Dabrafenib With Trametinib in the Adjuvant Treatment of High-risk BRAF V600 Mutation-positive Melanoma (COMBI-AD). (COMBI-AD)
COMBI-AD: A Phase III Randomized Double Blind Study of Dabrafenib (GSK2118436) in COMBInation With Trametinib (GSK1120212) Versus Two Placebos in the ADjuvant Treatment of High-risk BRAF V600 Mutation-positive Melanoma After Surgical Resection
Sponsor: Novartis Pharmaceuticals
A observational or N/A phase clinical study on Melanoma, this trial is completed. The trial is conducted by Novartis Pharmaceuticals and has accumulated 21 data snapshots since 2013. Oncology trials at this stage typically focus on safety, tolerability, and early efficacy signals.
Study Description(click to expand)The study periods were follows:
1. Screening: Assessments were to be completed within 28 days of randomization.
2. Treatment: The treatment period was 12 months. Discontinuation of study treatment could occur earlier than 12 months for disease recurrence, death, unacceptable toxicity or withdrawal of consent.
3. Post treatment follow-up (before recurrence): Patients were to be followed for disease recurrence every 3 months after the end of treatment until Month 24, every 6 months after Month 24 and annually after Month 60 (365 days +/- 14 days from last visit).
4. Post treatment follow-up (after recurrence): After disease recurrence patients remained on study for follow-up assessments every 3 months until Month 24, every 6 months after Month 24, and annually after Month 60 (365 days +/- 14 days from last visit).
The study periods were follows:
1. Screening: Assessments were to be completed within 28 days of randomization. 2. Treatment: The treatment period was 12 months. Discontinuation of study treatment could occur earlier than 12 months for disease recurrence, death, unacceptable toxicity or withdrawal of consent. 3. Post treatment follow-up (before recurrence): Patients were to be followed for disease recurrence every 3 months after the end of treatment until Month 24, every 6 months after Month 24 and annually after Month 60 (365 days +/- 14 days from last visit). 4. Post treatment follow-up (after recurrence): After disease recurrence patients remained on study for follow-up assessments every 3 months until Month 24, every 6 months after Month 24, and annually after Month 60 (365 days +/- 14 days from last visit).
Status Flow
Change History
21 versions recorded-
Apr 21, 2026 — Present [daily]
Completed
Phase: PHASE3 → None
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Sep 2025 — Apr 2026 [monthly]
Completed PHASE3
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Sep 2024 — Sep 2025 [monthly]
Completed PHASE3
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Jul 2024 — Sep 2024 [monthly]
Completed PHASE3
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Sep 2023 — Jul 2024 [monthly]
Completed PHASE3
Status: Active Not Recruiting → Completed
▶ Show 16 earlier versions
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Apr 2023 — Sep 2023 [monthly]
Active Not Recruiting PHASE3
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Jan 2023 — Apr 2023 [monthly]
Active Not Recruiting PHASE3
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Sep 2022 — Jan 2023 [monthly]
Active Not Recruiting PHASE3
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Sep 2021 — Sep 2022 [monthly]
Active Not Recruiting PHASE3
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Jan 2021 — Sep 2021 [monthly]
Active Not Recruiting PHASE3
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Oct 2020 — Jan 2021 [monthly]
Active Not Recruiting PHASE3
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Oct 2019 — Oct 2020 [monthly]
Active Not Recruiting PHASE3
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Oct 2018 — Oct 2019 [monthly]
Active Not Recruiting PHASE3
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Jun 2018 — Oct 2018 [monthly]
Active Not Recruiting PHASE3
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May 2018 — Jun 2018 [monthly]
Active Not Recruiting PHASE3
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Mar 2018 — May 2018 [monthly]
Active Not Recruiting PHASE3
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Sep 2017 — Mar 2018 [monthly]
Active Not Recruiting PHASE3
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Jun 2017 — Sep 2017 [monthly]
Active Not Recruiting PHASE3
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Mar 2017 — Jun 2017 [monthly]
Active Not Recruiting PHASE3
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Feb 2017 — Mar 2017 [monthly]
Active Not Recruiting PHASE3
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Jan 2017 — Feb 2017 [monthly]
Active Not Recruiting PHASE3
First recorded
Jan 2013
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
This was a two-arm, randomized, double-blind Phase III study of dabrafenib in combination with trametinib versus 2 placebos in the adjuvant treatment of melanoma after surgical resection. Patients with completely resected, histologically confirmed, BRAF V600E/K mutation-positive, high-risk (Stage IIIa \[lymph node metastasis \>1 mm\], IIIb or IIIc) cutaneous melanoma were screened for eligibility. Approximately 852 patients were planned to be randomized in a 1:1 ratio, stratified by BRAF mutation status (V600E, V600K) and stage of disease (Stage IIIa, IIIb, IIIc). Patients received either dabrafenib (150 milligram (mg) twice daily \[BID\]) and trametinib (2 mg once daily \[QD\]) combination therapy or 2 matching placebos (one each for dabrafenib and trametinib) for 12 months or until disease recurrence, death, unacceptable toxicity, or withdrawal of consent. Patients were followed for disease recurrence and survival during and after the treatment period. The study did not permit crossover. Doses of study treatment could be modified and/or interrupted for management of toxicities associated with study treatment.
Contact Information
- Novartis Pharmaceuticals
For direct contact, visit the study record on ClinicalTrials.gov .