Investigator-Initiated Trial of Combined Ipilimumab, Nivolumab and Stereotactic Radiation in Patients With Metastatic Clear-Cell RCC (ccRCC) Who Have Failed Treatment With Single-Agent Nivolumab
- Conditions
- Clear Cell Renal Cell CarcinomaMetastatic Renal Cell Carcinoma
- Interventions
- Registration Number
- NCT03149159
- Lead Sponsor
- Medical University of South Carolina
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Nivolumab + Ipilimumab + SRT Steriotactic radiation therapy - Nivolumab + Ipilimumab + SRT Nivolumab - Nivolumab + Ipilimumab + SRT Ipilimumab -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Progression free survival (PFS) 2 years PFS will be determined from the onset of treatment to the time of documented disease progression.
Trial Locations
- Locations (1)
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States