Phase
Condition
Carcinoma
Urothelial Cancer
Urothelial Tract Cancer
Treatment
Coformulated favezelimab/pembrolizumab
Coformulated vibostolimab/pembrolizumab
EV
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Must have histologically documented, locally advanced/metastatic urothelialcarcinoma (la/mUC).
Participants with mixed histology are eligible provided the urothelialcomponent is ≥50% (and <10% plasmacytoid component)
Participants whose tumors contain any neuroendocrine component are not eligible (variant histology to be confirmed locally)
Must not have received prior systemic therapy for la/mUC. The following therapies inearlier disease setting (eg, muscle-invasive urothelial carcinoma (MIUC)) arepermitted:
Participants that received neoadjuvant or adjuvant chemotherapy are permitted.
Participants who received anti- programmed cell death 1 protein (PD-1) orprogrammed cell death ligand 1 (PD-L1) therapy for an earlier disease stage (eg, NMIBC, MIUC) with progression/recurrence >12 months from completion oftherapy are permitted.
Must provide an archival tumor tissue sample or newly obtained core or excisionalbiopsy of a tumor lesion demonstrating UC, not previously irradiated, and adequatefor biomarker evaluation. A newly obtained biopsy is strongly preferred, but notrequired if archival tissue is evaluable.
Any AEs due to previous anticancer therapies must have recovered to ≤Grade 1 orbaseline. Endocrine-related AEs adequately treated with hormone replacement or with <Grade 2 neuropathy are eligible.
Exclusion
Exclusion Criteria:
Has a known additional malignancy, except if the participant has undergonepotentially curative therapy with no evidence of that disease recurrence for atleast 3 years since initiation of that therapy.
Central nervous system (CNS) metastases are permitted on-study if all of thefollowing are true: a) CNS metastases have been clinically stable for at least 4weeks prior to screening and baseline scans show no evidence of new or enlargedmetastasis; b) the participant is on a stable dose of ≤10 mg/day of prednisone orequivalent for at least 2 weeks (if requiring steroid treatment); c) participantdoes not have leptomeningeal disease.
Has received a live or live-attenuated vaccine within 30 days prior to the firstdose of study intervention.
Has received an investigational agent or has used an investigational device within 4weeks prior to study intervention administration.
Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapyor any other form of immunosuppressive therapy within 7 days prior the first dose ofstudy intervention. Inhaled or topical steroids are permitted in the absence ofactive autoimmune disease. Physiologic replacement doses of corticosteroids arepermitted for participants with adrenal insufficiency.
Has active keratitis or corneal ulcerations. Superficial punctate keratitis isallowed if the disorder is being adequately treated in the opinion of theinvestigator.
Has an active autoimmune disease that has required systemic treatment in past 2years except replacement therapy.
Has a history of uncontrolled diabetes.
Has a history of (noninfectious) pneumonitis that required steroids or has currentpneumonitis
Has an active infection (viral, bacterial, or fungal) requiring systemic therapy.
Has a known history of human immunodeficiency virus (HIV) infection.
Has hepatitis B or hepatitis C virus infection.
Has had major surgery within 4 weeks prior to first dose of study intervention.
Has had an allogenic tissue/solid organ transplant
Study Design
Study Description
Connect with a study center
Royal Brisbane and Women's Hospital-Medical Oncology Clinical Trials Unit, Cancer Care Services ( Si
Brisbane, Queensland 4029
AustraliaSite Not Available
Austin Health-Cancer Clinical Trials Centre ( Site 3950)
Heidelberg, Victoria 3084
AustraliaSite Not Available
The Ottawa Hospital - General Campus-The Ottawa Hospital Cancer Centre ( Site 3105)
Ottawa, Ontario K1H 8L6
CanadaSite Not Available
Princess Margaret Cancer Centre ( Site 3106)
Toronto, Ontario M5G 2M9
CanadaSite Not Available
Sunnybrook Research Institute - Odette Cancer Centre ( Site 3108)
Toronto, Ontario M4N 3M5
CanadaSite Not Available
Bradfordhill-Clinical Area ( Site 3155)
