Detection of Plasmatic Cell-free BRAF and NRAS Mutations : a New Tool for Monitoring Patients With Metastatic Malignant Melanoma Treated With Targeted Therapies or Immunotherapy ( MALT )

Malignant Melanoma Stage IV Clinical Trial

— MALT  

Official title:

Detection of Plasmatic Cell-free BRAF and NRAS Mutations: a New Tool for Monitoring Patients With Metastatic Malignant Melanoma Treated With Targeted Therapies or Immunotherapy ( MALT )

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03493230
• Other study ID #: 17-AOI-07
• Status: Not yet recruiting
• Phase: N/A
• First received: March 26, 2018
• Last updated: April 11, 2018
• Start date: April 2018
• Est. completion date: December 2022

Study information

• Verified date: March 2018
• Source: Centre Hospitalier Universitaire de Nice
• Contact: Elodie LONG-MIRA, MD
• Phone: 04 92 03 88 55
• Email: long-mira.e[@]chu-nice.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The main objective of this project is to perform a longitudinal monitoring of BRAF and NRAS cell-free DNA in a large cohort of metastatic melanomas patients before treatment and during the follow-up. Results will be compared with clinical data as imaging (based on RECIST criteria) and the activity of lactate dehydrogenase in serum (LDH).

Description:

During a consultation of follow-up for an advanced malignant melanoma (stage IIIb or IIIC or IV), an investigator presents the study to the patient and give him the note of information and the informed consent.

The patient can benefit from a reflexion period of of 7 days.

In case of agreement, a first blood draw will take place before initiation of any treatment. Between D15 and D30 a second blood draw will be taken. Then a blood draw will be necessary every two months until recurrence or progression of the disease for a maximum of 22 months.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 35
• Est. completion date: December 2022
• Est. primary completion date: April 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients in metastatic situation for a malignant melanoma inoperable stage IIIB or IIIC or stage IV

• In first line of treatment by a targeted therapy (only or in association) or immunotherapy

• Every histological types of cutaneous or mucous malignant melanoma (excepted choroid melanomas)

• The tumor must be mutates for BRAF or NRAS

• The mutation status must have been realized in the Laboratory Pathology Clinical and Experimental (LPCE) of the CHU de Nice analysis of the status on-site metastatic mutational and/or primitive tumor must

• Membership or beneficiary of the national insurance scheme

Exclusion Criteria:

• Histories of cancer or other synchronous cancer

• Pregnant, breast-feeding Women. A pregnancy test will be practiced to the women old enough to procreate.

• Vulnerable People: adults under guardianship, patients deprived of freedom, minor

Related Conditions & MeSH terms

• Malignant Melanoma Stage III
• Malignant Melanoma Stage IV
• Melanoma

Intervention

Biological:
• quantification of BRAF and NRAS mutation
Quantification of cell-free BRAF and NRAS mutations with digital PCR

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

References & Publications (3)

Bahadoran P, Allegra M, Le Duff F, Long-Mira E, Hofman P, Giacchero D, Passeron T, Lacour JP, Ballotti R. Major clinical response to a BRAF inhibitor in a patient with a BRAF L597R-mutated melanoma. J Clin Oncol. 2013 Jul 1;31(19):e324-6. doi: 10.1200/JCO — View Citation

de Vries E, Bray FI, Coebergh JW, Parkin DM. Changing epidemiology of malignant cutaneous melanoma in Europe 1953-1997: rising trends in incidence and mortality but recent stabilizations in western Europe and decreases in Scandinavia. Int J Cancer. 2003 Oct 20;107(1):119-26. — View Citation

Dhillon AS, Hagan S, Rath O, Kolch W. MAP kinase signalling pathways in cancer. Oncogene. 2007 May 14;26(22):3279-90. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quantify plasmatic BRAF and NRAS mutation determine by PCR digitale in µg/ml before treatment		Day 0
Primary	Study the longitudinal monitoring of cell-free the kinetics of the plasma mutation of BRAF and NRAS mutation in µg/ml and comparing them with imaging (based on RECIST criteria) and with the activity of the lactate dehydrogenase in serum ( LDH) in U/l .		Month 24
Secondary	Compare the results obtained by PCR digitale from the cell-free with the results on FFPE tissue samples		Month 24
Secondary	Identify genomic alterations and mutations of resistances in a restricted subgroup of patient by New Generation Sequencing analysis		Month 24