addition of x4p-001 to nivolumab treatment in participants with renal cell carcinoma

Conditions: Clear Cell Renal Cell Carcinoma

Summary: the purpose of this study is to determine if the combination of x4p-001 plus nivolumab is safe and tolerable. secondly, the study will investigate if adding x4p-001 to nivolumab treatment has an effect on the body and the cancer tumor, in participants receiving nivolumab but not exhibiting a radiological response.


Eligibility criteria:
inclusion criteria: * histologically confirmed diagnosis of renal cell carcinoma with a documented clear cell component (ccrcc). * currently receiving nivolumab and considered by investigator to have the potential to derive clinical benefit from continuing treatment with nivolumab. * based on response evaluation criteria in solid tumors (recist) version 1.1 criteria on current nivolumab treatment (prior to initiation of this study), has a best response of confirmed stable disease (sd) or confirmed progressive disease (pd). confirmed sd or confirmed pd refers to a response that is confirmed by a second scan which is at least 4 weeks apart from the previous scan. * at least one extra-renal measurable target lesion meeting the criteria of recist version 1.1. * agree to use contraception from screening, through the study, and for at least 5 months after the last dose of nivolumab as follows: for women of childbearing potential agree to use highly-effective contraceptive methods; for males, agree to use a condom with sexual partner. exclusion criteria: * pregnant or nursing. * life expectancy of less than 3 months. * performance status greater than or equal to (≥) 2 (eastern cooperative oncology group \[ecog\] criteria). * new york heart association (nyha) class iii or iv, uncontrolled hypertension, or clinically significant arrhythmia. * previously received x4p-001. * has a second malignancy. except: malignancies that were treated curatively and have not recurred within 2 years prior to study treatment; completely resected basal cell and squamous cell skin cancers; any malignancy considered to be indolent and that has never required therapy; and completely resected carcinoma in situ of any type. * has active central nervous system (cns) metastases (including evidence of cerebral edema by magnetic resonance imaging \[mri\], or progression from prior imaging study, or any requirement for steroids, or clinical symptoms of/from cns metastases) within 28 days prior to study treatment. subjects with known cns metastases must have a baseline mri scan within 28 days of study treatment. * ongoing clinical adverse events national cancer institute common terminology criteria for adverse events (nci ctcae) grade greater than (\>) 2 resulting from prior cancer therapies. * known history of human immunodeficiency virus (hiv) or acquired immunodeficiency syndrome (aids); or positive test for hepatitis c virus (hcv), or hepatitis b surface antigen (hbsag). * history of clinically significant or uncontrolled cardiac, hepatic, or pulmonary disease. * has had within the past 6 months the occurrence of one or more of the following events: myocardial infarction, cerebrovascular accident, deep vein thrombosis, pulmonary embolism, hemorrhage (nci ctcae grade 3 or 4), chronic liver disease (meeting criteria for child-pugh class b or c), or organ transplantation. * inadequate hematologic, hepatic, or renal function.