Clinical trial • Phase II • Oncology

BUDIGALIMAB for Urothelial carcinoma|Metastatic urothelial carcinoma

Phase II trial of BUDIGALIMAB for Urothelial carcinoma|Metastatic urothelial carcinoma.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Urothelial carcinoma|Metastatic urothelial carcinoma
Trial Stage
Phase II
Drug Modality
Monoclonal antibody|Small molecule

Key dates

Initial CTIS Submission Date
29-10-2024
First CTIS Authorization Date
03-03-2025

Trial design

Randomised, open-label, comparator arms: paclitaxel (paclitaxel 6 mg/ml concentrate for solution for infusion; active substance paclitaxel) — max daily dose listed 175 mg/m2; gemcitabine (gemcitabine 38 mg/ml concentrate for solution for infusion; active substance gemcitabine) — max daily dose listed 1000 mg/m2; taxotere (docetaxel 20 mg/1 ml concentrate for solution for infusion; active substance docetaxel) — max daily dose listed 75 mg/m2. exact schedules not specified in the provided data.-controlled, adaptive Phase II trial across 20 sites in Belgium, France, Poland and others.

Randomised
Yes
Open Label
Yes
Comparator
Comparator arms: Paclitaxel (Paclitaxel 6 mg/mL concentrate for solution for infusion; active substance PACLITAXEL) — max daily dose listed 175 mg/m2; Gemcitabine (Gemcitabine 38 mg/mL concentrate for solution for infusion; active substance GEMCITABINE) — max daily dose listed 1000 mg/m2; TAXOTERE (Docetaxel 20 mg/1 ml concentrate for solution for infusion; active substance DOCETAXEL) — max daily dose listed 75 mg/m2. Exact schedules not specified in the provided data.
Adaptive
True - trial objective includes dose optimization to identify a recommended phase 3 dose (RP3D) for livmoniplimab in combination with budigalimab, indicating dose-escalation/dose-finding elements; specific escalation rules/interim analyses/stopping rules are not provided in the available data.
Single Multiple Or Escalation Dose Combined
Yes
Target Sample Size
98
Trial Duration For Participant
730

Eligibility

Recruits 98 No vulnerable population selected; participants are adults. Consent provided by adult participants. A child follow-up authorization document is present for France (document title: 'L1 M25-204 - FR -ICF Child follow-up authorization_Public')..

Vulnerable Population
No vulnerable population selected; participants are adults. Consent provided by adult participants. A child follow-up authorization document is present for France (document title: 'L1 M25-204 - FR -ICF Child follow-up authorization_Public').

Inclusion criteria

  • {"criterion_text":"- Participant has histologically or cytologically confirmed urothelial carcinoma (i.e., cancer of the bladder, renal pelvis, ureter, or urethra). Mixed histologic types are allowed if urothelial (transitional cell) is the predominant histology.\n- Participant has radiologically documented metastatic disease.\n- Participant must have experienced radiographic progression or relapse on checkpoint inhibitor (anti-programmed cell death protein 1 [PD-1] or anti-programmed death-ligand 1 [PD-L1]) in the metastatic, adjuvant, or neo-adjuvant setting. Subject must have received at least 2 cycles of anti-PD-1 or anti-PD-L1.\n- Participants eligible for platinum must have received a platinum containing regimen (cisplatin or carboplatin) in the metastatic, locally advanced, neoadjuvant, or adjuvant setting. If platinum was administered in the neoadjuvant or adjuvant setting, participant must have progressed within 6 months of completion of treatment. Platinum ineligible participants may enroll in this study without receiving a platinum containing regimen.\n- Participant has at least 1 measurable lesion per RECIST v1.1 as determined by investigator.\n- Life expectancy must be at least 3 months."}

