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New treatment option for Melanoma Metastatic
Official title Stereotactic Ablative Radiotherapy (XRT) and Immunotherapy for Oligometastatic Extracranial Melanoma
ClinicalTrials.gov ID: NCT06767306
What this study is testing
What is Immunotherapy alone?
Immunotherapy alone is an investigational medicine, being studied as a potential treatment for melanoma metastatic.
Also referred to as Immune checkpoint inhibitor, Standard of care immunotherapy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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...
You likely can't join if
- 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...
- Prior radiotherapy for Stage IV disease (prior adjuvant radiotherapy to primary site or nodal field (Stage I-III disease) is permitted, however...
- 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
See the full eligibility 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...
- 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...
- 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Westmead, New South Wales, Australia
- Wollstonecraft, New South Wales, Australia
- Woolloongabba, Queensland, Australia
- Melbourne, Victoria, Australia
- Toronto, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Westmead, New South Wales, Australia; Wollstonecraft, New South Wales, Australia; Woolloongabba, Queensland, Australia; Melbourne, Victoria, Australia; Toronto, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.