Clinical trials are a crucial part of the research undertaken at Melanoma Institute Australia. Coordinated from the Poche Centre in Wollstonecraft and conducted at locations throughout our network, these trials help us find better ways to prevent, diagnose and treat melanoma, as well as help improve the quality of life of melanoma patients.

All of MIA’s clinical trials follow a strict protocol approved by a Human Research Ethics Committee. This committee ensures that the rights, safety and wellbeing of participants are protected throughout the trial.

Patients – To read more about participating in Clinical Trials see here.

Clinicians – For information on referring patients to an MIA Clinical Trial see here.

Download our Clinical Trial brochure to find out more about clinical trials.

Current Clinical Trials

Please use the Stage tabs below to find a suitable clinical trial being run at MIA. Includes Melanoma and Non-Melanoma trials which are currently recruiting and trials that will open soon.

SONIB

For patients with BCC that cannot be removed by surgery or that has spread through the body.
Diagnosis: Non-Melanoma
Stage: I/II
Setting: Neoadjuvant
Status: Recruiting
Trial ID: NCT03534947
More info >


I-MAT

A randomised, placebo-controlled, phase II trial in patients with stage I-III Merkel cell carcinoma aiming to explore the efficacy of avelumab as adjuvant immunotherapy.
Diagnosis: Non-Melanoma
Stage: I/II/III
Setting: Adjuvant
Status: Recruiting
Trial ID: NCT04291885
More info >

SONIB

For patients with BCC that cannot be removed by surgery or that has spread through the body.
Diagnosis: Non-Melanoma
Stage: I/II
Setting: Neoadjuvant
Status: Recruiting
Trial ID: NCT03534947
More info >


I-MAT

A randomised, placebo-controlled, phase II trial in patients with stage I-III Merkel cell carcinoma aiming to explore the efficacy of avelumab as adjuvant immunotherapy.
Diagnosis: Non-Melanoma
Stage: I/II/III
Setting: Adjuvant
Status: Recruiting
Trial ID: NCT04291885
More info >


MelMartII

For patients with a primary invasive melanoma who have been recommended excision with a wide margin.
Diagnosis: Melanoma
Stage: II
Setting: Surgical
Status: Recruiting
Trial ID: NCT03860883
More info >


COLUMBUS

Details TBA
Diagnosis: Melanoma
Stage: II
Setting: Adjuvant
Status: Open May 2022
Trial ID: NCT05270044
More info >


I-MAT

A randomised, placebo-controlled, phase II trial in patients with stage I-III Merkel cell carcinoma aiming to explore the efficacy of avelumab as adjuvant immunotherapy.
Diagnosis: Non-Melanoma
Stage: I/II/III
Setting: Adjuvant
Status: Recruiting
Trial ID: NCT04291885
More info >


Keymaker-02C

To evaluate the safety and efficacy of investigational treatment arms to identify the agent(s) that, when used in combination, are superior to the current treatment options.
Diagnosis: Melanoma
Stage: III
Setting: Neoadjuvant
Status: Recruiting
Trial ID: NCT04303169
More info >


DONIMI

A multicenter Phase 1b trial testing the neoadjuvant combination of nomatinostat, nivolumab and ipilimumab in IFN-gamma signature-low and IFN-gamma signature-high RECIST 1.1-measurable Stage III cutaneous or unknown primary melanoma.
Diagnosis: Melanoma
Stage: III
Setting: Neoadjuvant
Status: Recruiting
Trial ID: NCT04133948
More info >


PIVOT-12

To compare adjuvant immunotherapy of bempegaldesleukin combined with nivolumab versus nivolumab after complete resection of melanoma in patients at high risk for recurrence.
Diagnosis: Melanoma
Stage: III
Setting: Adjuvant
Status: Recruiting
Trial ID: NCT04410445
More info >


Keymaker-02B

To evaluate the safety and efficacy of investigational treatment arms to identify the agent(s) that, when used in combination, are superior to the current treatment options.
Diagnosis: Melanoma
Stage: III/IV
Setting: Metastatic
Status: Recruiting
Trial ID: NCT04305041
More info >


QB46C-H06

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.
Diagnosis: Melanoma
Stage: III/IV
Setting: Metastatic
Status: Recruiting
Trial ID: NCT04834973
More info >


Keymaker-02A

To evaluate the safety and efficacy of investigational treatment arms to identify the agent(s) that, when used in combination, are superior to the current treatment options.
Diagnosis: Melanoma
Stage: III/IV
Setting: Metastatic
Status: Recruiting
Trial ID: NCT04305041
More info >