Exclusion criteria

  • {"criterion_text":"- Participant has received more than 1 prior chemotherapy regimen for urothelial cancer in metastatic setting, including chemotherapy agents planned in comparator arm. • Platinum based chemotherapy administered in adjuvant or neoadjuvant setting will count towards this criterion if participant progressed within 6 months of completion. • Chemotherapy administered during concurrent chemoradiotherapy for primary cancer will not count towards this criterion. • The substitution of carboplatin for cisplatin does not constitute a new regimen provided no new chemotherapeutic agents were added to the regimen and no progression was noted prior to the change in platinum. • Antibody-drug conjugate (ADC) will not count towards this criterion. • Participant who previously received gemcitabine in combination with platinum in metastatic setting will be eligible to receive docetaxel or paclitaxel in comparator arm.\n- Participant has received more than 1 antibody-drug conjugate (ADC) in metastatic setting.\n- Has had prior radiation therapy within 28 days prior to first dose of study drug or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to radiotherapy.\n- History of additional malignancy or history of prior malignancy, except for adequately treated basal or squamous skin cancer, or cervical carcinoma in situ without evidence of disease, or malignancy treated with curative intent and with no evidence of disease recurrence for 5 years since the initiation of that therapy.\n- Prior allogeneic stem cell or solid organ transplantation."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Overall survival (OS): The time measured from randomization until death from any cause.","definition_or_measurement_approach":"Overall survival (OS): The time measured from randomization until death from any cause."}

Secondary endpoints

  • {"endpoint_text":"- Progression-Free survival (PFS): The time measured 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.","definition_or_measurement_approach":"Progression-Free survival (PFS): The time measured 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."}
  • {"endpoint_text":"- Best Overall Response (BOR) of CR/PR: Defined as achieving complete response (CR) or partial response (PR) according to RECIST 1.1 as determined by investigators at any time prior to subsequent anticancer therapy.","definition_or_measurement_approach":"Best Overall Response (BOR) of CR/PR: Achieving complete response (CR) or partial response (PR) per RECIST 1.1 as determined by investigators prior to subsequent anticancer therapy."}
  • {"endpoint_text":"- Duration of Response (DoR): The time from first CR/PR until the first documentation of progressive disease according to RECIST 1.1 as determined by investigators or death from any cause, whichever occurs first.","definition_or_measurement_approach":"Duration of Response (DoR): Time from first CR/PR until first documentation of progressive disease per RECIST 1.1 by investigators or death from any cause."}

Recruitment

Planned Sample Size
98
Recruitment Window Months
43
Consent Approach
Informed consent is obtained from adult participants. Country- and language-specific ICFs are provided: Belgium (Main ICF English, Dutch, French and addenda), France (Main ICF French and child follow-up authorization), Poland (Main ICF Polish), Spain (Main ICF Spanish). Documents include main ICFs, addenda, pregnancy-part ICFs and optional/other ICFs as listed. Consent is provided by the participant (adult); no vulnerable population selected.

Geography

Total Number Of Sites
20
Total Number Of Participants
60

Belgium

Earliest CTIS Part Ii Submission Date
11-02-2025
Latest Decision Or Authorization Date
04-03-2025
Processing Time Days
21
Number Of Sites
5
Number Of Participants
15

Sites

Site Name
Institut Jules Bordet
Department Name
Oncology
Contact Person Name
Maria Nieves Martinez Chanza
Site Name
Cliniques Universitaires Saint-Luc
Department Name
Oncology
Contact Person Name
Emmanuel Seront
Site Name
Centre Hospitalier Universitaire De Liege
Department Name
Oncology
Contact Person Name
Pierre Freres
Contact Person Email
pfreres@chu.ulg.ac.be
Site Name
Az Maria Middelares Gent
Department Name
Oncology
Contact Person Name
Christof Vulsteke
Site Name
UZ Leuven
Department Name
Oncology
Contact Person Name
Herlinde Dumez
Contact Person Email
herlinde.dumez@uz.kuleuven.be

France

Earliest CTIS Part Ii Submission Date
24-02-2025
Latest Decision Or Authorization Date
18-07-2025
Processing Time Days
144
Number Of Sites
5
Number Of Participants
15

