A Study to Assess Livmoniplimab in Combination with Budigalimab Versus Chemotherapy in Adult Participants with Metastatic Urothelial Carcinoma

Overview

Sponsor-declared trial summary

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] - Neoplasms [C04]

Trial duration

24 Mar 2025 → ongoing

Decision date (initial)

2025-03-04

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, Pharmacokinetic

1) To optimize livmoniplimab dose in combination with budigalimab and identify the recommended phase 3 dose (RP3D) in subjects with metastatic urothelial carcinoma who progressed on previous checkpoint inhibitor treatment.
2) Evaluate the efficacy of livmoniplimab in combination with budigalimab as measured by Overall Survival (OS).

Secondary objectives 2

1. To evaluate the efficacy of livmoniplimab in combination with budigalimab as measured by progression-free survival (PFS), Best Overall Response (BOR) of Complete Response (CR)/Partial Response (PR), and Duration of Response (DoR).
2. To assess the safety, tolerability, pharmacokinetics (PK), and immunogenicity of livmoniplimab in combination with budigalimab.

Conditions and MedDRA coding

Urothelial Carcinoma

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. 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.
2. Participant has radiologically documented metastatic disease.
3. 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.
4. 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.
5. Participant has at least 1 measurable lesion per RECIST v1.1 as determined by investigator.
6. Life expectancy must be at least 3 months.

Exclusion criteria 5

1. 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.
2. Participant has received more than 1 antibody-drug conjugate (ADC) in metastatic setting.
3. 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.
4. 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.
5. Prior allogeneic stem cell or solid organ transplantation.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Overall survival (OS): The time measured from randomization until death from any cause.

Secondary endpoints 3

1. 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.
2. 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.
3. 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.

Investigational products

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

Test 2

Comparator 3

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 4

Locations

4 EU/EEA countries · 19 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 44 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

3 submissions — initial application plus substantial / non-substantial modifications