Einschlusskriterien
Age 1 Participant must be 18 or the legal age of consent in the jurisdiction in which the study is taking place, at the time of signing the informed consent. Type of Par ticipant and Disease Charac teristics 2 Locally advanced or metastatic and/or unresectable HCC with diagnosis confirmed by histopathology/ cytology or clinically by AASLD criteria in cirrhotic patients. (a) Participants without cirrhosis require histological confirmation of diagnosis. 3 WHO/ECOG performance status of 0 or 1 with no deterioration over 2 weeks prior to baseline at screening and prior to randomisation. 4 Must not have received prior systemic therapy for intermediate, advanced, or metastatic HCC. 5 Disease that is not amenable to curative surgical and/or locoregional therapies. Participants with recurrent/progressive disease after surgical and/or locoregional therapies are eligible. Participants who have received approved adjuvant therapy (including immune checkpoint inhibitor treatment) must have a minimum interval of 6 months between the completion of such therapy and the documented diagnosis of recurrent or metastatic disease. For participants who received locoregional therapy for HCC, locoregional therapy must have been completed ≥ 28 days prior to the baseline scan for the current study. 6 BCLC stage B (that is not eligible for locoregional therapy) or stage C. 7 Child-Pugh Score class A with no deterioration over the previous 2 weeks prior to baseline at screening and prior to randomisation. 8 For randomised period, mandatory provision of an FFPE tumour tissue sample (newly acquired or archival ≤12 months old prior to screening) in a quantity sufficient to allow for central PD-L1 testing before randomisation. 9 At least one measurable target lesion, not previously treated with local therapy, that can be accurately measured at baseline and suitable for accurate repeated measurements as per RECIST 1.1 guidelines. Lesions within the field of local therapy could be eligible if they subsequently progressed after previous treatments in accordance with RECIST 1.1. 10 Adequate organ and bone marrow function measured during the screening period (ie, Day -28 to Day -1) as defined in Table 6. 11 Participants with active HBV infection (as characterized by positive HBsAg and/or anti-HBc with detectable HBV DNA [≥10 IU/mL or above the limit of detection per local laboratory]) must receive antiviral therapy for a minimum of 14 days prior to randomisation per institutional practice to show evidence of HBV stabilization or signs of viral response (eg, reduction HBV DNA levels) prior to enrolment. Participants must remain on antiviral therapy for the study duration and for 6 months after the last dose of study treatment. Participants with active co-infection of HBV and HDV are not eligible (active HBV infection is indicated by the presence of HBsAg and/or anti-HBcAb with detectable HBV DNA; active HDV infection is indicated by detectable HDV-RNA with/without the presence of anti-HDV antibodies). 12 Participants with active HCV infection must be well-controlled per local institutional practice for the study determined by investigators. Participants with active HCV infection must have a confirmed diagnosis of HCV characterized by the presence of detectable HCV RNA with/without anti-HCV antibody upon enrolment. Participants co-infected with HBV and HCV are not eligible (HCV-positive infection is indicated by the presence of anti-HCV antibodies). 13 Participants must have a life expectancy of at least 12 weeks at the time of screening. Weight 14 Participants must be ≥ 35 kg. Sex and Contr aceptive/Bar rier Requirements 15 Male and female. Contraceptive use by males or females should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies; see Appendix G for further details. (a) Male participants: • Non-sterilized male participants who intend to be sexually active with a WOCBP must use an acceptable method of contraception (see Appendix G) from enrolment to 180 days after last dose of tremelimumab, atezolizumab and bevacizumab, 90 days after last dose of rilvegostomig (b) Female participants: • Females not of child-bearing potential, see Appendix G for definition. • Females receiving HRT and whose menopausal status is in doubt will be required to use one of the highly effective contraception methods outlined for WOCBP if they wish to continue using HRT during the study. Otherwise, HRT must be discontinued to allow confirmation of post-menopausal status prior to randomisation; see Appendix G for further details. • Female participants of child-bearing potential who are not totally sexually abstinent and intend to be sexually active with a non-sterilized male partner must use at least one highly effective form of contraception from enrolment throughout study and until at least 180 days after last dose of tremelimumab, atezolizumab and bevacizumab, 90 days after last dose of rilvegostomig ; see Appendix G for further details. All WOCBP must have a negative serum pregnancy test result at Cycle 1 Day 1; must not breastfeed and must not donate, or retrieve for their own use, ova from screening to at least 180 days after last dose of tremelimumab, atezolizumab and bevacizumab, 90 days after last dose of rilvegostomig. (c) Pregnancy test: • All WOCBP must have negative pregnancy test at screening and prior to each administration of investigational product. In formed Consent 16 Capable of giving signed informed consent as described in Appendix A which includes compliance with the requirements and restrictions listed in the ICF and in this protocol. 17 Provision of signed and dated written Optional Genetic Research Information informed consent prior to collection of samples for optional genetic research that supports the Genomic Initiative (see Appendix D 2)
Ausschlusskriterien
