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De klinische studie NCT04524871 (MORPHEUS-LIVER) voor Gevorderde leverkankers is rekruterend. Bekijk de kaartweergave van de Klinische Studies Radar en de AI-ontdekkingstools voor alle details. Of stel hier een vraag. | ||
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RocheA Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatment Combinations in Patients With Advanced Liver Cancers (Morpheus-Liver) (MORPHEUS-LIVER) Fase 1, Fase 2 518 Immuuntherapie Gerandomiseerd Open-label
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De klinische studie NCT04524871 (MORPHEUS-LIVER) onderzoekt behandeling bij Gevorderde leverkankers. Deze Fase 1 Fase 2 interventioneel-studie heeft de status rekruterend. Het doel is om 518 deelnemers te includeren vanaf 1 november 2020. De studie wordt geleid door Roche en de voltooiing is gepland op 31 december 2027. Laatste update op ClinicalTrials.gov: 27 maart 2026.
Beknopte samenvatting
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 ty...Toon meer
Officiële titel
A Phase Ib/II, Open-Label, Multicenter, Randomized Umbrella Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatment Combinations in Patients With Advanced Liver Cancers (Morpheus-Liver)
Aandoeningen
Gevorderde leverkankersPublicaties
Wetenschappelijke artikelen en onderzoekspapers gepubliceerd over deze klinische studie:Andere studie-ID's
- MORPHEUS-LIVER
- GO42216
NCT-ID
Startdatum (Werkelijk)
2020-11-01
Laatste update geplaatst
2026-03-27
Verwachte einddatum
2027-12-31
Inschrijving (Geschat)
518
Studietype
Interventioneel
FASE
Fase 1
Fase 2
Fase 2
Status
Rekruterend
Primaire doel
Behandeling
Toewijzing
Gerandomiseerd
Interventiemodel
Parallel
Blindering
Geen (Open-label)
Armen / Interventies
| Deelnemersgroep/Studiearm | Interventie/Behandeling |
|---|---|
Actieve comparatorStage 1: Atezolizumab + Bevacizumab 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. | Atezolizumab Atezolizumab will be administered at a dose of 1200 mg by IV on Day 1 of each 21 day cycle. Bevacizumab 15 mg/kg Bevacizumab will be administered at a dose of 15 mg/kg by IV infusion on Day 1 of each 21 day cycle. |
ExperimenteelStage 1: Atezolizumab + Bevacizumab + Tiragolumab 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. | Atezolizumab Atezolizumab will be administered at a dose of 1200 mg by IV on Day 1 of each 21 day cycle. Bevacizumab 15 mg/kg Bevacizumab will be administered at a dose of 15 mg/kg by IV infusion on Day 1 of each 21 day cycle. Tiragolumab Tiragolumab will be administered at a dose of 600 mg by IV infusion on Day 1 of each 21 day cycle. |
ExperimenteelStage 1: Atezolizumab + Bevacizumab + Tocilizumab 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. | Atezolizumab Atezolizumab will be administered at a dose of 1200 mg by IV on Day 1 of each 21 day cycle. Bevacizumab 15 mg/kg Bevacizumab will be administered at a dose of 15 mg/kg by IV infusion on Day 1 of each 21 day cycle. Tocilizumab Tocilizumab will be administered at a dose of 8 mg/kg by IV infusion on Day 1 of each 21 day cycle. |
ExperimenteelStage 1: Atezolizumab + Bevacizumab + TPST-1120 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. | Atezolizumab Atezolizumab will be administered at a dose of 1200 mg by IV on Day 1 of each 21 day cycle. Bevacizumab 15 mg/kg Bevacizumab will be administered at a dose of 15 mg/kg by IV infusion on Day 1 of each 21 day cycle. TPST-1120 TPST-1120 will be administered at a dose of 1200 mg by mouth on Days 1-21 of each 21 day cycle. |
ExperimenteelStage 1: Tobemstomig 2100 mg Q2W + Bevacizumab 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. | Bevacizumab 15 mg/kg Bevacizumab will be administered at a dose of 15 mg/kg by IV infusion on Day 1 of each 21 day cycle. Tobemstomig 2100 mg Tobemstomig will be administered at a dose of 2100 mg by IV infusion on Days 1 and 15 of each 28 day cycle. Bevacizumab 10 mg/kg Bevacizumab will be administered at a dose of 10 mg/kg by IV infusion on Days 1 and 15 of each 28 day cycle. |
