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.

IMAGE

Melanoma Surveillance Photography (MSP) to Improve Early Detection of Melanoma in Ultra-high and High Risk Patients

Diagnosis: Melanoma
Stage: High risk primary
Setting: Imaging Surveillance
Status: Recruiting
Trial ID: NCT04385732
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 >

IMAGE

Melanoma Surveillance Photography (MSP) to Improve Early Detection of Melanoma in Ultra-high and High Risk Patients.

Diagnosis: Melanoma
Stage: High risk primary
Setting: Imaging Surveillance
Status: Recruiting
Trial ID: NCT04385732
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-AD

Evaluate the efficacy and safety of 12 months of encorafenib in combination with binimetinib in adjuvant setting of BRAF V600E/K mutant stage IIB/C melanoma versus the current standard of care (surveillance).
Diagnosis: Melanoma
Stage: II
Setting: Adjuvant
Status: Recruiting
Trial ID: NCT05270044
More info >

KeyVibe-10

To compare pembrolizumab/vibostolimab to pembrolizumab with respect to recurrence-free survival (RFS). The primary hypothesis is that pembrolizumab/vibostolimab is superior to pembrolizumab with respect to RFS as assessed by the investigator in participants with high-risk resected Stage IIB, IIC, III and IV melanoma.
Diagnosis: Melanoma
Stage: II/III/IV resected
Setting: Adjuvant
Status: Recruitment pending
Trial ID: NCT05665595
More info >

Neo ReNi II

A Phase 2 Clinical Trial of Neoadjuvant Relatlimab and Nivolumab in High Risk, Clinical Stage II Cutaneous Melanoma.  Neoadjuvant therapy is feasible in stage II melanoma, and the dual inhibition of the distinct LAG-3 and PD-1 checkpoint pathways with relatlimab and nivolumab has a synergistic effect in the tumour microenvironment leading to a pathological response after 2 doses of therapy.

Diagnosis: Melanoma
Stage: II resectable
Setting: Neoadjuvant
Status: Recruitment pending
Trial ID: NCT05418972
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 in participants with Stage III melanoma who are candidates for neoadjuvant therapy to identify the investigational agent(s) that, when used in combination, are superior to the current treatment options/historical control available.
Diagnosis: Melanoma
Stage: III Resectable
Setting: Neoadjuvant
Status: Recruiting
Trial ID: NCT04303169
More info >

Keymaker-02B

To evaluate the safety and efficacy of investigational treatment arms in participants with 1L advanced melanoma and to identify the investigational agent(s) that, when used in combination, are superior to the current treatment options/pembrolizumab monotherapy.
Diagnosis: Melanoma
Stage: III/IV Unresectable
Setting: Metastatic (first line)
Status: Recruiting
Trial ID: NCT04305054
More info >

BMS 030-001

A study of BMS-986249 Alone and In Combination with Nivolumab in Advanced Solid Tumors.
Diagnosis: Melanoma
Stage: III/IV Unresectable
Setting: Metastatic (first line)
Status: Recruiting
Trial ID:NCT03369223
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 Resectable
Setting: Neoadjuvant 
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 Resectable
Setting: Neoadjuvant
Status: Recruiting
Trial ID: NCT04949113
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.
Diagnosis: Melanoma
Stage: III/IV Unresectable
Setting: Metastatic (immunotherapy relapse)
Status: Recruiting
Trial ID: NCT04526899
More info >

BMS 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 Unresectable
Setting: Metastatic (immunotherapy relapse)
Status: Recruiting
Trial ID: NCT03400332
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 Unresectable
Setting: Metastatic (immunotherapy relapse)
Status: Recruiting
Trial ID: NCT04526899
More info >

ROCHE BP43963

A Study of Multiple Doses of RO7247669 in Participants With Previously Untreated Unresectable or Metastatic Melanoma
Diagnosis: Melanoma
Stage: III/IV Unresectable
Setting: Metastatic (first line)
Status: Recruiting
Trial ID: NCT05419388
More info >

EVAXION

A Study of EVX-01 Vaccine in Combination With Pembrolizumab in Adults With Unresectable or Metastatic Melanoma
Diagnosis: Melanoma
Stage: III/IV Unresectable
Setting: Metastatic (first line)
Status: Recruiting
Trial ID: NCT05309421
More info >

SEAGEN

A Study of Ladiratuzumab Vedotin in Advanced Solid Tumors
Diagnosis: Melanoma and other solid tumours
Stage: III/IV Unresectable
Setting: Metastatic (immunotherapy relapse)
Status: Recruiting
Trial ID: NCT04032704
More info >

KINNATE

A Study to Evaluate KIN-2787 in Participants With BRAF and/or NRAS Mutation Positive Solid Tumors
Diagnosis: Melanoma and other solid tumours
Stage: III/IV Unresectable
Setting: Metastatic (immunotherapy relapse)
Status: Recruiting
Trial ID: NCT04913285
More info >

