Trial record 1 of 1 for:
ML44719
A Study Evaluating Atezolizumab, With or Without Bevacizumab, in Patients With Unresectable Hepatocellular Carcinoma and Child-Pugh B7 and B8 Cirrhosis (Kirros)
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| ClinicalTrials.gov Identifier: NCT06096779 |
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Recruitment Status :
Recruiting
First Posted : October 24, 2023
Last Update Posted : May 2, 2024
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Sponsor:
Genentech, Inc.
Information provided by (Responsible Party):
Genentech, Inc.
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Brief Summary:
The purpose of this study is to assess the safety and efficacy of atezolizumab and bevacizumab, or atezolizumab alone, as first-line treatment in participants with unresectable, locally advanced or metastatic hepatocellular carcinoma (HCC) with Child-Pugh B7 or B8 cirrhosis.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Hepatocellular Carcinoma | Drug: Atezolizumab Drug: Bevacizumab | Phase 2 |
This is a Phase II, open-label, multicohort, multicenter study in participants with unresectable, locally advanced, or metastatic hepatocellular carcinoma (HCC) who have Child-Pugh B7 or B8 liver cirrhosis and have received no prior systemic therapy in this treatment setting. The study is designed to non-comparatively evaluate the safety and efficacy of atezolizumab plus bevacizumab (Cohort A) or atezolizumab monotherapy (Cohort B) in this population.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 120 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase II, Open-Label, Multi-Cohort, Multicenter Study in Patients With Unresectable Hepatocellular Carcinoma and Child-Pugh B7 and B8 Cirrhosis |
| Estimated Study Start Date : | May 31, 2024 |
| Estimated Primary Completion Date : | May 2, 2026 |
| Estimated Study Completion Date : | November 16, 2026 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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Experimental: Cohort A: Atezolizumab+Bevacizumab
Participants will receive Atezolizumab plus Bevacizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
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Drug: Atezolizumab
Atezolizumab will be administered at a dose of 1200 mg by IV infusion on Day 1 of each 21-day cycle.
Other Name: Tecentriq Drug: Bevacizumab Bevacizumab will be administered at a dose of 15 mg/kg by IV infusion on Day 1 of each 21-day cycle.
Other Name: Avastin |
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Experimental: Cohort B: Atezolizumab
Participants will receive Atezolizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
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Drug: Atezolizumab
Atezolizumab will be administered at a dose of 1200 mg by IV infusion on Day 1 of each 21-day cycle.
Other Name: Tecentriq |
Primary Outcome Measures :
- Percentage of Participants with Adverse Events [ Time Frame: Baseline through the end of the study (up to approximately 36 months) ]
Secondary Outcome Measures :
- Objective Response Rate (ORR) [ Time Frame: Randomization up to approximately 36 months ]Investigator-assessed confirmed ORR is defined as proportion of participants with a CR/PR on two consecutive occasions ≥ 4 weeks apart with the use of RECIST v1.1 and HCC mRECIST in Cohorts A and B.
- Duration of Response (DOR) [ Time Frame: Randomization up to approximately 36 months ]Investigator-assessed DOR is defined as the time from the first occurrence of a confirmed objective response to the time of disease progression, or death from any cause, whichever occurs first, with the use of RECIST v1.1 and HCC mRECIST in Cohorts A and B
- Progression Free Survival (PFS) [ Time Frame: Randomization up to approximately 36 months ]Investigator-assessed PFS is defined as the time from treatment initiation to the first occurrence of disease progression with the use of RECIST v1.1 and HCC mRECIST, or death from any cause, whichever occurs first, in Cohorts A and B.
- Overall Survival (OS) [ Time Frame: Randomization up to approximately 36 months ]OS is defined as the time from treatment initiation to the date of death due to any cause in Cohorts A and B.
- Change From Baseline in EORTC QLQ-C30 Scores [ Time Frame: Baseline up to approximately 36 months ]The QLQ-C30 is a validated, reliable self-reported measure. It consists of 30 questions that assess five aspects of participant functioning, three symptom scales, global health status and quality of life (QoL), and six single items with a recall period of the previous week. Scale scores can be obtained for the multi-item scales. The functioning and symptoms items are scored on a 4-point scale that ranges from "not at all" to "very much," and the global health status and QoL items are scored on a 7-point scale that ranges from "very poor" to "excellent."
