deltatrials
Completed PHASE3 INTERVENTIONAL 2-arm NCT01584648

A Study Comparing Trametinib and Dabrafenib Combination Therapy to Dabrafenib Monotherapy in Subjects With BRAF-mutant Melanoma

A Phase III, Randomized, Double-blinded Study Comparing the Combination of the BRAF Inhibitor, Dabrafenib and the MEK Inhibitor, Trametinib to Dabrafenib and Placebo as First-line Therapy in Subjects With Unresectable (Stage IIIC) or Metastatic (Stage IV) BRAF V600E/K Mutation-positive Cutaneous Melanoma

Sponsor: Novartis Pharmaceuticals

Conditions Melanoma
Interventions Dabrafenib Trametinib Trametinib placebo
Updated 13 times since 2017 Last updated: Feb 8, 2021 Started: May 4, 2012 Primary completion: Aug 26, 2013 Completion: Feb 28, 2019
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE3 trial investigates Melanoma and is currently completed. Novartis Pharmaceuticals leads this study, which shows 13 recorded versions since 2012 — indicating substantial longitudinal coverage. As an oncology study, it adds to the longitudinal record of treatment development for this indication.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshot~Feb 2017 – ~May 2017 · 3 months · monthly snapshot~May 2017 – ~Oct 2017 · 5 months · monthly snapshot~Oct 2017 – ~Jun 2018 · 8 months · monthly snapshot~Jun 2018 – ~Sep 2018 · 3 months · monthly snapshot~Sep 2018 – ~May 2019 · 8 months · monthly snapshot~May 2019 – ~Jan 2021 · 20 months · monthly snapshot~Jan 2021 – ~Mar 2021 · 59 days · monthly snapshot~Mar 2021 – ~Jul 2024 · 40 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshot~Sep 2025 – present · 7 months · monthly snapshot~Jan 2026 – present · 3 months · monthly snapshot

Change History

13 versions recorded

  1. Jan 2026 — Present [monthly]

    Completed PHASE3

  2. Sep 2025 — Present [monthly]

    Completed PHASE3

  3. Sep 2024 — Sep 2025 [monthly]

    Completed PHASE3

  4. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE3

  5. Mar 2021 — Jul 2024 [monthly]

    Completed PHASE3

▶ Show 8 earlier versions

  1. Jan 2021 — Mar 2021 [monthly]

    Completed PHASE3

  2. May 2019 — Jan 2021 [monthly]

    Completed PHASE3

    Status: Active Not Recruiting → Completed

  3. Sep 2018 — May 2019 [monthly]

    Active Not Recruiting PHASE3

  4. Jun 2018 — Sep 2018 [monthly]

    Active Not Recruiting PHASE3

  5. Oct 2017 — Jun 2018 [monthly]

    Active Not Recruiting PHASE3

  6. May 2017 — Oct 2017 [monthly]

    Active Not Recruiting PHASE3

  7. Feb 2017 — May 2017 [monthly]

    Active Not Recruiting PHASE3

  8. Jan 2017 — Feb 2017 [monthly]

    Active Not Recruiting PHASE3

    First recorded

May 2012

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Novartis Pharmaceuticals
Data source: Novartis

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Aberdeen, United Kingdom , Adelaide, Australia , Amsterdam, Netherlands , Athens, Greece , Augsburg, Germany , Barcelona, Spain , Bebington, United Kingdom , Bergamo, Italy , Berlin, Germany , Bonn, Germany and 98 more locations