Spots Global Cancer Trial Database for A Trial of Intratumoural Tigilanol Tiglate in Adult Participants With Stage IIIB to IV M1c Melanoma
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Trial Identification
Brief Title: A Trial of Intratumoural Tigilanol Tiglate in Adult Participants With Stage IIIB to IV M1c Melanoma
Official Title: A Phase IIb, Multicentre, Open Label Study to Evaluate the Effectiveness, Safety and Tolerability of Intratumoural Tigilanol Tiglate in Adult Participants With Stage IIIB to IV M1c Melanoma
Study ID: NCT05234437
Conditions
Interventions
Study Description
Brief Summary: A phase IIb, multicentre, open label study to evaluate the effectiveness, safety, and tolerability of intratumoural tigilanol tiglate in adult participants with Stage IIIB to IV M1c melanoma
Detailed Description: Primary Objective 1. To evaluate the tumour responses of both injected and non injected tumours following treatment with intratumoural injections of tigilanol tiglate into one or more tumours (according to RECIST v1.1); and 2. To assess the tumour ablation rate following treatments with intratumoural injections of tigilanol tiglate. Secondary Objectives 1. To assess the tumour recurrence rate at injected tumour site(s); 2. To assess the safety and tolerability of intratumoural injections of tigilanol tiglate; 3. To assess the degree of wound healing at injection sites; and 4. To evaluate disease control by looking at Progression Free Survival (PFS) in melanoma participants receiving tigilanol tiglate injections over 36 months. Exploratory Objectives 1. To evaluate Overall Survival (OS) in melanoma participants receiving tigilanol tiglate injections over 36 months; 2. To assess the tumour microenvironment by looking at the degree of immune cell infiltration in non-injected tumours; and 3. To assess the Quality of Life (QoL) in melanoma participants receiving tigilanol tiglate injections.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Melanoma Institute Australia, Wollstonecraft, New South Wales, Australia
Cairns and Hinterland Hospital and Health Service, Cairns, Queensland, Australia
Metro South Hospital and Health Service via Princess Alexandra Hospital, Woolloongabba, Queensland, Australia
Contact Details
Name: A/Prof. Robyn Saw, MBBS FRACS MS
Affiliation: Melanoma Institute Australia
Role: PRINCIPAL_INVESTIGATOR
Name: Dr Megan Lyle, BMed FRACP
Affiliation: Cairns and Hinterland Hospital and Health Service
Role: PRINCIPAL_INVESTIGATOR
Name: A/Professor Victoria Atkinson
Affiliation: Metro South Hospital and Health Service via Princess Alexandra Hospital
Role: PRINCIPAL_INVESTIGATOR
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