MONTEROSA - Italian Multicenter Observational Study to Evaluate Time to Clinical Hepatic Decompensation, Quality of Life, Effectiveness, and Safety of Tremelimumab Plus Durvalumab in Patients With Advanced or Unresectable Hepatocellular Carcinoma Who Have Received no Prior Systemic Treatment.

NCT07607769 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2026-05-26

No results posted yet for this study

Summary

Italian multicenter observational study to evaluate time to clinical hepatic decompensation, quality of life, effectiveness, and safety of tremelimumab plus durvalumab in patients with advanced or unresectable hepatocellular carcinoma who have received no prior systemic treatment.

Conditions

Interventions

DRUG

STRIDE

Tremelimumab 300 mg as a single dose administered in combination with durvalumab 1500 mg at Cycle 1/Day 1, followed by durvalumab monotherapy every 4 weeks.

Sponsors & Collaborators

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-16
Primary Completion
2028-10-31
Completion
2028-10-31
FDA Drug
Yes

Countries

  • Italy

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07607769 on ClinicalTrials.gov