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Immunotherapy

Immunotherapy Combinations for Advanced Liver Cancer (MORPHEUS-LIVER Trial)

Phase 1 & 2

Recruiting

Research Sponsored by Hoffmann-La Roche

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Adequate hematologic and end-organ function within 7 days prior to initiation of study treatment

Must not have

History of hepatic encephalopathy

Treatment with locoregional therapy to liver within 28 days prior to initiation of study, or non-recovery from side effects of any such procedure

Timeline

Screening 3 weeks

Treatment Varies

Follow Up randomization to first occurrence of disease progression or death from any cause in stage 1 (up to approximately 7-9 years)

Awards & highlights

No Placebo-Only Group

Summary

This trial is designed to study new treatments for advanced liver cancer. It is open-label, meaning that participants and researchers will know which treatment is being received, and it is multicenter, meaning that it will be conducted at multiple research sites. The trial is also randomized, meaning that participants will be assigned to different treatment groups by chance.

Who is the study for?

Adults with advanced liver cancer (HCC) who haven't had systemic therapy can join this trial. They must have measurable disease, proper organ function, and no HIV or active hepatitis. Participants need to agree to use contraception and should not have a history of certain medical conditions like severe allergies or autoimmune diseases.

What is being tested?

The study tests multiple immunotherapy combinations including RO7247669 at different doses, Bevacizumab, ADG126, Atezolizumab, Tiragolumab, Tocilizumab, TPST-1120 for effectiveness and safety in treating liver cancer. It's flexible to adapt as new treatments emerge or existing ones show minimal benefit or high toxicity.

What are the potential side effects?

Potential side effects include immune reactions that may cause inflammation in organs like the liver or lungs; infusion-related reactions; fatigue; blood disorders; increased risk of infections; digestive issues such as nausea and diarrhea.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My liver cancer cannot be removed by surgery and is confirmed by tests or clinical criteria.

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My blood and organ functions are within normal ranges as of last week.

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I have not received any systemic treatment for liver cancer.

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I am fully active or restricted in physically strenuous activity but can do light work.

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I can take care of myself and am up and about more than half of my waking hours.

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My condition cannot be cured with surgery or local treatments.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had episodes of brain confusion due to liver problems.

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I've had liver therapy within the last 28 days or am still experiencing side effects.

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I have serious blood vessel problems.

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I have moderate to severe fluid buildup in my abdomen.

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My cancer has spread to major airways or blood vessels.

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I have a serious wound, ulcer, or untreated bone fracture that is not healing.

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I have had a severe hypertension crisis or brain issues due to high blood pressure.

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I take NSAID medication every day for a chronic condition.

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I haven't had major heart problems or unstable heart conditions in the last 3 months.

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I have not received a live vaccine in the last 4 weeks and do not plan to during or within 5 months after treatment.

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My liver cancer is a specific type (Fibrolamellar, sarcomatoid, or mixed).

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I haven't had major surgery or serious injuries recently.

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I have pain from my cancer that isn't relieved by treatment.

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I am currently taking or have recently taken high-dose aspirin or certain blood thinners.

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I have had inflammation in my abdomen before.

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I have had cancer spread to the lining of my brain and spinal cord.

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I haven't had major surgery in the last 4 weeks and don't expect any during the study.

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I have untreated or partially treated varices in my esophagus or stomach that are bleeding or likely to bleed.

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I have previously been treated with immune system boosting drugs.

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I have active tuberculosis.

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I have moderate to severe protein in my urine.

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I have high calcium levels in my blood that are causing symptoms.

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I am currently using or have recently used blood thinners for treatment.

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I had a biopsy or minor surgery within the last 3 days.

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I have had lung conditions like IPF or pneumonia, or signs of these on a chest CT scan.

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I have had a stem cell or organ transplant in the past.

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My high blood pressure is not well-controlled.

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I have brain metastases that are causing symptoms or getting worse.

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I have had serious stomach or throat complications.

