Locally Advanced or Metastatic Hepatocellular Carcinoma (HCC): Evaluation of the Optimized Dose, Safety, and Efficacy of Livmoniplimab in Combination with Budigalimab

Start 1 Mar 2024 · Status Ongoing, recruitment ended · 3 EU/EEA countries · 21 sites · Protocol M24-147

Overview

Sponsor-declared trial summary

Phase Therapeutic exploratory (Phase II)

Status Ongoing, recruitment ended

Participants planned 120

Countries 3

Sites 21

Hepatocellular Carcinoma

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 measure…

Key facts

Sponsor: Abbvie Deutschland GmbH & Co. KG
Participant type: Patients
Age range: 18-64 years, 65+ years
Gender: Male and Female
Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trial duration: 1 Mar 2024 → ongoing
Decision date (initial): 2023-11-17
Transition trial: No
Low-intervention: No
Rare-disease indication: No
Vulnerable population: No
Funding sources: Abbvie Inc

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy

Secondary objectives 2

To evaluate the efficacy of livmoniplimab in combination with budigalimab as measured by the DoR by investigators, PFS by investigators, and OS
To assess the safety, tolerability, immunogenicity, and PK of livmoniplimab in combination with budigalimab

Conditions and MedDRA coding

Hepatocellular Carcinoma

Regulatory references

Scientific advice from competent authorities: Food And Drug Administration
Plan to share IPD: Yes
IPD plan description: AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information. To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/ For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

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 5

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.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

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 endpoints 3

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.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Budigalimab

PRD10277708 · Product

Active substance: Budigalimab
Pharmaceutical form: SOLUTION FOR INJECTION/INFUSION
Route of administration: ORAL USE
Max daily dose: 00 mg milligram(s)
Max total dose: 00 g gram(s)
Max treatment duration: 104 Week(s)
Authorisation status: Not Authorised
MA holder: ABBVIE DEUTSCHLAND GMBH & CO. KG
Paediatric formulation: No
Orphan designation: No

Livmoniplimab

PRD10284221 · Product

Active substance: Livmoniplimab
Pharmaceutical form: SOLUTION FOR INFUSION
Route of administration: INTRAVENOUS
Max daily dose: 00 mg milligram(s)
Max total dose: 00 g gram(s)
Max treatment duration: 104 Week(s)
Authorisation status: Not Authorised
MA holder: ABBVIE DEUTSCHLAND GMBH & CO. KG
Paediatric formulation: No
Orphan designation: No

Comparator 2

Kisplyx 4 mg hard capsules

PRD4413425 · Product

Active substance: Lenvatinib
Pharmaceutical form: CAPSULE, HARD
Route of administration: ORAL USE
Max daily dose: 12 mg milligram(s)
Max total dose: 8.75 g gram(s)
Max treatment duration: 104 Week(s)
Authorisation status: Authorised
ATC code: L01XE29 — -
Marketing authorisation: EU/1/16/1128/001
MA holder: EISAI GMBH
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Sorafenib STADA 200 mg Filmtabletten

PRD8342711 · Product

Active substance: Sorafenib
Pharmaceutical form: FILM-COATED TABLET
Route of administration: ORAL USE
Max daily dose: 800 mg milligram(s)
Max total dose: 584 g gram(s)
Max treatment duration: 104 Week(s)
Authorisation status: Authorised
ATC code: L01EX02 — -
Marketing authorisation: 2204214.00.00
MA holder: STADAPHARM GMBH
MA country: Germany
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Abbvie Deutschland GmbH & Co. KG

Sponsor organisation: Abbvie Deutschland GmbH & Co. KG
Address: Knollstrasse
City: Ludwigshafen Am Rhein
Postcode: 67061
Country: Germany

Scientific contact point

Organisation: Abbvie Deutschland GmbH & Co. KG
Contact name: Global Clinical Trials Helpdesk

Public contact point

Organisation: Abbvie Deutschland GmbH & Co. KG
Contact name: Global Clinical Trials Helpdesk

Third parties 7

Organisation	City, country	Duties
Veeva Systems Inc. ORG-100006053	Pleasanton, United States	Data management
Cytel Inc. ORG-100042560	Waltham, United States	Code 13
Medable Inc. ORG-100043083	Palo Alto, United States	Interactive response technologies (IRT)
Labcorp Central Laboratory Services S.a.r.l. ORG-100011524	Meyrin, Switzerland	Laboratory analysis
Greenphire LLC ORG-100041621	King Of Prussia, United States	Other
Massive Bio Inc. ORG-100044618	New York, United States	Code 5
Endpoint And Outcomes Research LLC ORG-100044473	Boston, United States	Interactive response technologies (IRT)

Sponsor responsibilities

Article 77 compliance: Abbvie Deutschland GmbH & Co. KG
Article 77 implementation: Abbvie Deutschland GmbH & Co. KG

Locations

3 EU/EEA countries · 21 investigational sites

By country

Country	MS status	Planned subjects	Sites
France	Ongoing, recruitment ended	18	6
Italy	Ongoing, recruitment ended	21	7
Spain	Ongoing, recruitment ended	24	8
Rest of world Taiwan, United States, Korea, Republic of, Japan	—	57	—

Investigational sites

France

6 sites · Ongoing, recruitment ended

Assistance Publique Hopitaux De Paris

n/a, 12 Avenue Paul Vaillant Couturier, 94800, Villejuif

Hopital Saint Eloi

n/a, 80 Avenue Augustin Fliche, 34295, Montpellier Cedex 5

Centre Hospitalier Universitaire Grenoble Alpes

n/a, Boulevard De La Chantourne, Cs 10217, Grenoble Cedex 9

Centre Hospitalier Universitaire De Lille

n/a, Rue Michel Polonovski, 59037, Lille Cedex

Centre Hospitalier Universitaire De Bordeaux

n/a, Avenue De Magellan, 33600, Pessac

Hopital Beaujon

n/a, 100 Boulevard Du General Leclerc, 92110, Clichy

Italy

7 sites · Ongoing, recruitment ended

Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone

n/a, Via Del Vespro 129, 90127, Palermo

Istituto Oncologico Veneto

n/a, Via Gattamelata 64, 35128, Padova

Careggi University Hospital

n/a, Largo Giovanni Alessandro Brambilla 3, 50134, Florence

Azienda Sanitaria Locale Napoli 1 Centro

n/a, Via Enrico Russo 1, 80147, Naples

Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico

n/a, Via Pietro Albertoni 15, 40138, Bologna

Ospedale San Raffaele S.r.l.

n/a, Via Olgettina 60, 20132, Milan

Fondazione Policlinico Universitario Campus Bio-Medico

n/a, Via Alvaro Del Portillo N 200, 00128, Rome

Spain

8 sites · Ongoing, recruitment ended

Hospital Universitario Marques De Valdecilla

n/a, Avenida Valdecilla Sn, 39008, Santander

Hospital Unviersitario Miguel Servet

n/a, Paseo De Isabel La Catolica 1-3, 50009, Zaragoza

Hospital Universitario Puerta De Hierro De Majadahonda

n/a, Calle De Manuel De Falla 1, 28222, Majadahonda

Vall D Hebron Institute Of Oncology

Oncology Service, Calle Natzaret 115, 08035, Barcelona

Clinica Universidad De Navarra

n/a, Calle Marquesado De Santa Marta 1, 28027, Madrid

Hospital Universitario Reina Sofia

n/a, Avenida Menendez Pidal S/n, 14004, Cordoba

University Hospital Virgen Del Rocio S.L.

n/a, Avenida De Manuel Siurot S/n, 41013, Sevilla