Urothelial CarcinomaPhase 2LIVIGNO-3NCT06632951
Study to Evaluate Adverse Events and Change in Disease Activity When Intravenously (IV) Infused Livmoniplimab is Used in Combination With IV Infused Budigalimab in Adult Participants With Urothelial Carcinoma (UC)
A Phase 2 study testing Livmoniplimab, Budigalimab and Docetaxel in people with Urothelial Carcinoma, run by AbbVie at 37 sites in 8 countries.
Trial summary
Urothelial carcinoma (UC) is the ninth most common cancer type worldwide. While the treatment of front-line metastatic urothelial carcinoma (mUC) has improved, there remains a high unmet need for effective therapies for participants who have recurrent disease and disease that has progressed after frontline treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urothelial Carcinoma
- What is being tested?
- Livmoniplimab, Budigalimab and Docetaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 37 sitesin 8 countries
- Study dates
- 20 Jan 2025to Aug 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Participant has radiologically documented metastatic disease.
- 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. Participant must have received at least 2 cycles of anti-PD-1 or anti-PD-L1.
- 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.
- Participant has at least 1 measurable lesion per response evaluation criteria in solid tumors (RECIST) v1.1 as determined by investigator.
- Life expectancy must be at least 3 months.
Who cannot join
- 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.
Show all 10Show fewer
- Participant has received more than 1 antibody-drug conjugate (ADC) in metastatic setting.
- 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.
- 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.
- Prior allogeneic stem cell or solid organ transplantation.
Trial locations and contacts
37 sites in 8 countries.
37 sites in 8 countries
United States11 sites
Texas Oncology - Austin Central /ID# 271284
Austin, Texas, 78731
University Hospitals Cleveland Medical Center /ID# 271010
Cleveland, Ohio, 44106
The Ohio State University /ID# 271349
Columbus, Ohio, 43210
SCRI Oncology Partners /ID# 270439
Nashville, Tennessee, 37203
Yale University School of Medicine /ID# 270449
New Haven, Connecticut, 06510
Icahn School of Medicine at Mount Sinai /ID# 270272
New York, New York, 10029
Medical Oncology Hematology Consultants /ID# 271347
Newark, Delaware, 19713
Utah Cancer Specialist /ID# 270810
Salt Lake City, Utah, 84124
University of California San Francisco - Mission Bay /ID# 270289
San Francisco, California, 94158
Highlands Oncology Group - Springdale /ID# 270290
Springdale, Arkansas, 72762
Florida Cancer Specialists - North /ID# 271215
St. Petersburg, Florida, 33705
Spain6 sites
Parc de Salut Mar - Hospital del Mar /ID# 270173
Barcelona, 08003
Hospital Universitario Vall d'Hebron /ID# 269783
Barcelona, 08035
Hospital Clinic de Barcelona /ID# 269789
Barcelona, 08036
Hospital MD Anderson Cancer Center Madrid /ID# 269780
Madrid, 28033
Hospital Clinico San Carlos /ID# 269786
Madrid, 28040
Hospital Universitario Virgen del Rocio /ID# 269782
Seville, 41013
Israel5 sites
Rambam Health Care Campus /ID# 270105
Haifa, 3525408
Meir Medical Center /ID# 270108
Kfar Saba, Central District, 4428164
Rabin Medical Center /ID# 270107
Petah Tikva, 4941492
The Chaim Sheba Medical Center /ID# 270096
Ramat Gan, Tel Aviv, 5265601
Tel Aviv Sourasky Medical Center /ID# 270106
Tel Aviv, Tel Aviv, 6423906
South Korea5 sites
National Cancer Center /ID# 270453
Goyang-si, Gyeonggido, 10408
Chonnam National University Hwasun Hospital /ID# 271299
Hwasun-gun, Jeonranamdo, 58128
Yonsei University Health System Severance Hospital /ID# 270317
Seoul, Seoul Teugbyeolsi, 03722
Asan Medical Center /ID# 270898
Seoul, Seoul Teugbyeolsi, 05505
Samsung Medical Center /ID# 270318
Seoul, Seoul Teugbyeolsi, 06351
Japan4 sites
Fukushima Medical University Hospital /ID# 270752
Fukushima, Fukushima, 960-1295
Hirosaki University Hospital /ID# 270531
Hirosaki, Aomori, 036-8563