ExperimenteelStage 1: Tobemstomig 600 mg Q3W + Bevacizumab 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. | Bevacizumab 15 mg/kg Bevacizumab will be administered at a dose of 15 mg/kg by IV infusion on Day 1 of each 21 day cycle. Tobemstomig 600 mg Tobemstomig will be administered at a dose of 600 mg by IV infusion on Day 1 of each 21 day cycle. |
ExperimenteelStage 1: Tobemstomig 1200 mg Q3W + Bevacizumab 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. | Bevacizumab 15 mg/kg Bevacizumab will be administered at a dose of 15 mg/kg by IV infusion on Day 1 of each 21 day cycle. Tobemstomig 1200 mg Tobemstomig will be administered at a dose of 1200 mg every 3 weeks. |
ExperimenteelStage 1: Atezolizumab + Bevacizumab + ADG126 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. | Atezolizumab Atezolizumab will be administered at a dose of 1200 mg by IV on Day 1 of each 21 day cycle. Bevacizumab 15 mg/kg Bevacizumab will be administered at a dose of 15 mg/kg by IV infusion on Day 1 of each 21 day cycle. ADG126 ADG126 will be administered at a dose of 6 mg/kg by IV infusion on Day 1 of every other cycle (cycle length = 21 days). |
ExperimenteelStage 1: Atezolizumab + Bevacizumab + IO-108 1200 mg Q3W 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. | Atezolizumab Atezolizumab will be administered at a dose of 1200 mg by IV on Day 1 of each 21 day cycle. Bevacizumab 15 mg/kg Bevacizumab will be administered at a dose of 15 mg/kg by IV infusion on Day 1 of each 21 day cycle. IO-108 1200 mg IO-108 will be administered at a dose 1200 mg by IV infusion on Day 1 of each 21 day cycle. |
ExperimenteelStage 1: Atezolizumab + Bevacizumab + NKT2152 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. | Atezolizumab Atezolizumab will be administered at a dose of 1200 mg by IV on Day 1 of each 21 day cycle. Bevacizumab 15 mg/kg Bevacizumab will be administered at a dose of 15 mg/kg by IV infusion on Day 1 of each 21 day cycle. NKT2152 NKT2152 will be administered by mouth. |
ExperimenteelStage 1: Atezolizumab + Bevacizumab+ IO-108 1800 mg Q3W 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 | IO-108 1800 mg IO-108 will be administered at a dose 1800 mg by IV infusion on Day 1 of each 21 day cycle. |
Primaire uitkomst
Secundaire uitkomst
| Uitkomstmaat | Beschrijving van de uitkomstmaat | Tijdsbestek |
|---|---|---|
Objective Response Rate (ORR) | 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. | From randomization until disease progression or loss of clinical benefit (up to approximately 7-9 years) |
| Uitkomstmaat | Beschrijving van de uitkomstmaat | Tijdsbestek |
|---|---|---|
Progression Free Survival (PFS) | PFS after randomization, defined as the time from randomization to the first occurrence of disease progression or death from any cause (whichever occurs first) in Stage 1, as determined by the investigator according to RECIST v1.1. | Randomization to first occurrence of disease progression or death from any cause in Stage 1 (up to approximately 7-9 years) |
Overall Survival (OS) | OS after randomization, defined as the time from randomization to death from any cause. | Randomization to death from any cause (up to approximately 7-9 years) |
OS at Specific Timepoints | OS at a specific timepoint, such as Month 6 | Randomization to a specific timepoint, such as Month 6 |
Duration of Response (DOR) | DOR, defined as the time from the first occurrence of a documented objective response to disease progression or death from any cause (whichever occurs first) in Stage 1, as determined by the investigator according to RECIST v1.1. | First occurrence of a documented objective response to disease progression or death (up to approximately 7-9 years) |
