Bladder Cancer Clinical Trial
Trilaciclib, a CDK 4/6 Inhibitor, in Patients With Advanced/Metastatic Bladder Cancer Receiving Chemotherapy Then Avelumab
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.
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.
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
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)
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There are 34 Locations for this study
Los Angeles California, 90067, United States
Whittier California, 90603, United States
Littleton Colorado, 80120, United States
Fort Myers Florida, 33901, United States
Pensacola Florida, 32503, United States
Saint Petersburg Florida, 33705, United States
Coeur d'Alene Idaho, 83814, United States
Baltimore Maryland, 21237, United States
Albany New York, 12206, United States
Bronx New York, 10461, United States
Chapel Hill North Carolina, 27599, United States
Tigard Oregon, 46241, United States
Nashville Tennessee, 37203, United States
Strasbourg Bas-Rhin, 67091, France
Bordeaux cedex Gironde, 33076, France
Lyon , 69373, France
Paris , 75015, France
Vandœuvre-lès-Nancy , 54519, France
Batumi Ajaria, 6010, Georgia
Tbilisi , 0144, Georgia
Tbilisi , 186, Georgia
Szolnok Jász-Nagykun-Szolnok, H-500, Hungary
Budapest , 1122, Hungary
Budapest , H-114, Hungary
Badalona Barcelona, 08916, Spain
Manresa Barcelona, 08243, Spain
Majadahonda Madrid, 28222, Spain
Barcelona , 08035, Spain
Barcelona , 08036, Spain
Barcelona , 08041, Spain
Granada , 18014, Spain
Lugo , 27003, Spain
Valencia , 46009, Spain
Valencia , 46026, Spain
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