Kanazawa University Hospital /ID# 270473
Kanazawa, Ishikawa-ken, 920-8641
University of Tsukuba Hospital /ID# 270354
Tsukuba, Ibaraki, 305-8576
France3 sites
Institut Paoli-Calmettes /ID# 270580
Marseille, Bouches-du-Rhone, 13273
Hôpital Foch /ID# 270573
Suresnes, Hauts-de-Seine, 92151
Institut Gustave Roussy /ID# 270575
Villejuif, Île-de-France Region, 94800
Poland2 sites
Aidport Sp. z o.o. /ID# 270049
Skórzewo, Greater Poland Voivodeship, 60-185
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Bada /ID# 270046
Warsaw, Masovian Voivodeship, 02-781
Canada1 site
Centre Hospitalier Affilié Universitaire de Québec - Hôpital de l'Enfant-Jésus /ID# 271635
Québec, Quebec, G1J 1Z4
About this study
Official title: A Phase 2, Open-Label, Randomized Study of Livmoniplimab in Combination With Budigalimab Versus Chemotherapy in Subjects With Metastatic Urothelial Carcinoma
Urothelial carcinoma (UC) is the ninth most common cancer type worldwide. While the treatment of front-line metastatic urothelial carcinoma (mUC) has improved, there remains a high unmet need for effective therapies for participants who have recurrent disease and disease that has progressed after frontline treatment. The purpose of this study is to evaluate the optimized dose, adverse events, and efficacy of livmoniplimab in combination with budigalimab.
Livmoniplimab is an investigational drug being developed for the treatment of mUC. There are 3 treatment arms in this study and participants will be randomized in a 1:1:1 ratio. Participants will either receive livmoniplimab (at one of 2 different doses) in combination with budigalimab (another investigational drug), or either docetaxel, paclitaxel, or gemcitabine (based on investigator's choice). Approximately 150 adult participants will be enrolled in the study across 56 sites worldwide.
Read more
In arm 1, participants will receive intravenously (IV) infused livmoniplimab (dose A) in combination with IV infused budigalimab. In arm 2, participants will receive IV infused livmoniplimab (dose B) in combination with IV infused budigalimab. In arm 3 (control), participants will receive the investigator's choice: IV infused or injected docetaxel; IV infused or injected paclitaxel; or IV infused gemcitabine. The estimated duration of the study is up to approximately 3.5 years.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic and may require frequent medical assessments, blood tests, questionnaires, and scans.
- Conditions
- Urothelial Carcinoma
- Being tested
- Livmoniplimab, Budigalimab, Docetaxel, Paclitaxel, Gemcitabine
- Keywords
- Urothelial Carcinoma, Metastatic Urothelial Carcinoma, Docetaxel, Paclitaxel, Gemcitabine, Livmoniplimab, Budigalimab, ABBV-181, ABBV-151, Cancer, LIVIGNO-3
- Medical subject headings
- Carcinoma, Transitional Cell, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LivmoniplimabDrug
Also called ABBV-151
Intravenous (IV) Infusion
BudigalimabDrug
Also called ABBV-181
IV Infusion
DocetaxelDrug
IV Infusion
PaclitaxelDrug
IV Injection
DocetaxelDrug
IV Injection
PaclitaxelDrug
IV Infusion
GemcitabineDrug
IV Infusion
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Livmoniplimab (Dose A) + Budigalimab | Experimental | Participants will receive livmoniplimab (dose A) in combination with budigalimab, as part of the approximately 3.5 years study duration. Receives: Drug: Livmoniplimab; Drug: Budigalimab |
| Arm 2: Livmoniplimab (Dose B) + Budigalimab | Experimental | Participants will receive livmoniplimab (dose B) in combination with budigalimab, as part of the approximately 3.5 years study duration. Receives: Drug: Livmoniplimab; Drug: Budigalimab |
| Arm 3: Docetaxel, Paclitaxel, or Gemcitabine | Experimental | Participants will receive docetaxel, paclitaxel, or gemcitabine, investigator's choice, as part of the approximately 3.5 years study duration. Receives: Drug: Docetaxel; Drug: Paclitaxel; Drug: Gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS)
OS is defined as the time measured from randomization until death from any cause.
