Melanoma MetastaticPhase 2AXIOMNCT06767306
Stereotactic Ablative Radiotherapy (XRT) and Immunotherapy for Oligometastatic Extracranial Melanoma
A Phase 2 study testing Stereotactic Body Radiotherapy (extracranial) concurrent with Immunotherapy and Immunotherapy alone in people with Melanoma Metastatic, run by Melanoma Institute Australia at 5 sites in 2 countries.
Trial summary
The purpose of this research is to evaluate the addition of radiotherapy to the standard immunotherapy drugs that are given to patients with advanced or metastatic melanoma that has spread to other parts of the body. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma Metastatic
- What is being tested?
- Stereotactic Body Radiotherapy (extracranial) concurrent with Immunotherapy and Immunotherapy alone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 129 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 6 Mar 2025to 1 Apr 2033
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female or male patients, age 18 or older
- Willing to provide signed informed consent
- Life expectancy > 6 months
- First presentation of AJCC Stage IV (any N, M1a, M1b, M1c), histologically confirmed cutaneous, acral or unknown primary melanoma with one to five extracranial metastases detected on CT and whole body PET-CT, and considered unresectable
- A primary lesion and / or up to 4 in-transit metastases(is) (ITM) in addition to distant metastases(is) are permitted and will be counted in the maximum number of permitted baseline lesions
- Prior surgery for symptomatic disease (e.g. small bowel obstruction) for this first presentation of Stage IV melanoma is permitted, provided the total number of remaining extracranial metastases is ≤ 5 (NOT including the resected lesion). No more than one excised metastatic lesion is permitted
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- At least one metastasis should be measurable as a target lesion per RECIST version 1.1
- No evidence of cerebral metastases on MRI brain (CT brain is acceptable if there is contraindication to MRI)
- All lesions can be treated with a minimum SBRT biologically effective dose (BED) of 48Gy
- Able to tolerate treatment with immunotherapy as determined by the medical oncologist
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- Women of childbearing potential (WOCBP) must have a negative serum pregnancy test within 7 days of randomisation
Who cannot join
- Ocular or mucosal melanoma
- Serious or unstable medical co-morbidities or other conditions that could interfere with the patient's safety, consent, or compliance
- Patients for whom there is a definite and immediate indication for radiotherapy (e.g., spinal cord compression, rapidly progressing disease associated with clinical signs and symptoms)
- Prior radiotherapy for Stage IV disease (prior adjuvant radiotherapy to primary site or nodal field (Stage I-III disease) is permitted, however adjuvant-treated sites must not be included in the baseline lesions
- Inability to treat all disease sites with SBRT as determined by radiation oncologist
- Prior systemic drug therapy for melanoma, unless given in the neoadjuvant or adjuvant setting for Stage I-III disease
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- Any contraindication to the planned standard of care immunotherapy regimen per regulatory approved product information
- For patients with liver metastases - moderate/severe liver dysfunction
- A known history of another malignancy or concurrent malignancy unless the patient is disease-free for a minimum of 1 year, is completely treated and is at low risk of recurrence
- Pregnant or breastfeeding females
Trial locations and contacts
5 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
5 sites in 2 countries
Australia4 sites, 4 recruiting
- Recruiting
The Alfred Hospital
Melbourne, Victoria, 3004
Jeremy Ruben
- Recruiting
Westmead Hospital
Westmead, New South Wales, 2145
Tim Wang
- Recruiting
Melanoma Institute Australia
Wollstonecraft, New South Wales, 2065
Maria Gonzalez, +612 9911 7200, maria.gonzalez@melanoma.org.au
Angela Hong
- Recruiting
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102
Mark Pinkham
Canada1 site, 1 recruiting
- Recruiting
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2C4
Philip Wong
About this study
Official title: A Phase II, Multicentre, Non-Comparative, Randomised Controlled Trial of Stereotactic Ablative Body Radiotherapy and Immunotherapy Versus Immunotherapy Alone in Patients With Treatment Naïve Oligometastatic Extracranial Melanoma
The purpose of this research is to evaluate the addition of radiotherapy to the standard immunotherapy drugs that are given to patients with advanced or metastatic melanoma that has spread to other parts of the body. Radiotherapy uses x-rays to target and kill melanoma cells and immunotherapy works by activating the body's own immune system to seek out and fight melanoma cells. Both of these treatments are commonly given to patients with advanced melanoma and other cancers. Both treatments are usually given separately but can also be given together. The aim of this research is to find out if giving radiotherapy and immunotherapy together is better than giving immunotherapy alone.