Medical Conditions 1. As judged by the investigator, any evidence of uncontrolled intercurrent diseases (such as severe or uncontrolled systemic diseases, including, but not limited to, active ILD or pneumonitis, serious chronic gastrointestinal conditions associated with diarrhoea (e.g. active inflammatory bowel disease), active non-infectious skin disease (including any grade rash, urticaria, dermatitis, ulceration, or psoriasis requiring systemic treatment) or psychiatric illness/social situations and uncontrolled tumour-related pain which, in the investigator's opinion, makes it undesirable for the participant to participate in the study or that would jeopardize compliance with the protocol. 2. History of allogeneic organ or stem cell transplantation or on the waiting list for allogeneic organ transplantation 3. Active or prior documented autoimmune or inflammatory disorders requiring chronic treatment with steroids or other immunosuppressive treatment (including but not limited to inflammatory bowel disease [eg, colitis or Crohn's disease], diverticulitis [with the exception of diverticulosis], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc]). The following are exceptions to this criterion: (a) Participants with vitiligo or alopecia. (b) Participants with hypothyroidism (eg, following Hashimoto syndrome) stable on hormone replacement. (c) Any chronic skin condition that does not require systemic therapy. (d) Participants with prior disorders who have not had an active disease in the last 5 years may be included only after consultation with the Study Physician. (e) Participants with coeliac disease controlled by diet alone. 4. History of another primary malignancy, except for: (a) Malignancy treated with curative intent and with no known active disease ≥5 years before the first dose of study treatment and of low potential risk for recurrence. (b) Adequately resected non-melanoma skin cancer or lentigo malignancy without evidence of disease. (c) Adequately treated carcinoma in situ without evidence of disease. 5. History of active primary immunodeficiency or active infection (except for HBV or HCV infection): including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and tuberculosis testing in line with local practice), or HIV (positive HIV 1/2 antibodies). 6. Persistent toxicities caused by previous anti-cancer therapy excluding alopecia, not yet improved to Grade ≤ 1 or baseline. Note: participants may be enrolled with the following chronic, stable Grade 2 toxicities (defined as no worsening to > Grade 2 for at least 3 months prior to the first dose of study intervention and managed with SoC treatment) which the investigator deems related to previous anticancer therapy: a) Chemotherapy-induced neuropathy. b) Fatigue. c) Vitiligo. d) Endocrine disorders, that are controlled with replacement hormone therapy. e) Participants with irreversible toxicity that is not reasonably expected to be exacerbated by study intervention in the opinion of the investigator may be included 7. History of leptomeningeal carcinomatosis. 8. Central nervous system metastases or spinal cord compression (including asymptomatic and adequately treated disease). Participants with suspected brain metastases at screening should have an MRI (preferred) or CT scan of the brain, each preferably with iv contrast, prior to study entry. 9. Known allergy or hypersensitivity to rilvegostomig, tremelimumab, atezolizumab, bevacizumab or any of the novel agents or any of the excipients of the products. 10. Clinically meaningful ascites, pleural effusion, or pericardial effusion requiring non-pharmacologic intervention (e.g., paracentesis) to maintain symptomatic control within 6 months prior to the first scheduled dose. Participants on stable doses of diuretics for effusion for ≥ 2 months are eligible. 11. History of hepatic encephalopathy. 12. Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC. 13. Disease ≥ 50% liver volume determined by investigator 14. Any of the following bleeding risks: a) History of significant bleeding disorders, vasculitis, or a significant bleeding episode from the GI tract within 6 months prior to study randomisation. History of haemoptysis (≥ 2.5 mL of bright red blood per episode) within 6 months prior to initiation of study treatment. b) Evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation). c) Metastatic or involved disease that involves major airways or blood vessels, or centrally located mediastinal tumour masses < 30 mm from the carina of large volume. Participants with vascular invasion of the portal or hepatic veins may be enrolled. d) Participants with untreated or incompletely treated varices with bleeding or high-risk (red wale signs or other high risk factors) for bleeding. Participants must undergo an esophagogastroduodenoscopy (EGD), and all size of varices (small to large) must be assessed and treated per local SoC prior to enrolment. Participants who have undergone an EGD within 6 months of prior to initiation of study treatment do not need to repeat the procedure. 15. History of abdominal or trachea-oesophageal fistula, GI perforation and/or fistulae, or intraabdominal abscess within 6 months prior to initiation of study treatment. 16. History of intestinal obstruction and/or clinical signs or symptoms of GI obstruction including sub-occlusive disease or requirement for routine parenteral hydration, parenteral nutrition, or tube feeding prior to initiation of study treatment. Participants with signs/symptoms of sub-/occlusive syndrome/intestinal obstruction at time of initial diagnosis may be enrolled if they had received definitive (surgical) treatment for symptom resolution 17. Serious or non-healing wound, active peptic ulcer, or untreated bone fracture (except asymptomatic spinal compression fractures that don't need any treatment determined by investigators) within 28 days prior to initiation of study treatment. 