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Locally Advanced or Metastatic Hepatocellular Carcinoma (HCC): Evaluation of the Optimized Dose, Safety, and Efficacy of Livmoniplimab in Combination with Budigalimab
EU CTIS ID: 2022-502948-13-00
What this study is testing
To optimize livmoniplimab dose in combination with budigalimab and identify the recommended phase 3 dose in locally advanced or metastatic Child-Pugh A HCC patients who have progressed after an immune CPI-containing regimen in 1L HCC. To evaluate the efficacy of livmoniplimab in combination with budigalimab as measured by the rate of BOR of confirmed CR/PR determined by investigators.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Child-Pugh A ECOG PS 0-1 Received an immune checkpoint inhibitor in 1L HCC treatment regimen.No symptomatic, untreated, or actively progressing CNS metastases. Adequate hematologic and end-organ function Tissue biopsy at screening
You likely can't join if
- No history of malignancy other than HCC within 5 years prior to screening, except for malignancies with a negligible risk of metastasis or death (e.g., 5-year OS rate > 90%),
- No major surgical procedure, other than for diagnosis, within 4 weeks prior to initiation of study treatment, or anticipation of need for a major surgical procedure during the study
- No prior allogeneic stem cell or solid organ transplantation
- Resolution of any acute clinically significant treatment-related toxicity from prior therapy to Grade ≤ 1 prior to study entry, except for alopecia.
- Negative HIV test at screening due to potential safety concerns on those immune compromised patients.
The study team makes the final eligibility decision.
Where it's taking place
- United States
- Japan
- Korea, Republic of
- Taiwan
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, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States; Japan; Korea, Republic of; Taiwan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.