The type of radiotherapy to be used in this project is known as 'stereotactic' body radiotherapy or SBRT (also known as stereotactic body ablative radiotherapy, SABR). SBRT targets the radiation very precisely at the metastatic deposits in the body. This method protects the healthy areas near the melanoma. SBRT works by delivering a high dose of radiation precisely to the areas of melanoma which causes the melanoma cells to break apart and eventually die. SBRT is given in 'fractions' which means the high dose is given in small measures over several days, depending on the number and size of metastases.
Read the detailed description
One of the promising treatment combinations for metastatic melanoma is the use of radiotherapy with immune checkpoint inhibitors. There have been multiple reports of the synergy between radiation and immunotherapy in preclinical studies and early phase clinical trials. This combination improves response rates compared to immunotherapy alone and without worsening the toxicity associated with each agent alone. Radiation has the potential to convert tumours considered immunologically "cold" into "warm" through the combination of three processes: 1) Changes in the balance of cytokines by increasing the production of immunostimulatory cytokines which overcome the immunosuppressive tumour microenvironment, 2) Recruitment, of antigen-presenting cells and immune effector cells in the tumour microenvironment, 3) Positive regulation of antigen expression, antigen processing, histocompatibility molecules, and costimulatory signals, thereby increasing tumour immunogenicity.
There is a significant body of data to suggest a reproducible clinical benefit can be achieved when stereotactic body radiotherapy (SBRT) is used with immunotherapy in a tightly sequenced treatment combination, in contrast to independently timed use of either treatment alone, for the management of a variety of malignancies. In metastatic non-small cell lung cancer, a pooled analysis of two randomised trials showed that the addition of radiotherapy improved the out-of-field response rate, progression-free survival, and the overall survival. In the Stereotactic Ablative Radiotherapy for Comprehensive Treatment of Oligometastatic Tumors trial (SABR-COMET - NCT01446744) of 1-5 oligo metastases in all tumour histologies, the 8-year overall survival was 27.2% in the experimental SBRT arm versus 13.6% in the palliative radiotherapy control arm (with the goal of alleviating symptoms) (hazard ratio, 0.50; 95% confidence interval, 0.30-0.84; P = 0.008). The eight-year progression free survival estimates were 21.3% versus 0.0%, respectively (hazard ratio, 0.45; 95% confidence interval, 0.28-0.72; P <0.001) (Harrow, Palma et al. 2022). There are two ongoing phase 3 randomised trials of SABR with standard of care (palliative radiotherapy with or without systemic anti-cancer therapy) vs standard of care alone for patients with 1-3 solid cancer metastases (SABR-COMET 3) and 4-10 metastases (SABR- COMET 10).
At present, patients with metastatic melanoma receive various treatment modalities in different combinations and sequencing, including a drug alone approach, palliative radiotherapy for symptom control, SBRT to persistent disease as salvage therapy if all or some metastases do not respond to initial drug therapy, and surgery. There is an ongoing randomised trial examining the role of upfront stereotactic radiosurgery to asymptomatic melanoma brain metastases in patients receiving concurrent combination of ipilimumab and nivolumab (Clinical Trials.gov Identifier: NCT03340129). However, there is no prospective randomised trial on the role of SBRT with immunotherapy in patients with extracranial melanoma oligometastases.
The AXIOM trial seeks to determine the role of upfront SBRT in patients with 1-5 extracranial melanoma oligometastases treated with concurrent immunotherapy. The efficacy of immunotherapy in this patient population is well established and therefore this randomised controlled study design is non-comparable with the control group. The randomisation ratio of 2:1 will provide more information on the response and safety of SBRT and immunotherapy, whilst limiting the number of patients randomised to the 'control' group, in order to provide minimum but contemporary immunotherapy efficacy and safety data.
