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Report for Clinical Trial NCT02296996

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Phase II Clinical Trial on the Combination of Dabrafenib and Trametinib for BRAF-inhibitor Pretreated Patients With Advanced BRAF V600 Mutant Melanoma

Patients with BRAF V600 mutant advanced melanoma benefit from treatment with a BRAF-inhibitor (e.g. dabrafenib, vemurafenib) and from combination of a BRAF- and MEK-inhibitor (e.g. dabrafenib and trametinib). Following initial tumor regression, progression is diagnosed in a majority of patients treated with BRAF-inhibitor mono-therapy within the first 12-months of therapy. Various molecular mechanisms that underlie the development of resistance to treatment with a BRAF-inhibitor have been reported. These mechanisms do not include secondary mutations in the BRAF-gene and therefore resistance to BRAF-inhibition could potentially be reversible when selective pressure by BRAF-inhibition is withheld for a sufficient period of time of melanoma progression. This clinical trial protocol addresses the potential renewed anti-tumor activity of combined BRAF- and MEK inhibition with the combination of dabrafenib and trametinib in patients with unresectable AJCC stage III or - IV BRAF V600 mutant melanoma who are documented with progression of disease at least 12 weeks following the last day of dosing of a BRAFinhibitor containing treatment regimen.

NCT02296996 Malignant Melanoma
MeSH:Melanoma
HPO:Cutaneous melanoma Melanoma

1 Interventions

Name: Dabrafenib + Trametinib

Type: Drug
Group Labels: 1

Dabrafenib + trametinib


Primary Outcomes

Measure: Overall response rate

Time: Participants will be monitored until progression, with an expected average of 6 months

Secondary Outcomes

Measure: Progression-free survival

Time: Participants will be monitored until progression, with an expected average of 6 months

Measure: Overall Survival

Time: 2 years

Description: Detect adverse events

Measure: Number of Participants with Adverse Events as a Measure of Safety and Tolerability

Time: Participants will be monitored until progression, with an expected average of 6 months

Other Outcomes

Description: To explore if tumor specific cfDNA levels can be used as a monitoring tool to detect early progression of disease

Measure: Tumour-specific cfDNA levels

Time: Participants will be monitored until progression, with an expected average of 6 months

Purpose: Treatment

Allocation: N/A

Single Group Assignment


There is one SNP

SNPs


1 V600E

2. Histologically confirmed cutaneous melanoma that is either Stage IIIC (unresectable) or Stage IV (metastatic), and determined to be BRAF V600E/K mutation-positive. --- V600E ---



HPO Nodes


HPO: