Addition of X4P-001 to Nivolumab Treatment in Participants With Renal Cell Carcinoma

• Status: Completed
• Trial end date: 2018-08-08
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: X4 Pharmaceuticals
• Treatments: Antibodies, Monoclonal; Nivolumab

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 RECIST v1.1 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.