Spots Global Cancer Trial Database for Evaluation of Efficacy and Safety of Neoadjuvant Treatment With Pamrevlumab in Combination With Chemotherapy (Either Gemcitabine Plus Nab-paclitaxel or FOLFIRINOX) in Participants With Locally Advanced Pancreatic Cancer
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Trial Identification
Brief Title: Evaluation of Efficacy and Safety of Neoadjuvant Treatment With Pamrevlumab in Combination With Chemotherapy (Either Gemcitabine Plus Nab-paclitaxel or FOLFIRINOX) in Participants With Locally Advanced Pancreatic Cancer
Official Title: A Phase 3, Randomized, Double-Blind Study of Pamrevlumab or Placebo in Combination With Either Gemcitabine Plus Nab-paclitaxel or FOLFIRINOX as Neoadjuvant Treatment in Patients With Locally Advanced, Unresectable Pancreatic Cancer
Study ID: NCT03941093
Conditions
Study Description
Brief Summary: This is a Phase 3, randomized, double-blind trial to evaluate the efficacy and safety of neoadjuvant treatment with pamrevlumab or placebo in combination with either gemcitabine plus nab-paclitaxel (G/NP) or FOLFIRINOX in the treatment of participants with locally advanced, unresectable pancreatic cancer.
Detailed Description: Participants will be randomized in a 1:1 ratio to one of the two study treatment arms; pamrevlumab with either G/NP or FOLFIRINOX, placebo with G/NP or FOLFIRINOX. Each participant may receive up to 6 cycles of treatment (each treatment cycle is 28 days). Tumor tissue will be collected during resection to determine surgical outcome and for biomarker analysis. Tumor response will be evaluated by changes in CT scan, FDG-PET, CA 19-9, and NCCN® guidelines. All participants randomized will have a safety follow-up visit approximately 28 days after the last dose of study treatment and a final safety follow-up phone call at approximately 60 days after the last dose. Participants who complete study treatment will be evaluated for surgical exploration for possible R0 or R1 resection. Surgery will occur at least 4 weeks after the last dose (allowing for a wash-out period from treatment) and only after receipt of the recommendation from the central review board with regards to surgical eligibility. Surgery will occur no longer than 8 weeks after the last dose. Participants who undergo surgery will be evaluated for surgical complications for at least an additional 90 days following discharge from surgery. Participants who are ineligible for surgical exploration (i.e. participants who did not complete study treatment or do not meet any of the protocol defined criteria or had a contraindication to surgery) will continue in the Follow-up period and receive treatment as per standard of care (SOC) for each institution. All participants will be followed for disease progression (if not previously detected) or recurrence following resection (local progression or metastatic disease). Participants will also be followed for any additional anti-cancer therapy received for their pancreatic cancer. All participants will be followed for survival (until death) or until the last participant to complete treatment reaches 18 months post-treatment.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
St. Joseph's Hospital and Medical Cancer Center, Phoenix, Arizona, United States
UC San Diego Moores Cancer Center, La Jolla, California, United States
UCLA, Los Angeles, California, United States
UC Davis Comprehensive Cancer Center, Sacramento, California, United States
Yale New Haven Hospital, New Haven, Connecticut, United States
Elmhurst Memorial Hospital - Nancy W. Knowles Cancer Center, Elmhurst, Illinois, United States
Edward Cancer Center, Naperville, Illinois, United States
Indiana University Melvin and Bren Simon Comprehensive Cancer Center, Indianapolis, Indiana, United States
University of Kansas Hospital, Westwood, Kansas, United States
Norton Cancer Institute, Audubon Hospital Campus, Louisville, Kentucky, United States
Maine Health Cancer Care, South Portland, Maine, United States
University of Massachusetts, Worcester, Massachusetts, United States
University of Michigan, Ann Arbor, Michigan, United States
Karmanos Cancer Institute, Detroit, Michigan, United States
Saint Luke's Hospital, Kansas City, Missouri, United States
University of Nebraska Medical Center, Omaha, Nebraska, United States
New Mexico Cancer Care Alliance, Albuquerque, New Mexico, United States
NYU Langone Health, New York, New York, United States
