Trilaciclib, a CDK 4/6 Inhibitor, in Patients With Advanced/Metastatic Bladder Cancer Receiving Chemotherapy Then Avelumab

PHASE2TerminatedINTERVENTIONAL
Enrollment

92

Participants

Timeline

Start Date

June 4, 2021

Primary Completion Date

April 7, 2023

Study Completion Date

March 1, 2024

Conditions
Urothelial CarcinomaBladder CancerMyelosuppression AdultChemotherapy-induced NeutropeniaMetastatic Bladder Cancer
Interventions
DRUG

Trilaciclib

Trilaciclib administered IV prior to chemotherapy and avelumab maintenance therapy on each day chemotherapy and avelumab maintenance therapy is administered.

DRUG

Gemcitabine

Gemcitabine administered IV on Day 1 and Day 8 of each 21-day cycle

DRUG

Cisplatin

Cisplatin administered IV on Day 1 of each 21-day cycle

DRUG

Carboplatin

Carboplatin administered IV on Day 1 of each 21-day cycle

DRUG

Avelumab

Avelumab administered IV on Day 1 of each 14-day maintenance cycle

Trial Locations (34)

186

"LTD Multiprofile Clinic Consilium Medulla", Tbilisi

1122

Országos Onkológiai Intézet, Budapest

6010

High Technology Hospital MedCenter LTD, Batumi

10461

Montefiore Medical Center, The Bronx

12206

New York Oncology Hematology, P.C., Albany

18014

H.U. V. de las Nieves, Granada

21237

The Harry and Jeanette Weinberg Cancer Institute, Baltimore

27003

Hospital Universitario Lucus Augusti, Lugo

27599

University of North Carolina at Chapel Hill, Chapel Hill

28222

Hospital Universitario Puerta de Hierro Majadahonda, Majadahonda

32503

Woodlands Medical Specialists, Pensacola

33076

Institut Bergonié - Oncologie Médicale et Pédiatrique, Bordeaux

33705

Florida Cancer Specialists - North, St. Petersburg

33901

Florida Cancer Specialists - South, Fort Myers

37203

Tennessee Oncology, PLLC, Nashville

46009

Fundación Instituto Valenciano de Oncología, Valencia

46026

Hospital Politecnic Universitari La Fe, Valencia

46241

Northwest Cancer Specialists, P.C., Tigard

54519

Institut de Cancérologie de Lorraine, Vandœuvre-lès-Nancy

67091

Hopitaux Universitaires de Strasbourg - Service Oncologie et Hématologie, Strasbourg

69373

Centre Léon Bérard - Département d'oncologie médicale, Lyon

75015

Hôpital Européen Georges Pompidou - Service d'Oncologie Médicale, Paris

80120

Rocky Mountain Cancer Centers, Littleton

83814

Beacon Cancer Center PLLC, Coeur d'Alene

90067

Valkyrie Clinical Trial, Los Angeles

90603

The Oncology Institute of Hope and Innovation, Whittier

0144

National Center of Urology Named after Laur Managadze, Tbilisi

H-5000

Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz - Rendeloint, Szolnok

H-1145

Uzsoki Utcai Kórház, Budapest

08916

Institut Català d'Oncologia-Hospital Universitari Germans Trias i Pujol, Badalona

08243

ALTHAIA, Xarxa Assistencial Universitiria de Manresa, Manresa

08035

Hospital Universitario Vall d´Hebron, Barcelona

08036

Hospital Clinic de Barcelona - Servicio de Oncología Médica, Barcelona

08041

Hospital de la Santa Creu i Sant Pau, Barcelona

Sponsors
All Listed Sponsors
lead

G1 Therapeutics, Inc.

INDUSTRY

NCT04887831 - Trilaciclib, a CDK 4/6 Inhibitor, in Patients With Advanced/Metastatic Bladder Cancer Receiving Chemotherapy Then Avelumab | Biotech Hunter | Biotech Hunter