Investigating the effect of Metabolomics on Responses to ImmunoTherapy - in Melanoma

Not Applicable

• Conditions: Melanoma; Cancer - Malignant melanoma

• Registration Number: ACTRN12622000487718
• Lead Sponsor: Wesley Medical Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-03-28
• Last Update Posted: 4 April 2022

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Patients with resected and unresectable melanoma who are undergoing checkpoint inhibitor therapy.

Exclusion Criteria

Patients with active, untreated brain metastases
Patients on > 10mg prednisone at baseline
Active autoimmune disease (excludes vitiligo, treated thyroid disease, diabetes)
Crohn’s disease or ulcerative colitis
The presence of any other neoplasm in the past 5 years – deemed ‘not under control’
Pregnancy
Inability to give informed consent
HIV
Hepatitis B or C
Prior treatment with immunotherapy – if patient had adjuvant immunotherapy – date of relapse must have been > = 6 months prior to study entry
Active mental illness that prohibits study entry
Radiotherapy within previous 4 weeks except to brain mets
Concurrent use of any other investigational or experimental product or therapeutic

Study & Design

• Study Type: Observational
• Study Design: Not specified