NCT04435977

Efficacy and Safety of Cabozantinib in Patients With Hepatocellular Carcinoma

Efficacy and Safety of Cabozantinib in Patients With Hepatocellular Carcinoma Progressing on or Intolerant to Prior Treatment With Immune Checkpoint Inhibitors: A Phase II Study (Immunocabo)

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 46 (estimated)
• Sponsor: Istituto Clinico Humanitas · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, single-center, Phase II trial designed to estimate in terms of PFS the efficacy of cabozantinib, given as second- or third- line treatment in HCC patients that progress on or are intolerant to immune checkpoint inhibitors, including anti-PD-1 and anti-PD-L1 antibodies.

Detailed description

Subjects who meet all study eligibility criteria will take tablets containing 60 mg of cabozantinib once daily orally. Required dose reductions will be in decrements of 20 mg cabozantinib (maximum two dose reductions). Subjects will receive study treatment as long as they continue to experience clinical benefit in the opinion of the investigator or until there is unacceptable toxicity. Primary objective of this study is to evaluate the efficacy of cabozantinib, given as second- or third-line treatment in HCC patients that progress on or are intolerant to immune checkpoint inhibitors. Secondary objectives for this study are as follows: * To evaluate the activity of cabozantinib, in terms of ORR (CR+PR) as per RECIST 1.1, duration of response, time to treatment failure (TTF), time to progression (TTP), and OS * To evaluate the safety and tolerability of cabozantinib

Conditions

• Hepatocarcinoma

Interventions

Type	Name	Description
DRUG	Cabozantinib 60 MG	• The assigned dose for study treatment is 60 mg qd. Two dose reductions will be permitted (Table 2): * 60 mg qd to 40 mg qd (level 1) * 40 mg qd to 20 mg qd (level 2)

Timeline

• Start date: 2020-01-30
• Primary completion: 2023-06-01
• Completion: 2023-09-01
• First posted: 2020-06-17
• Last updated: 2020-06-17

Locations

1 site across 1 country: Italy