Addition of X4P-001 to Nivolumab Treatment in Participants With Renal Cell Carcinoma
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ClinicalTrials.gov Identifier: NCT02923531 |
Recruitment Status :
Completed
First Posted : October 4, 2016
Last Update Posted : August 1, 2019
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Condition or disease | Intervention/treatment | Phase |
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Clear Cell Renal Cell Carcinoma | Drug: X4P-001 Drug: Nivolumab | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 9 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase 1B/2A Trial Adding X4P-001 in Patients Receiving Nivolumab for Treatment of Advanced Clear Cell Renal Cell Carcinoma |
Actual Study Start Date : | December 7, 2016 |
Actual Primary Completion Date : | August 8, 2018 |
Actual Study Completion Date : | August 8, 2018 |

Arm | Intervention/treatment |
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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.
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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 Name: Opdivo |
- Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) [ Time Frame: Up to 15 months, from time of enrollment through disease progression, study completion or early termination ]
- Maximum Plasma Concentration (Cmax) [ Time Frame: Up to 8 hrs post-dose ]
- Area Under the Curve (AUC) [ Time Frame: Up to 8 hrs post-dose ]
- Minimum Plasma Concentration (Cmin) [ Time Frame: Up to 8 weeks ]
- Objective Response Rate [ Time Frame: Up to 15 months, from time of enrollment through disease progression, study completion or early termination ]
- Duration of Objective Response [ Time Frame: Up to 15 months, from time of enrollment through disease progression, study completion or early termination ]
- Time to Objective Response [ Time Frame: Up to 15 months, from time of enrollment through disease progression, study completion or early termination ]
- Disease Control Rate [ Time Frame: 16 weeks and 24 weeks ]
- Progression Free Survival [ Time Frame: Up to 15 months, from time of enrollment through disease progression, study completion or early termination ]
- Time to Progression [ Time Frame: Up to 15 months, from time of enrollment through disease progression, study completion or early termination ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02923531
United States, District of Columbia | |
Washington, District of Columbia, United States | |
United States, Massachusetts | |
Boston, Massachusetts, United States | |
United States, New Jersey | |
Hackensack, New Jersey, United States | |
United States, North Carolina | |
Chapel Hill, North Carolina, United States |
Study Director: | Chief Medical Officer | X4 Pharmaceuticals, Inc. |
Responsible Party: | X4 Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT02923531 |
Other Study ID Numbers: |
X4P-001-RCCB |
First Posted: | October 4, 2016 Key Record Dates |
Last Update Posted: | August 1, 2019 |
Last Verified: | July 2019 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Carcinoma Carcinoma, Renal Cell Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Adenocarcinoma Kidney Neoplasms Urologic Neoplasms Urogenital Neoplasms |
Neoplasms by Site Kidney Diseases Urologic Diseases Nivolumab Antineoplastic Agents, Immunological Antineoplastic Agents Immune Checkpoint Inhibitors Molecular Mechanisms of Pharmacological Action |