- Change From Baseline in QLQ-HCC18 Scores [ Time Frame: Baseline up to approximately 36 months ]The EORTC QLQ-HCC18 is a disease-specific measure designed for use along with the EORTC QLQ-C30 in patients with HCC. It contains six multi-item symptom scales, and two single-item scales for a total of 18 questions with a recall period the past week.
- Change from baseline in PRO-CTCAE Scores [ Time Frame: Baseline up to approximately 36 months ]The PRO-CTCAE is a validated item bank that is used to characterize the presence, frequency of occurrence, severity, and/or degree of interference with daily function of 78 patient-reportable symptomatic treatment toxicities.
- Change From Baseline in IL46 Scores [ Time Frame: Baseline up to approximately 36 months ]The EORTC IL46 is a single question that assesses bother (burden) of treatment. It is rated on a scale from 1 to 4, ranging from "not at all" to "very much".
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
General Inclusion Criteria:
- Locally advanced or metastatic and/or unresectable HCC with diagnosis confirmed by histology/cytology or clinically by American Association for the Study of Liver Diseases (AASLD) criteria in cirrhotic patients
- Disease that is not amenable to curative surgical and/or locoregional therapies
- No prior systemic treatment (including systemic investigational agents) for locally advanced or metastatic and/or unresectable HCC
- Measurable disease (at least one untreated target lesion) according to RECIST v1.1
- ECOG Performance Status of 0-2 within 7 days prior to initiation of study treatment
- Child-Pugh B7 or B8 cirrhosis at screening and within 7 days prior to study treatment
- Adequate hematologic and end-organ function
- Life expectancy of at least 12 weeks
- Female participants of childbearing potential must be willing to avoid pregnancy and egg donation
General Exclusion Criteria:
- Pregnancy or breastfeeding
- Prior treatment with CD137 agonists or immune checkpoint blockade therapies
- Treatment with investigational therapy within 28 days prior to initiation of study treatment
- Treatment with locoregional therapy to liver within 28 days prior to initiation of study treatment, or non-recovery from side effects of any such procedure
- Treatment with systemic immunostimulatory agents
- Treatment with systemic immunosuppressive medication
- Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study treatment
- Inadequately controlled hypertension
- Active or history of autoimmune disease or immune deficiency
- History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan
- History of malignancy other than HCC within 3 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death
- Known fibrolamellar HCC, sarcomatoid HCC, other rare HCC variant, or mixed cholangiocarcinoma and HCC
- Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases
- Prior allogeneic stem cell or solid organ transplantation
- Listed for liver transplantation
- Co-infection with hepatitis B virus (HBV) and hepatitis C virus (HCV)
- Untreated or incompletely treated esophageal and/or gastric varices with bleeding or that are at high risk for bleeding
- A prior bleeding event due to esophageal and/or gastric varices within 6 months prior to initiation of study treatment
- Grade ≥3 hemorrhage or bleeding event within 6 months prior to initiation of study treatment
- History of hepatic encephalopathy requiring hospitalization or treatment escalation within 6 months prior to study treatment, or any continued symptoms of encephalopathy despite medical management
- History, planned, or recommended placement of transjugular intrahepatic portosystemic shunt (TIPS)
- History of ascites requiring therapeutic paracentesis over the last 3 months
- History of spontaneous bacterial peritonitis within last 12 months
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06096779
Contacts
| Contact: Reference Study ID Number: ML44719 https://forpatients.roche.com/ | 888-662-6728 (U.S. and Canada) | global-roche-genentech-trials@gene.com |
Locations
Show 17 study locations
Sponsors and Collaborators
Genentech, Inc.
Investigators
| Study Director: | Clinical Trials | Hoffmann-La Roche |
| Responsible Party: | Genentech, Inc. |
| ClinicalTrials.gov Identifier: | NCT06096779 |
| Other Study ID Numbers: |
ML44719 |
| First Posted: | October 24, 2023 Key Record Dates |
| Last Update Posted: | May 2, 2024 |
| Last Verified: | May 2024 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here ( https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm). |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Genentech, Inc.:
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Cirrhosis liver cancer liver tumor Child-Pugh B hepatocellular carcinoma |
atezolizumab bevacizumab Immune Checkpoint Inhibitor Digestive System Neoplasms |
Additional relevant MeSH terms:
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Carcinoma Carcinoma, Hepatocellular Fibrosis Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Adenocarcinoma Liver Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Liver Diseases |
Pathologic Processes Bevacizumab Atezolizumab Antineoplastic Agents, Immunological Antineoplastic Agents Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors Immune Checkpoint Inhibitors Molecular Mechanisms of Pharmacological Action |