NeoPeLe

A Phase II Study of Neoadjuvant Pembrolizumab & Lenvatinib for Resectable Stage III Melanoma
Diagnosis: Melanoma
Stage: III Resectable
Setting: Neoadjuvant
Status: Recruiting
Trial ID: NCT04207086
More info >

KeyVibe-10

A Study of Adjuvant Pembrolizumab/Vibostolimab (MK-7684A) Versus Pembrolizumab for Resected High-Risk Melanoma in Participants With High-Risk Stage II-IV Melanoma. 
Diagnosis: Melanoma
Stage: II /III /IV resected
Setting: Adjuvant
Status: Recruitment pending
Trial ID: NCT05665595
More info >

Moderna

A clinical study to assess the safety and tolerability of escalating intratumoral doses of mRNA-2752 in participants with relapsed/refractory solid tumor malignancies or lymphoma. 
Diagnosis: Melanoma
Stage: III/IV unresectable
Setting: Metastatic (immunotherapy relapse)
Status: Recruitment pending
Trial ID: NCT03739931
More info >

Neo PeLeMM

A study to access Neoadjuvant Pembrolizumab and Lenvatinib for Mucosal Melanoma. 
Diagnosis: Melanoma (Mucosal)
Stage: III unresectable
Setting: Neoadjuvant
Status: Recruitment pending
Trial ID: NCT05545969
More info >

RELATIVITY-127

A Study of Subcutaneous Nivolumab + Relatlimab Fixed-dose Combination (FDC) in Previously Untreated Metastatic or Unresectable Melanoma. 
Diagnosis: Melanoma
Stage: III/IV unresectable
Setting: Metastatic (first line)
Status: Recruitment pending
Trial ID: NCT05625399
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 Brain metastases
Setting: Metastatic (first line)
Status: Recruiting
Trial ID: NCT03340129
More info on clinicaltrials.gov >

See our ABC-X Clinical Trial page >

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: III/IV Unresectable
Setting: Metastatic (first line) 
Status: Recruiting
Trial ID: NCT03369223
More info >

Keymaker-02B

To evaluate the safety and efficacy of investigational treatment arms in participants with 1L advanced melanoma and to identify the investigational agent(s) that when used in combination, are superior to the current treatment options/pembrolizumab monotherapy.
Diagnosis: Melanoma
Stage: III/IV
Setting: Metastatic
Status: Recruiting
Trial ID: NCT04305054
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 Unresectable
Setting: Metastatic (immunotherapy relapse) 
Status: Recruiting
Trial ID: NCT04526899
More info >

BMS 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 Unresectable
Setting: Metastatic (immunotherapy relapse) 
Status: Recruiting
Trial ID:NCT03400332
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 (immunotherapy relapse)
Status: Recruiting
Trial ID:NCT04526899
More info >

ROCHE BP43963

A Study of Multiple Doses of RO7247669 in Participants With Previously Untreated Unresectable or Metastatic Melanoma
Diagnosis: Melanoma
Stage: III/IV Unresectable
Setting: Metastatic (first line)
Status: Recruiting
Trial ID:NCT05419388
More info >

EVAXION

A Study of EVX-01 Vaccine in Combination With Pembrolizumab in Adults With Unresectable or Metastatic Melanoma
Diagnosis: Melanoma
Stage: III/IV Unresectable
Setting: Metastatic (first line)
Status: Recruiting
Trial ID:NCT05309421
More info >

SEAGEN

A Study of Ladiratuzumab Vedotin in Advanced Solid Tumors
Diagnosis: Melanoma and other solid tumours
Stage: III/IV Unresectable
Setting: Metastatic (immunotherapy relapse)
Status: Open August 2022
Trial ID:NCT04032704
More info >

KINNATE

A Study to Evaluate KIN-2787 in Participants With BRAF and/or NRAS Mutation Positive Solid Tumors
Diagnosis: Melanoma and other solid tumours
Stage: III/IV Unresectable
Setting: Metastatic (immunotherapy relapse)
Status: Recruiting
Trial ID:NCT04913285
More info >

KeyVibe-10

A Study of Adjuvant Pembrolizumab/Vibostolimab (MK-7684A) Versus Pembrolizumab for Resected High-Risk Melanoma in Participants With High-Risk Stage II-IV Melanoma. 
Diagnosis: Melanoma
Stage: II /III /IV resected
Setting: Adjuvant
Status: Recruitment pending
Trial ID: NCT05665595
More info >

Moderna

A clinical study to assess the safety and tolerability of escalating intratumoral doses of mRNA-2752 in participants with relapsed/refractory solid tumor malignancies or lymphoma. 
Diagnosis: Melanoma
Stage: III/IV unresectable
Setting: Metastatic (immunotherapy relapse)
Status: Recruitment pending
Trial ID: NCT03739931
More info >

RELATIVITY-127

A Study of Subcutaneous Nivolumab + Relatlimab Fixed-dose Combination (FDC) in Previously Untreated Metastatic or Unresectable Melanoma. 
Diagnosis: Melanoma
Stage: III/IV unresectable
Setting: Metastatic (first line)
Status: Recruitment pending
Trial ID: NCT05625399
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.