Phase 2 Study of Cabozantinib Combined With Ipilimumab/Nivolumab and Transarterial Chemoembolization (TACE) in Patients With Hepatocellular Carcinoma (HCC) Who Are Not Candidates for Curative Intent Treatment

Who is this study for? Patients with Hepatocellular Carcinoma
Status: Recruiting
Location: See location...
Intervention Type: Drug, Procedure
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

This is a phase 2 single-arm, open-label clinical trial determining efficacy of cabozantinib in combination with ipilimumab/nivolumab and transarterial chemoembolization (TACE) in subjects with hepatocellular carcinoma (HCC). These are subjects who are not candidates for curative intent treatment.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Histologic or radiographic diagnosis of hepatocellular carcinoma

• At least one lesion amenable to TACE treatment

• Child-Pugh A-B7 (B7 based on Albumin allowed)

• Not a candidate for resection or transplantation

• Age ≥ 18 years.

• Performance status: ECOG performance status ≤2

• Must have at least one measurable lesion (either untreated or progressed after previous locoregional treatment)

• Adequate organ and marrow function as defined below:

∙ Leukocytes ≥ 2,000/mcL

‣ absolute neutrophil count ≥ 1000/mcL

‣ platelets ≥ 60,000/mcl

‣ total bilirubin within normal institutional limits

‣ AST(SGOT)/ALT(SPGT) ≤ 3 X institutional upper limit of normal or ≤ 5 X if liver metastases are present

‣ creatinine \<1.5ULN

‣ hemoglobin ≥ 8 g/dL

‣ Serum albumin ≥ 2.8 g/dL

‣ Urine protein/creatinine ration (UPCR) ≤ 1 mg/mg

• The effects of cabozantinib on the developing human fetus at the recommended therapeutic dose are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 4 months following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.

• Based on its mechanism of action, ipilimumab can cause fetal harm when administered to a pregnant woman. Females of reproductive potential must use effective contraception during treatment with ipilimumab and for 3 months following the last dose of ipilimumab.

• Based on its mechanism of action, nivolumab can cause fetal harm when administered to a pregnant woman. Females of reproductive potential must use effective contraception during treatment with nivolumab and for 5 months following the last dose of nivolumab.

• 1\. A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:

⁃ Has not undergone a hysterectomy or bilateral oophorectomy; or

⁃ Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).

∙ Life expectancy of greater than 3 months

‣ Ability to swallow tablets

‣ Ability to understand and the willingness to sign a written informed consent.

Locations
United States
California
Chao Family Comprehensive Cancer Center, University of California, Irvine
RECRUITING
Orange
Contact Information
Primary
Chao Family Comprehensive Cancer Center University of California, Irvine
ucstudy@uci.edu
1-877-827-7883
Backup
University of California Irvine Medical
Time Frame
Start Date: 2020-08-07
Estimated Completion Date: 2027-09-01
Participants
Target number of participants: 35
Treatments
Experimental: Cabozantinib with Ipilimumab/Nivolumab and TACE
Subjects receive Cabozantinib 40 mg daily on days 1-28 of a 28 day cycle, this is to be started 7-14 days after the last TACE procedure.~Nivolumab 480 mg IV on day 1 of a 28 day cycle (cycle 2 and beyond), this is to be started 7-14 days after the last TACE procedure.~Nivolumab: 3mg/kg IV on day 1 of a 21 day cycle x 1 dose.~Ipilimumab: 1 mg/kg on day 1 of a 21 day cycle x 1 dose~TACE: Within 3-4 weeks of cycle 1 day 1; may be done up to 3 times (9-12 weeks total), the intervals between each TACE treatment can vary based on investigator's discretion
Related Therapeutic Areas
Sponsors
Leads: University of California, Irvine
Collaborators: Exelixis

This content was sourced from clinicaltrials.gov

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