Combining targeted radiotherapy with immunotherapy for advanced melanoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This research evaluates the effectiveness of combining stereotactic body radiotherapy (SBRT) with standard immunotherapy for patients with advanced or metastatic melanoma. The study aims to determine if this combination treatment improves outcomes compared to immunotherapy alone. SBRT precisely targets melanoma cells while minimizing damage to surrounding healthy tissue, potentially enhancing the immune response against the cancer. The trial will include patients with unresectable metastatic melanoma and will assess the synergy between these two treatment modalities.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* 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

Where it's running

• Westmead Hospital
  Westmead, New South Wales, Australia Recruiting
• Melanoma Institute Australia
  Wollstonecraft, New South Wales, Australia Recruiting
• Princess Alexandra Hospital
  Woolloongabba, Queensland, Australia Recruiting
• The Alfred Hospital
  Melbourne, Victoria, Australia Recruiting
• Princess Margaret Cancer Centre
  Toronto, Ontario, Canada Recruiting

Study contacts

• Study coordinator: Monica Osorio
• Email: monica.osorio@melanoma.org.au
• Phone: +61 2 9911 7296

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.