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

Part of paid clinical trials in Washington D.C., District of Columbia.

Sponsor
X4 Pharmaceuticals
Study ID
NCT02923531
Phase
PHASE1/PHASE2
Status
Terminated

Conditions

  • Clear Cell Renal Cell Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • X4P-001 — DRUG
    X4P-001 will be administered as per the dose and schedule specified in the arm.
  • Nivolumab — DRUG
    Nivolumab will be administered as per the dose and schedule specified in the arm.

Study Details

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.

Key Dates

Start date
Dec 7, 2016
Status verified
Nov 2022
Primary completion
Aug 8, 2018
Completion
Aug 8, 2018

Study Design

Enrollment
9 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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 medication will be administered in 28-day cycles and will continue until treatment-limiting toxicity or disease progression.

Primary Outcome Measure

Number of Participants With Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: From administration of first dose of study medication (Day 1) up to 30 days after last dose (up to 16 months) ]

Locations (4)

FacilityCityStateZIPSite coordinators
-Washington D.C.District of Columbia--
-BostonMassachusetts--
-HackensackNew Jersey--
-Chapel HillNorth Carolina--

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