Combining targeted radiotherapy with immunotherapy for advanced melanoma
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
This study is testing if combining targeted radiotherapy with immunotherapy can help people with advanced melanoma live better and longer compared to just using immunotherapy alone.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 129 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Melanoma Institute Australia Academic / other |
| Drugs / interventions | immunotherapy, radiation, ipilimumab, nivolumab |
| Locations | 5 sites (Westmead, New South Wales and 4 other locations) |
| Trial ID | NCT06767306 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 or older with unresectable AJCC Stage IV melanoma and one to five extracranial metastases.
Not a fit: Patients with cerebral metastases or those with a life expectancy of less than six months may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve treatment outcomes for patients with advanced melanoma.
How similar studies have performed: Previous studies have shown promising results with the combination of radiotherapy and immunotherapy in treating various malignancies, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Westmead, New South Wales and 4 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.