18. History of arterial thrombotic event, including myocardial infarction, cerebrovascular accident, or transient ischaemic attack, within 6 months prior to initiation of study treatment. Significant vascular disease (e.g., aortic aneurysm requiring surgical repair or recent peripheral arterial thrombosis) within 6 months prior to initiation of study treatment 19. History of deep vein thrombosis, pulmonary embolism, or any other significant thromboembolism (venous port or catheter thrombosis or superficial venous thrombosis are not considered 'significant') during the 3 months prior to treatment allocation. 20. Participants with main portal vein tumour thrombosis (ie thrombosis in the main trunk of the portal vein, with or without blood flow) on baseline imaging. 21. Any history of nephrotic or nephritic syndrome. 22. Any of the following cardiac conditions: • Cardiomyopathy of any aetiology or history of myocarditis • Heart failure [as defined by New York Heart Association class III-IV] • Uncontrolled hypertension: defined as systolic BP ≥ 150 mmHg and/or diastolic BP ≥ 100 mmHg (anti-hypertensive therapy to achieve these parameters is allowed); participants with prior history of hypertensive crisis or hypertensive encephalopathy are ineligible • Unstable angina pectoris • Clinically significant coronary, carotid, or peripheral artery stenosis • Acute coronary syndrome/acute myocardial infarction and/or coronary intervention with Percutaneous coronary intervention/coronary artery bypass grafting within 12 months prior to initiation of study treatment • Prior arterial or peripheral vascular intervention within 12 months prior to initiation of study treatment • Ventricular arrhythmias requiring treatment, high degree atrioventricular (AV) block (II-III), or sinus node dysfunction with significant sinus pause, untreated with pacemaker. Note: Participants with atrial fibrillation or flutter who are clinically stable and have an optimally controlled ventricular rate (eg, mean of < 100 bpm on resting ECG or 24-hour Holter-ECG) may be eligible if all other cardiac eligibility criteria are met, and a cardiology assessment confirms suitability for study treatment. • History of QT prolongation associated with other medications that required discontinuation of that medication. • Congenital long QT syndrome, family history of long QT syndrome, or unexplained sudden death under 40 years of age in first-degree relatives. • Planned or scheduled cardiac surgery or percutaneous coronary intervention procedure. • Planned revascularization procedure within 6 months of initiation of study Prior/Concomitant Therapy 23. Any concurrent chemotherapy, study treatment, biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (eg, hormone replacement therapy) is acceptable. Prior treatment with anti-CTLA-4 and/or anti-TIGIT. 24. Radiotherapy within 28 days and abdominal/ pelvic radiotherapy within 60 days prior to initiation of study treatment, except palliative radiotherapy to bone lesions within 7 days prior to initiation of study treatment 25. Receipt of live attenuated vaccine within 30 days prior to the first dose of study treatment. Note that participants, if enrolled, should not receive live vaccine while receiving study treatment and within 30 days after the last dose of study treatment. COVID-19 vaccination should not be given for 72 hours prior to administration of the first dose of study treatment. 26. Receipt of treatment with herbal medications or traditional Chinese medicines with anticancer activity included in the label within 14 days prior to first dose of study treatment. These medications should be discontinued prior to consent and should be avoided during the treatment. 27. Major surgical procedure (as defined by the investigator), open biopsy, or significant traumatic injury within 28 days prior to the first dose of study treatment or anticipation of need for a major surgical procedure during the study. Abdominal surgery, abdominal interventions or significant abdominal traumatic injury within 60 days prior to initiation of study treatment or anticipation of need for major surgical procedure during the course of the study or non-recovery from side effects of any such procedure. Note that minor surgery of isolated lesions for palliative intent is acceptable if performed more than 14 days prior to the first dose of study treatment. Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 3 days prior to the first dose of bevacizumab 28. Current or prior use of immunosuppressive medication within 14 days before the first dose of study treatment. The following are exceptions to this criterion: a) Intranasal, inhaled, or topical steroids or local steroid injections (eg, intra articular injection). b) Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or 2mg/day of dexamethasone or equivalent (except for the treatment of adverse events). c) Steroids as premedication for hypersensitivity reactions (eg, CT scan premedication). 29. Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation of study treatment. Participants receiving prophylactic antibiotics (e.g., to prevent a urinary tract infection or chronic obstructive pulmonary disease exacerbation) are eligible for the study. 30. Current or recent (within 10 days of first dose of study treatment) use of aspirin (≥ 325 mg/day) or treatment with dipyridamole, ticlopidine, clopidogrel, and cilostazol 31. Current or recent (within 10 days prior to study treatment start) use of full-dose oral or parenteral anticoagulants or thrombolytic agents for therapeutic (as opposed to prophylactic) purpose is ineligible; Prophylactic anticoagulation or thrombolytic agents may be used as needed upon discussion with study physician. 32. Chronic daily treatment with a NSAID. Occasional use of NSAIDs for the symptomatic relief of medical conditions such as headache or fever is allowed. Low-dose aspirin (