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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04090710
Registration number
NCT04090710
Ethics application status
Date submitted
9/09/2019
Date registered
16/09/2019
Titles & IDs
Public title
SBRT With Combination Ipilimumab/Nivolumab for Metastatic Kidney Cancer
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Scientific title
Cytoreductive Stereotactic Hypofractionated Radiotherapy With Combination Ipilimumab/Nivolumab for Metastatic Kidney Cancer
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Secondary ID [1]
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CA209-7DR
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Secondary ID [2]
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OCOG-2019-CYTOSHRINK
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Universal Trial Number (UTN)
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Trial acronym
CYTOSHRINK
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Metastatic Renal Cell Carcinoma
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Condition category
Condition code
Cancer
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Kidney
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Treatment: Other
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Progression free survival (PFS)
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Assessment method [1]
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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.
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Timepoint [1]
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2 years
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Secondary outcome [1]
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Subject safety
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Assessment method [1]
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Incidence and attribution of deaths
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Timepoint [1]
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Date of randomization until 1year post treatment
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Secondary outcome [2]
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Overall Survival
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Assessment method [2]
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• 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.
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Timepoint [2]
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2 years
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Secondary outcome [3]
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Objective response rate
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Assessment method [3]
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• 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.
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Timepoint [3]
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1 year
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Secondary outcome [4]
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Quality of Life: EORTC QLQ-C30 questionnaire
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Assessment method [4]
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• Quality of life, which will be evaluated using the EORTC QLQ-C30 questionnaire.
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Timepoint [4]
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1 year
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Secondary outcome [5]
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Subject safety
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Assessment method [5]
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Number of Adverse Events and Serious Adverse Events using NCI CTCAE v5.0
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Timepoint [5]
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1 Year
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Secondary outcome [6]
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Ipilimumab/ Nivolumab drug tolerability
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Assessment method [6]
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Ipilimumab/Nivolumab treatment discontinuation rates
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Timepoint [6]
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From the date of randomization until date of first documented disease progression up to 1 year.
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Secondary outcome [7]
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Ipilimumab/ Nivolumab drug tolerability
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Assessment method [7]
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Number of doses of Ipilimumab/Nivolumab combination treatment
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Timepoint [7]
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From the date of randomization until date of first documented disease progression, up to 1 year.
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Secondary outcome [8]
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Ipilimumab/ Nivolumab drug tolerability
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Assessment method [8]
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Number of Nivolumab maintenance doses
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Timepoint [8]
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From the date of randomization until date of first documented disease progression, up to 1 year.
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Secondary outcome [9]
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Ipilimumab/ Nivolumab drug tolerability
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Assessment method [9]
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Time to treatment discontinuation from the date of randomization
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Timepoint [9]
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From the date of randomization until date of first documented disease progression, up to 1 year.
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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.
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Minimum age
No limit
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
29/01/2020
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
31/03/2025
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Actual
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Sample size
Target
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Accrual to date
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Final
66
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Peter MacCallum Cancer Centre - Melbourne
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Recruitment postcode(s) [1]
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3000 - Melbourne
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Recruitment outside Australia
Country [1]
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Canada
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State/province [1]
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Alberta
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Country [2]
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Canada
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State/province [2]
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Ontario
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Funding & Sponsors
Primary sponsor type
Other
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Name
Ontario Clinical Oncology Group (OCOG)
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Address
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Country
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Other collaborator category [1]
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Commercial sector/industry
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Name [1]
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Bristol-Myers Squibb
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/study/NCT04090710
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Aly-Khan Lalani, MD
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Address
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Juravinski Cancer Centre
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT04090710