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
Status: | Withdrawn |
---|---|
Conditions: | Cancer, Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 6/20/2018 |
Start Date: | April 1, 2018 |
End Date: | April 1, 2018 |
An 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
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.
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.
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
We found this trial at
1
site
171 Ashley Avenue
Charleston, South Carolina 29425
Charleston, South Carolina 29425
843-792-1414
![Medical University of South Carolina](/wp-content/uploads/logos/medical-university-of-south-carolina.jpg)
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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