RCC renal cell carcinoma
Conditions
Interventions
Part A Treatments
A1.Nivolumab/Ipilimumab combination therapy (nivolumab 240 mg every 2 weeks and
ipilimumab 1 mg/kg every 6 weeks (or every third nivolumab dose if dosing is
delayed)
A2.Placebo (P
Sponsors
Bristol-Myers Squibb
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: a) Kidney tumor has been completely resected with negative surgical margins obtained. The randomization must occur greater than 4 weeks and less than (or equal to) 12 weeks from the date of nephrectomy. Partial nephrectomy is allowed provided all inclusion criteria are met. b) Post-nephrectomy tumor shows RCC with a predominately clear cell histology, including participants with sarcomatoid features. c) Pathological TNM staging per AJCC staging version 2010: i) pT2a, G3 or G4, N0M0 ii) pT2b, G any, N0M0 iii) pT3, G any, N0M0 iv) pT4, G any, N0M0 v) pT any, G any, N1M0 d) Participants must have no clinical or radiological evidence of macroscopic residual disease or distant metastases (M0) after nephrectomy i) Baseline tumor assessment, performed 4 to approximately 12 weeks after nephrectomy, shows no metastasis or residual tumor lesions per local review and as confirmed by Blinded Independent Central Review (BICR). Results of BICR of the baseline tumor assessment confirming absence of metastasis or residual tumor lesions must be received before randomization. Note: participants with one or more regional lymph nodes identified with short axis 15 mm on the baseline (Post-Operative) tumor assessments are considered to have gross residual disease and are therefore ineligible. e) Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-1 (Appendix 5). f) Either a formalin-fixed, paraffin-embedded (FFPE) tissue block or unstained tumor tissue sections, obtained within 3 months prior to enrollment, preferably from nephrectomy, with an associated pathology report, must be submitted to the central laboratory prior to randomization. FFPE block or 20 unstained slides is ideal, but a minimum of 10 unstained slides will be acceptable if tumor tissue is limited. Biopsy should be excisional, incisional, or core needle. Fine needle aspiration is unacceptable for submission. g) Males and Females, ages *18 years or age of majority. h) Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 72 hours prior to the start of study treatment. i) Women must not be breastfeeding. j) Women of childbearing potential (WOCBP) must agree to follow instructions for method(s) of contraception k) Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception
Exclusion criteria
Exclusion criteria: a) Any severe or serious, acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration including ongoing or active infection requiring parental antibiotics b) Participants with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days prior to the first dose of study drug. Topical, ocular, intra-articular, intranasal, inhaled steroids, and adrenal replacement steroid doses > 10 mg daily prednisone or the equivalent are permitted in the absence of active immune disease. c) Uncontrolled adrenal insufficiency d) Participants with an active known or suspected autoimmune disease. Participants with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enrol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is DFS. The primary endpoint of DFS will be programmatically determined based on the disease recurrence date provided by the BICR. DFS is defined as the time from randomization to development of local disease recurrence (ie, recurrence of primary tumor in situ or occurrence of a secondary RCC primary cancer), distance metastasis, or death, whichever came first. | — |
Secondary
| Measure | Time frame |
|---|---|
| - OS, defined as the time between the date of randomization and the date of death. For participants without documentation of death, OS will be censored on the last date the participants were known to be alive. -Safety and tolerability endpoint: type, incidence, severity (graded by the National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE, Version 4.0], timing, seriousness, and relatedness, and laboratory abnormalities in all treated participants -DFS and OS in contemporaneously randomized combination and monotherapy participants. | — |
Countries
Netherlands
Outcome results
None listed