A Study of Tivozanib in Combination With Durvalumab in Subjects With Advanced Hepatocellular Carcinoma

Phase 1

Terminated

• Conditions: Hepatocellular Carcinoma
• Interventions: Drug: Tivozanib; Drug: Durvalumab

• Registration Number: NCT03970616
• Lead Sponsor: AVEO Pharmaceuticals, Inc.

Brief Summary

This study will evaluate the safety, tolerability, DLTs, MTD, and preliminary anti tumor activity of tivozanib in combination with durvalumab in subjects with advanced HCC.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-05-28
• Study First Submitted QC: 2019-05-30
• Study First Posted: 2019-05-31
• Study Start: 2019-09-30
• Primary Completion: 2023-04-04
• Study Completion: 2023-04-04
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-10
• Last Update Posted: 2023-07-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 27

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Tivozanib in Combination with Durvalumab	Tivozanib	Tivozanib in Combination with Durvalumab
Tivozanib in Combination with Durvalumab	Durvalumab	Tivozanib in Combination with Durvalumab

Primary Outcome Measures

Name	Time	Method
Incidence of Treatment Emergent Adverse Events (TEAEs)	Approximately 24 months; Through study completion	To establish the safety of tivozanib in combination with durvalumab in subjects with advanced hepatocellular carcinoma (HCC) previously treated with both bevacizumab and atezolizumab or both bevacizumab and atezolizumab in combination with a second immune checkpoint inhibitor in a prior line of therapy.

Secondary Outcome Measures

Name	Time	Method
Response Rate (Objective Response Rate)	Approximately 24 months	To estimate the response rate of tivozanib in combination with durvalumab in subjects with advanced HCC previously treated with both bevacizumab and atezolizumab or both bevacizumab and atezolizumab in combination with a second immune checkpoint inhibitor in a prior line of therapy.
Overall Survival (OS)	Approximately 24 months; Through study completion	To estimate the overall survival (OS) of tivozanib in combination with durvalumab in subjects with advanced HCC previously treated with both bevacizumab and atezolizumab or both bevacizumab and atezolizumab in combination with a second immune checkpoint inhibitor in a prior line of therapy.
Progression Free Survival (PFS)	Approximately 24 months; Through study completion	To estimate the progression free survival (PFS) of tivozanib in combination with durvalumab in subjects with advanced HCC previously treated with both bevacizumab and atezolizumab or both bevacizumab and atezolizumab in combination with a second immune checkpoint inhibitor in a prior line of therapy.

Trial Locations

Locations (10)

University of California - Irvine; 🇺🇸 Orange, California, United States

Banner MD Anderson Cancer Center; 🇺🇸 Gilbert, Arizona, United States

City of Hope; 🇺🇸 Duarte, California, United States

UT Southwestern Medical Center; 🇺🇸 Dallas, Texas, United States

Northwestern University Feinberg School of Medicine; 🇺🇸 Chicago, Illinois, United States

The University of Texas Health Science Center at Houston (UTHealth); 🇺🇸 Houston, Texas, United States

The University of Texas Health Science Center at Tyler (UTHealth); 🇺🇸 Tyler, Texas, United States

Dana Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States

Roswell Park Cancer Institute; 🇺🇸 Buffalo, New York, United States

Montefiore Medical Center; 🇺🇸 Bronx, New York, United States