Morpheus-Liver Study for Advanced Liver Cancers
This study is looking at different combinations of medicines for people with advanced liver cancers, specifically hepatocellular carcinoma (HCC) that has spread or cannot be removed. It's testing drugs like Atezolizumab, Bevacizumab, Tiragolumab, Tocilizumab, and TPST-1120. The goal is to see how well these combinations shrink tumors (Objective Response Rate). You might be able to join if you have advanced HCC that hasn't been treated with other systemic therapies, are at least 18 years old, and meet other health requirements. The study is currently recruiting for 518 participants, but its overall status is unclear.
- Study design
- This is a Phase Ib/II, open-label, multicenter, randomized 'umbrella' study. This means new treatment arms can be added or removed, and participants will be randomly assigned to one of several treatment groups.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed from randomization until their disease progresses or they no longer benefit from the treatment, which could be up to approximately 7-9 years.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT04524871
A Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatment Combinations in Patients With Advanced Liver Cancers (Morpheus-Liver)
Recruiting
PHASE1Ages 18+InterventionalTreatmentHoffmann-La Roche
~518 participants
Updated 2026-08-14 on ClinicalTrials.gov
What's tested:AtezolizumabBevacizumab 15 mg/kgTiragolumabTocilizumabTPST-1120Tobemstomig 2100 mg
At a glance
Recruiting sites
24 of 33 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Objective Response Rate (ORR)
Measured over From randomization until disease progression or loss of clinical benefit (up to approximately 7-9 years)
Conditions
Where it's being run
33 sites across 14 statesCalifornia6
France4
Israel4
South Korea4
Colorado3
Texas2
China2
Taiwan2
Study leadership
- Clinical Trials · STUDY_DIRECTOR · Hoffmann-La Roche
Who to contact
Reference Study ID Number: GO42216 https://forpatients.roche.com/ No attachments to email below.
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 within 7 days prior to randomization
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
Child-Pugh class A within 7 days prior to randomization
Disease that is not amenable to curative surgical and/or locoregional therapies
No prior systemic treatment for HCC
Life expectancy \>= 3 months
Availability of a representative tumor specimen that is suitable for determination of PD-L1 and/or additional biomarker status via central testing
Measurable disease according to Response Evaluation Criteria in Solid Tumors v1.1
Adequate hematologic and end-organ function within 7 days prior to initiation of study treatment
Documented virology status of hepatitis, as confirmed by screening tests for hepatitis B virus - (HBV) and hepatitis C virus (HCV)
Negative HIV test at screening
For women of childbearing potential: agreement to remain abstinent or use contraception and for men: agreement to remain abstinent or use contraception, and agreement to refrain from donating sperm
ECOG Performance Status of 0, 1, or 2
Ability to initiate Stage 2 treatment within 3 months after experiencing unacceptable toxicity not related to atezolizumab or RO7247669 or loss of clinical benefit as determined by the investigator while receiving Stage 1 treatment
Availability of a tumor specimen from a biopsy performed upon discontinuation of Stage 1 (if deemed clinically feasible)
Total bilirubin ≤ 1.5 X ULN in the absence of Gilbert's disease (≤ 3.0 X ULN if Gilbert's disease)
AST/ALT ≤ 2.5 X ULN (≤ 5 X ULN if liver metastases present)
Exclusion
Prior treatment with CD137 agonists or immune checkpoint blockade therapies or inhibitors targeting HIF2a
Treatment with investigational therapy within 28 days prior to initiation of study
Treatment with locoregional therapy to liver within 28 days prior to initiation of study, or non-recovery from side effects of any such procedure
Untreated or incompletely treated esophageal and/or gastric varices with bleeding or at high risk for bleeding
Prior bleeding event due to esophageal and/or gastric varices within 6 months prior to initiation of study
AEs from prior anti-cancer therapy that have not resolved to Grade \<= 1 or better, with the exception of alopecia of any grade
Inadequately controlled hypertension
History of hypertensive crisis or hypertensive encephalopathy
Significant vascular disease
History of hemoptysis within 1 month prior to initiation of study
Evidence of bleeding diathesis or significant coagulopathy
Current or recent use of aspirin (\>325 mg/day) or treatment with clopidogrel, dipyramidole, ticlopidine, or cilostazol
Current or recent use of full-dose oral or parenteral anticoagulants or thrombolytic agents for therapeutic (as opposed to prophylactic) purpose
Core biopsy or other minor surgical procedure within 3 days prior to initiation of study
History of abdominal or tracheoesophageal fistula, GI perforation, or intra-abdominal abscess, intestinal obstruction and/or clinical signs/symptoms of GI obstruction
Evidence of abdominal free air not explained by paracentesis or recent surgery
Serious, non-healing/dehiscing wound, active ulcer, or untreated bone fracture
Grade \>=2 proteinuria
Metastatic disease involving major airways/blood vessels, or centrally located mediastinal tumor masses of large volume
History of clinically significant intra-abdominal inflammatory process
Radiotherapy within 28 days or abdominal/pelvic radiotherapy within 60 days prior to initiation of study with the exception of palliative radiotherapy to bone lesions within 7 days prior to initiation of study
Major surgery, open biopsy, or significant traumatic injury within 28 days prior to initiation of study; or abdominal surgery, abdominal interventions or significant abdominal traumatic injury within 60 days prior to initiation of study; or anticipation of need for major surgery during study or non-recovery from side effects of any such procedure
Chronic daily treatment with NSAID
Eligible only for control arm
Fibrolamellar or sarcomatoid HCC, or mixed cholangiocarcinoma and HCC
History of hepatic encephalopathy
Moderate or severe ascites
HBV and HCV coinfection
Symptomatic, untreated, or actively progressing CNS metastases
History of leptomeningeal disease
Uncontrolled tumor-related pain
Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
Uncontrolled or symptomatic hypercalcemia
Active or history of autoimmune disease or immune deficiency
History of IPF, organizing pneumonia, drug-induced or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan
Active TB
Significant CV disease within 3 months prior to initiation of study, unstable arrhythmia, or unstable angina
Major surgery, other than for diagnosis, within 4 weeks prior to initiation of study, or anticipated major surgery during study
History of malignancy other than HCC within 5 years prior to screening
Severe infection within 4 weeks prior to initiation of study
Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation of study
Prior allogeneic stem cell or solid organ transplantation
Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study, or anticipation of need for such a vaccine during atezolizumab treatment or within 5 months after the final dose of atezolizumab
History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins
Known allergy or hypersensitivity to any of the study drugs or any of their excipients
Treatment with systemic immunostimulatory, immunosuppressive agents within 4 weeks or 5 drug-elimination half-lives (whichever is longer) prior to initiation of study
Treatment with systemic immunosuppressive medication within 2 weeks prior to initiation of study
Grade \>= 3 hemorrhage or bleeding event within 8 weeks prior to initiation of study treatment
Patients entering Stage 2: immunotherapy-related adverse events that have not resolved to Grade 1 or better or to baseline at time of consent
What this trial measures
- Objective Response Rate (ORR)From randomization until disease progression or loss of clinical benefit (up to approximately 7-9 years)
ORR, defined as the proportion of participants with a complete response or partial response on two consecutive occasions \>=4 weeks apart during Stage 1, as determined by the investigator according to RECIST v1.1.