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

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)

INTRODUCTION

  • Org Study ID: G1T28-209
  • Secondary ID: N/A
  • NTC ID: NCT04887831
  • Sponsor: G1 Therapeutics, Inc.

BRIEF 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.

DETAILED 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.

  • Overall Status
    Recruiting
  • Start Date
    June 4, 2021
  • Phase
    Phase 2
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Progression-Free Survival

Primary Outcome 1 - Timeframe: 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)

CONDITION

  • Urothelial Carcinoma
  • Bladder Cancer
  • Myelosuppression Adult
  • Chemotherapy-induced Neutropenia
  • Metastatic Bladder Cancer

ELIGIBILITY

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)

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Clinical Contact

Role: Study Director

Affiliation: G1 Therapeutics, Inc.

Overall Contact

Name: Clinical Contact

Phone: 919-213-9835

Email: clinicalinfo@g1therapeutics.com

LOCATION

Facility Status Contact
Facility: Sarcoma Oncology Research Center
Santa Monica, California 90403
United States
Status: Recruiting Contact: Contact
Victoria Chua-Acala
310-552-9999 4423
vchua@sarcomaoncology.com
Facility: The Oncology Institute of Hope and Innovation
Whittier, California 90603
United States
Status: Recruiting Contact: Principal Investigator
Sant P Chawla, MD
562-693-4477 1151
kbettino@airesearch.us
Facility: Rocky Mountain Cancer Centers
Littleton, Colorado 80120
United States
Status: Recruiting Contact: Contact
Kerstin Bettino
303-730-4700 451
lynne.boynton@usoncology.com
Facility: Florida Cancer Specialists - South
Fort Myers, Florida 33901
United States
Status: Recruiting Contact: Principal Investigator
Eddie Thara, D.O.
239-236-5680 1491
amy.chu@flcancer.com
Facility: Mid Florida Hematology and Oncology Center
Orange City, Florida 32763
United States
Status: Recruiting Contact: Contact
Lynne Boynton
407-204-1030 1492
kiran@aorcorp.com
Facility: Woodlands Medical Specialists
Pensacola, Florida 32503
United States
Status: Recruiting Contact: Principal Investigator
Manojkumar Bupathi, M.D.
850-696-4000 2701
lbellamy@woodlandsmed.com
Facility: Florida Cancer Specialists , North
Saint Petersburg, Florida 33705
United States
Status: Recruiting Contact: Contact
Amy Chu
727-216-1143 4816
bconklin@flcancer.com
Facility: Saint Alphonsus Regional Medical Center
Boise, Idaho 83706
United States
Status: Recruiting Contact: Principal Investigator
Elizabeth Ann Guancial, MD
208-302-0515
Marlia.Harnden@saintalphonsus.org
Facility: XCancer / Northwest Oncology and Hematology
Rolling Meadows, Illinois 60008
United States
Status: Recruiting Contact: Contact
Kiran Penta
(208) 205-0368
Julie.Bird@saintalphonsus.org
Facility: XCancer / Pontchartrain Cancer Center
Hammond, Louisiana 70403
United States
Status: Recruiting Contact: Principal Investigator
Santosh Nair, MD
985-888-1523
nowsheena@northwestoncology.com
Facility: The Harry and Jeanette Weinberg Cancer Institute
Baltimore, Maryland 21237
United States
Status: Recruiting Contact: Contact
Leslie Bellamy
985-888-1523
daniellef@northwestoncology.com
Facility: Maryland Oncology Hematology, P.A.
Silver Spring, Maryland 20904
United States
Status: Recruiting Contact: Principal Investigator
Rami Owera, MD
443-777-8876
jfaucheaux@pcclouisiana.com
Facility: New York Oncology Hematology, P.C.
Albany, New York 12206
United States
Status: Recruiting Contact: Contact
BJ Conklin
410-964-2212
candice@pcclouisiana.com
Facility: Montefiore Medical Center
Bronx, New York 10461
United States
Status: Recruiting Contact: Principal Investigator
Vijay Patel, MD
518-489-0044
amy.m.avergas@medstar.net
Facility: University of Buffalo
Williamsville, New York 14203
United States
Status: Recruiting Contact: Contact
Marlia Harnden
718-862-8840
teresa.saavedra@usoncology.com
Facility: Northwest Cancer Specialists, P.C.
Tigard, Oregon 46241
United States
Status: Recruiting Contact: Contact
Julie Bird
516-470-6924
Josephine.Faruol@usoncology.com
Facility: Tennessee Oncology, PLLC
Nashville, Tennessee 37203
United States
Status: Recruiting Contact: Principal Investigator
Ian Qureshi, D.O., Ph.D.
716-529-6470
Ambri.Cicchinelli@USONCOLOGY.COM
Facility: Texas Oncology-Austin Central
Austin, Texas 78705
United States
Status: Recruiting Contact: Contact
Nowsheen Azeemuddin
360-597-1316
rigandhi@montefiore.org
Facility: Valley Cancer Associates PA
Harlingen, Texas 78550
United States
Status: Recruiting Contact: Contact
Danielle Flemming
615-329-7658
cbroyles@brany.com
Facility: Texas Oncology - Longview Cancer Center
Longview, Texas 75601
United States
