Phase
Condition
Carcinoma
Urothelial Carcinoma
Treatment
Livmoniplimab
Gemcitabine
Budigalimab
Clinical Study ID
Ages > 18 All Genders
Study Summary
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
Connect with a study center
Centre Hospitalier Affilié Universitaire de Québec - Hôpital de l'Enfant-Jésus /ID# 271635
Québec, Quebec G1J 1Z4
CanadaSite Not Available
Institut Paoli-Calmettes /ID# 270580
Marseille, Bouches-du-Rhone 13273
FranceSite Not Available
Hôpital Foch /ID# 270573
Suresnes CEDEX, Hauts-de-Seine 92151
FranceSite Not Available
Institut Gustave Roussy /ID# 270575
Villejuif, Ile-de-France 94800
FranceSite Not Available
Meir Medical Center /ID# 270108
Kfar Saba, HaMerkaz 4428164
IsraelSite Not Available
The Chaim Sheba Medical Center /ID# 270096
Ramat Gan, Tel-Aviv 5265601
IsraelSite Not Available
Tel Aviv Sourasky Medical Center /ID# 270106
Tel Aviv, Tel-Aviv 6423906
IsraelSite Not Available
Rabin Medical Center /ID# 270107
Haifa, 4941492
IsraelSite Not Available
Rambam Health Care Campus /ID# 270105
Haifa, 3525408
IsraelSite Not Available
Rabin Medical Center /ID# 270107
Petah Tikva, 4941492
IsraelSite Not Available
Hirosaki University Hospital /ID# 270531
Hirosaki, Aomori 036-8563
JapanSite Not Available
Fukushima Medical University Hospital /ID# 270752
Fukushima-shi, Fukushima 960-1295
JapanSite Not Available
University of Tsukuba Hospital /ID# 270354
Tsukuba-shi, Ibaraki 305-8576
JapanSite Not Available
Kanazawa University Hospital /ID# 270473
Kanazawa City, Ishikawa 920-8641
JapanSite Not Available
National Cancer Center /ID# 270453
Goyang-si, Gyeonggido 10408
Korea, Republic ofSite Not Available
Chonnam National University Hwasun Hospital /ID# 271299
Hwasun-gun, Jeonranamdo 58128
Korea, Republic ofSite Not Available
Asan Medical Center /ID# 270898
Seoul, Seoul Teugbyeolsi 05505
Korea, Republic ofSite Not Available
Samsung Medical Center /ID# 270318
Seoul, Seoul Teugbyeolsi 06351
Korea, Republic ofSite Not Available
Yonsei University Health System Severance Hospital /ID# 270317
Seoul, Seoul Teugbyeolsi 03722
Korea, Republic ofSite Not Available
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Bada /ID# 270046
Warszawa, Mazowieckie 02-781
PolandSite Not Available
Aidport Sp. z o.o. /ID# 270049
Skorzewo, Wielkopolskie 60-185
PolandSite Not Available
Hospital Clinic de Barcelona /ID# 269789
Barcelona, 08036
SpainSite Not Available
Hospital Universitario Vall d'Hebron /ID# 269783
Barcelona, 08035
SpainSite Not Available
Parc de Salut Mar - Hospital del Mar /ID# 270173
Barcelona, 08003
SpainSite Not Available
Hospital Clinico San Carlos /ID# 269786
Madrid, 28040
SpainSite Not Available
Hospital MD Anderson Cancer Center Madrid /ID# 269780
Madrid, 28033
SpainSite Not Available
Hospital Universitario Virgen del Rocio /ID# 269782
Sevilla, 41013
SpainSite Not Available
Highlands Oncology Group - Springdale /ID# 270290
Springdale, Arkansas 72762
United StatesSite Not Available
University of California San Francisco - Mission Bay /ID# 270289
San Francisco, California 94158
United StatesSite Not Available
Yale University School of Medicine /ID# 270449
New Haven, Connecticut 06510
United StatesSite Not Available
Medical Oncology Hematology Consultants /ID# 271347
Newark, Delaware 19713
United StatesSite Not Available
Florida Cancer Specialists - North /ID# 271215
Saint Petersburg, Florida 33705
United StatesSite Not Available
Icahn School of Medicine at Mount Sinai /ID# 270272
New York, New York 10029
United StatesSite Not Available
University Hospitals Cleveland Medical Center /ID# 271010
Cleveland, Ohio 44106
United StatesSite Not Available
The Ohio State University /ID# 271349
Columbus, Ohio 43210
United StatesSite Not Available
SCRI Oncology Partners /ID# 270439
Nashville, Tennessee 37203
United StatesSite Not Available
Texas Oncology - Austin Central /ID# 271284
Austin, Texas 78731
United StatesSite Not Available
Utah Cancer Specialist /ID# 270810
Salt Lake City, Utah 84124
United StatesSite Not Available

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