Measured: Up to Approximately 3.5 Years
Secondary outcomes (23)
Progression-Free survival (PFS)
PFS is defined as the time measured from randomization until the first documentation of progressive disease according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 as determined by investigators or death from any cause, whichever occurs first.
Measured: Up to Approximately 3.5 Years
Best Overall Response (BOR) per Investigator
BOR is 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.
Measured: Up to Approximately 3.5 Years
Duration of Response (DOR) per Investigator
DOR id defined as 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.
Measured: Up to Approximately 3.5 Years
Percentage of Participants with Adverse Events (AE)s
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
Measured: Up to Approximately 3.5 Years
Percentage of Participants with Serious Adverse Events (SAE)s
An SAE is defined as an AE that results in the death of the participant, threat to the participant's life, hospitalization, congenital abnormality, persistent or significant disability/incapacitation, or medical event requiring medical or surgical interventions to prevent a serious outcome.
Measured: Up to Approximately 3.5 Years
Percentage of Participants with Treatment Emergent Adverse Events (TEAE)s
The treatment-emergent period is defined as time from the date of the first dose of study drug up to 90 days after the date of the last dose of study drug, or the first date starting new anticancer therapy, whichever occurs earlier. TEAEs include all AEs that occurred or worsened during the treatment emergent period and all treatment related SAEs as assessed by investigators.
Measured: Up to Approximately 3.5 Years
Percentage of Participants with Clinically Significant Vital Sign Measurements as Assessed by the Investigator
Vital signs are defined as systolic and diastolic blood pressure, pulse rate, respiratory rate, and body temperature.
Measured: Up to Approximately 3.5 Years
Percentage of Participants with Clinically Significant Laboratory Values
Percentage of participants with clinically significant laboratory values (hematology, chemistry, coagulation, and urinalysis) as assessed by the investigator.
Measured: Up to Approximately 3.5 Years
Percentage of Participants with Immune-Related Reactions as AEs of Special Interest
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
Measured: Up to Approximately 3.5 Years
Maximum Observed Serum Concentration (Cmax) of Livmoniplimab
Cmax is defined as the maximum observed serum concentration of livmoniplimab.
Measured: Up to Approximately 3.5 Years
Cmax of Budigalimab
Cmax is defined as the maximum observed serum concentration of budigalimab.
Measured: Up to Approximately 3.5 Years
Time to Reach Cmax (Tmax) of Livmoniplimab
Tmax is defined as the time to reach Cmax of livmoniplimab.
Measured: Up to Approximately 3.5 Years
Tmax of Budigalimab
Tmax is defined as the time to reach Cmax of budigalimab.
Measured: Up to Approximately 3.5 Years
Area Under the Serum Concentration Versus Time Curve (AUC) of Livmoniplimab
AUC is defined as the area under the serum concentration versus time curve of livmoniplimab.
Measured: Up to Approximately 3.5 Years
AUC of Budigalimab
AUC is defined as the area under the serum concentration versus time curve of budigalimab.
Measured: Up to Approximately 3.5 Years
Clearance (CL) of Livmoniplimab
CL is defined as the Clearance of livmoniplimab.
Measured: Up to Approximately 3.5 Years
CL of Budigalimab
CL is defined as the Clearance of budigalimab.
Measured: Up to Approximately 3.5 Years
Volume of Distribution (Vd) of Livmoniplimab
Vd is defined as the volume of distribution of livmoniplimab.
Measured: Up to Approximately 3.5 Years
Vd of Budigalimab
Vd is defined as the volume of distribution of budigalimab.
Measured: Up to Approximately 3.5 Years
Incidence of Anti-Drug Antibodies (ADAs) of Livmoniplimab
Incidence of anti-drug antibodies of livmoniplimab.
Measured: Up to Approximately 3.5 Years
ADAs of Budigalimab
Incidence of anti-drug antibodies of budigalimab.
