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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
Scientific title
Cytoreductive Stereotactic Hypofractionated Radiotherapy With Combination Ipilimumab/Nivolumab for Metastatic Kidney Cancer
Secondary ID [1] 0 0
CA209-7DR
Secondary ID [2] 0 0
OCOG-2019-CYTOSHRINK
Universal Trial Number (UTN)
Trial acronym
CYTOSHRINK
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metastatic Renal Cell Carcinoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Kidney

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression free survival (PFS)
Timepoint [1] 0 0
2 years
Secondary outcome [1] 0 0
Subject safety
Timepoint [1] 0 0
Date of randomization until 1year post treatment
Secondary outcome [2] 0 0
Overall Survival
Timepoint [2] 0 0
2 years
Secondary outcome [3] 0 0
Objective response rate
Timepoint [3] 0 0
1 year
Secondary outcome [4] 0 0
Quality of Life: EORTC QLQ-C30 questionnaire
Timepoint [4] 0 0
1 year
Secondary outcome [5] 0 0
Subject safety
Timepoint [5] 0 0
1 Year
Secondary outcome [6] 0 0
Ipilimumab/ Nivolumab drug tolerability
Timepoint [6] 0 0
From the date of randomization until date of first documented disease progression up to 1 year.
Secondary outcome [7] 0 0
Ipilimumab/ Nivolumab drug tolerability
Timepoint [7] 0 0
From the date of randomization until date of first documented disease progression, up to 1 year.
Secondary outcome [8] 0 0
Ipilimumab/ Nivolumab drug tolerability
Timepoint [8] 0 0
From the date of randomization until date of first documented disease progression, up to 1 year.
Secondary outcome [9] 0 0
Ipilimumab/ Nivolumab drug tolerability
Timepoint [9] 0 0
From the date of randomization until date of first documented disease progression, up to 1 year.

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.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
29/01/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/03/2025
Actual
Sample size
Target
Accrual to date
Final
66
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment postcode(s) [1] 0 0
3000 - Melbourne
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
Alberta
Country [2] 0 0
Canada
State/province [2] 0 0
Ontario

Funding & Sponsors
Primary sponsor type
Other
Name
Ontario Clinical Oncology Group (OCOG)
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Bristol-Myers Squibb
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Aly-Khan Lalani, MD
Address 0 0
Juravinski Cancer Centre
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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