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Report for Clinical Trial NCT02392871

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

An Open-label, Single-arm, Phase I/II, Multicentre Study to Evaluate the Safety and Efficacy of the Combination of Dabrafenib, Trametinib and Palliative Radiotherapy in Patients With Unresectable (Stage IIIc) and Metastatic (Stage IV) BRAF V600E/K Mutation-positive Cutaneous Melanoma

The purpose of this study is to investigate the side effects and safety, and effectiveness of combining dabrafenib and trametinib with radiotherapy. Previous and ongoing clinical trials have demonstrated the effectiveness and safety of combining both dabrafenib and trametinib compared with dabrafenib alone. This has led to the approval for the use of both drugs in combination in people with metastatic melanoma with the BRAF mutation. Melanoma that has spread to other parts of the body may also benefit from radiotherapy to help reduce symptoms from melanoma. Previous studies have shown that melanoma may be sensitive to radiotherapy and that it can help to improve quality of life. The intention of the CombiRT study is to establish if dabrafenib, trametinib and radiotherapy combined is a safe and effective treatment for metastatic melanoma.

NCT02392871 Metastatic Melanoma
MeSH: Melanoma
HPO: Cutaneous melanoma Melanoma

2 Interventions

Name: Palliative radiotherapy

Type: Radiation

Radiotherapy

Name: Dabrafenib and trametinib (combination)

Description: Patients should be taking dabrafenib and trametinib for at least 2 weeks prior to enrolment into the study.

Type: Drug

Radiotherapy


Primary Outcomes

Measure: Toxicity profile for patients receiving dabrafenib and trametinib in combination with RT, by measuring adverse events and radiotherapy associated toxicities.

Time: 0-12 months

Secondary Outcomes

Measure: Patients' pain using a visual analog scale (questionnaire)

Time: 0-12 months

Measure: Overall disease response by measuring progression free survival and overall survival.

Time: 0-12 months

Measure: Local treatment response in the irradiated index lesion(s).

Time: 0-12 months

Measure: Time to local progression in the irradiated index lesion(s).

Time: 0-12 months

Purpose: Treatment

Single Group Assignment


There is one SNP

SNPs


1 V600E

An Open-label, Single-arm, Phase I/II, Multicentre Study to Evaluate the Safety and Efficacy of the Combination of Dabrafenib, Trametinib and Palliative Radiotherapy in Patients With Unresectable (Stage IIIc) and Metastatic (Stage IV) BRAF V600E/K Mutation-positive Cutaneous Melanoma. --- V600E ---

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



HPO Nodes


HPO:
Cutaneous melanoma
Genes 15
HRAS MITF CDKN2A BRAF NRAS NRAS WRN CDKN2A CXCR4 BAP1 POLH CDK4 ERCC3 XPC MC1R
Melanoma
Genes 98
MGMT NRAS POT1 NRAS XPA CTSC BRCA1 SDHC ERCC4 CXCR4 RAD51C CDKN2B ERCC3 XPC PALLD ERCC2 ERCC2 CHEK2 CDKN2A RAD51D GNAQ SDHD KRAS MBTPS2 BAP1 BAP1 CYSLTR2 RNF43 BAP1 CDKN2A PTPN11 CDK4 BRCA2 ERCC3 MITF TERF2IP ERCC4 CHEK2 BRCA1 TRPV3 POT1 OCA2 TERT CDKN2A AKT1 CDKN2A SF3B1 ERCC6 ERCC5 ERCC5 MDM2 BRCA2 BAP1 GNA11 ACD BRIP1 HRAS MRE11 BRAF TYR TP53 KLLN SEC23B PTEN PIK3CA XPA PERP MITF RAF1 BRAF POLH TP53 BARD1 NRAS SMAD4 RAD50 DDB2 ERCC2 NBN TERT MC1R SLC45A2 WRN PALB2 DDB2 PALB2 CDKN2A SDHB MC1R RAD51 TP53 XPC ERCC3 PTEN CDKN2A POLH CDK4 MC1R