Clear Cell Renal Cell Carcinoma, Metastatic Renal Cell Carcinoma
Conditions
Brief summary
The purpose of this study is to see if continued nivolumab with the addition of ipilimumab plus hypo-fractionated stereotactic radiation (sTR) of a single lesions results in partial or complete responses in patients with metastatic ccRCC who fail initial treatment with single agent nivolumab.
Interventions
DRUGNivolumab
Nivolumab will be given every 21 days for the first 12 weeks at a dose of 3mg/kg. After 12 weeks, the dose will be 240mg and will be given every 14 days.
DRUGIpilimumab
Ipilimumab will be given at a dose of 1mg/kg every 21 days for up to 12 weeks.
RADIATIONSteriotactic radiation therapy
The dose of radiation will be 6 Gy daily x 5 days. Radiation will be given between the first and second doses of ipilimumab plus nivolumab.
Sponsors
Bristol-Myers Squibb
Medical University of South Carolina
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
* Histologically or cytologically confirmed diagnosis of metastatic ccRCC. * Age 18 years and older * ECOG 0-1 * Progressive disease after treatment with single-agent nivolumab * Life expectancy at least 3 months * Presence of measurable disease per RECIST 1.1 criteria * Presence of a metastatic lesion greater than 1 cm in size that is amenable to radiation treatment * Adequate organ system function * WOCBP and men who are sexually active with WOCBP must agree to use appropriate method(s) of contraception.
Exclusion criteria
* Patients are excluded if they have active brain metastases or leptomeningeal metastases (exceptions outlined in the protocol). * Active, known or suspected autoimmune disease, such as systemic lupus erythematosus, that require treatment with immune suppressing drugs. Note: Subjects are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger * Presence of a condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone or equivalents) or other immunosuppressive medications within 14 days of study drug administration. Note: Inhaled or topical steroids and adrenal replacement doses \> 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease. * Unstable angina or uncontrolled congestive heart failure * Uncontrolled hypercalcemia * Positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection * Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS) * Presence of other malignant diseases, except non-melanoma skin care * History of allergy to study drug components. * History of severe hypersensitivity reaction to any monoclonal antibody. * Anti-cancer treatment including surgery, radiotherapy, chemotherapy, other immunotherapy, or investigational therapy within 14 days of registration. * Women must not be pregnant or breastfeeding. WOCBP must have a negative serum pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 7 days prior to registration. * Any other medical condition for which treatment with ipilimumab or nivolumab would be medically contraindicated
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with a partial or complete response | 12 weeks | The response rate of combined ipilimumab and nivolumab plus STR will be determined using irRECIST criteria. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression free survival (PFS) | 2 years | PFS will be determined from the onset of treatment to the time of documented disease progression. |
Countries
United States
Outcome results
None listed