Recruiting
Phase 4

Dabrafenib & Trametinib

Sponsor:

Novartis Pharmaceuticals

Code:

NCT03340506

Conditions

Melanoma

Non Small Cell Lung Cancer

Solid Tumor

Rare Cancers

High Grade Glioma

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

dabrafenib

trametinib

Study Details

Brief 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 benefiting from continued treatment in the parent study as judged by the Investigator at the completion of the parent study.

Conditions

Melanoma

Non Small Cell Lung Cancer

Solid Tumor

Rare Cancers

High Grade Glioma

Study ID

NCT03340506

Start date

Jan 26, 2018

Status verified date

Oct, 2026

Completion date

Dec 28, 2032

Anticipated

Primary completion date

Dec 28, 2032

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

100 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: dabrafenib monotherapy

Patients in this study may receive:

\- monotherapy of dabrafenib

experimental: trametinib monotherapy

Patients in this study may receive:

\- monotherapy of trametinib

experimental: Combination therapy (dabrafenib & trametinib)

Patients in this study may receive:

\- the combination of dabrafenib and trametinib

Interventions

dabrafenib

dabrafenib is available in capsules (50mg and 75mg) taken twice a day

trametinib

trametinib is available in tablets (0.5mg, 2mg dose)

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. ]

Central Contacts and Locations

Central contacts

Novartis Pharmaceuticals

1-888-669-6682novartis.email@novartis.com

Novartis Pharmaceuticals

+41613241111novartis.email@novartis.com

Locations

Novartis Investigative Site

Recruiting

Toronto, Ontario, Canada, M5G 1X8

More Information

Sponsor

Novartis Pharmaceuticals

Last update posted

Oct 22, 2026

Last verified

Oct, 2026

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-24. This information was provided to ClinicalTrials.gov by Novartis Pharmaceuticals on 2026-10-22. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.