The hypothesis is that for patients with extracranial melanoma oligometastases, concurrent stereotactic body radiotherapy with immunotherapy is safe and prolongs survival through enhanced anti-tumour immunity due to the potential synergy of the combination therapies, than immunotherapy alone.
- Conditions
- Melanoma Metastatic
- Being tested
- Stereotactic Body Radiotherapy (extracranial) concurrent with Immunotherapy, Immunotherapy alone
- Keywords
- SABR, stereotactic body radiotherapy, Stereotactic Ablative Body Radiotherapy, SABRT, Immunotherapy, Immune Checkpoint Inhibitors, Oligometastases, Extracranial, Quality of life, Biomarkers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic Body Radiotherapy (extracranial) concurrent with ImmunotherapyOther
Radiotherapy A minimum SBRT biologically effective dose (BED) of 48Gy10 to all sites of extracranial metastatic disease should be administered between cycle 1 and cycle 3 of standard of care immunotherapy.
Immunotherapy All patients will receive standard of care 1st line immunotherapy as decided by the treating clinician and in accordance with the current listing on the Australian Register of Therapeutic Goods (ARTG) or applicable international regulatory agency.
Other Names:
Immune checkpoint inhibitor Standard of care immunotherapy First line treatment
Immunotherapy aloneDrug
Also called Immune checkpoint inhibitor, Standard of care immunotherapy, First line treatment
All patients will receive standard of care 1st line immunotherapy as decided by the treating clinician and in accordance with the current listing on the Australian Register of Therapeutic Goods (ARTG) or applicable international regulatory agency.
| Study group | Role | What they receive |
|---|---|---|
| Arm A: Concurrent stereotactic body radiotherapy + Immune checkpoint inhibitor(s) | Experimental | Concurrent stereotactic body radiotherapy (SBRT) with standard of care immune checkpoint inhibitor(s) (ICI). Patients will receive a minimum SBRT biologically effective dose (BED) of 48Gy10 to all sites of metastatic disease between cycle 1 and cycle 3 of immunotherapy. The interval between cycles 1 and 3 will depend on the prescribed immunotherapy regimen that is standard of care at each participating site. Standard of care 1st line immunotherapy, as decided by the treating clinician and in accordance with the current listing on the Australian Register of Therapeutic Goods (ARTG) or applicable international regulatory agency will be administered concurrently |
| Arm B: Immune checkpoint inhibitor(s) | Active comparator | Immunotherapy alone
Standard of care 1st line immunotherapy, as decided by the treating clinician and in accordance with the current listing on the Australian Register of Therapeutic Goods (ARTG) or applicable international regulatory agency will be administered alone. Receives: Drug: Immunotherapy alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Proportion of patients alive at 6 months 1, 2, 3 and 5 years from the time of randomization
Measured: 5 years
Secondary outcomes (8)
Overall progression-free survival
Proportion of patients alive and with no evidence of disease progression or new melanoma lesions as assessed by RECIST 1.1 criteria
Measured: 5 years
Progression-free survival related to new lesions only
Proportion of patients alive and with no evidence of new melanoma lesions as assessed by RECIST 1.1 criteria
Measured: 5 years
Overall response rate
Overall response rate from the time of randomization to the best response as assessed by RECIST 1.1
Measured: 5 years
Local control of the initial oligometastases
The proportion of patients with local control of all baseline metastases: complete response, partial response or stable disease) as assessed per RECIST 1.1 criteria
Measured: 5 years
Safety and tolerability of each treatment arm and study procedures
Proportion of patients with adverse events related to SBRT alone, combined SBRT and immunotherapy, immunotherapy-related Suspected Unexpected Serious Adverse Reaction (SUSAR), or related to study specific procedures with causality determined by the investigator and described per Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Only AEs greater than CTCAE grade 1 will be recorded.
Measured: 5 years
The requirement for immunosuppressive agents to treat adverse events
Proportion of patients receiving corticosteroids or other immunosuppressive agents to treat each adverse event including duration and maximum dose.