Status: Recruiting Contact: Principal Investigator
Bruce Bank, MD
615-524-4186
DColeman1@KaleidaHealth.org
Facility: Fred Hutchinson Cancer Research Center
Seattle, Washington 98109
United States
Status: Recruiting Contact: Contact
Jessica M Faucheaux
512-427-9400
Julian.Kern@compassoncology.com
Facility: Medical Oncology Associates, PS (dba Summit Cancer Centers)
Spokane, Washington 99208
United States
Status: Recruiting Contact: Contact
Candice B Pittman
956-688-9042
Cristina.Parcescu@sarahcannon.com
Facility: Hopitaux Universitaires de Strasbourg - Service Oncologie et Hématologie
Strasbourg, Bas-Rhin 67091
France
Status: Recruiting Contact: Principal Investigator
David Oubre, MD
903-757-2122
Sandy.Miller@sarahcannon.com
Facility: Hopitaux Universitaires de Strasbourg - Service Oncologie et Hématologie
Strasbourg, Bas-Rhin 67091
France
Status: Recruiting Contact: Contact
Amy Avergas
206-288-2048
monica.arellano@usoncology.com
Facility: CHU de Nîmes - Institut de Cancérologie du Gard
Nîmes, Cedex 9 30029
France
Status: Recruiting Contact: Principal Investigator
Kevin Chen, MD
509-462-2273
liana.maldonado@elligodirect.com
Facility: Institut Bergonié - Oncologie Médicale et Pédiatrique
Bordeaux cedex, Gironde 33076
France
Status: Recruiting Contact: Contact
Teresa Saavedra
33 (0)3 68 76 7 207
Shelly.Maxfield@USOncology.com
Facility: Centre Léon Bérard - Département d'oncologie médicale
Lyon, Ajaria 69373
France
Status: Recruiting Contact: Principal Investigator
Vinni Juneja, MD
33 5 49 44 33 52
alexak6@seattlecca.org
Facility: Hôpital Européen Georges Pompidou - Service d'Oncologie Médicale
Paris, Jász-Nagykun-Szolnok 75015
France
Status: Recruiting Contact: Contact
Josephine Faruol
33 5 49 44 45 38
monika.chaudhry@aoncology.com
Facility: Institut de Cancérologie de Lorraine
Vandœuvre-lès-Nancy, Barcelona 54519
France
Status: Recruiting Contact: Contact
Ambri Cicchineli
+33 4 66 68 35 28
c.jung@icans.eu
Facility: High Technology Hospital MedCenter LTD
Batumi, Madrid 6010
Georgia
Status: Recruiting Contact: Principal Investigator
Rahul Ravilla, M.D.
+33 5 56 33 78 54
warren.guilmain@chu-poitiers.fr
Facility: National Center of Urology Named after Laur Managadze
Tbilisi, 0144
Georgia
Status: Recruiting Contact: Contact
Rikin Gandhi
+33 5 56 33 33 33
lydie.doussot@chu-poitiers.fr
Facility: LTD "Aversi Clinic"
Tbilisi, 0160
Georgia
Status: Recruiting Contact: Contact
Celeste Broyles
+33 4 69 85 62 43
gwendoline.marel.lopez@chu-nimes.fr
Facility: LTD "Multiprofile Clinic Consilium Medulla"
Tbilisi, 186
Georgia
Status: Recruiting Contact: Principal Investigator
Benjamin Gartrell, MD
+331 56 09 22 84
c.roy@bordeaux.unicancer.fr
Facility: Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz - Rendeloint
Szolnok, H-5000
Hungary
Status: Recruiting Contact: Contact
Deonna Coleman
+33 3 83 59 85 51
S.Louchet@bordeaux.unicancer.fr
Facility: Országos Onkológiai Intézet
Budapest, 1122
Hungary
Status: Recruiting Contact: Principal Investigator
Roberto Pili, MD
+995 577417060
agathe.anselin@lyon.unicancer.fr
Facility: Semmelweis Egyetem, Urológiai Klinika
Budapest, H-1082
Hungary
Status: Recruiting Contact: Contact
Julian Kern
+995 599910186
anais.trochereau@lyon.unicancer.fr
Facility: Uzsoki Utcai Kórház
Budapest, H-1145
Hungary
Status: Recruiting Contact: Principal Investigator
Ian Schnadig, MD
+995599883639
celine.le-rest-ext@aphp.fr
Facility: Institut Català d'Oncologia-Hospital Universitari Germans Trias i Pujol
Badalona, 08916
Spain
Status: Recruiting Contact: Contact
Cristina Parcescu
+995599564080
c.kadouci@nancy.unicancer.fr
Facility: Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, 28222
Spain
Status: Recruiting Contact: Contact
Sandy Miller
+995593343266
enver.kejeradze@gmail.com
Facility: Hospital Universitario Vall d´Hebron
Barcelona, 08035
Spain
Status: Recruiting Contact: Principal Investigator
Meredith A. McKean, MD
+995322304502
marisikharulidze8@gmail.com
Facility: Hospital Clinic de Barcelona - Servicio de Oncología Médica
Barcelona, 08036
Spain
Status: Recruiting Contact: Contact
Monica Arellano
36204437248
zaza.2006@yahoo.com
Facility: Hospital Universitari Parc Tauli
Barcelona, 08208
Spain
Status: Recruiting Contact: Principal Investigator
Jeffrey Yorio, M.D.
36204437248
nakopia121@yahoo.com
Facility: H.U. V. de las Nieves
Granada, 18014
Spain
Status: Recruiting Contact: Contact
Liana Maldanado
+36 20 999 7483
mkatsia@yahoo.com
Facility: M.D. Anderson Center Madrid
Madrid, 28033
Spain
Status: Recruiting Contact: Principal Investigator
Todd Shenkenberg, MD
+36 20-290-9561
khato82@yahoo.com
Facility: Fundación Instituto Valenciano de Oncología
Valencia, 46009
Spain
Status: Recruiting Contact: Contact
Shelly Maxfield
36203625768
janos.balazsi96@gmail.com