Clinical trial Recruiting at 5 sites Phase 4 Interventional Ages 18 to 100

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.

More Non-Small Cell Lung Cancer trials

Quick facts

PhasePhase 4
Study typeInterventional
Ages18 Years to 100 Years
SexAll
Enrollment100 (estimated)
SponsorNovartis
Industry-sponsored
Drugs / interventionstrametinib
Locations37 sites (Scottsdale, Arizona and 36 other locations)
StatusRecruiting
StartedJanuary 26, 2018
Main results expectedDecember 28, 2032
Study endsDecember 28, 2032
Registry record updatedNovember 10, 2026
Trial IDNCT03340506 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

  • 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
  • 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

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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  • Testing a new treatment for advanced solid tumors with pembrolizumab

    This study is testing a new treatment using INBRX-106 alone and with pembrolizumab to see if it can help people with advanced solid tumors that haven't responded to other treatments.

    Recruiting at 17 sites Phase 1/2 Inhibrx Biosciences, Inc · Duarte, California and 59 other locations · NCT04198766

  • SI-B036 safety test in advanced and metastatic solid tumors

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  • IBI3028 in advanced solid tumors

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.