Sites

Site Name
Centre Leon Berard
Department Name
Department of Medical Oncology
Contact Person Name
Aude FLECHON
Contact Person Email
aude.flechon@lyon.unicancer.fr
Site Name
Institut Paoli Calmettes
Department Name
Department Medical Oncology
Contact Person Name
Gwenaelle GRAVIS
Contact Person Email
gravisg@ipc.unicancer.fr
Site Name
Hospital Foch
Department Name
Department Medical Oncology
Contact Person Name
Christine ABRAHAM
Contact Person Email
c.abraham@hopital-foch.com
Site Name
Oncopole Claudius Regaud
Department Name
Department Medical Oncology
Contact Person Name
Loïc MOUREY
Contact Person Email
mourey.loic@iuct-oncopole.fr
Site Name
Institut Gustave Roussy
Department Name
Department of Early Drug Development and Genitourinary Oncology Group
Contact Person Name
Yohann LORIOT
Contact Person Email
Yohann.LORIOT@gustaveroussy.fr

Poland

Earliest CTIS Part Ii Submission Date
18-02-2025
Latest Decision Or Authorization Date
18-07-2025
Processing Time Days
150
Number Of Sites
3
Number Of Participants
15

Sites

Site Name
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Department Name
Klinika Nowotworow Ukladu Moczowego
Contact Person Name
Jakub Kucharz
Contact Person Email
jakub.kucharz@nio.gov.pl
Site Name
Aidport Sp. z o.o.
Contact Person Name
Piotr Tomczak
Contact Person Email
md.piotr.tomczak@gmail.com
Site Name
Dolnoslaskie Centrum Onkologii Pulmonologii I Hematologii
Department Name
Oddział chirurgii onkologicznej II, Pododdział Urologii
Contact Person Name
Łukasz Dołowy
Contact Person Email
lukasz.dolowy@dcopih.pl

Spain

Earliest CTIS Part Ii Submission Date
21-02-2025
Latest Decision Or Authorization Date
09-12-2025
Processing Time Days
291
Number Of Sites
7
Number Of Participants
15

Sites

Site Name
Hospital Del Mar
Department Name
Medical Oncology
Contact Person Name
Alejo Rodríguez-Vida
Contact Person Email
arodriguezvida@psmar.cat
Site Name
MD Anderson Cancer Center
Department Name
Medical Oncology
Contact Person Name
Ana Lucrecia Ruiz Echeverría
Contact Person Email
alruiz@hospiten.es
Site Name
Hospital Universitari Vall D Hebron
Department Name
Medical Oncology
Contact Person Name
Rafael Morales Barrera
Contact Person Email
rmorales@vhio.net
Site Name
University Hospital Virgen Del Rocio S.L.
Department Name
Medical Oncology
Contact Person Name
Begoña Pérez-Valderrama
Site Name
Hospital Clinic De Barcelona
Department Name
Medical Oncology
Contact Person Name
Oscar Reig Torras
Contact Person Email
oreig@clinic.cat
Site Name
Hospital Clinico San Carlos
Department Name
Medical Oncology
Contact Person Name
Javier Puente Vázquez
Contact Person Email
javier.puente@salud.madrid.org
Site Name
Hospital (other listed) - Madrid/Barcelona sites
Department Name
Medical Oncology

Sponsor

Primary sponsor

Full Name
AbbVie Deutschland GmbH & Co. KG
Organisation Type
Pharmaceutical company
Country Of Registered Address
Germany

Contract research organisations

Name
IQVIA Limited

Third parties

  • {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"Central laboratory","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Veeva Systems Inc.","duties_or_roles":"EDC Electronic Data Collection Tool","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"ePro","organisation_type":"Non-Pharmaceutical company"}

Investigational products

Investigational Product Name
Budigalimab
Active Substance
BUDIGALIMAB
Modality
Monoclonal antibody
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Maximum Dose
375 mg
Investigational Product Name
Livmoniplimab
Active Substance
LIVMONIPLIMAB
Modality
Monoclonal antibody
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Maximum Dose
1200 mg
Combination Treatment
Yes

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