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Clinical Trials/2022-502948-13-00
2022-502948-13-00RecruitingPhase 2

A Phase 2, Randomized Study to Evaluate the Optimized Dose, Safety, and Efficacy of Livmoniplimab in Combination with Budigalimab for locally advanced or Metastatic Hepatocellular Carcinoma patients who have progressed after an approved immune checkpoint inhibitor containing regimen in First-Line HCC

Abbvie Deutschland GmbH & Co. KG20 sites in 3 countries63 target enrollmentStarted: November 15, 2023Last updated:
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Conditions

Trial Snapshot

Phase
Phase 2
Status
Recruiting
Enrollment
63
Locations
20
Primary Endpoint
The primary endpoint is the BOR of confirmed CR or confirmed PR per RECIST 1.1 as determined by investigators at any time prior to subsequent anticancer therapy.
Study OverviewEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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.

Eligibility Criteria

Ages
18 years to 65+ years (18-64 Years, 65+ Years)
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •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

Exclusion Criteria

  • •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.

Outcomes

Primary Outcomes

The primary endpoint is the BOR of confirmed CR or confirmed PR per RECIST 1.1 as determined by investigators at any time prior to subsequent anticancer therapy.

The primary endpoint is the BOR of confirmed CR or confirmed PR per RECIST 1.1 as determined by investigators at any time prior to subsequent anticancer therapy.

Secondary Outcomes

  • The secondary endpoints are DoR by investigators, PFS by investigators, and OS.
  • PFS by investigators: The time from randomization until the first documentation of progressive disease according to RECIST 1.1 as determined by investigators or death from any cause, whichever occurs first.
  • OS: The time from randomization until death from any cause.

Investigators

Sponsor Class
Pharmaceutical company
Responsible Party
Principal Investigator
Principal Investigator

Global Clinical Trials Helpdesk

Scientific

Abbvie Deutschland GmbH & Co. KG

Study Sites (20)

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