Bladder Cancer Clinical Trial
— PRESERVE3Official title:
A Phase 2, Randomized, Open-Label Study of Trilaciclib Administered With First-Line Platinum-Based Chemotherapy and Avelumab Maintenance Therapy in Patients With Untreated, Locally Advanced or Metastatic Urothelial Carcinoma (PRESERVE 3)
Verified date | March 2024 |
Source | G1 Therapeutics, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 92 |
Est. completion date | March 1, 2024 |
Est. primary completion date | April 7, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Age =18 years 2. Histologically documented, locally advanced (T4b, any N; or any T, N 2-3) or metastatic urothelial carcinoma (M1, Stage IV) 3. Measurable disease as defined by RECIST v1.1 4. No prior systemic therapy in the inoperable, locally advanced, or metastatic setting including chemotherapy, immune checkpoint inhibitor therapy, targeted therapy, or investigational agents 5. Archival tumor tissue must be available or a fresh biopsy must be obtained, unless approved by the Medical Monitor 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 7. Adequate organ function as demonstrated by normal laboratory values Exclusion Criteria: 1. Prior treatment with IL-2, IFN-a, 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 2. 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) 3. Presence of central nervous system (CNS) metastases/leptomeningeal disease requiring immediate treatment with radiation therapy or steroids. 4. QTcF interval > 480 msec. For patients with ventricular pacemakers, QTcF > 500 msec 5. Known hypersensitivity or allergy to avelumab, gemcitabine, cisplatin or carboplatin 6. Known severe hypersensitivity reactions to monoclonal antibodies (Grade =3), any history of anaphylaxis, or uncontrolled asthma 7. Prior hematopoietic stem cell or bone marrow transplantation, or solid organ transplantation 8. Pregnant or lactating women 9. Active autoimmune disease that might deteriorate when receiving an immunostimulatory agent 10. Current use of immunosuppressive medication, EXCEPT for the following: 1. Intranasal, inhaled, topical steroids, or local steroid injection (e.g., intra-articular injection) 2. Systemic corticosteroids at physiological doses =10 mg/day of prednisone or equivalent 3. Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication) |
Country | Name | City | State |
---|---|---|---|
France | Institut Bergonié - Oncologie Médicale et Pédiatrique | Bordeaux cedex | Gironde |
France | Centre Léon Bérard - Département d'oncologie médicale | Lyon | |
France | Hôpital Européen Georges Pompidou - Service d'Oncologie Médicale | Paris | |
France | Hopitaux Universitaires de Strasbourg - Service Oncologie et Hématologie | Strasbourg | Bas-Rhin |
France | Institut de Cancérologie de Lorraine | VandÅ“uvre-lès-Nancy | |
Georgia | High Technology Hospital MedCenter LTD | Batumi | Ajaria |
Georgia | LTD "Multiprofile Clinic Consilium Medulla" | Tbilisi | |
Georgia | National Center of Urology Named after Laur Managadze | Tbilisi | |
Hungary | Országos Onkológiai Intézet | Budapest | |
Hungary | Uzsoki Utcai Kórház | Budapest | |
Hungary | Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz - Rendeloint | Szolnok | Jász-Nagykun-Szolnok |
Spain | Institut Català d'Oncologia-Hospital Universitari Germans Trias i Pujol | Badalona | Barcelona |
Spain | Hospital Clinic de Barcelona - Servicio de Oncología Médica | Barcelona | |
Spain | Hospital de la Santa Creu i Sant Pau | Barcelona | |
Spain | Hospital Universitario Vall d´Hebron | Barcelona | |
Spain | H.U. V. de las Nieves | Granada | |
Spain | Hospital Universitario Lucus Augusti | Lugo | |
Spain | Hospital Universitario Puerta de Hierro Majadahonda | Majadahonda | Madrid |
Spain | ALTHAIA, Xarxa Assistencial Universitiria de Manresa | Manresa | Barcelona |
Spain | Fundación Instituto Valenciano de Oncología | Valencia | |
Spain | Hospital Politecnic Universitari La Fe | Valencia | |
United States | New York Oncology Hematology, P.C. | Albany | New York |
United States | The Harry and Jeanette Weinberg Cancer Institute | Baltimore | Maryland |
United States | Montefiore Medical Center | Bronx | New York |
United States | University of North Carolina at Chapel Hill | Chapel Hill | North Carolina |
United States | Beacon Cancer Center PLLC | Coeur d'Alene | Idaho |
United States | Florida Cancer Specialists - South | Fort Myers | Florida |
United States | Rocky Mountain Cancer Centers | Littleton | Colorado |
United States | Valkyrie Clinical Trial | Los Angeles | California |
United States | Tennessee Oncology, PLLC | Nashville | Tennessee |
United States | Woodlands Medical Specialists | Pensacola | Florida |
United States | Florida Cancer Specialists - North | Saint Petersburg | Florida |
United States | Northwest Cancer Specialists, P.C. | Tigard | Oregon |
United States | The Oncology Institute of Hope and Innovation | Whittier | California |
Lead Sponsor | Collaborator |
---|---|
G1 Therapeutics, Inc. |
United States, France, Georgia, Hungary, Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Progression-Free Survival | To evaluate the effect of trilaciclib on progression-free survival (PFS) when administered with platinum-based chemotherapy followed by trilaciclib administered with avelumab maintenance therapy compared with platinum-based chemotherapy followed by avelumab maintenance therapy alone. | From date of randomization until date of documented radiologic disease progression per RECIST v1.1 or death due to any cause, whichever comes first (on average 7 months) | |
Secondary | Anti-tumor Effects | To assess objective response rates as measured by RECIST 1.1 | From date of randomization until date of documented radiologic disease progression per RECIST v1.1 or death due to any cause, whichever comes first (on average 7 months) | |
Secondary | Anti-tumor Effects | To evaluate the effect of trilaciclib on overall survival (OS) when administered with platinum-based chemotherapy followed by trilaciclib administered with avelumab maintenance therapy compared with platinum-based chemotherapy followed by avelumab maintenance therapy alone. | From date of randomization until date of death due to any cause (on average 25 months) | |
Secondary | Myeloprotective Effects | To assess the effects of trilaciclib on the neutrophil lineage as measured by the occurrence of severe neutropenia during platinum-based chemotherapy treatment | Cycle 1 Day 1 (each cycle is 21 days) through treatment with platinum-based chemotherapy (up to 4 months) |
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