Measured: 5 years
Patient reported quality of life
The mean change from baseline quality of life scores [EuroQol Group Association ED-5Q-5L and European Organisation for Research and Treatment of Cancer QLQ-C30] from randomization to best and lowest scores for each instrument.
Measured: 5 years
Salvage radiotherapy in the immunotherapy alone arm
The incidence of salvage radiotherapy for symptomatic control or progressing baseline lesions or new metastasis(es) in the immunotherapy arm.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2025
- Study start6 Mar 2025
- Primary completion1 Apr 2033 (estimated)
- Study completion1 Apr 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Melanoma MetastaticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Open label, 2-arm parallel group, non-comparative, randomised (2:1 ratio) controlled, trial with stratification by: * Liver metastasis vs no liver metastasis * Baseline LDH: normal vs elevated * Immunotherapy agents: anti-PD-1 alone vs anti-PD-1 combination with anti-CTLA-4 or anti-LAG-3
- Masking
- None (open label)
- Enrolment
- 129 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Melanoma Institute Australia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Angela Hong, Study chair, Melanoma Institute Australia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06767306
- Sponsor's protocol ID
- MIA2024/508
- Acronym
- AXIOM
- Status last verified
- Apr 2026
- First submitted
- 4 Jan 2025
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Hong AM, Wang T, Carlino MS, Lo SN, Menzies AM, da Silva IP, Long GV. Study protocol of a randomised phase II trial of concurrent stereotactic body radiotherapy with immunotherapy versus immunotherapy alone in patients with 1-5 extracranial melanoma oligometastases (AXIOM). BMC Cancer. 2025 Oct 21;25(1):1615. doi: 10.1186/s12885-025-15066-z.
PubMed 41120904
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Multicentre, Non-Comparative, Randomised Controlled Trial of Stereotactic Ablative Body Radiotherapy and Immunotherapy Versus Immunotherapy Alone in Patients With Treatment Naïve Oligometastatic Extracranial Melanoma
- ClinicalTrials.gov ID
- NCT06767306
- Acronym / sponsor ID
- AXIOM / MIA2024/508
- Conditions
- Melanoma Metastatic
- Keywords
- SABR, stereotactic body radiotherapy, Stereotactic Ablative Body Radiotherapy, SABRT, Immunotherapy, Immune Checkpoint Inhibitors, Oligometastases, Extracranial
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 129 participants (estimated)
- Lead sponsor
- Melanoma Institute AustraliaUniversity, hospital or other
- Study start
- 6 Mar 2025 (actual)
- Primary completion
- 1 Apr 2033 (estimated)
- Study completion
- 1 Apr 2033 (estimated)
- First posted
- 9 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research is to evaluate the addition of radiotherapy to the standard immunotherapy drugs that are given to patients with advanced or metastatic melanoma that has spread to other parts of the body. Radiotherapy uses x-rays to target and kill melanoma cells and immunotherapy works by activating the body's own immune system to seek out and fight melanoma cells. Both of these treatments are commonly given to patients with advanced melanoma and other cancers. Both treatments are usually given separately but can also be given together. The aim of this research is to find out if giving radiotherapy and immunotherapy together is better than giving immunotherapy alone.
The type of radiotherapy to be used in this project is known as 'stereotactic' body radiotherapy or SBRT (also known as stereotactic body ablative radiotherapy, SABR). SBRT targets the radiation very precisely at the metastatic deposits in the body. This method protects the healthy areas near the melanoma. SBRT works by delivering a high dose of radiation precisely to the areas of melanoma which causes the melanoma cells to break apart and eventually die. SBRT is given in 'fractions' which means the high dose is given in small measures over several days, depending on the number and size of metastases.
