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NCT04524871 · ClinicalTrials.gov registry record · Phase 1
A Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatment Combinations in Patients With Advanced Liver Cancers (Morpheus-Liver)
A Phase 1 study of Advanced Liver Cancers, sponsored by Hoffmann-La Roche.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 518
- Enrollment target
- 20
- Study locations
NCT04524871: Recruiting Phase 1 study of Advanced Liver Cancers, sponsored by Hoffmann-La Roche.
NCT04524871 is a Phase 1 study of Advanced Liver Cancers that is actively recruiting participants, run by Hoffmann-La Roche. The registered enrollment target is 518 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (763% higher). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04524871, a Phase 1 study of Advanced Liver Cancers, is actively recruiting participants, sponsored by Hoffmann-La Roche.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 518 participants
- Enrollment target
- 20
- Study locations
Study Summary
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. Cohort 1 will enroll participants with locally advanced or metastatic hepatocellular carcinoma (HCC) who have not received prior systemic therapy for their disease. Eligible participants will initially be randomly assigned to one of several treatment arms (Stage 1). Participants who experience loss of clinical benefit or unacceptable toxicity during Stage 1 may be eligible to receive treatment with a different treatment combination (Stage 2). When a Stage 2 treatment combination is available, this will be introduced by amending the protocol.
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG Atezolizumab
- DRUG Tocilizumab
- DRUG Bevacizumab 15 mg/kg
- DRUG Tiragolumab
- DRUG TPST-1120
Study Locations (20)
California
- UC Irvine Medical Center - Costa Mesa
- City of Hope - Duarte
- UC Irvine Medical Center - Orange
- University of California San Diego Medical Center - San Diego
- University of California San Francisco Cancer Center - San Francisco
- UCLA Center for East - Santa Monica
Other
- Beijing Cancer Hospital - Beijing
- Zhongshan Hospital Fudan University - Shanghai
- Centre Georges Francois Leclerc - Dijon
- CHU Hôpitaux de Marseille - Marseille
Colorado
- Cherry Creek Medical Center - Aurora
- University of Colorado Hospital - Anschutz Cancer Pavilion - Aurora
- UCHealth Cancer Center Pharmacy - Highlands Ranch Hospital - Highlands Ranch
Texas
- Parkland Health & Hospital System - Dallas
- The University of Texas Southwestern Medical Center at Dallas - Dallas
Connecticut
- Smilow Cancer Hospital at Yale New Haven - New Haven
District of Columbia
- Georgetown University Medical Center - Washington D.C.
Kentucky
- University of Kentucky - Markey Cancer Center - Lexington
Oregon
- Oregon Health & Science University - Portland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 518 participants |
| Start Date | 2020-11-01 |
| Est. Completion | 2027-12-31 |
| Phase | Phase 1 |
What NCT04524871 shows while recruiting
NCT04524871 is an interventional study that assigns participants to a tested intervention. The registered 518 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (763% higher).
The record links to 1 condition, with Advanced Liver Cancers appearing as the primary indexed condition, and to 5 interventions - of which Atezolizumab is the first listed.
NCT04524871 names 20 study sites across 9 states, led by California, Other, Colorado.
Frequently Asked Questions
What is clinical trial NCT04524871 about?
NCT04524871 is a clinical study titled "A Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatment Combinations in Patients With Advanced Liver Cancers (Morpheus-Liver)". 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...
What is the current status of trial NCT04524871?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 518 participants. The study started on 2020-11-01. Estimated completion is 2027-12-31.
What conditions does trial NCT04524871 study?
This clinical trial studies the following conditions: Advanced Liver Cancers.
What interventions are being tested in trial NCT04524871?
The interventions under investigation include: Atezolizumab (DRUG), Tocilizumab (DRUG), Bevacizumab 15 mg/kg (DRUG), Tiragolumab (DRUG), TPST-1120 (DRUG).
Who is sponsoring clinical trial NCT04524871?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04524871 being conducted?
This trial has 20 study locations across California, Colorado, Connecticut, District of Columbia, Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04524871's enrollment target sits among peer trials
518 40th of 2000 higher than 1,961 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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