Measured: Up to Approximately 3.5 Years
Incidences of Neutralizing Anti-Drug Antibodies (nADAs) of Livmoniplimab
Incidences of neutralizing anti-drug antibodies of livmoniplimab.
Measured: Up to Approximately 3.5 Years
Incidences of nADAs of Budigalimab
Incidences of neutralizing anti-drug antibodies of budigalimab.
Measured: Up to Approximately 3.5 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2024
- Study start20 Jan 2025
- Primary completionMar 2027 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urothelial CarcinomaStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06632951
- Sponsor's protocol ID
- M25-204
- Other IDs
- 2024-515506-11-00
- Acronym
- LIVIGNO-3
- Status last verified
- Aug 2025
- First submitted
- 8 Oct 2024
- Last updated
- 11 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Open-Label, Randomized Study of Livmoniplimab in Combination With Budigalimab Versus Chemotherapy in Subjects With Metastatic Urothelial Carcinoma
- ClinicalTrials.gov ID
- NCT06632951
- Acronym / sponsor ID
- LIVIGNO-3 / M25-204
- Conditions
- Urothelial Carcinoma
- Keywords
- Urothelial Carcinoma, Metastatic Urothelial Carcinoma, Docetaxel, Paclitaxel, Gemcitabine, Livmoniplimab, Budigalimab, ABBV-181
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 20 Jan 2025 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 9 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Urothelial carcinoma (UC) is the ninth most common cancer type worldwide. While the treatment of front-line metastatic urothelial carcinoma (mUC) has improved, there remains a high unmet need for effective therapies for participants who have recurrent disease and disease that has progressed after frontline treatment. The purpose of this study is to evaluate the optimized dose, adverse events, and efficacy of livmoniplimab in combination with budigalimab.
Livmoniplimab is an investigational drug being developed for the treatment of mUC. There are 3 treatment arms in this study and participants will be randomized in a 1:1:1 ratio. Participants will either receive livmoniplimab (at one of 2 different doses) in combination with budigalimab (another investigational drug), or either docetaxel, paclitaxel, or gemcitabine (based on investigator's choice). Approximately 150 adult participants will be enrolled in the study across 56 sites worldwide.
In arm 1, participants will receive intravenously (IV) infused livmoniplimab (dose A) in combination with IV infused budigalimab. In arm 2, participants will receive IV infused livmoniplimab (dose B) in combination with IV infused budigalimab. In arm 3 (control), participants will receive the investigator's choice: IV infused or injected docetaxel; IV infused or injected paclitaxel; or IV infused gemcitabine. The estimated duration of the study is up to approximately 3.5 years.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic and may require frequent medical assessments, blood tests, questionnaires, and scans.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Livmoniplimab (Dose A) + Budigalimab | Experimental | Drug: Livmoniplimab, Drug: BudigalimabParticipants will receive livmoniplimab (dose A) in combination with budigalimab, as part of the approximately 3.5 years study duration. |
| Arm 2: Livmoniplimab (Dose B) + Budigalimab | Experimental | Drug: Livmoniplimab, Drug: BudigalimabParticipants will receive livmoniplimab (dose B) in combination with budigalimab, as part of the approximately 3.5 years study duration. |
| Arm 3: Docetaxel, Paclitaxel, or Gemcitabine | Experimental | Drug: Docetaxel, Drug: Paclitaxel, Drug: GemcitabineParticipants will receive docetaxel, paclitaxel, or gemcitabine, investigator's choice, as part of the approximately 3.5 years study duration. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
- Participant has radiologically documented metastatic disease.
- 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. Participant must have received at least 2 cycles of anti-PD-1 or anti-PD-L1.
- 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.
- Participant has at least 1 measurable lesion per response evaluation criteria in solid tumors (RECIST) v1.1 as determined by investigator.
Key exclusion criteria (10 listed)
- Participant has received more than 1 prior chemotherapy regimen for urothelial cancer in metastatic setting, including chemotherapy agents planned in comparator arm.
- Participant has received more than 1 antibody-drug conjugate (ADC) in metastatic setting.
