Phase 4
N=142
An Investigational Immuno-therapy Safety Trial of Nivolumab in Patients With Advanced or Metastatic Renal Cell Carcinoma
Renal Cell Carcinoma
Bottom Line
View on ClinicalTrials.gov: NCT02596035 ↗Enrolled (actual)
142
Serious AEs
51.4%
Results posted
Aug 2019
Primary outcome: Primary: Percentage of Participants Who Experienced High-Grade (Grade 3-4 and Grade 5) Immune Mediated Adverse Events (IMAEs) — 4.1; 0; 0; 0 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Nivolumab (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bristol-Myers Squibb
- Primary completion
- Mar 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Experienced High-Grade (Grade 3-4 and Grade 5) Immune Mediated Adverse Events (IMAEs) |
4.1; 0; 0; 0; 0; 0 | — |
| SECONDARY Median Time to Onset of High Grade (Grade 3-5) Immune Mediated Adverse Events |
76.0; 89.0; 84.5; 43.0; 7.0; 645.0 | — |
| SECONDARY Median Time to Resolution of High Grade (Grade 3-5) Immune Mediated Adverse Events |
31.5; 22.0; 23.0; 154.0; NA | — |
| SECONDARY Percentage of Participants Who Receive Immune Modulating Medication for the Immune-Mediated Event (Any Grade) |
66.7; 0; 5.3; 0; 41.7; 0 | — |
| SECONDARY Percentage of Participants Who Receive More Than Equal to (>=) 40 mg Prednisone Equivalents for the Immune-Mediated Event |
66.7; 0; 5.3; 0; 41.7; 0 | — |
| SECONDARY Total Duration of All Immune Modulating Medications Given for the Immune-Mediated Event |
111.07; 7.9; 7.00; 241.14; 1.14; 1.9 | — |
| SECONDARY Percentage of Participants With a Resolution of IMAEs After Initiating Immune Modulating Medication |
100; 100; 100; 0; 66.7; 0 | — |
Summary
This study will generate safety data on Nivolumab given by itself in treatment of advanced Renal Cell Carcinoma (RCC). The primary objective of this study is to assess immune related side effects, also known as immune-mediated adverse events (IMAEs), in patients treated with Nivolumab.
Eligibility Criteria
Inclusion Criteria
- Advanced or Metastatic renal cell carcinoma (RCC)
- Predominant clear cell histology:
- At least 1 but no more than 2 prior systemic anti vascular endothelial growth factor (anti-VEGF) treatments
- No more than 3 total prior systemic treatment regimens in the advanced or metastatic setting
- Subjects with prior treatment with a mechanistic target of rapamycin (mTOR) are eligible
- Non-clear cell histology: 0-3 prior systemic therapies and may include mTOR inhibitor
- Brain metastases allowed if asymptomatic, without edema, and not receiving corticosteroids or radiation
- Performance Status (PS): ≥ 70% Karnofsky Performance Scale (KPS)
- All Memorial Sloan-Kettering Cancer Center (MSKCC) prognostic scores allowed
Exclusion Criteria
- Subjects with any active autoimmune disease or a history of known autoimmune disease
- History of severe hypersensitivity reaction to other monoclonal antibodies
- Prior malignancy, active within the last 3 years, except for locally curable cancers which have been apparently cured
- Known HIV or AIDS-related illness
- Any positive tests for Hepatitis B or Hepatitis C virus indicating acute or chronic infection
Other protocol-defined inclusion/exclusion criteria apply
Data sourced from ClinicalTrials.gov (NCT02596035). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.