3-FLUORO-5-{[(2AR,4S)-1,1,2,2,4-PENTAFLUORO-2A-HYDROXY-2,2A,3,4-TETRAHYDRO-1H-CYCLOPENTA[CD]INDEN-5-YL]OXY}BENZONITRILE for Advanced liver cancer | Hepatocellular carcinoma (HCC)

Inclusion criteria

• {"criterion_text":"- 1. Age ≥ 18 years, with an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 within 7 days prior to randomization"}
• {"criterion_text":"- 2. Locally advanced or metastatic and/or unresectable hepatocellular carcinoma (HCC) with diagnosis confirmed by histology/cytology or clinically by American Association for the Study of Liver Diseases criteria in cirrhotic patients"}
• {"criterion_text":"- 3. Child-Pugh class A within 7 days prior to randomization"}
• {"criterion_text":"- 4. Disease that is not amenable to curative surgical and/or locoregional therapies"}
• {"criterion_text":"- 5. No prior systemic treatment (including systemic investigational agents) for HCC"}
• {"criterion_text":"- 6. Life expectancy ≥ 3 months, as determined by the investigator and availability of a representative tumor specimen that is suitable for determination of PD-L1 and/or additional biomarker status via central testing"}

Exclusion criteria

• {"criterion_text":"- 1. Prior treatment with CD137 agonists or immune checkpoint blockade therapies or inhibitors targeting HIF2alpha"}
• {"criterion_text":"- 2. Treatment with investigational therapy within 28 days prior to initiation of study"}
• {"criterion_text":"- 3. Treatment with locoregional therapy to liver within 28 days prior to initiation of study, or non-recovery from side effects of any such procedure"}
• {"criterion_text":"- 4. Untreated or incompletely treated esophageal and/or gastric varices with bleeding or at high risk for bleeding"}
• {"criterion_text":"- 5. A prior bleeding event due to esophageal and/or gastric varices within 6 months prior to initiation of study"}
• {"criterion_text":"- 6. AEs from prior anti-cancer therapy that have not resolved to Grade 1 or better, with the exception of alopecia of any grade"}

Primary endpoints

• {"endpoint_text":"- 1. ORR (determined by the investigator according to RECIST 1.1)","definition_or_measurement_approach":"Objective response rate as determined by the investigator according to RECIST v1.1"}
• {"endpoint_text":"- 2. Incidence, nature, and severity of adverse events and laboratory abnormalities","definition_or_measurement_approach":"Standard safety assessment via reporting of adverse events and clinical laboratory evaluations (incidence, nature, severity); specific assessment methods not further detailed in the record"}
• {"endpoint_text":"- 3. Change from baseline in vital signs and ECG parameters","definition_or_measurement_approach":"Assessment of change from baseline in vital signs and ECG parameters; specific measurement schedule not provided in the record"}
• {"endpoint_text":"- 4. Change from baseline in targeted clinical laboratory test results","definition_or_measurement_approach":"Assessment of change from baseline in targeted clinical laboratory tests; specific tests and schedule not provided in the record"}

Secondary endpoints

• {"endpoint_text":"- 1. PFS","definition_or_measurement_approach":"Not specified in the CTIS record"}
• {"endpoint_text":"- 2. OS after randomization","definition_or_measurement_approach":"Not specified in the CTIS record"}
• {"endpoint_text":"- 3. OS at specific timepoints","definition_or_measurement_approach":"Not specified in the CTIS record"}
• {"endpoint_text":"- 4. DOR","definition_or_measurement_approach":"Not specified in the CTIS record"}
• {"endpoint_text":"- 5. Disease control","definition_or_measurement_approach":"Not specified in the CTIS record"}

France

Earliest CTIS Part Ii Submission Date

21-06-2023

Latest Decision Or Authorization Date

05-03-2026

Processing Time Days

988

Number Of Sites

4

Number Of Participants

29

Primary sponsor

Full Name

F. Hoffmann-La Roche AG

Organisation Type

Pharmaceutical company

Country Of Registered Address

Switzerland

Contract research organisations

Name

Fortrea Inc.

Responsibilities

sponsorDuties codes: ["1","12","15","5","8"] (includes value: "Global CRO")

Name

Icon Development Solutions LLC

Responsibilities

sponsorDuties codes: ["4"]

Name

Almac Clinical Technologies LLC

Responsibilities

sponsorDuties codes: ["3"]

Third parties

• {"country":"United States","full_name":"Almac Clinical Technologies LLC","duties_or_roles":"sponsorDuties codes: [\"3\"]","organisation_type":"Pharmaceutical company"}
• {"country":"France","full_name":"Pharmaspecific","duties_or_roles":"sponsorDuties codes: [\"15\"] (value: \"Other Third Party Duty\")","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Icon Development Solutions LLC","duties_or_roles":"sponsorDuties codes: [\"4\"]","organisation_type":"Pharmaceutical company"}
• {"country":"Belgium","full_name":"CellCarta","duties_or_roles":"sponsorDuties codes: [\"4\"]","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United States","full_name":"Frontage Laboratories Inc.","duties_or_roles":"sponsorDuties codes: [\"4\"]","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Q Squared Solutions LLC","duties_or_roles":"sponsorDuties codes: [\"4\"]","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United States","full_name":"Fortrea Inc.","duties_or_roles":"sponsorDuties codes: [\"1\",\"12\",\"15\",\"5\",\"8\"] (includes value: \"Global CRO\")","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Precision For Medicine Inc.","duties_or_roles":"sponsorDuties codes: [\"4\"]","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Natera Inc.","duties_or_roles":"sponsorDuties codes: [\"4\"]","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"Netherlands","full_name":"QPS Netherlands B.V.","duties_or_roles":"sponsorDuties codes: [\"4\"]","organisation_type":"Pharmaceutical company"}