Addition of X4P-001 to Nivolumab Treatment in Participants With Renal Cell Carcinoma
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1/Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: X4P-001 Plus Nivolumab Participants will receive X4P-001 400 milligrams (mg) (as 4 capsules of 100 mg each) orally once daily in combination with nivolumab 240 mg intravenous (IV) infusion (over 60 minutes) every 2 weeks. Study treatment will be administered in 28-day cycles and will continue until treatment-limiting toxicity or disease progression. |
Drug: X4P-001
X4P-001 will be administered as per the dose and schedule specified in the arm.
Drug: Nivolumab
Nivolumab will be administered as per the dose and schedule specified in the arm.
Other Names:
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Outcome Measures
Primary Outcome Measures
- Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) [Up to 15 months, from time of enrollment through disease progression, study completion or early termination]
Secondary Outcome Measures
- Maximum Plasma Concentration (Cmax) [Up to 8 hrs post-dose]
- Area Under the Curve (AUC) [Up to 8 hrs post-dose]
- Minimum Plasma Concentration (Cmin) [Up to 8 weeks]
- Objective Response Rate [Up to 15 months, from time of enrollment through disease progression, study completion or early termination]
- Duration of Objective Response [Up to 15 months, from time of enrollment through disease progression, study completion or early termination]
- Time to Objective Response [Up to 15 months, from time of enrollment through disease progression, study completion or early termination]
- Disease Control Rate [16 weeks and 24 weeks]
- Progression Free Survival [Up to 15 months, from time of enrollment through disease progression, study completion or early termination]
- Time to Progression [Up to 15 months, from time of enrollment through disease progression, study completion or early termination]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Histologically confirmed diagnosis of Renal Cell Carcinoma with a documented clear cell component (ccRCC).
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Currently receiving nivolumab and considered by Investigator to have the potential to derive clinical benefit from continuing treatment with nivolumab.
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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.
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At least one extra-renal measurable target lesion meeting the criteria of RECIST version 1.1.
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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:
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Pregnant or nursing.
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Life expectancy of less than 3 months.
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Performance status greater than or equal to (≥) 2 (Eastern Cooperative Oncology Group [ECOG] criteria).
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New York Heart Association (NYHA) Class III or IV, uncontrolled hypertension, or clinically significant arrhythmia.
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Previously received X4P-001.
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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.
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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.
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Ongoing clinical adverse events National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Grade greater than (>) 2 resulting from prior cancer therapies.
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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).
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History of clinically significant or uncontrolled cardiac, hepatic, or pulmonary disease.
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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.
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Inadequate hematologic, hepatic, or renal function.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Washington | District of Columbia | United States | ||
| 2 | Boston | Massachusetts | United States | ||
| 3 | Hackensack | New Jersey | United States | ||
| 4 | Chapel Hill | North Carolina | United States |
Sponsors and Collaborators
- X4 Pharmaceuticals
Investigators
- Study Director: Chief Medical Officer, X4 Pharmaceuticals, Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- X4P-001-RCCB