Bladder Cancer Clinical Trial

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

Summary

This is a Phase 2, multicenter, randomized, open-label study evaluating the safety and efficacy of trilaciclib administered with platinum-based chemotherapy followed by trilaciclib administered with avelumab maintenance therapy compared with platinum-based chemotherapy followed by avelumab maintenance therapy in patients receiving first-line treatment for advanced/metastatic bladder cancer.

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Full Description

Patients will be randomly assigned (1:1) to receive standard of care platinum-based chemotherapy (with or without the addition of trilaciclib) administered intravenously (IV) in 21-day cycles followed by standard of care avelumab maintenance therapy (with or without the addition of trilaciclib) administered IV in 14-day cycles.

Patients enrolled in the study will be eligible to receive 4-6 cycles of platinum-based chemotherapy, and patients without progressive disease (PD) as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 guidelines (i.e., with an ongoing complete response [CR], partial response [PR], or stable disease) after platinum-based chemotherapy will be eligible to receive avelumab maintenance therapy until disease progression, unacceptable toxicity, withdrawal of consent, Investigator decision, or the end of the trial, whichever comes first.

Patients will be followed for survival approximately every 3 months after receiving the last dose of study medication.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Age ≥18 years
Histologically documented, locally advanced (T4b, any N; or any T, N 2-3) or metastatic urothelial carcinoma (M1, Stage IV)
Measurable disease as defined by RECIST v1.1
No prior systemic therapy in the inoperable, locally advanced, or metastatic setting including chemotherapy, immune checkpoint inhibitor therapy, targeted therapy, or investigational agents
Archival tumor tissue must be available or a fresh biopsy must be obtained, unless approved by the Medical Monitor
Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
Adequate organ function as demonstrated by normal laboratory values

Exclusion Criteria:

Prior treatment with IL-2, IFN-α, or an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137 or CD137 agonists, or cytotoxic T-lymphocyte associated protein 4 (CTLA-4) antibody (including ipilimumab), or any other therapeutic antibody or drug specifically targeting T cell co-stimulation or immune checkpoint pathways in any setting
Malignancies other than urothelial carcinoma within 3 years prior to randomization, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the breast or of the cervix, or low-grade (Gleason ≤6) prostate cancer on surveillance without any plans for treatment intervention (e.g., surgery, radiation, or castration)
Presence of central nervous system (CNS) metastases/leptomeningeal disease requiring immediate treatment with radiation therapy or steroids.
QTcF interval > 480 msec. For patients with ventricular pacemakers, QTcF > 500 msec
Known hypersensitivity or allergy to avelumab, gemcitabine, cisplatin or carboplatin
Known severe hypersensitivity reactions to monoclonal antibodies (Grade ≥3), any history of anaphylaxis, or uncontrolled asthma
Prior hematopoietic stem cell or bone marrow transplantation, or solid organ transplantation
Pregnant or lactating women
Active autoimmune disease that might deteriorate when receiving an immunostimulatory agent

Current use of immunosuppressive medication, EXCEPT for the following:

Intranasal, inhaled, topical steroids, or local steroid injection (e.g., intra-articular injection)
Systemic corticosteroids at physiological doses ≤10 mg/day of prednisone or equivalent
Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication)

Study is for people with:

Bladder Cancer

Phase:

Phase 2

Estimated Enrollment:

92

Study ID:

NCT04887831

Recruitment Status:

Active, not recruiting

Sponsor:

G1 Therapeutics, Inc.

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There are 33 Locations for this study

See Locations Near You

Valkyrie Clinical Trial
Los Angeles California, 90067, United States
The Oncology Institute of Hope and Innovation
Whittier California, 90603, United States
Rocky Mountain Cancer Centers
Littleton Colorado, 80120, United States
Florida Cancer Specialists - South
Fort Myers Florida, 33901, United States
Woodlands Medical Specialists
Pensacola Florida, 32503, United States
Florida Cancer Specialists , North
Saint Petersburg Florida, 33705, United States
Beacon Cancer Center PLLC
Coeur d'Alene Idaho, 83814, United States
The Harry and Jeanette Weinberg Cancer Institute
Baltimore Maryland, 21237, United States
New York Oncology Hematology, P.C.
Albany New York, 12206, United States
Montefiore Medical Center
Bronx New York, 10461, United States
University of North Carolina at Chapel Hill
Chapel Hill North Carolina, 27599, United States
Northwest Cancer Specialists, P.C.
Tigard Oregon, 46241, United States
Tennessee Oncology, PLLC
Nashville Tennessee, 37203, United States
Hopitaux Universitaires de Strasbourg - Service Oncologie et Hématologie
Strasbourg Bas-Rhin, 67091, France
Institut Bergonié - Oncologie Médicale et Pédiatrique
Bordeaux cedex Gironde, 33076, France
Centre Léon Bérard - Département d'oncologie médicale
Lyon , 69373, France
Hôpital Européen Georges Pompidou - Service d'Oncologie Médicale
Paris , 75015, France
Institut de Cancérologie de Lorraine
Vandœuvre-lès-Nancy , 54519, France
High Technology Hospital MedCenter LTD
Batumi Ajaria, 6010, Georgia
National Center of Urology Named after Laur Managadze
Tbilisi , 0144, Georgia
LTD "Multiprofile Clinic Consilium Medulla"
Tbilisi , 186, Georgia
Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz - Rendeloint
Szolnok Jász-Nagykun-Szolnok, H-500, Hungary
Országos Onkológiai Intézet
Budapest , 1122, Hungary
Uzsoki Utcai Kórház
Budapest , H-114, Hungary
Institut Català d'Oncologia-Hospital Universitari Germans Trias i Pujol
Badalona Barcelona, 08916, Spain
ALTHAIA, Xarxa Assistencial Universitiria de Manresa
Manresa Barcelona, 08243, Spain
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda Madrid, 28222, Spain
Hospital Universitario Vall d´Hebron
Barcelona , 08035, Spain
Hospital Clinic de Barcelona - Servicio de Oncología Médica
Barcelona , 08036, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona , 08041, Spain
H.U. V. de las Nieves
Granada , 18014, Spain
Hospital Universitario Lucus Augusti
Lugo , 27003, Spain
Fundación Instituto Valenciano de Oncología
Valencia , 46009, Spain

How clear is this clinincal trial information?

Study is for people with:

Bladder Cancer

Phase:

Phase 2

Estimated Enrollment:

92

Study ID:

NCT04887831

Recruitment Status:

Active, not recruiting

Sponsor:


G1 Therapeutics, Inc.

How clear is this clinincal trial information?

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