CA224-098

To assess relatlimab and nivolumab fixed-dose combination (FDC) versus nivolumab alone in participants with completely resected stage III-IV melanoma.
Diagnosis: Melanoma
Stage: III/IV
Setting: Adjuvant
Status: Recruiting
Trial ID: NCT05002569
More info >


MORPHEUS

A Phase Ib/II, Open-Label, Multicenter, Randomized Umbrella Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Melanoma (Morpheus-Melanoma)
Diagnosis: Melanoma
Stage: III/IV
Setting: Neoadjuvant & Metastatic
Status: Recruiting
Trial ID: NCT05116202
More info >


NADINA

Multicenter open-label two-arm randomized Phase 3 Trial Comparing Neoadjuvant Ipilimumab Plus Nivolumab Versus Standard Adjuvant Nivolumab in Macroscopic Stage III Melanoma
Diagnosis: Melanoma
Stage: III
Setting: Neoadjuvant
Status: Recruiting
Trial ID: NCT04949113
More info >


QB46C-H04

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
Diagnosis: Melanoma
Stage: III/IV
Setting: Metastatic
Status: Recruiting
Trial ID: NCT05234437
More info >


BNT111-01

An open-label, randomized, multi-site, Phase II, interventional trial designed to evaluate the efficacy, tolerability, and safety of BNT111 + cemiplimab in anti-PD-1-refractory/relapsed patients with unresectable Stage III or IV melanoma.
Diagnosis: Melanoma
Stage: III/IV
Setting: Metastatic
Status: Recruiting
Trial ID: NCT04526899
More info >


MONETTE

Open-label, Randomized Phase II Trial With BNT111 and Cemiplimab in Combination or as Single Agents in Patients With Anti-PD-1-refractory/Relapsed, Unresectable Stage III or IV Melanoma
Diagnosis: Melanoma
Stage: III/IV
Setting: Metastatic
Status: Open July 2022
Trial ID:NCT04526899
More info >


CA027-002

A Phase 1/2 Study of BMS-986253 in Combination With Nivolumab or Nivolumab Plus Ipilimumab in Advanced Cancers
Diagnosis: Melanoma
Stage: III/IV
Setting: Metastatic
Status: Open May 2022
Trial ID:NCT03400332
More info >


RAPTOR

A Phase 1/2a, Multicentre, Open-label Trial of TBio-6517, an Oncolytic Vaccinia Virus, Administered Alone and in Combination With Pembrolizumab, in Patients With Advanced Solid Tumors
Diagnosis: Melanoma
Stage: III/IV
Setting: Metastatic
Status: Open June 2022
Trial ID:NCT04301011
More info >

ABC-X

A phase II, open label, randomised trial of ipilimumab and nivolumab with concurrent intracranial stereotactic radiotherapy versus ipilimumab and nivolumab alone in patients with asymptomatic, untreated melanoma brain metastases.
Diagnosis: Melanoma
Stage: IV
Setting: Metastatic
Status: Recruiting
Trial ID: NCT03340129
More info >


BMS 030-001

To determine whether BMS-986249 both by itself and in combination with Nivolumab is safe and tolerable in the treatment of advanced solid tumors.
Diagnosis: Melanoma
Stage: IV
Setting: Metastatic
Status: Recruiting
Trial ID: NCT03369223
More info >


NL201-101

To understand the safety of NL-201 when given intravenously as monotherapy in patients with advanced cancer to evaluate tolerability and to identify a recommended dose and schedule for further testing.
Diagnosis: Melanoma
Stage: IV
Setting: Metastatic
Status: Recruiting
Trial ID: NCT04659629
More info >


Keymaker-02D

To evaluate the safety and efficacy of investigational treatment arms in programmed cell-death 1 (PD-1) naïve or PD-1 exposed participants with melanoma brain metastasis (MBM) and to identify the investigational agent(s) that, when used in combination, are superior to the current treatment options.
Diagnosis: Melanoma
Stage: IV
Setting: Metastatic
Status: Recruiting
Trial ID: NCT04700072
More info >


CLXH254C12201

To evaluate the efficacy of LXH254 combinations in previously treated unresectable or metastatic melanoma.
Diagnosis: Melanoma
Stage: IV
Setting: Metastatic
Status: Recruiting
Trial ID: NCT04417621
More info >


20140318

A Phase 1b/2, Multicenter, Open-label, Basket Trial to Evaluate the Safety of Talimogene Laherparepvec Injected Into Liver Tumors Alone and in Combination With Systemic Pembrolizumab in Phase 1b and to Evaluate the Efficacy and Safety of Intratumoral Talimogene Laherparepvec in Combination With Systemic Pembrolizumab to Treat Subjects With Advanced Solid Tumors in Phase 2 (MASTERKEY-318)
Diagnosis: Non-Melanoma
Stage: IV
Setting: Metastatic
Status: Recruiting
Trial ID: NCT02509507
More info >


