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RecruitingLast updated: 25 May 2026

AXIOM: Testing whether giving precise radiation therapy at the same time as immunotherapy can improve outcomes compared to immunotherapy alone for people with metastatic melanoma who have not had prior treatmentA Phase II, Multicentre, Non-Comparative, Randomised Controlled Trial of Stereotactic Ablative Body Radiotherapy and Immunotherapy Versus Immunotherapy Alone in Patients With Treatment Naive Oligometastatic Extracranial Melanoma

Trial purpose

Medical clipboardCancer treatment

Tumor type

Skin Cancers Skin

Age

People18+

Trial acronym

AXIOM

Clinical summary

Summary

This study is looking at whether adding targeted radiation therapy to standard immunotherapy can improve outcomes for people with advanced melanoma that has spread to a small number of places in the body.
 
Immunotherapy is already a standard treatment for advanced melanoma. Radiation therapy is also commonly used, but these treatments are usually given at different times. This study is testing whether giving them together works better than immunotherapy on its own.
 
The type of radiation therapy used in this study is called stereotactic body radiotherapy (SBRT). SBRT uses high‑dose X‑rays aimed very precisely at melanoma deposits and this precision helps protect nearby healthy tissue. The radiation damages the cancer cells so they break down and die. Treatment is usually given over a few sessions (called fractions) across several days, depending on how many tumours there are and where they are located.
 
Who can participate?
This trial is recruiting people:
  • a first diagnosis of stage IV melanoma
  • the melanoma has spread to 1-5 places outside of the brain (called extracranial metastases) 
  • who have not received prior treatment for your advanced disease

Study details
Eligible participants will be randomly assigned (by chance) to receive either:

  • standard of care immunotherapy, or
  • immunotherapy plus SBRT given early in treatment.

People will be randomised on a 1:2 ratio, meaning more people will receive the combination treatment than immunotherapy alone. This helps researchers learn more about how safe and effective the combined treatment is, while still ensuring everyone receives standard care.

What is the aim of the study?
Researchers want to find out whether:

  • Adding SBRT to immunotherapy is safe
  • The combination helps people live longer
  • The immune system responds more strongly to treatment

Conditions

This trial is treating people with oligometastatic extracranial melanoma that is treatment naive

Eligibility

Inclusion

  • 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
  • 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

Exclusion

  • 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
  • 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

Inclusion

  • Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

Recruiting hospitals

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:

Trial sponsor

Melanoma Institute Australia

Scientific Title

A Phase II, Multicentre, Non-Comparative, Randomised Controlled Trial of Stereotactic Ablative Body Radiotherapy and Immunotherapy Versus Immunotherapy Alone in Patients With Treatment Naive Oligometastatic Extracranial Melanoma

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