Detailed description
One of the promising treatment combinations for metastatic melanoma is the use of radiotherapy with immune checkpoint inhibitors. There have been multiple reports of the synergy between radiation and immunotherapy in preclinical studies and early phase clinical trials. This combination improves response rates compared to immunotherapy alone and without worsening the toxicity associated with each agent alone. Radiation has the potential to convert tumours considered immunologically "cold" into "warm" through the combination of three processes: 1) Changes in the balance of cytokines by increasing the production of immunostimulatory cytokines which overcome the immunosuppressive tumour microenvironment, 2) Recruitment, of antigen-presenting cells and immune effector cells in the tumour microenvironment, 3) Positive regulation of antigen expression, antigen processing, histocompatibility molecules, and costimulatory signals, thereby increasing tumour immunogenicity.
There is a significant body of data to suggest a reproducible clinical benefit can be achieved when stereotactic body radiotherapy (SBRT) is used with immunotherapy in a tightly sequenced treatment combination, in contrast to independently timed use of either treatment alone, for the management of a variety of malignancies. In metastatic non-small cell lung cancer, a pooled analysis of two randomised trials showed that the addition of radiotherapy improved the out-of-field response rate, progression-free survival, and the overall survival. In the Stereotactic Ablative Radiotherapy for Comprehensive Treatment of Oligometastatic Tumors trial (SABR-COMET - NCT01446744) of 1-5 oligo metastases in all tumour histologies, the 8-year overall survival was 27.2% in the experimental SBRT arm versus 13.6% in the palliative radiotherapy control arm (with the goal of alleviating symptoms) (hazard ratio, 0.50; 95% confidence interval, 0.30-0.84; P = 0.008). The eight-year progression free survival estimates were 21.3% versus 0.0%, respectively (hazard ratio, 0.45; 95% confidence interval, 0.28-0.72; P <0.001) (Harrow, Palma et al. 2022). There are two ongoing phase 3 randomised trials of SABR with standard of care (palliative radiotherapy with or without systemic anti-cancer therapy) vs standard of care alone for patients with 1-3 solid cancer metastases (SABR-COMET 3) and 4-10 metastases (SABR- COMET 10).
At present, patients with metastatic melanoma receive various treatment modalities in different combinations and sequencing, including a drug alone approach, palliative radiotherapy for symptom control, SBRT to persistent disease as salvage therapy if all or some metastases do not respond to initial drug therapy, and surgery. There is an ongoing randomised trial examining the role of upfront stereotactic radiosurgery to asymptomatic melanoma brain metastases in patients receiving concurrent combination of ipilimumab and nivolumab (Clinical Trials.gov Identifier: NCT03340129). However, there is no prospective randomised trial on the role of SBRT with immunotherapy in patients with extracranial melanoma oligometastases.
The AXIOM trial seeks to determine the role of upfront SBRT in patients with 1-5 extracranial melanoma oligometastases treated with concurrent immunotherapy. The efficacy of immunotherapy in this patient population is well established and therefore this randomised controlled study design is non-comparable with the control group. The randomisation ratio of 2:1 will provide more information on the response and safety of SBRT and immunotherapy, whilst limiting the number of patients randomised to the 'control' group, in order to provide minimum but contemporary immunotherapy efficacy and safety data.
