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Report for Clinical Trial NCT01682083

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

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

This was a two-arm, randomized, double-blind Phase III study of dabrafenib in combination with trametinib versus two 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. Subjects were randomized to receive either dabrafenib (150 milligram (mg) twice daily [BID]) and trametinib (2 mg once daily [QD]) combination therapy or two placebos for 12 months.

NCT01682083 Melanoma
MeSH:Melanoma
HPO:Cutaneous melanoma Melanoma

3 Interventions

Name: Dabrafenib

Description: Each capsule contained 50 mg or 75 mg of free base (present as the mesylate salt)
Type: Drug
Group Labels: 1

Dabrafenib and trametinib

Name: Trametinib

Description: Each tablet contained 0.5 mg or 2.0 mg of trametinib parent (present as the DMSO solvate)
Type: Drug
Group Labels: 1

Dabrafenib and trametinib

Name: Placebos

Description: The placebo capsules and tablets contained the same inactive ingredients and film coatings as the dabrafenib and trametinib study treatment
Type: Drug
Group Labels: 1

Dabrafenib and trametinib placebos


Primary Outcomes

Description: Recurrence-free survival was defined as the time from randomization to disease recurrence (local recurrence, distant recurrence, second primary melanoma), or death from any cause.

Measure: Relapse-free Survival (RFS)

Time: Approximately 3.5 years

Secondary Outcomes

Description: Overall survival (OS) of dabrafenib and trametinib as a combination therapy versus placebo

Measure: Overall Survival

Time: approximately 3.5 years

Description: Distant metastasis-free survival (DMFS) of dabrafenib and trametinib as a combination therapy versus placebo. In the DMFS analysis, the first occurrence of distant metastasis or death (if it occurred before documented recurrence) was counted as an event.

Measure: Distant Metastasis-free Survival

Time: approximately 3.5 years

Description: Freedom from relapse (FFR) of dabrafenib and trametinib as a combination therapy versus placebo. In the FFR analysis, local or distant recurrence or a new primary melanoma were counted as events, and patients who died of causes other than melanoma or treatment-related toxicity were censored.

Measure: Freedom From Relapse

Time: approximately 3.5 years

Purpose: Treatment

Allocation: Randomized

Parallel Assignment


There is one SNP

SNPs


1 V600E

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. --- V600E ---

In the FFR analysis, local or distant recurrence or a new primary melanoma were counted as events, and patients who died of causes other than melanoma or treatment-related toxicity were censored.. Key Inclusion Criteria: - Completely resected histologically confirmed high-risk [Stage IIIa (LN metastasis more than 1 mm), IIIb or IIIc cutaneous melanoma determined to be V600E/K mutation positive by a central laboratory. --- V600E ---

- History or current evidence of retinal vein occlusion (RVO) or central serous retinopathy (CSR) Key Inclusion Criteria: - Completely resected histologically confirmed high-risk [Stage IIIa (LN metastasis more than 1 mm), IIIb or IIIc cutaneous melanoma determined to be V600E/K mutation positive by a central laboratory. --- V600E ---

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. --- V600E ---



HPO Nodes


HPO: