Clear Cell Renal Cell Carcinoma
Conditions
Keywords
Immunotherapy, PD-1, anti-PD-1, antibody, Kidney Cancer, RCC, non-metastatic
Brief summary
This study will evaluate the use of nivolumab before surgery in patients with high-risk clear cell renal cell carcinoma who are eligible for nephrectomy. Nivolumab is an antibody that may help activate the immune system by blocking the function of an inhibitory molecule, Programmed cell death-1 (PD-1).
Interventions
DRUGNivolumab
3 mg/kg, IV (in the vein) on day 1 of each 2-week cycle, for a total of 3 doses prior to nephrectomy.
Sponsors
Bristol-Myers Squibb
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
(abbreviated): 1. Confirmed non-metastatic high-risk clear cell renal cell carcinoma (T2a-T4NanyM0 or TanyN1M0) 2. Schedule to undergo either partial or radical nephrectomy as part of treatment plan 3. Patient agrees to have a tumor biopsy 4. ECOG performance status of 0 or 1 5. Adequate organ and marrow function defined by study-specified laboratory tests 6. Must use acceptable form of birth control while on study and for approximately 31 weeks post-treatment completion 7. Willingness and ability to comply with scheduled visits, treatment plans, lab tests and other study procedures
Exclusion criteria
(abbreviated): 1. Other active malignancies within last 3 years (with some exceptions for skin, prostate, cervical, or breast cancer) 2. Need for urgent or emergent nephrectomy to relieve symptoms 3. Prior treatment for RCC including surgery, radiation, thermoablation or systemic therapy 4. Surgery within 28 days of starting study treatment (some exceptions for minor procedures) 5. Received live vaccine for infectious diseases within 28 days of starting study treatment 6. Prior treatment with any antibody or drug targeting T-cell costimulation or immune checkpoint pathways (anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4, etc) 7. Use of immunosuppressive doses of systemic medications within 14 days prior to starting study drug. 8. Current use of immunosuppressive agents 9. History of severe hypersensitivity reaction to other monoclonal antibodies 10. Current signs or symptoms of severe progressive or uncontrolled hepatic, hematologic, gastrointestinal, endocrine, pulmonary or cardiac disease other than directly related to RCC 11. Uncontrolled psychiatric illness/social situations that would limit compliance with study requirements. 12. Active infection requiring therapy. 13. Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness. 14. Positive tests for Hepatitis B surface antigen or Hepatitis C ribonucleic acid (RNA). 15. History of autoimmune disease or syndrome requiring systemic steroids or immunosuppressants (some exceptions apply). 16. Pulse oximetry of \<92% on room air 17. Pregnant or breastfeeding women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety as assessed by number of participants experiencing adverse events | From the first dose of nivolumab treatment through 100 days post-surgery | Number of participants experiencing any adverse event as defined by Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4.0) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective Tumor Response Rate (by RECIST) | Assessed at baseline, prior to surgery, and 3 months after surgery | Number of patients achieving a complete response (CR) or partial response (PR) by Response Evaluation Criteria in Solid Tumors (RECIST) |
| Objective Tumor Response Rate (by irRC) | Assessed at baseline, prior to surgery, and 3 months after surgery | Number of patients achieving a complete response (CR) or partial response (PR) by immune-related response criteria (irRC) |
| Quality of Life as assessed by the Functional Assessment of Cancer Therapy-Kidney Symptom Index (FKSI) -15 questionnaire | Baseline, 2 weeks, 4 weeks, prior to surgery, and at 1-, 3-, 6-, and 12-months after surgery | Total score range 0-60 with higher scores indicating a less symptomatic respondent. |
| Metastasis-Free Survival | 12 months post-operatively, then every 6 months for 5 years | Number of months without evidence of metastasis. |
| Overall Survival | 12 months post-operatively, then every 6 months for 5 years | Number of months alive. |
Countries
United States
Outcome results
None listed