Disease Control | Disease control, defined as stable disease for \>=12 weeks or a complete or partial response, as determined by the investigator according to RECIST v1.1. | Randomization to end of study (approximately 7-9 years) |
Percentage of Participants With Adverse Events During Stage 1 | Baseline through the end of the study (approximately 7-9 years) | |
Percentage of Participants With Adverse Events During Stage 2 | Baseline through the end of the study (approximately 7-9 years) |
Deelname-assistent
Geschiktheidscriteria
Leeftijd van deelnemers
Volwassene, Oudere volwassene
Minimumleeftijd
18 Years
Geslachten die in aanmerking komen voor de studie
Allen
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 1 treatment
- 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)
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 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
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
RocheCentraal Contactpersoon
Contact: Reference Study ID Number: GO42216 https://forpatients.roche.com/, 888-662-6728 (U.S. and Canada), [email protected]
33 Studielocaties in 7 landen
California
UC Irvine Medical Center, Costa Mesa, California, 92627, United States
Rekruterend
City of Hope, Duarte, California, 91010, United States
Rekruterend
UC Irvine Medical Center, Orange, California, 92868, United States
Rekruterend
University of California San Diego Medical Center, San Diego, California, 92103, United States
Rekruterend
University of California San Francisco Cancer Center, San Francisco, California, 94115, United States
Rekruterend
UCLA Center for East, Santa Monica, California, 90404, United States
Rekruterend
Colorado
Cherry Creek Medical Center, Aurora, Colorado, 80045, United States
Rekruterend
University of Colorado Hospital - Anschutz Cancer Pavilion, Aurora, Colorado, 80045, United States
Rekruterend
UCHealth Cancer Center Pharmacy - Highlands Ranch Hospital, Highlands Ranch, Colorado, 80129-6694, United States
Rekruterend
Connecticut
Smilow Cancer Hospital at Yale New Haven, New Haven, Connecticut, 06510, United States
Rekruterend
District of Columbia
Georgetown University Medical Center, Washington D.C., District of Columbia, 20007, United States
Rekruterend
Kentucky
University of Kentucky - Markey Cancer Center, Lexington, Kentucky, 40536-7001, United States
Rekruterend
Oregon
Oregon Health & Science University, Portland, Oregon, 97239, United States
Rekruterend
Tennessee
Sarah Cannon Research Institute / Tennessee Oncology, Nashville, Tennessee, 37203, United States
Afgerond
Texas
Parkland Health & Hospital System, Dallas, Texas, 75235, United States
Rekruterend
The University of Texas Southwestern Medical Center at Dallas, Dallas, Texas, 75390, United States
Rekruterend
Beijing Cancer Hospital, Beijing, 100036, China
Rekruterend
Zhongshan Hospital Fudan University, Shanghai, 200032, China
Afgerond
Centre Georges Francois Leclerc, Dijon, 21079, France
Actief, niet rekruterend
CHU Hôpitaux de Marseille, Marseille, France
Rekruterend
Centre Eugène Marquis, Rennes, 35042, France
Rekruterend
Gustave Roussy, Villejuif, 94800, France
Actief, niet rekruterend
Rambam Medical Center, Haifa, 3109601, Israel
Rekruterend
Hadassah University Medical Center, Jerusalem, Israel
Rekruterend
Davidof Center - Rabin Medical Center, Petah Tikva, 4941492, Israel
Rekruterend
Sourasky Medical Centre, Tel Aviv, 64239, Israel
Rekruterend
Auckland City Hospital, Auckland, 1023, New Zealand
Rekruterend
CHA Bundang Medical Center, Gyeonggi-do, 13496, South Korea
Actief, niet rekruterend
Seoul National University Hospital, Seoul, 03080, South Korea
Ingetrokken
Samsung Medical Center, Seoul, 06351, South Korea
Rekruterend
Asan Medical Center, Seoul, 5505, South Korea
Rekruterend
National Cheng Kung University Hospital, Tainan, 70457, Taiwan
Rekruterend
National Taiwan University Hospital, Taipei, 10002, Taiwan
Rekruterend