An Observational Study to Learn More About How Well a Treatment Works When Given After Treatment With Atezolizumab and Bevacizumab or Another Similar Combination of Drugs in Adults With Liver Cancer That Cannot be Treated With Surgery

Unresectable Hepatocellular Carcinoma Clinical Trial

— REFINE-IO  

Official title:

An Observational Study in Patients With Unresectable Hepatocellular Carcinoma (uHCC) Following Treatment With Atezolizumab Plus Bevacizumab (AB) or With Another Approved Immuno-oncology Immune Checkpoint Inhibitor Combination in First-line

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06117891
• Other study ID #: 22453
• Status: Recruiting
• Start date: November 27, 2023
• Est. completion date: February 1, 2027

Study information

• Verified date: June 2024
• Source: Bayer
• Contact: Bayer Clinical Trials Contact
• Phone: (+)1-888-84 22937
• Email: clinical-trials-contact[@]bayer.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is an observational study in which only data will be collected from adults with unresectable hepatocellular carcinoma. These adults should be prescribed a different treatment after treatment with atezolizumab and bevacizumab, or another similar combination of drugs, by their doctors.

Unresectable hepatocellular carcinoma (uHCC) is a type of liver cancer that cannot be treated with surgery.

In the past, sorafenib was the only approved first-line anti-cancer drug for people with uHCC. Regorafenib and other drugs were approved as second-line treatments for uHCC if a person could not take sorafenib or it stopped working for them.

Lately, another first-line (1L) treatment called immuno-oncology (IO) immune checkpoint inhibitor combination (1L-IO combo), like atezolizumab with bevacizumab (AB), has become the preferred choice of treatment. This is because of the meaningful impact on patient survival. 1L-IO combo are drugs that help the body's defense system recognize and kill cancer cells.

Since the other treatments were previously approved for use following sorafenib, the best order to take these treatments in following an 1L-IO combo is unknown.

To better understand and determine this order, more knowledge is needed about how well different treatments work in participants with uHCC who have been treated with AB or another 1L-IO combo.

The main purpose of this study is to learn more about how well different treatments work when given after first-line treatment with AB or another approved 1L-IO combo. To do this, researchers will collect data on how long the participants live (also called overall survival) from the start of any treatment given after the first-line treatment.

In addition, researchers will also collect the following information to learn more about the participants who will be given a different treatment after the 1L-IO combo:

• characteristics including age, sex, and race, and signs and symptoms of the participants over the duration of their first-line treatment

• the length of time from the first to the last dose (also called duration of therapy) of the treatments given after the 1L-IO combo

• the length of time until a participant's cancer worsens, or they die (also called progression free survival) from the start of the treatments given after the 1L-IO combo

• the number of participants whose tumor completely disappears or shrinks (also called overall tumor response) after taking the treatments given after the 1L-IO combo

• the sequence of treatments given after the 1L-IO combo Data will be collected from September 2023 to December 2026 and cover a period of around 3 years. The data will be collected using medical records or by interviewing the participants during their routine visits to the doctor.

Researchers will observe participants from the start of the treatment given after the 1L-IO combo until the end of their participation in the study.

In this study, only data from routine care will be collected. No visits or tests are required as part of this study.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: February 1, 2027
• Est. primary completion date: November 27, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients, = 18 years of age on the day of signing informed consent.

• Confirmed diagnosis of uHCC, treated in a first-line setting with AB or another approved 1L-IO combo therapy.

• Decision to initiate treatment with a second-line systemic treatment was made as per investigator's routine treatment practice prior to study enrollment.

• Signed informed consent or (for patients under legal age) signed informed assent by the patient (where applicable) and signed informed consent by parents / legal guardian.

• No participation in an investigational program with interventions outside of routine clinical practice.

Exclusion Criteria:

• Not applicable

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Unresectable Hepatocellular Carcinoma

Intervention

Drug:
• Atezolizumab
Atezolizumab combined with Bevacizumab, immune checkpoint inhibitors combination.
• Bevacizumab
Atezolizumab combined with Bevacizumab, immune checkpoint inhibitors combination.
• Durvalumab
Durvalumab combined with Tremelimumab, another immuno-oncology (IO) checkpoint inhibitors combination.
• Tremelimumab,
Durvalumab combined with Tremelimumab, another immuno-oncology (IO) checkpoint inhibitors combination.

Locations

Country	Name	City	State
Argentina	Many Locations	Multiple Locations
Brazil	Many Locations	Multiple Locations
China	Many Locations	Multiple Locations
Colombia	Many Locations	Multiple Locations
France	Many Locations	Multiple Locations
Greece	Many Locations	Multiple Locations
Italy	Many Locations	Multiple Locations
Korea, Republic of	Many Locations	Multiple Locations
Mexico	Many Locations	Multiple Locations
Saudi Arabia	Many Locations	Multiple Locations
Spain	Many Locations	Multiple Locations
Taiwan	Many Locations	Multiple Locations
Thailand	Many Locations	Multiple Locations
Turkey	Many Locations	Multiple Locations
United States	University of Michigan Health System	Ann Arbor	Michigan
United States	Mercy Medical Center - Medline Healthcare Services LLC	Baltimore	Maryland
United States	Roswell Park Comprehensive Cancer Center	Buffalo	New York
United States	University Of Cincinnati Division Of Hematology Oncology - UC Health System	Cincinnati	Ohio
United States	Corporal Michael J Crescenz Department Of Veterans Affairs Medical Center	Philadelphia	Pennsylvania
United States	Einstein Medical Center	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

United States,  Argentina,  Brazil,  China,  Colombia,  France,  Greece,  Italy,  Korea, Republic of,  Mexico,  Saudi Arabia,  Spain,  Taiwan,  Thailand,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival (OS)	OS is defined as the time (days) from start of second-line systemic treatment to the date of death, due to any cause. Patients alive or lost to follow-up will be censored at their last date of follow-up.	Approximately 36 months
Secondary	Discriptive analysis of demographic characteristics		At baseline before the first drug administration of second-line systemic treatment
Secondary	Discriptive analysis of clinical characteristics		At baseline before the first drug administration of second-line systemic treatment
Secondary	Duration of therapy (DoT)	DoT in second-line setting will be calculated as the time (days) from the date of initiation of the second -line systemic treatment to the stop of this treatment regimen or to last date of follow-up, if treatment was ongoing on that date.	Approximately 36 months
Secondary	Progression-free survival (PFS)	PFS is defined as the time (days) from the date of initiation of systemic treatment to the earliest date of first observed disease progression (radiological or clinical) or death due to any cause.	Approximately 36 months
Secondary	Best overall response rate (ORR)	ORR will be defined according to investigator-assessed data according to local standard.	Approximately 36 months
Secondary	Treatment sequences post first-line AB or other IO combinations		Approximately 36 months

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