Stony Brook University, Stony Brook, New York, United States
SUNY Upstate Medical University, Syracuse, New York, United States
University of Cincinnati Medical Center, Cincinnati, Ohio, United States
Ohio State University, Columbus, Ohio, United States
Thomas Jefferson University, Philadelphia, Pennsylvania, United States
Allegheny General Hospital, Pittsburgh, Pennsylvania, United States
Reading Hospital McGlinn Cancer Institute, West Reading, Pennsylvania, United States
Baylor College of Medicine, Houston, Texas, United States
Baylor Scott & White Medical Center, Temple, Texas, United States
Renovatio Clinic, The Woodlands, Texas, United States
Inova Schar Cancer Institute, Fairfax, Virginia, United States
Virginia Mason Medical Center, Seattle, Washington, United States
University of Washington Medical Center, Seattle, Washington, United States
West Virginia University, Morgantown, West Virginia, United States
Klinikum Wels-Grieskirchen GmbH, Wels, , Austria
Medizinische Universität Wien, Wien, , Austria
CUB Hôpital Erasme, Brussels, , Belgium
The Ottawa Hospital, Ottawa, Ontario, Canada
Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada
Princess Margaret Cancer Centre/University Health Network, Toronto, Ontario, Canada
McGill University Health Center, Montreal, Quebec, Canada
Peking Union Medical College Hospital, Dongcheng, Beijing, China
Union Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology, Wuhan, Hubei, China
The First Affiliated Hospital Of Xi'an Jiaotong University, Xi'an, Shaanxi, China
Huashan Hospital affiliated with Fudan University, Jing'an, Shanghai, China
West China Hospital of Sichuan University, Chengdu, , China
Jiangsu Province Hospital, Nanjing, , China
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, , China
Xinhua Hospital Affiliated to Shanghai Jiaotong University School Of Medicine, Shanghai, , China
CHRU Jean Minjoz, Besançon Cedex, , France
CHU Estaing, Clermont Ferrand, , France
Hopital BEAUJON, Clichy, , France
Centre Georges-François Leclerc, Dijon, , France
CHU Grenoble Alpes, La Tronche, , France
Centre Léon Bérard, Lyon, , France
Hôpital Edouard Herriot, Lyon, , France
Groupe Hospitalier Pitié Salpêtrière, Paris, , France
Haut-Lévêque, Pessac, , France
Institut de Cancérologie de l'Ouest Pays de Loire, Saint Herblain Cedex, , France
Medizinische Klinik mit Schwerpunkt Hämatologie, Onkologie und Tumorimmunologie, Berlin, , Germany
Technische Universität Dresden, Medizinische Klinik und Poliklinik I, Dresden, , Germany
Klinikum der Universität München, Medizinische Klinik und Poliklinik III, München, , Germany
Klinikum rechts der Isar der Technischen Universität München, München, , Germany
Shamir Medical center Asaf Harofeh, Be'er Ya'aqov, , Israel
Hadassah University Hospital Ein Kerem, Jerusalem, , Israel
Meir Medical center, Kfar Saba, , Israel
Rabin Medical Center, Petach Tikva, , Israel
Instituto Scientifico Romagnolog per lo Studio e la Cura dei Tumori, Meldola, , Italy
IRCCS Ospedale San Raffaele, Milano, , Italy
Istituto Europeo di Oncologia, Milano, , Italy
Grande Ospedale Metropolitano Niguarda, Oncologia Medica Falck, Milano, , Italy
AOU Federico II, Napoli, , Italy
Istituto Clinico Humanitas, Rozzano, , Italy
CRC di Verona, Verona, , Italy
Seoul National University Budang Hospital, Seongnam-si, Geyonggi-do, Korea, Republic of
National Cancer Center, Goyang-si, Gyeonggi-do, Korea, Republic of
Chonnam National University Hwasun Hospital, Hwasun, Jeollanam-do, Korea, Republic of
Seoul National University Hospital, Seoul, , Korea, Republic of
Severance Hospital, Yonsei University Health System, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
The Catholic University of Korea, Seoul St. Mary's Hospital, Seoul, , Korea, Republic of
Alvaro Cunqueiro Hospital, Vigo, Pontevedra, Spain
Hospital Universitaro Vall D'Hebron, Barcelona, , Spain
Hospital de la Santa Creu i Sant Pau, Barcelona, , Spain
Institut Catalá d'Oncologia (ICO Girona). Hospital Dr. Josep Trueta, Girona, , Spain
Hospital General Universitario Gregorio Marañon, Madrid, , Spain
MD Anderson Cancer Center, Madrid, , Spain
Hospital Clinico San Carlos, Madrid, , Spain
Hospital Clinico Universitario de Valencia, Valencia, , Spain
Hospital Universitario Miguel Servet, Zaragoza, , Spain
University College London Hospitals NHS Foundation Trust, London, , United Kingdom
Imperial College Healthcare NHS Trust, London, , United Kingdom
Contact Details
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