Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:28 PM
Ignite Modification Date:
2025-12-24 @ 2:28 PM
NCT ID:
NCT03149159
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03149159
Study Brief:
Protocol Section:
NCT03149159