- 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.
- 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.
- Prior allogeneic stem cell or solid organ transplantation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LivmoniplimabAlso: ABBV-151Intravenous (IV) Infusion | Drug | Arm 1: Livmoniplimab (Dose A) + Budigalimab, Arm 2: Livmoniplimab (Dose B) + Budigalimab |
| BudigalimabAlso: ABBV-181IV Infusion | Drug | Arm 1: Livmoniplimab (Dose A) + Budigalimab, Arm 2: Livmoniplimab (Dose B) + Budigalimab |
| DocetaxelIV Infusion | Drug | Arm 3: Docetaxel, Paclitaxel, or Gemcitabine |
| PaclitaxelIV Injection | Drug | Arm 3: Docetaxel, Paclitaxel, or Gemcitabine |
| DocetaxelIV Injection | Drug | Arm 3: Docetaxel, Paclitaxel, or Gemcitabine |
| PaclitaxelIV Infusion | Drug | Arm 3: Docetaxel, Paclitaxel, or Gemcitabine |
| GemcitabineIV Infusion | Drug | Arm 3: Docetaxel, Paclitaxel, or Gemcitabine |
Primary outcome
Overall Survival (OS)
Time frame: Up to Approximately 3.5 Years
OS is defined as the time measured from randomization until death from any cause.
23 secondary outcomes
Progression-Free survival (PFS)
Time frame: Up to Approximately 3.5 Years
Best Overall Response (BOR) per Investigator
Time frame: Up to Approximately 3.5 Years
Duration of Response (DOR) per Investigator
Time frame: Up to Approximately 3.5 Years
Percentage of Participants with Adverse Events (AE)s
Time frame: Up to Approximately 3.5 Years
Percentage of Participants with Serious Adverse Events (SAE)s
Time frame: Up to Approximately 3.5 Years
Percentage of Participants with Treatment Emergent Adverse Events (TEAE)s
Time frame: Up to Approximately 3.5 Years
Percentage of Participants with Clinically Significant Vital Sign Measurements as Assessed by the Investigator
Time frame: Up to Approximately 3.5 Years
Percentage of Participants with Clinically Significant Laboratory Values
Time frame: Up to Approximately 3.5 Years
Percentage of Participants with Immune-Related Reactions as AEs of Special Interest
Time frame: Up to Approximately 3.5 Years
Maximum Observed Serum Concentration (Cmax) of Livmoniplimab
Time frame: Up to Approximately 3.5 Years
Cmax of Budigalimab
Time frame: Up to Approximately 3.5 Years
Time to Reach Cmax (Tmax) of Livmoniplimab
Time frame: Up to Approximately 3.5 Years
Tmax of Budigalimab
Time frame: Up to Approximately 3.5 Years
Area Under the Serum Concentration Versus Time Curve (AUC) of Livmoniplimab
Time frame: Up to Approximately 3.5 Years
AUC of Budigalimab
Time frame: Up to Approximately 3.5 Years
Clearance (CL) of Livmoniplimab
Time frame: Up to Approximately 3.5 Years
CL of Budigalimab
Time frame: Up to Approximately 3.5 Years
Volume of Distribution (Vd) of Livmoniplimab
Time frame: Up to Approximately 3.5 Years
Vd of Budigalimab
Time frame: Up to Approximately 3.5 Years
Incidence of Anti-Drug Antibodies (ADAs) of Livmoniplimab
Time frame: Up to Approximately 3.5 Years
ADAs of Budigalimab
Time frame: Up to Approximately 3.5 Years
Incidences of Neutralizing Anti-Drug Antibodies (nADAs) of Livmoniplimab
Time frame: Up to Approximately 3.5 Years
Incidences of nADAs of Budigalimab
Time frame: Up to Approximately 3.5 Years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2025.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ABBVIE INC. study director
AbbVie
37 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Livmoniplimab, Budigalimab and Docetaxel in people with Urothelial Carcinoma, run by AbbVie at 37 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 11 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 37 sites in United States, Spain, Israel, South Korea, Japan and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (OS) (time frame: Up to Approximately 3.5 Years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2025.