Access to continued treatment with dabrafenib and/or trametinib for eligible patients
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
Run by Novartis · NCT03340506 · Data updated 2026-11-12
This study is for patients with melanoma, lung cancer, or other solid tumors who have been doing well on dabrafenib and/or trametinib and want to keep getting these treatments without a break.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Novartis Industry-sponsored |
| Drugs / interventions | trametinib |
| Locations | 37 sites (Scottsdale, Arizona and 36 other locations) |
| Status | Recruiting |
| Started | January 26, 2018 |
| Main results expected | December 28, 2032 |
| Study ends | December 28, 2032 |
| Registry record updated | November 10, 2026 |
| Trial ID | NCT03340506 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are patients currently receiving dabrafenib and/or trametinib in a qualifying study who are judged by their investigator to benefit from ongoing treatment.
✕Probably not a fit
Patients who have been permanently discontinued from study treatment in the parent protocol or whose indication is commercially available may not receive benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study provides ongoing access to patients who have been receiving treatment with dabrafenib and/or trametinib in previous Novartis or former GSK-sponsored studies. It aims to allow patients who have met the primary objectives of those studies and are deemed by investigators to benefit from continued treatment to remain on these therapies. The study focuses on patients with conditions such as melanoma, non-small cell lung cancer, and other solid tumors. It is designed to ensure that patients who have shown positive responses can continue their treatment without interruption.
Why it matters
Potential benefit: If successful, this study could provide patients with continued access to effective cancer treatments that they have already benefited from.
How similar studies have gone: Other studies involving dabrafenib and trametinib have shown success in treating similar conditions, indicating a promising approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
Where it's running
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Novartis Investigative Site
Toronto, Ontario, Canada Recruiting -
Novartis Investigative Site
Villejuif, France Recruiting -
Novartis Investigative Site
Barcelona, Spain Recruiting -
Novartis Investigative Site
Madrid, Spain Recruiting -
Novartis Investigative Site
Madrid, Spain Recruiting -
Honor Health Research Institute
Scottsdale, Arizona, United States Active not recruiting
Show 31 more locations
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National Institute Of Health
Bethesda, Maryland, United States Active not recruiting -
James Cancer Hospital and Solove Research Institute Ohio State
Columbus, Ohio, United States Completed -
Mary Crowley Cancer Research
Dallas, Texas, United States Completed -
Novartis Investigative Site
Caba, Buenos Aires, Argentina Completed -
Novartis Investigative Site
Innsbruck, Tyrol, Austria Active not recruiting -
Novartis Investigative Site
Beijing, China Completed -
Novartis Investigative Site
Brno, Czechia Active not recruiting -
Novartis Investigative Site
Prague, Czechia Active not recruiting -
Novartis Investigative Site
Copenhagen, Denmark Active not recruiting -
Novartis Investigative Site
Lyon, France Active not recruiting -
Novartis Investigative Site
Nantes, France Completed -
Novartis Investigative Site
Paris, France Active not recruiting -
Novartis Investigative Site
Paris, France Completed -
Novartis Investigative Site
Mannheim, Baden-Wurttemberg, Germany Completed -
Novartis Investigative Site
Augsburg, Germany Active not recruiting -
Novartis Investigative Site
Berlin, Germany Completed -
Novartis Investigative Site
Essen, Germany Active not recruiting -
Novartis Investigative Site
Hamburg, Germany Completed -
Novartis Investigative Site
Hamburg, Germany Active not recruiting -
Novartis Investigative Site
Heidelberg, Germany Active not recruiting -
Novartis Investigative Site
Debrecen, Hajdu Bihar Megye, Hungary Completed -
Novartis Investigative Site
Budapest, Hungary Completed -
Novartis Investigative Site
Kashiwa, Chiba, Japan Completed -
Novartis Investigative Site
Chuo Ku, Tokyo, Japan Completed -
Novartis Investigative Site
Rotterdam, South Holland, Netherlands Completed -
Novartis Investigative Site
Utrecht, Netherlands Active not recruiting -
Novartis Investigative Site
Moscow, Russia Active not recruiting -
Novartis Investigative Site
Madrid, Spain Active not recruiting -
Novartis Investigative Site
Madrid, Spain Completed -
Novartis Investigative Site
Valencia, Spain Active not recruiting -
Novartis Investigative Site
Songkhla, Hat Yai, Thailand Active not recruiting
Study contacts
- Study coordinator: Novartis Pharmaceuticals
- Email: novartis.email@novartis.com
- Phone: 1-888-669-6682
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.