Molecular Profiling and Matched Targeted Therapy for Patients with Metastatic Melanoma (MatchMel)

Phase 2

• Conditions: Metastatic Melanoma; Cancer - Malignant melanoma

• Registration Number: ACTRN12616001187437
• Lead Sponsor: Melanoma Institute Australia

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-08-29
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

INITIAL INCLUSION CRITERIA:
Newly diagnosed and treatment naive unresectable Stage IIIB, IIIC or Stage IV melanoma.
Archival or fresh metastatic tumour tissue available for genetic testing. Archival tissue from primary melanoma may be considered if no recent sample is available.
Male or female patients aged 18 or over.
Written informed consent for molecular genetic testing of tumour tissue (for both standard and research tests).

INCLUSION CRITERIA FOR EXTENDED MOLECULAR TESTING:
Standard of care molecular tumour testing which has identified BRAF / NRAS wild type tumour tissue.

INCLUSION CRITERIA FOR MATCHED TARGETED THERAPY:
Received available standard therapies for metastatic melanoma and progressed, unable to tolerate standard therapy, or standard therapy contraindicated.
Written informed consent to receive targeted therapy (if applicable) and clinical follow up.
ECOG status 0 - 2.
Adequate haematological, hepatic and renal organ function as defined by:
White cell count = or > 2.0 × 10^9/L
Neutrophil count = or > 1.5 × 10^9/L
Haemoglobin = or > 90 g/L
Platelet count = or >100 x 10^9/L
Total bilirubin < or = 3.0 x ULN
Alanine transaminase < or = 3.0 x ULN
Aspartate aminotransferase < or = 3.0 x ULN
Serum creatinine < or = 1.5 x the upper limit of normal (ULN).
Life expectancy > 30 days.
Women of child bearing potential (WOCBP) to use contraception to avoid pregnancy.
Non sterile men with female partners of CBP to use contraception to avoid pregnancy.
Drug specific inclusions (refer to the regulatory approved drug specific Product Information provided)

Exclusion Criteria

EXCLUSION CRITERIA FOR MATCHED TARGETED THERAPY:
An expectation for the need for concurrent radiotherapy (unless safety has been established with the matched drug regimen).
Any investigational drug or other systemic drug therapy for melanoma within 14 days or 5 half-lives from baseline, whichever is shorter.
Pregnant or breast feeding females.
Drug specific exclusions (refer to the regulatory approved drug specific Product Information Sheet provided)

Study & Design

• Study Type: Interventional
• Study Design: Not specified