Radiotherapy + Immunotherapy for Melanoma
(AXIOM Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether adding radiotherapy (targeted x-ray treatment) to immunotherapy (a treatment that uses the body's immune system) is more effective than immunotherapy alone for individuals with advanced melanoma that has spread. Radiotherapy aims to precisely target and destroy melanoma cells, while immunotherapy helps the immune system fight these cells. Participants should have melanoma that has spread to other parts of the body, with one to five sites of spread that cannot be removed by surgery. The trial seeks individuals who have not yet received drug therapy for their Stage IV melanoma and do not have cancer that has spread to the brain.
As a Phase 2 trial, this research focuses on measuring how well the treatment works in an initial, smaller group of people, offering participants a chance to contribute to important advancements in melanoma treatment.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that combining radiotherapy with immunotherapy is generally safe for treating melanoma. Studies have found that patients usually tolerate these treatments well when used together. One study concluded that using a precise form of radiotherapy, called stereotactic body radiotherapy (SBRT), along with immune checkpoint inhibitors, does not increase the risk of serious side effects, provided the radiation carefully avoids healthy tissues.
Another study found that administering immune checkpoint inhibitors before, during, or after radiotherapy is safe. Even when treating the spine, there is a low risk of long-term side effects. This suggests that adding radiotherapy to immunotherapy does not significantly raise safety concerns.
Overall, evidence suggests that this combination treatment is safe for humans, with a focus on protecting healthy tissues during radiation.12345Why are researchers excited about this trial's treatments?
Most treatments for melanoma, like immune checkpoint inhibitors, work by helping the immune system recognize and attack cancer cells. However, researchers are excited about combining these inhibitors with stereotactic body radiotherapy (SBRT) because SBRT can directly target and destroy cancer cells with high precision. This combination could potentially enhance the immune response and improve treatment effectiveness by not only shrinking tumors but also preventing their spread, offering a promising approach beyond the standard immunotherapy alone.
What evidence suggests that this trial's treatments could be effective for melanoma?
Research has shown that combining a precise type of radiation therapy, called stereotactic body radiotherapy (SBRT), with immunotherapy may be promising for treating advanced melanoma. In this trial, some participants will receive concurrent SBRT with immunotherapy. One study found that 39.1% of patients responded to this combination treatment, with 8.7% experiencing complete tumor disappearance and 30.4% seeing their tumors shrink. Another study reported that 85% of patients were still alive two years after treatment. These results suggest that using SBRT with immunotherapy could enhance treatment effectiveness by directly targeting tumors and aiding the immune system in fighting cancer cells. Meanwhile, other participants in this trial will receive immunotherapy alone, which is the standard of care.16789
Who Is on the Research Team?
Angela Hong
Principal Investigator
Melanoma Institute Australia
Are You a Good Fit for This Trial?
This trial is for adults with advanced melanoma that has spread but can't be removed by surgery. They should have 1-5 detectable metastases outside the brain, which are treatable with high-dose targeted radiotherapy. Participants need to have a life expectancy of more than 6 months and must be able to handle immunotherapy treatments.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive concurrent stereotactic body radiotherapy (SBRT) with immune checkpoint inhibitors or immunotherapy alone
Follow-up
Participants are monitored for safety, tolerability, and effectiveness after treatment
Extension
Long-term monitoring for overall survival and progression-free survival
What Are the Treatments Tested in This Trial?
Interventions
- Immunotherapy
- Stereotactic Body Radiotherapy
Trial Overview
The study compares two approaches: one group receives both stereotactic body radiotherapy (SBRT) and standard immunotherapy drugs, while another group gets only immunotherapy. SBRT delivers precise radiation doses directly to melanoma cells over several days.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
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
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Melanoma Institute Australia
Lead Sponsor
Citations
Checkpoint Inhibitors in Combination With Stereotactic ...
In recent years, stereotactic body radiotherapy (SBRT) has emerged as a safe and effective treatment option for patients with limited metastatic ...
a meta-analysis of prospective clinical trials - PMC - NIH
Stereotactic ablative radiotherapy (SABR) can increase the immunogenicity of tumours through modulation of the tumour and its environment.
NCT06767306 | Stereotactic Ablative Radiotherapy (XRT) ...
The AXIOM trial seeks to determine the role of upfront SBRT in patients with 1-5 extracranial melanoma oligometastases treated with concurrent immunotherapy.
Combined stereotactic radiation therapy and ...
Results: Overall response rate (ORR) was 39.1%. Complete response (CR) was achieved in 8.7% patients and partial response (PR) – in 30.4% patients, median ...
Multicenter Evaluation of Radiation and Immune ...
Two-year OS was 85%; distant metastasis-free survival 44%. The 2-year cumulative incidence of local recurrence (LR) was 26% (95% CI, 13%-41%). For 9 patients ...
Immune Checkpoints Inhibitors and SRS/SBRT Synergy in ...
Results: Thirty-nine articles were included of the 2141 initial results. The reported rates for local control were 16.5–100% and 40–94% in brain ...
SBRT as a Vaccination for Metastatic Melanoma
Recent evidence suggests that radiation can enhance the immune response in the presence of checkpoint blockade.
Safety of combined ablative radiotherapy and immune ...
We conclude that multi-site SBRT and ICI can be safely co-administered when SBRT is delivered with prioritization of normal tissue constraints.
Safety and clinical efficacy of immune checkpoint inhibition ...
Treatment regimens that combine ICIs before, concurrent with, and after SBRT for spine metastases are safe, with minimal risk for increased rates of long-term ...
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