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)

Last updated: August 7, 2025
Sponsor: AbbVie
Overall Status: Active - Not Recruiting

Phase

2

Condition

Carcinoma

Urothelial Carcinoma

Treatment

Livmoniplimab

Gemcitabine

Budigalimab

Clinical Study ID

NCT06632951
M25-204
2024-515506-11-00
  • Ages > 18
  • All Genders

Study 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. 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participant has histologically or cytologically confirmed urothelial carcinoma (i.e., cancer of the bladder, renal pelvis, ureter, or urethra). Mixed histologictypes 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 checkpointinhibitor (anti-programmed cell death protein 1 [PD-1] or anti-programmeddeath-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, oradjuvant setting. If platinum was administered in the neoadjuvant or adjuvantsetting, participant must have progressed within 6 months of completion oftreatment. Platinum ineligible participants may enroll in this study withoutreceiving a platinum containing regimen.

  • Participant has at least 1 measurable lesion per response evaluation criteria insolid tumors (RECIST) v1.1 as determined by investigator.

  • Life expectancy must be at least 3 months.

Exclusion

Exclusion Criteria:

  • Participant has received more than 1 prior chemotherapy regimen for urothelialcancer in metastatic setting, including chemotherapy agents planned in comparatorarm.

  • Platinum based chemotherapy administered in adjuvant or neoadjuvant settingwill count towards this criterion if participant progressed within 6 months ofcompletion.

  • Chemotherapy administered during concurrent chemoradiotherapy for primarycancer will not count towards this criterion.

  • The substitution of carboplatin for cisplatin does not constitute a new regimenprovided no new chemotherapeutic agents were added to the regimen and noprogression 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 inmetastatic setting will be eligible to receive docetaxel or paclitaxel incomparator arm.

  • Participant has received more than 1 antibody-drug conjugate (ADC) in metastaticsetting.

  • Has had prior radiation therapy within 28 days prior to first dose of study drug orwho has not recovered (i.e., <= Grade 1 or at baseline) from adverse events due toradiotherapy.

  • History of additional malignancy or history of prior malignancy, except foradequately treated basal or squamous skin cancer, or cervical carcinoma in situwithout evidence of disease, or malignancy treated with curative intent and with noevidence of disease recurrence for 5 years since the initiation of that therapy.

  • Prior allogeneic stem cell or solid organ transplantation.

Study Design

Total Participants: 150
Treatment Group(s): 5
Primary Treatment: Livmoniplimab
Phase: 2
Study Start date:
January 20, 2025
Estimated Completion Date:
August 31, 2028

Connect with a study center

  • Centre Hospitalier Affilié Universitaire de Québec - Hôpital de l'Enfant-Jésus /ID# 271635

    Québec, Quebec G1J 1Z4
    Canada

    Site Not Available

  • Institut Paoli-Calmettes /ID# 270580

    Marseille, Bouches-du-Rhone 13273
    France

    Site Not Available

  • Hôpital Foch /ID# 270573

    Suresnes CEDEX, Hauts-de-Seine 92151
    France

    Site Not Available

  • Institut Gustave Roussy /ID# 270575

    Villejuif, Ile-de-France 94800
    France

    Site Not Available

  • Meir Medical Center /ID# 270108

    Kfar Saba, HaMerkaz 4428164
    Israel

    Site Not Available

  • The Chaim Sheba Medical Center /ID# 270096

    Ramat Gan, Tel-Aviv 5265601
    Israel

    Site Not Available

  • Tel Aviv Sourasky Medical Center /ID# 270106

    Tel Aviv, Tel-Aviv 6423906
    Israel

    Site Not Available

  • Rabin Medical Center /ID# 270107

    Haifa, 4941492
    Israel

    Site Not Available

  • Rambam Health Care Campus /ID# 270105

    Haifa, 3525408
    Israel

    Site Not Available

  • Rabin Medical Center /ID# 270107

    Petah Tikva, 4941492
    Israel

    Site Not Available

  • Hirosaki University Hospital /ID# 270531

    Hirosaki, Aomori 036-8563
    Japan

    Site Not Available

  • Fukushima Medical University Hospital /ID# 270752

    Fukushima-shi, Fukushima 960-1295
    Japan

    Site Not Available

  • University of Tsukuba Hospital /ID# 270354

    Tsukuba-shi, Ibaraki 305-8576
    Japan

    Site Not Available

  • Kanazawa University Hospital /ID# 270473

    Kanazawa City, Ishikawa 920-8641
    Japan

    Site Not Available

  • National Cancer Center /ID# 270453

    Goyang-si, Gyeonggido 10408
    Korea, Republic of

    Site Not Available

  • Chonnam National University Hwasun Hospital /ID# 271299

    Hwasun-gun, Jeonranamdo 58128
    Korea, Republic of

    Site Not Available

  • Asan Medical Center /ID# 270898

    Seoul, Seoul Teugbyeolsi 05505
    Korea, Republic of

    Site Not Available

  • Samsung Medical Center /ID# 270318

    Seoul, Seoul Teugbyeolsi 06351
    Korea, Republic of

    Site Not Available

  • Yonsei University Health System Severance Hospital /ID# 270317

    Seoul, Seoul Teugbyeolsi 03722
    Korea, Republic of

    Site Not Available

  • Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Bada /ID# 270046

    Warszawa, Mazowieckie 02-781
    Poland

    Site Not Available

  • Aidport Sp. z o.o. /ID# 270049

    Skorzewo, Wielkopolskie 60-185
    Poland

    Site Not Available

  • Hospital Clinic de Barcelona /ID# 269789

    Barcelona, 08036
    Spain

    Site Not Available

  • Hospital Universitario Vall d'Hebron /ID# 269783

    Barcelona, 08035
    Spain

    Site Not Available

  • Parc de Salut Mar - Hospital del Mar /ID# 270173

    Barcelona, 08003
    Spain

    Site Not Available

  • Hospital Clinico San Carlos /ID# 269786

    Madrid, 28040
    Spain

    Site Not Available

  • Hospital MD Anderson Cancer Center Madrid /ID# 269780

    Madrid, 28033
    Spain

    Site Not Available

  • Hospital Universitario Virgen del Rocio /ID# 269782

    Sevilla, 41013
    Spain

    Site Not Available

  • Highlands Oncology Group - Springdale /ID# 270290

    Springdale, Arkansas 72762
    United States

    Site Not Available

  • University of California San Francisco - Mission Bay /ID# 270289

    San Francisco, California 94158
    United States

    Site Not Available

  • Yale University School of Medicine /ID# 270449

    New Haven, Connecticut 06510
    United States

    Site Not Available

  • Medical Oncology Hematology Consultants /ID# 271347

    Newark, Delaware 19713
    United States

    Site Not Available

  • Florida Cancer Specialists - North /ID# 271215

    Saint Petersburg, Florida 33705
    United States

    Site Not Available

  • Icahn School of Medicine at Mount Sinai /ID# 270272

    New York, New York 10029
    United States

    Site Not Available

  • University Hospitals Cleveland Medical Center /ID# 271010

    Cleveland, Ohio 44106
    United States

    Site Not Available

  • The Ohio State University /ID# 271349

    Columbus, Ohio 43210
    United States

    Site Not Available

  • SCRI Oncology Partners /ID# 270439

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • Texas Oncology - Austin Central /ID# 271284

    Austin, Texas 78731
    United States

    Site Not Available

  • Utah Cancer Specialist /ID# 270810

    Salt Lake City, Utah 84124
    United States

    Site Not Available

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