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.

AstraZeneca200 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

200

Conditions

Hepatocellular Carcinoma

Interventions

STRIDEDRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 100 Years

Medical Language ↔ Plain English

Inclusion Criteria: * \- Signed informed consent. * Age ≥ 18 years. * Histologically or radiologically confirmed diagnosis of advanced or unresectable HCC. * BCLC B or C HCC. * Child-Pugh A (score 5 or 6). * Eastern Cooperative Oncology Group (ECOG) Performance Status score 0 or 1. * Planned first-line treatment of advanced/uHCC with STRIDE. Exclusion Criteria: * \- Any previous line of systemic therapy for HCC. * Any prior or concomitant immunotherapy. * Prior allogeneic organ or bone marrow transplant. * Documented active or previous GI bleeding within the previous 12 months. * Main trunk portal vein thrombosis. * Autoimmune disease requiring treatment with immunosuppressive medication. * Known hypersensitivity to the active substance or to any of the STRIDE excipients. * Pregnancy or breastfeeding

Locations (16)

Research site

Ancona, Italy

ACTIVE_NOT_RECRUITING

Research site

Bergamo, Italy

ACTIVE_NOT_RECRUITING

Research site

Foggia, Italy

RECRUITING

Research site

Meldola, Italy

ACTIVE_NOT_RECRUITING

Research site

Milan, Italy

ACTIVE_NOT_RECRUITING

Research site

Milan, Italy

ACTIVE_NOT_RECRUITING

Research site

Modena, Italy

ACTIVE_NOT_RECRUITING

Research site

Naples, Italy

RECRUITING

Research site

Padova, Italy

ACTIVE_NOT_RECRUITING

Research site

Palermo, Italy

ACTIVE_NOT_RECRUITING

...and 6 more locations

Outcomes

Primary Outcomes

Time To Decompensation (TTDec)

time from index date (start of new treatment) to the first occurrence of events such as ascites of any grade according to the European Association for the Study of the Liver (EASL) classification, hepatic encephalopathy of any grade according to West Haven classification, variceal hemorrhage, or jaundice (total bilirubin \>3 mg/dL). In Child-Pugh (CP)-A participants with a score of 6 at index date, TTDec is defined as the time from index date to any worsening in ascites, hepatic encephalopathy, variceal hemorrhage, or jaundice (defined as an increase in total bilirubin to greater than 3 mg/dL or a worsening of more than 1.0 mg/dL from index date). At the time of decompensation (± 30 days) a CT scan should be performed to exclude worsening of liver function due to tumor progression.

Time frame: From index date to first hepatic decompensation/study completion, up to 30 months

Secondary Outcomes

Time To Worsening (TTWors)

Time To Worsening (TTWors) based on the EORTC QLQ-C30 and QLQ-HCC18 PROs within the first 18 months of treatment. TTWors is the time from first treatment to first clinically meaningful deterioration confirmed at a subsequent visit/assessment or death from any cause. A clinically meaningful change (deterioration or improvement) is defined as an absolute change ≥ 10 points in total score from index date.

Time frame: Baseline and every 8 weeks during treatment, up to 30 months

Overall Survival (OS)

time from first treatment to death

Time frame: From index date through study completion, up to 30 months

Progression free survival (PFS)

time from first treatment to radiologic evidence of tumor progression or death based on investigator assessment (RECIST v1.1).

Time frame: From index date until tumor progression, assessed until study completion, up to 30 months

Overall response rate (ORR)

proportion of participants with a complete response (CR) or partial response (PR) per RECIST v1.1.

Time frame: From index date until objective tumor progression, assessed until study completion, up to 30 months

Disease Control Rate (DCR)

proportion of participants with a CR, PR, or stable disease (SD) per RECIST v1.1. (stable disease needs to be maintained for a minimum of 8 weeks to be included in the DCR).

Time frame: From index date until objective tumor progression or date of death, assessed until study completion, up to 30 months

Downstaging

Proportion of participants who undergo liver transplant following downstaging with the STRIDE regimen

Time frame: From index date until study completion, up to 30 months

safety

Adverse events: severity, seriousness, causality, action taken with durvalumab, and outcome.

Time frame: From index date until study completion, up to 33 months

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.

Overview

Conditions

Interventions

Eligibility

Locations (16)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts