SBRT + Immunotherapy for Kidney Cancer
(CYTOSHRINK Trial)
Trial Summary
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 exclude those on chronic corticosteroids or immune suppressive therapy, except for certain low-dose or topical forms. It also excludes those using medicinal herbal preparations unless prescribed by a doctor.
What data supports the effectiveness of the treatment SBRT + Immunotherapy for Kidney Cancer?
Research shows that the combination of nivolumab and ipilimumab, which are part of the immunotherapy treatment, has been effective in treating advanced kidney cancer, producing positive responses in patients. Additionally, combining radiotherapy with immunotherapy may enhance the treatment's effectiveness.12345
Is the combination of SBRT and immunotherapy safe for kidney cancer patients?
The combination of nivolumab and ipilimumab, which are types of immunotherapy, can cause immune-related side effects like colitis (inflammation of the colon), hepatitis (liver inflammation), dermatitis (skin inflammation), and thyroiditis (thyroid inflammation). Rare but serious side effects include myocarditis (heart inflammation) and pneumonitis (lung inflammation). These side effects are important to monitor and manage during treatment.678910
How is the SBRT + Ipilimumab/Nivolumab treatment different for kidney cancer?
The combination of stereotactic body radiotherapy (SBRT) with the immunotherapy drugs Ipilimumab and Nivolumab is unique because it aims to enhance the immune system's ability to fight kidney cancer by potentially overcoming resistance to immunotherapy. This approach uses SBRT to improve drug delivery and activate antitumor immune cells, which may lead to better outcomes compared to using immunotherapy alone.311121314
What is the purpose of this trial?
This trial is testing if adding targeted radiation therapy to standard immunotherapy drugs can better treat advanced kidney cancer. It focuses on patients with advanced kidney cancer who can't have surgery. The treatment works by boosting the immune system and directly targeting the tumor with radiation. Evidence suggests that targeted radiation therapy can impact anti-tumor immune responses, and may potentially be combined with immunotherapy for synergistic effect.
Research Team
Aly-Khan Lalani, MD
Principal Investigator
Juravinski Cancer Centre
Eligibility Criteria
This trial is for adults with biopsy-proven metastatic kidney cancer, who haven't had systemic therapy for it and can lie still for at least 30 minutes. They should be at an intermediate/poor risk level and have a primary kidney lesion small enough (<20 cm) to be treated with SBRT. Patients must not have plans for nephrectomy, previous abdominal radiation that prevents SBRT use, severe autoimmune disorders, or be on chronic immune suppressive drugs.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Induction Treatment
Induction ipilimumab combined with nivolumab every 3 weeks for cycles 1-4
Radiation (Experimental Arm)
SBRT to the primary disease in-situ, delivered between cycles 1 and 2 of I/N
Maintenance Treatment
Nivolumab maintenance treatment every 2 or 4 weeks until disease progression or intolerance
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Ipilimumab/Nivolumab
- SBRT
Ipilimumab/Nivolumab is already approved in United States, European Union, Japan, Canada for the following indications:
- Melanoma
- Non-Small Cell Lung Cancer (NSCLC)
- Hepatocellular Carcinoma (HCC)
- Colorectal Cancer (MSI-H or dMMR)
- Melanoma
- Non-Small Cell Lung Cancer (NSCLC)
- Hepatocellular Carcinoma (HCC)
- Colorectal Cancer (MSI-H or dMMR)
- Melanoma
- Non-Small Cell Lung Cancer (NSCLC)
- Hepatocellular Carcinoma (HCC)
- Melanoma
- Non-Small Cell Lung Cancer (NSCLC)
- Hepatocellular Carcinoma (HCC)
- Colorectal Cancer (MSI-H or dMMR)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Ontario Clinical Oncology Group (OCOG)
Lead Sponsor
Bristol-Myers Squibb
Industry Sponsor
Christopher Boerner
Bristol-Myers Squibb
Chief Executive Officer since 2023
PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis
Deepak L. Bhatt
Bristol-Myers Squibb
Chief Medical Officer since 2024
MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania