Immunotherapy with Steroids for Brain Metastases
(ACT-FAST Trial)
Trial Summary
What is the purpose of this trial?
Immunotherapy treatments are intended to boost a person's immune system to fight their cancer. Treatment with immunotherapy has been shown to be effective in a wide range of cancers, including melanoma skin cancer, lung cancer and kidney cancer, among others. Steroids are anti-inflammatory medications which may suppress the immune system. For this reason, persons requiring treatment with steroids have not previously been allowed to participate in immunotherapy clinical trials. Therefore, we do not know whether or not immunotherapy treatments are effective in patients who are also receiving treatment with steroids. When cancer has spread to the brain swelling may occur around the tumors, and headache, nausea, seizures or stroke-like symptoms may occur. In this instance, steroids are important to reduce swelling within the brain, thus alleviating these symptoms. Because patients requiring treatment with steroids have not previously been allowed to participate in immunotherapy clinical trials, we do not know whether treatment with immunotherapy is effective when steroid treatments are also used. This study will investigate this question, and also attempt to determine whether treatment with one steroid versus another results in a better response to immunotherapy.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but it does require that you are already on corticosteroid therapy. If you are taking non-steroid immunosuppressive agents, you will not be eligible for this study.
What data supports the effectiveness of the drug combination Nivolumab and Ipilimumab for treating brain metastases?
Research shows that the combination of Nivolumab and Ipilimumab can lead to significant responses in brain metastases, particularly in patients with melanoma, with over 50% of asymptomatic patients showing an intracranial response. Additionally, a case study reported an exceptional response in a patient with brain metastases from lung cancer using Nivolumab while on high-dose steroids.12345
Is the combination of Nivolumab and Ipilimumab safe for humans?
The combination of Nivolumab and Ipilimumab has been used in patients with advanced melanoma and non-small-cell lung cancer, but it can cause serious side effects. In a study, about half of the patients experienced severe side effects, and many needed hospital care. While it can help some patients live longer, the treatment comes with significant risks.14678
How is the drug combination of Nivolumab and Ipilimumab unique for treating brain metastases?
The combination of Nivolumab and Ipilimumab is unique because it can induce significant responses in brain metastases, even in patients who are symptomatic or on steroids, which is challenging for other treatments. This drug combination works by enhancing the immune system's ability to fight cancer cells in the brain, offering a novel approach compared to traditional therapies.12349
Eligibility Criteria
This trial is for adults with brain tumors who need steroids to reduce swelling and have started steroid therapy. They must be eligible for standard immunotherapy, have measurable brain disease, stable thyroid issues on hormones if present, and use birth control if applicable. Excluded are those with HIV, hepatitis B/C, recent autoimmune treatments or severe drug allergies.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive immunotherapy while on corticosteroid therapy to assess efficacy and safety
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Accelerated Checkpoint Therapy
- Glucocorticoid therapy
Accelerated Checkpoint Therapy is already approved in European Union, United States, Canada, Japan for the following indications:
- Melanoma
- Renal cell carcinoma
- Colorectal cancer
- Hepatocellular carcinoma
- Non-small cell lung cancer
- Melanoma
- Renal cell carcinoma
- Colorectal cancer
- Hepatocellular carcinoma
- Non-small cell lung cancer
- Melanoma
- Renal cell carcinoma
- Colorectal cancer
- Melanoma
- Renal cell carcinoma
- Non-small cell lung cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
AHS Cancer Control Alberta
Lead Sponsor