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I frequently need procedures to remove excess fluid from my chest or abdomen.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ randomization to first occurrence of disease progression or death from any cause in stage 1 (up to approximately 7-9 years)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~randomization to first occurrence of disease progression or death from any cause in stage 1 (up to approximately 7-9 years)

This trial's timeline: 3 weeks for screening, Varies for treatment, and randomization to first occurrence of disease progression or death from any cause in stage 1 (up to approximately 7-9 years) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Objective Response Rate (ORR)

Secondary study objectives

Disease Control

Duration of Response (DOR)

OS at Specific Timepoints

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

11Treatment groups

Experimental Treatment

Active Control

Group I: Stage 1: Tobemstomig 600 mg Q3W + BevacizumabExperimental Treatment2 Interventions

Participants will receive Tobemstomig plus bevacizumab until unacceptable toxicity or loss of clinical benefit, as determined by the investigator after an integrated assessment of radiographic and biochemical data, local biopsy results (if available), and clinical status.

Group II: Stage 1: Tobemstomig 2100 mg Q2W + BevacizumabExperimental Treatment3 Interventions

Group III: Stage 1: Tobemstomig 1200 mg Q3W + BevacizumabExperimental Treatment2 Interventions

Group IV: Stage 1: Atezolizumab + Bevacizumab+ IO-108 1800 mg Q3WExperimental Treatment1 Intervention

Participants will receive atezolizumab plus bevacizumab plus IO-108 until unacceptable toxicity or loss of clinical benefit, as determined by the investigator after an integrated assessment of radiographic andbiochemical data, local biopsy results (if available), and clinical status

Group V: Stage 1: Atezolizumab + Bevacizumab + TocilizumabExperimental Treatment3 Interventions

Participants will receive atezolizumab plus bevacizumab plus tocilizumab until unacceptable toxicity or loss of clinical benefit, as determined by the investigator after an integrated assessment of radiographic and biochemical data, local biopsy results (if available), and clinical status.

Group VI: Stage 1: Atezolizumab + Bevacizumab + TiragolumabExperimental Treatment3 Interventions

Participants will receive atezolizumab plus bevacizumab plus tiragolumab until unacceptable toxicity or loss of clinical benefit, as determined by the investigator after an integrated assessment of radiographic and biochemical data, local biopsy results (if available), and clinical status.

Group VII: Stage 1: Atezolizumab + Bevacizumab + TPST-1120Experimental Treatment3 Interventions

Participants will receive atezolizumab plus bevacizumab plus TPST-1120 until unacceptable toxicity or loss of clinical benefit, as determined by the investigator after an integrated assessment of radiographic and biochemical data, local biopsy results (if available), and clinical status.

Group VIII: Stage 1: Atezolizumab + Bevacizumab + NKT2152Experimental Treatment3 Interventions

Participants will receive atezolizumab plus bevacizumab plus NKT2152 until unacceptable toxicity or loss of clinical benefit, as determined by the investigator after an integrated assessment of radiographic and biochemical data, local biopsy results (if available), and clinical status.

Group IX: Stage 1: Atezolizumab + Bevacizumab + IO-108 1200 mg Q3WExperimental Treatment3 Interventions

Participants will receive atezolizumab plus bevacizumab plus IO-108 until unacceptable toxicity or loss of clinical benefit, as determined by the investigator after an integrated assessment of radiographic and biochemical data, local biopsy results (if available), and clinical status.

Group X: Stage 1: Atezolizumab + Bevacizumab + ADG126Experimental Treatment3 Interventions

Participants will receive atezolizumab plus bevacizumab plus ADG126 until unacceptable toxicity or loss of clinical benefit as determined by the investigator after an integrated assessment of radiographic and biochemical data, local biopsy results (if available), and clinical status.

Group XI: Stage 1: Atezolizumab + BevacizumabActive Control2 Interventions

Participants will receive atezolizumab plus bevacizumab until unacceptable toxicity or loss of clinical benefit, as determined by the investigator after an integrated assessment of radiographic and biochemical data, local biopsy results (if available), and clinical status.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Bevacizumab 15 mg/kg

2010

N/A

~20

Atezolizumab

2016

Completed Phase 3

~5860