The hypothesis is that for patients with extracranial melanoma oligometastases, concurrent stereotactic body radiotherapy with immunotherapy is safe and prolongs survival through enhanced anti-tumour immunity due to the potential synergy of the combination therapies, than immunotherapy alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open label, 2-arm parallel group, non-comparative, randomised (2:1 ratio) controlled, trial with stratification by: * Liver metastasis vs no liver metastasis * Baseline LDH: normal vs elevated * Immunotherapy agents: anti-PD-1 alone vs anti-PD-1 combination with anti-CTLA-4 or anti-LAG-3
| Arm | Type | Receives |
|---|---|---|
| Arm A: Concurrent stereotactic body radiotherapy + Immune checkpoint inhibitor(s) | Experimental | –Concurrent stereotactic body radiotherapy (SBRT) with standard of care immune checkpoint inhibitor(s) (ICI). Patients will receive a minimum SBRT biologically effective dose (BED) of 48Gy10 to all sites of metastatic disease between cycle 1 and cycle 3 of immunotherapy. The interval between cycles 1 and 3 will depend on the prescribed immunotherapy regimen that is standard of care at each participating site. Standard of care 1st line immunotherapy, as decided by the treating clinician and in accordance with the current listing on the Australian Register of Therapeutic Goods (ARTG) or applicable international regulatory agency will be administered concurrently |
| Arm B: Immune checkpoint inhibitor(s) | Active comparator | Drug: Immunotherapy aloneImmunotherapy alone Standard of care 1st line immunotherapy, as decided by the treating clinician and in accordance with the current listing on the Australian Register of Therapeutic Goods (ARTG) or applicable international regulatory agency will be administered alone. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Female or male patients, age 18 or older
- Willing to provide signed informed consent
- Life expectancy > 6 months
- First presentation of AJCC Stage IV (any N, M1a, M1b, M1c), histologically confirmed cutaneous, acral or unknown primary melanoma with one to five extracranial metastases detected on CT and whole body PET-CT, and considered unresectable
- A primary lesion and / or up to 4 in-transit metastases(is) (ITM) in addition to distant metastases(is) are permitted and will be counted in the maximum number of permitted baseline lesions
Key exclusion criteria (10 listed)
- Ocular or mucosal melanoma
- Serious or unstable medical co-morbidities or other conditions that could interfere with the patient's safety, consent, or compliance
- Patients for whom there is a definite and immediate indication for radiotherapy (e.g., spinal cord compression, rapidly progressing disease associated with clinical signs and symptoms)
- Prior radiotherapy for Stage IV disease (prior adjuvant radiotherapy to primary site or nodal field (Stage I-III disease) is permitted, however adjuvant-treated sites must not be included in the baseline lesions
- Inability to treat all disease sites with SBRT as determined by radiation oncologist
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stereotactic Body Radiotherapy (extracranial) concurrent with ImmunotherapyRadiotherapy A minimum SBRT biologically effective dose (BED) of 48Gy10 to all sites of extracranial metastatic disease should be administered between cycle 1 and cycle 3 of standard of care immunotherapy. Immunotherapy All patients will receive standard of care 1st line immunotherapy as decided by the treating clinician and in accordance with the current listing on the Australian Register of Therapeutic Goods (ARTG) or applicable international regulatory agency. Other Names: Immune checkpoint inhibitor Standard of care immunotherapy First line treatment | Other | – |
| Immunotherapy aloneAlso: Immune checkpoint inhibitor, Standard of care immunotherapy, First line treatmentAll patients will receive standard of care 1st line immunotherapy as decided by the treating clinician and in accordance with the current listing on the Australian Register of Therapeutic Goods (ARTG) or applicable international regulatory agency. | Drug | Arm B: Immune checkpoint inhibitor(s) |
Primary outcome
Overall survival
Time frame: 5 years
Proportion of patients alive at 6 months 1, 2, 3 and 5 years from the time of randomization
8 secondary outcomes
Overall progression-free survival
Time frame: 5 years
Progression-free survival related to new lesions only
Time frame: 5 years
Overall response rate
Time frame: 5 years
Local control of the initial oligometastases
Time frame: 5 years
Safety and tolerability of each treatment arm and study procedures
Time frame: 5 years
The requirement for immunosuppressive agents to treat adverse events
Time frame: 5 years
Patient reported quality of life
Time frame: 5 years
Salvage radiotherapy in the immunotherapy alone arm
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- Derived from this study: PubMed 41120904Hong AM, Wang T, Carlino MS, Lo SN, Menzies AM, da Silva IP, Long GV. Study protocol of a randomised phase II trial of concurrent stereotactic body radiotherapy with immunotherapy versus immunotherapy alone in patients with 1-5 extracranial melanoma oligometastases (AXIOM). BMC Cancer. 2025 Oct 21;25(1):1615. doi: 10.1186/s12885-025-15066-z.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Angela Hong study chair
Melanoma Institute Australia
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Stereotactic Body Radiotherapy (extracranial) concurrent with Immunotherapy and Immunotherapy alone in people with Melanoma Metastatic, run by Melanoma Institute Australia at 5 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Australia, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Monica Osorio (+61 2 9911 7296, monica.osorio@melanoma.org.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06767306, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026.