenib, trametinib or combination (time frame: Baseline up to approximately 10 years after the first subject's first visit, or will remain open until treatment becomes commercially available and reimbursed, or another access program becomes available, whichever comes first.). 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 22 Oct 2026.