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Checkpoint Inhibitor
SBRT + Immunotherapy for Kidney Cancer (CYTOSHRINK Trial)
Phase 2
Waitlist Available
Led By Aly-Khan Lalani, MD
Research Sponsored by Ontario Clinical Oncology Group (OCOG)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Biopsy proven renal cell carcinoma of any histology
Primary kidney lesion amenable to SBRT
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
CYTOSHRINK Trial Summary
This trial will compare the effect of adding radiation therapy to the standard care treatment of immunotherapy drugs for metastatic kidney cancer.
Who is the study for?
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.Check my eligibility
What is being tested?
The study compares two approaches: one group will receive standard care ipilimumab/nivolumab (I/N) treatment alone; the other group will get I/N plus stereotactic body radiation therapy (SBRT). The goal is to see if adding SBRT improves outcomes in metastatic kidney cancer patients.See study design
What are the potential side effects?
Ipilimumab/nivolumab may cause immune-related side effects like inflammation of organs, skin rash, hormone gland problems (like thyroid), fatigue, and flu-like symptoms. Radiation from SBRT could lead to localized pain or skin changes where the treatment is given.
CYTOSHRINK Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My kidney cancer diagnosis was confirmed with a biopsy.
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My kidney tumor can be treated with targeted radiation.
Select...
My condition is considered intermediate or poor risk.
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I am eligible for standard cancer treatment with ipilimumab and nivolumab.
CYTOSHRINK Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression free survival (PFS)
Secondary outcome measures
Ipilimumab/ Nivolumab drug tolerability
Objective response rate
Overall Survival
+2 moreOther outcome measures
Correlation with blood or stool immune signatures
Exploratory Outcomes: Evaluation of baseline and changes during treatment in blood immune signatures
Exploratory Outcomes: Evaluation of baseline and changes during treatment in stool microbiome
CYTOSHRINK Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Standard of Care I/N plus primary disease SBRTExperimental Treatment1 Intervention
induction ipilimumab 1 mg/kg combined with nivolumab 3 mg/kg (I/N) every 3 weeks for one cycle, followed by SBRT to the primary disease in-situ, prior to cycle 2-4 of I/N. Patients randomized to SBRT will undergo radiation planning during the first cycle of I/N to their primary kidney mass, and then the radiation will be delivered between cycles 1 and 2 to a dose of 30-40 Gy in 5 fractions every other day over 1.5 weeks. Approximately one week following completion of SBRT, patients will start cycle 2 of immunotherapy as per standard of care. The total time elapsed between the start of cycle 1 and 2 of I/N should be no more than 6 weeks. After completion of up to four cycles of I/N, patients will proceed to standard of care maintenance treatment with nivolumab 240mg every 2 weeks or 480mg every 4 weeks until disease progression (as determined by RECIST 1.1), intolerance, or patient/physician decision to stop treatment.
Group II: Standard of Care I/N aloneActive Control1 Intervention
induction ipilimumab 1 mg/kg combined with nivolumab 3 mg/kg (I/N) every 3 weeks for cycles 1-4 followed by maintenance treatment with nivolumab 240mg every 2 weeks or 480mg every 4 weeks until disease progression (as determined by RECIST 1.1), intolerance, or patient/physician decision to stop treatment.
Find a Location
Who is running the clinical trial?
Ontario Clinical Oncology Group (OCOG)Lead Sponsor
62 Previous Clinical Trials
41,819 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,638 Previous Clinical Trials
4,128,434 Total Patients Enrolled
Aly-Khan Lalani, MDPrincipal InvestigatorJuravinski Cancer Centre
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I've had radiation in my abdomen that prevents further targeted radiation.I only use herbal medicines if they are prescribed by my doctor.I have an autoimmune disease that prevents me from taking certain cancer treatments.My kidney cancer diagnosis was confirmed with a biopsy.My kidney tumor is 20 cm or larger.You live too far away to come for check-up visits.I need considerable assistance and medical care.My kidney tumor can be treated with targeted radiation.I have a condition that makes me sensitive to radiation.I cannot lie still flat on my back for 30 minutes.I use steroids or immune-suppressing drugs, but only in forms that don't affect my whole body.I have had treatment for kidney cancer before it spread or after.My condition is considered intermediate or poor risk.I am a candidate for surgery to remove part of my kidney, or I have chosen not to undergo this surgery.My scans show cancer has spread, and these were done within the last 10 weeks.I am eligible for standard cancer treatment with ipilimumab and nivolumab.
Research Study Groups:
This trial has the following groups:- Group 1: Standard of Care I/N alone
- Group 2: Standard of Care I/N plus primary disease SBRT
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
In how many locations has this trial been initiated?
"Potential participants for this medical research can be found at the Juravinski Cancer Centre in Hamilton, Grand River Regional Cancer Centre in Kitchener and McGill University Health Centre - Glen site in Montréal. Furthermore, there are 6 additional clinical trial sites enrolled patients."
Answered by AI
What is the uppermost cap of participants on this research?
"This clinical trial necessitates the enrollment of 78 eligible patients from across Canada, with specific sites located in Hamilton and Kitchener."
Answered by AI
What is the usual purpose of SBRT + Ipilimumab/Nivolumab treatment?
"SBRT + Ipilimumab/Nivolumab is a recommended treatment for patients who have previously undergone anti-angiogenic therapy. It can also be prescribed to treat certain malignant neoplasms, unresectable melanoma, and squamous cell carcinomas."
Answered by AI
Have scholars conducted research on the combination of stereotactic body radiation therapy with Ipilimumab/Nivolumab?
"Currently, 765 medical studies are being conducted for SBRT + Ipilimumab/Nivolumab. Of these trials, 86 have reached Phase 3 and the majority of them are based in Pittsburgh, Pennsylvania; however there is a total of 42755 sites conducting trials worldwide."
Answered by AI
Is admission to the trial still available for participants?
"Data posted on clinicaltrials.gov indicates that recruitment for this trial is currently in progress; it was inaugurated on January 29th 2020 and has most recently been updated as of March 30th 2022."
Answered by AI
Has the FDA sanctioned utilizing SBRT in conjunction with Ipilimumab/Nivolumab?
"Although no clinical data currently supports its efficacy, SBRT + Ipilimumab/Nivolumab has some proof of safety, leading it to receive a rating of 2."
Answered by AI
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