Early stage localized Renal Cell Carcinoma MedDRA version: 21.0 Level: LLT Classification code 10038395 Term: Renal carcinoma System Organ Class: 100000004864
Conditions
Sponsors
Bristol-Myers Squibb International Corporation
Eligibility
Sex/Gender
All
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: (refer to Appendix 9 for correlations of classifications in cancer staging systems): ? pT2a, G3 or G4, N0M0 ? pT2b, G any, N0M0 ? pT3, (a, b, c), G any, N0M0 ? pT4, G any, N0M0 ? 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. ii) If the Investigator is not certain the participant is disease free, the participant should: 1) not be consented or be enrolled into the study and 2) evaluation for eligibility should not be submitted to BICR. 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. 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 1360 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 240
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 enroll.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Part A: TTo compare disease-free survival (DFS) per Blinded Independent Central Review (BICR) of nivolumab combined with ipilimumab versus placebo infusions in participants with localized RCC, with a predominantly clear cell histology, who have undergone a nephrectomy Part B: To compare disease-free survival (DFS) per Blinded Independent Central Review (BICR) of nivolumab versus placebo infusions in participants with localized renal cell carcinoma, with a predominantly clear cell histology who have undergone nephrectomy.;Secondary Objective: 1) • Part A: To compare OS, including the 5-year OS rates, of nivolumab combined with ipilimumab versus placebo infusions in participants with localized renal cell carcinoma with a predominantly clear cell histology who have undergone a nephrectomy • Part B: To compare OS, including the 5-year OS rates, of nivolumab versus placebo infusions in participants with localized renal cell carcinoma with a predominantly clear cell histology who have undergone a nephrectomy • Part B: To evaluate differences in disease-free survival (DFS) per Blinded Independent Central Review (BICR) and overall survival (OS) of contemporaneously randomized nivolumab combined with ipilimumab participants versus nivolumab participants with localized renal cell carcinoma, with a predominantly clear cell histology, who have undergone a nephrectomy. 2) To describe the safety and tolerability of nivolumab combined with ipilimumab and nivolumab monotherapy up to 30 and 100 days of last dose of study therapy.;Primary end point(s): The primary endpoint is DFS (disease-free survival). ;Timepoint(s) of evaluation of this end point: 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, | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Overall survival OS;Timepoint(s) of evaluation of this end point: • 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 was known to be alive. • DFS and OS in contemporaneously randomized combination and monotherapy participants. | — |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Canada, Czechia, Czech Republic, France, Germany, Hungary, Italy, Mexico, Netherlands, Peru, Poland, Romania, Russian Federation, Singapore, Spain, Switzerland, United Kingdom
Contacts
Public ContactGCT-SU
Bristol-Myers Squibb International Corporation
Outcome results
None listed