Join us at Health Research Day — June 6th at Canton Waterfront Park, Baltimore!   Learn More →
← Back to all trials
Completed NCT03143270

A Study to Test the Safety and Feasibility of Nivolumab With Drug Eluting Bead Transarterial Chemoembolization in Patients With Liver Cancer

Conditions: Liver Cancer

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: EARLY_PHASE1
Enrollment: 20
Sponsor: Memorial Sloan Kettering Cancer Center

Location: Washington University School of Medicine St Louis Missouri

Summary

The purpose of the study is to find out the effects of using nivolumab with Drug Eluting Bead Transarterial Chemoembolization (deb-TACE) in the treatment of liver cancer.

Eligibility Criteria

Inclusion Criteria: * Age 18 and over at the time of consent * Histology and/or cytology confirmed HCC per the enrolling institution. Subjects in Cohort 1 are permitted to enroll w ithout confirmation of HCC as long as imaging LiRADs criteria are met and a biopsy is scheduled prior to or the day of the deb-TACE procedure. HCC confirmation must be completed prior to initiation of nivolumab for all cohorts. If a patient is found to not have confirmed HCC, they w ill be removed from the study. * Measurable disease per RECIST v1.1 * Disease not amenable to curative or transplant surgery (BCLC Stage B); disease must be reviewed by members of disease management team at the local enrolling institution and be amenable to deb-TACE. For the dose escalation and the expansion, regional lymphadenopathy and sub-centimeter pulmonary nodules are allowed as well as segmental portal vein involvement. * ECOG Performance status 0 or 1 * Child-Pugh Class A * Child-Pugh Scoring Note: PI INR \ 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses \> 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease. Patients with contrast allergies who can tolerate contrast with corticosteroid premedication are not excluded. * An active, known or suspected autoimmune disease. Subjects are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger. * Subjects with history of another primary cancer, with the exception of: a) curatively resected non-melanoma skin cancer; b) curatively treated cervical carcinoma in situ; or c) other primary solid tumor with no known active disease present that in the opinion of the investigator will not affect patient outcome in the setting of current HCC diagnosis. * Any condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of subject safety or study results * Women of childbearing potential (WOCBP) or sexually active men must use appropriate method(s) of contraception. * Women of childbearing potential (WOCBP) must use appropriate method(s) of contraception while on study treatment. WOCBP should use an adequate method to avoid pregnancy during study treatment and for 5 months (30 days plus the time required for nivolumab to undergo five half-lives) after the last dose of investigational drug * Men who are sexually active with WOCBP must use any contraceptive method with a failure rate of less than 1% per year Men receiving nivolumab and who are sexually active with WOCBP will be instructed to adhere to contraception during study treatment and for a period of 7 months after the last dose of investigational product * Women who are not of childbearing potential (ie, who are postmenopausal or surgically sterile, as well as azoospermic men do not require contraception * Women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of nivolumab. Elevated HCG for other explained and documented reasons is allowed. * Lactating woman

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT03143270). StuddyBuddy aggregates publicly available trial information.