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Tests treatment safety and results for Advanced Liver Cancers
Official title A Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatment Combinations in Patients With Advanced Liver Cancers (Morpheus-Liver)
ClinicalTrials.gov ID: NCT04524871
What this study is testing
What is Atezolizumab?
Atezolizumab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for advanced liver cancers.
Also referred to as Tecentriq.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a Phase Ib/II, open-label, multicenter, randomized umbrella study in participants with advanced liver cancers. The study is designed with the flexibility to open new treatment arms as new treatments become available, close existing treatment arms that demonstrate minimal clinical activity or unacceptable toxicity, modify the participant population, or introduce additional cohorts of participants with other types of advanced primary liver cancer.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Stage 1
- 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...
- Liver Diseases criteria in cirrhotic patients
- Child-Pugh class A within 7 days prior to randomization
You likely can't join if
- Stage 1
- 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
See the full eligibility criteria
Who can join
- Stage 1
- 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 Stage 1 and Stage 2
- 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 Stage 2
- 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...
- Availability of a tumor specimen from a biopsy performed upon discontinuation of Stage 1 (if deemed clinically feasible) NKT2152-Containing Arm:
- 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)
What rules you out
- Stage 1
- 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...
- Chronic daily treatment with NSAID
- Eligible only for control arm Stage 1 and 2
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Costa Mesa, California, United States
- Duarte, California, United States
- Orange, California, United States
- San Diego, California, United States
- San Francisco, California, United States
- Santa Monica, California, United States
- Aurora, Colorado, United States
- Highlands Ranch, Colorado, United States
- New Haven, Connecticut, United States
- Washington D.C., District of Columbia, United States
- Lexington, Kentucky, United States
- Portland, Oregon, United States
- Nashville, Tennessee, United States
- Dallas, Texas, United States
- Beijing, China
- Shanghai, China
- Dijon, France
- Marseille, France
- Rennes, France
- Villejuif, France
+ 9 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Costa Mesa, California, United States; Duarte, California, United States; Orange, California, United States; San Diego, California, United States; San Francisco, California, United States; Santa Monica, California, United States and 23 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.