Santiago, Region M. De Santiago 8420383
ChileSite Not Available
FALP-UIDO ( Site 3151)
Santiago, Region M. De Santiago 7500921
ChileSite Not Available
ONCOCENTRO APYS-ACEREY ( Site 3158)
Viña del Mar, Valparaiso 2520598
ChileSite Not Available
Bradford Hill Norte ( Site 3152)
Antofagasta, 1240000
ChileSite Not Available
Centro de Investigación Oncológica del Norte ( Site 3152)
Antofagasta, 1240000
ChileActive - Recruiting
CHU de Bordeaux Hop St ANDRE ( Site 3607)
Bordeaux, Aquitaine 33075
FranceSite Not Available
Centre Georges François Leclerc-Centre de recherche clinique ( Site 3608)
Dijon, Cote-d Or 21079
FranceSite Not Available
Oncopole Claudius Regaud ( Site 3610)
Toulouse, Haute-Garonne 31059
FranceSite Not Available
Hôpital Européen Georges Pompidou ( Site 3605)
Paris, Ile-de-France 75015
FranceSite Not Available
centre hospitalier lyon sud ( Site 3606)
Pierre-Bénite, Rhone 69310
FranceSite Not Available
Rambam Health Care Campus-Oncology Division ( Site 3501)
Haifa, 3109601
IsraelSite Not Available
Rabin Medical Center-Oncology ( Site 3504)
Petah Tikva, 4941492
IsraelSite Not Available
Sheba Medical Center-ONCOLOGY ( Site 3503)
Ramat Gan, 5265601
IsraelSite Not Available
Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 3405)
Milan, Lombardia 20133
ItalySite Not Available
Ospedale San Raffaele-Oncologia Medica ( Site 3403)
Milano, Lombardia 20132
ItalySite Not Available
Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 3406)
Napoli, 80131
ItalySite Not Available
Asan Medical Center-Department of Oncology ( Site 3901)
Seoul, 05505
Korea, Republic ofSite Not Available
Samsung Medical Center ( Site 3902)
Seoul, 06351
Korea, Republic ofSite Not Available
Severance Hospital, Yonsei University Health System-Medical oncology ( Site 3903)
Seoul, 03722
Korea, Republic ofSite Not Available
Maastricht UMC+ ( Site 3304)
Maastricht, Limburg 6229 HX
NetherlandsSite Not Available
Nederlands Kanker Instituut - Antoni van Leeuwenhoek (NKI-AVL)-medical oncology ( Site 3302)
Amsterdam, Noord-Holland 1066 CX
NetherlandsSite Not Available
Erasmus Medisch Centrum-Medical Oncology ( Site 3303)
Rotterdam, Zuid-Holland 3015 GD
NetherlandsSite Not Available
Hospital Universitari Vall d'Hebron ( Site 3767)
Barcelona, 08035
SpainSite Not Available
Hospital Clinico San Carlos ( Site 3765)
Madrid, 28040
SpainSite Not Available
Chang Gung Memorial Hospital at Kaohsiung-Oncology and Hematology ( Site 3802)
Kaohsiung, 83301
TaiwanSite Not Available
National Cheng Kung University Hospital-Clinical Trial Center ( Site 3803)
Tainan, 704
TaiwanSite Not Available
National Taiwan University Hospital-Oncology ( Site 3801)
Taipei, 10002
TaiwanSite Not Available
ROYAL MARSDEN HOSPITAL (CHELSEA) ( Site 3201)
London, London, City Of SW3 6JJ
United KingdomSite Not Available
St Bartholomew's Hospital-Centre for Experimental Cancer Medicine ( Site 3206)
London, London, City Of EC1A 7BE
United KingdomSite Not Available
Moores Cancer Center ( Site 3028)
La Jolla, California 92093
United StatesSite Not Available
University of California, Irvine (UCI) Health - UC Irvine Medical Center ( Site 3045)
Orange, California 92868
United StatesSite Not Available
Anschutz Cancer Pavilion ( Site 3017)
Aurora, Colorado 80045
United StatesSite Not Available
Emory University School of Medicine ( Site 3043)
Atlanta, Georgia 30322
United StatesSite Not Available
Indiana University Melvin and Bren Simon Cancer Center ( Site 3011)
Indianapolis, Indiana 46202
United StatesSite Not Available
Washington University School of Medicine ( Site 3038)
Saint Louis, Missouri 63110
United StatesSite Not Available
Icahn School of Medicine at Mount Sinai ( Site 3018)
New York, New York 10029
United StatesSite Not Available
Memorial Sloan Kettering Cancer Center ( Site 3031)
New York, New York 10065
United StatesSite Not Available
Cleveland Clinic-Taussig Cancer Center ( Site 3036)
Cleveland, Ohio 44195
United StatesSite Not Available
UPMC Hillman Cancer Center ( Site 3014)
Pittsburgh, Pennsylvania 15232
United StatesSite Not Available
Huntsman Cancer Institute-HCI Clinical Trials Office ( Site 3041)
Salt Lake City, Utah 84112
United StatesSite Not Available
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