Keymaker-02B

To evaluate the safety and efficacy of investigational treatment arms to identify the agent(s) that, when used in combination, are superior to the current treatment options.
Diagnosis: Melanoma
Stage: III/IV
Setting: Metastatic
Status: Recruiting
Trial ID: NCT04305041
More info >


QB46C-H06

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.
Diagnosis: Melanoma
Stage: III/IV
Setting: Metastatic
Status: Recruiting
Trial ID: NCT04834973
More info >


Keymaker-02A

To evaluate the safety and efficacy of investigational treatment arms to identify the agent(s) that, when used in combination, are superior to the current treatment options.
Diagnosis: Melanoma
Stage: III/IV
Setting: Metastatic
Status: Recruiting
Trial ID: NCT04305041
More info >


CA224-098

To assess relatlimab and nivolumab fixed-dose combination (FDC) versus nivolumab alone in participants with completely resected stage III-IV melanoma.
Diagnosis: Melanoma
Stage: III/IV
Setting: Adjuvant
Status: Recruiting
Trial ID: NCT05002569
More info >


MORPHEUS

A Phase Ib/II, Open-Label, Multicenter, Randomized Umbrella Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Melanoma (Morpheus-Melanoma)
Diagnosis: Melanoma
Stage: III/IV
Setting: Neoadjuvant & Metastatic
Status: Recruiting
Trial ID: NCT05116202
More info >


BNT111-01

An open-label, randomized, multi-site, Phase II, interventional trial designed to evaluate the efficacy, tolerability, and safety of BNT111 + cemiplimab in anti-PD-1-refractory/relapsed patients with unresectable Stage III or IV melanoma.
Diagnosis: Melanoma
Stage: III/IV
Setting: Metastatic
Status: Recruiting
Trial ID: NCT04526899
More info >


QB46C-H04

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
Diagnosis: Melanoma
Stage: III/IV
Setting: Metastatic
Status: Recruiting
Trial ID: NCT05234437
More info >


MONETTE

Open-label, Randomized Phase II Trial With BNT111 and Cemiplimab in Combination or as Single Agents in Patients With Anti-PD-1-refractory/Relapsed, Unresectable Stage III or IV Melanoma
Diagnosis: Melanoma
Stage: III/IV
Setting: Metastatic
Status: Open July 2022
Trial ID:NCT04526899
More info >


CA027-002

A Phase 1/2 Study of BMS-986253 in Combination With Nivolumab or Nivolumab Plus Ipilimumab in Advanced Cancers
Diagnosis: Melanoma
Stage: III/IV
Setting: Metastatic
Status: Open May 2022
Trial ID:NCT03400332
More info >


RAPTOR

A Phase 1/2a, Multicentre, Open-label Trial of TBio-6517, an Oncolytic Vaccinia Virus, Administered Alone and in Combination With Pembrolizumab, in Patients With Advanced Solid Tumors
Diagnosis: Melanoma
Stage: III/IV
Setting: Metastatic
Status: Open June 2022
Trial ID:NCT04301011
More info >

Clinical Trial Types and Phases

Clinical Trial Types

The U.S. National Institutes of Health (NIH) classify clinical trials into five types as follows:

1. Treatment Trials– the most common type of trial involving testing experimental treatments such as new drug combinations or new approaches to surgery or radiotherapy.
2. Prevention Trials – test new ways to prevent disease and disease recurrence.
3. Screening Trials – test the most effective way to detect a disease.
4. Diagnostic Trials– conducted to find better ways to diagnose disease.
5. Quality of Life Trials (or Supportive Care Trials)– explore ways to improve the comfort and quality of life for people with a disease.

Clinical Trial phases

New treatments must go through three “phases” of trials before they can be considered for use;

  • Phase 1 – Involves only a small number of participants where a range of dosage levels are tested and any side effects analysed.
  • Phase 2 – Involves a larger group of participants where a more detailed evaluation of safety and effectiveness is conducted.
  • Phase 3 – Involves a much larger group of participants where the experimental treatment is formally compared with the current standard treatment by randomly allocating each treatment across the test group.Random treatment allocation is necessary in Phase 3 trials to ensure the treatments can be compared without bias. Neither the patient nor the trial team can choose which treatment is received. If the trial involves a new drug it is possible that the patient and the trial team might not be told which treatment group you are in; this is known as blinding and is used to prevent bias. In some trials experimental treatments are compared with a placebo – an inactive pill, liquid or powder that has no treatment value. Patients are informed if the trial being considered is blinded or placebo controlled.