Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04090710
Registration number
NCT04090710
Ethics application status
Date submitted
9/09/2019
Date registered
16/09/2019
Date last updated
8/04/2024
Titles & IDs
Public title
SBRT With Combination Ipilimumab/Nivolumab for Metastatic Kidney Cancer
Query!
Scientific title
Cytoreductive Stereotactic Hypofractionated Radiotherapy With Combination Ipilimumab/Nivolumab for Metastatic Kidney Cancer
Query!
Secondary ID [1]
0
0
CA209-7DR
Query!
Secondary ID [2]
0
0
OCOG-2019-CYTOSHRINK
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
CYTOSHRINK
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Metastatic Renal Cell Carcinoma
0
0
Query!
Condition category
Condition code
Cancer
0
0
0
0
Query!
Kidney
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - Ipilimumab/ Nivolumab
Treatment: Other - SBRT + Ipilimumab/Nivolumab
Active Comparator: Standard of Care I/N alone - 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.
Experimental: Standard of Care I/N plus primary disease SBRT - 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.
Treatment: Drugs: Ipilimumab/ Nivolumab
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
Treatment: Other: SBRT + Ipilimumab/Nivolumab
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.
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Intervention code [2]
0
0
Treatment: Other
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Progression free survival (PFS)
Query!
Assessment method [1]
0
0
The primary outcome of this study is the hazard ratio for progression-free survival (PFS), defined from the date of randomization until the date of progression (PFS truncated at subsequent systemic therapy) as determined by RECIST 1.1, or death due to any cause, whichever comes first. All attempts will be made to follow-up patients for the primary outcome measure for at least one year, even if a patient stops treatment. Patients who do not have a primary outcome event at the time of analysis will be censored on the last date the patient can be confirmed as alive and progression-free.
Query!
Timepoint [1]
0
0
2 years
Query!
Secondary outcome [1]
0
0
Subject safety
Query!
Assessment method [1]
0
0
Incidence and attribution of deaths
Query!
Timepoint [1]
0
0
Date of randomization until 1year post treatment
Query!
Secondary outcome [2]
0
0
Overall Survival
Query!
Assessment method [2]
0
0
• Overall survival, defined from the date of randomization to the date of death due to any cause. Patients with no known death date at the time of analysis will be censored on the last date they are confirmed alive.
Query!
Timepoint [2]
0
0
2 years
Query!
Secondary outcome [3]
0
0
Objective response rate
Query!
Assessment method [3]
0
0
• Objective response rate, which is defined as the proportion of randomized subjects who achieve a best response of complete response (CR) or partial response (PR) using the RECIST 1.1 criteria.
Query!
Timepoint [3]
0
0
1 year
Query!
Secondary outcome [4]
0
0
Quality of Life: EORTC QLQ-C30 questionnaire
Query!
Assessment method [4]
0
0
• Quality of life, which will be evaluated using the EORTC QLQ-C30 questionnaire.
Query!
Timepoint [4]
0
0
1 year
Query!
Secondary outcome [5]
0
0
Subject safety
Query!
Assessment method [5]
0
0
Number of Adverse Events and Serious Adverse Events using NCI CTCAE v5.0
Query!
Timepoint [5]
0
0
1 Year
Query!
Secondary outcome [6]
0
0
Ipilimumab/ Nivolumab drug tolerability
Query!
Assessment method [6]
0
0
Ipilimumab/Nivolumab treatment discontinuation rates
Query!
Timepoint [6]
0
0
From the date of randomization until date of first documented disease progression up to 1 year.
Query!
Secondary outcome [7]
0
0
Ipilimumab/ Nivolumab drug tolerability
Query!
Assessment method [7]
0
0
Number of doses of Ipilimumab/Nivolumab combination treatment
Query!
Timepoint [7]
0
0
From the date of randomization until date of first documented disease progression, up to 1 year.
Query!
Secondary outcome [8]
0
0
Ipilimumab/ Nivolumab drug tolerability
Query!
Assessment method [8]
0
0
Number of Nivolumab maintenance doses
Query!
Timepoint [8]
0
0
From the date of randomization until date of first documented disease progression, up to 1 year.
Query!
Secondary outcome [9]
0
0
Ipilimumab/ Nivolumab drug tolerability
Query!
Assessment method [9]
0
0
Time to treatment discontinuation from the date of randomization
Query!
Timepoint [9]
0
0
From the date of randomization until date of first documented disease progression, up to 1 year.
Query!
Eligibility
Key inclusion criteria
1. Biopsy proven renal cell carcinoma of any histology.
2. Imaging proven metastatic disease based on CT or MRI within 10 weeks of screening.
3. Intermediate/poor risk disease based on IMDC criteria (see Appendix II).
4. Primary kidney lesion amenable to SBRT.
5. Eligible for standard of care delivery of ipilimumab and nivolumab (I/N) according to
approved product monograph.
Query!
Minimum age
No limit
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
1. A maximum primary renal lesion size of 20 cm or greater.
2. Candidate for cytoreductive nephrectomy, unless a patient has refused cytoreductive
nephrectomy (in this case, a discussion of cytoreductive nephrectomy and patient
refusal must be documented).
3. Treatment with prior systemic therapy in the adjuvant or metastatic setting for renal
cell carcinoma.
4. Previous abdominal radiation precluding SBRT.
5. Kanofsky Performance (KPS) score below 60 (see Appendix III).
6. History of auto-immune disorder precluding treatment with ipilimumab or nivolumab.
7. History of ataxia telangiectasia or other radiation sensitivity disorders.
8. Chronic corticosteroid use or other chronic immune suppressive therapy. (Participants
are permitted the use of topical, ocular, intra-articular, intranasal, and
inhalational corticosteroids (with minimal systemic absorption). Adrenal replacement
steroid doses of prednisone = 10 mg daily are permitted).
9. Use of medicinal herbal preparations (not including medical cannabis) unless
prescribed by a treating physician.
10. Inability to lie flat for at least 30 minutes without moving.
11. Pregnant or lactating women.
12. Geographic inaccessibility for follow-up.
13. Inability to provide informed consent.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 2
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Active, not recruiting
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
29/01/2020
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
31/03/2025
Query!
Actual
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
66
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Recruitment hospital [1]
0
0
Peter MacCallum Cancer Centre - Melbourne
Query!
Recruitment postcode(s) [1]
0
0
3000 - Melbourne
Query!
Recruitment outside Australia
Country [1]
0
0
Canada
Query!
State/province [1]
0
0
Alberta
Query!
Country [2]
0
0
Canada
Query!
State/province [2]
0
0
Ontario
Query!
Funding & Sponsors
Primary sponsor type
Other
Query!
Name
Ontario Clinical Oncology Group (OCOG)
Query!
Address
Query!
Country
Query!
Other collaborator category [1]
0
0
Commercial sector/Industry
Query!
Name [1]
0
0
Bristol-Myers Squibb
Query!
Address [1]
0
0
Query!
Country [1]
0
0
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
This trial will evaluate the addition of cytoreductive stereotactic body radiation therapy
(SBRT) to standard of care combination ipilimumab and nivolumab (I/N) versus I/N alone for
the treatment of metastatic kidney cancer.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT04090710
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Aly-Khan Lalani, MD
Query!
Address
0
0
Juravinski Cancer Centre
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04090710
Download to PDF