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A Trial of Tigilanol Tiglate in Combination With Pembrolizumab in Stage IIIB to IV M1c-melanoma

NCT04834973 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2023-04-18

No results posted yet for this study

Summary

A Phase Ib/IIa, multicentre, open label, dose-escalation study to evaluate the safety, tolerability, and preliminary effectiveness of intratumoural tigilanol tiglate in combination with intravenous pembrolizumab in adult patients with unresectable, Stage IIIB to IV M1c melanoma.

Conditions

Interventions

DRUG

tigilanol tiglate

Single or multiple Intratumoural treatment of tigilanol tiglate at escalating doses of 0.6 mg/m2, 1.2 mg/m2 and 2.4 mg/m2. Tigilanol tiglate is a novel, short-chain diterpene ester in early clinical development for local treatment of a wide range of solid tumours.

DRUG

pembrolizumab

Three weekly 200 mg intravenous pembrolizumab treatment. Pembrolizumab is a systemic anti-programmed cell death receptor 1 (PD 1) immunotherapy.

Sponsors & Collaborators

Principal Investigators

  • Prof. Georgina Long, BSc PhD MBBS FRACP FAHMS · Melanoma Institute Australia

  • Dr Megan Lyle, BMed FRACP · Cairns and Hinterland Hospital and Health Service

  • Dr Melvin Chin · Prince of Wales Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-07
Primary Completion
2022-07-12
Completion
2022-07-12

Countries

  • Australia

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04834973 on ClinicalTrials.gov