Pancreatic Cancer Non-resectable Clinical Trial
— LAPISOfficial 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
Verified date | January 2024 |
Source | FibroGen |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 284 |
Est. completion date | April 30, 2024 |
Est. primary completion date | April 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Understand and sign informed consent; be willing to comply with study procedures, including surgery 2. Age = 18 years 3. Be a male, or non-pregnant and non-lactating female 4. Negative serum B-hCG pregnancy test at screening for women of childbearing potential 5. Male participants with partners of childbearing potential and female participants of childbearing potential are required to use highly effective contraception methods during the conduct of the study and for 6 months after the last dose of study drug 6. Histologically or cytologically proven diagnosis of pancreatic ductal adenocarcinoma (PDAC) 7. Locally advanced pancreatic cancer considered unresectable according to NCCN Guidelines® Version 2.2018 as determined by central imaging 8. Measurable disease as defined by RECIST 1.1 criteria as determined by central imaging 9. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 10. Adequate liver function: aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <2.5 x upper limit of normal (ULN), alkaline phosphatase <2.5 x ULN, and bilirubin =1.5 x ULN or in participants with biliary stenting =2.0 x ULN 11. Adequate bone marrow function: platelets >100,000 cells/mm3, hemoglobin >9.0 g/dl and absolute neutrophil count (ANC) >1,500 cells/mm3 12. Adequate renal function: creatinine < 1.5 x ULN, creatinine clearance = 30 mL/min 13. Less than grade 2 pre-existing peripheral neuropathy (per CTCAE) Exclusion Criteria: 1. Prior chemotherapy or radiation for pancreatic cancer 2. Previous (within the past 3 years) or concurrent malignancy diagnosis except non-melanoma skin cancer and in situ carcinomas (excluding in situ breast cancer) 3. Major surgery within 4 weeks prior to signing informed consent form. Biliary stents are permitted. 4. History of allergy or hypersensitivity to human, humanized or chimeric monoclonal antibodies 5. History of allergy or hypersensitivity to any of the chemotherapy agents being prescribed or their excipients 6. Any medical or surgical condition that may place the participant at increased risk while on study 7. Any condition potentially decreasing compliance to study procedures 8. Exposure to another investigational drug within 28 days of first dosing visit, or 5 half-lives of the investigational drug (whichever is longer) 9. Uncontrolled intercurrent illness including, but not limited to, ongoing or active systemic infections, symptomatic congestive heart failure, unstable angina pectoris, clinically significant cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements 10. Documented history of drug or alcohol abuse within 6 months of signing informed consent 11. Any medical condition that, in the opinion of the investigator, may pose a safety risk to a participant in this trial, may confound the assessment of safety and efficacy, or may interfere with study participation 12. Participants with a history of interstitial pulmonary disease, hepatitis C virus (HCV), hepatitis B virus (HBV) or human immunodeficiency virus (HIV) infection 13. Participants who have been administered a live vaccine within 4 weeks prior to the first administration of therapy 14. Participants who cannot stop chronic medications that inhibit or induce cytochrome P (CYP) 2C8 or CYP3A4 15. Participants with poorly controlled comorbid conditions, including; congestive heart failure (CHF), chronic obstructive pulmonary disease (COPD), uncontrolled diabetes mellitus (DM) or neurologic disorders (not acutely related to pancreatic cancer) or limited function |
Country | Name | City | State |
---|---|---|---|
Austria | Klinikum Wels-Grieskirchen GmbH | Wels | |
Austria | Medizinische Universität Wien | Wien | |
Belgium | CUB Hôpital Erasme | Brussels | |
Canada | McGill University Health Center | Montreal | Quebec |
Canada | The Ottawa Hospital | Ottawa | Ontario |
Canada | Princess Margaret Cancer Centre/University Health Network | Toronto | Ontario |
Canada | Sunnybrook Health Sciences Centre | Toronto | Ontario |
China | West China Hospital of Sichuan University | Chengdu | |
China | Peking Union Medical College Hospital | Dongcheng | Beijing |
China | Huashan Hospital affiliated with Fudan University | Jing'an | Shanghai |
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 | 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 |
France | 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 | |
Germany | 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 | |
Israel | 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 | |
Italy | Instituto Scientifico Romagnolog per lo Studio e la Cura dei Tumori | Meldola | |
Italy | Grande Ospedale Metropolitano Niguarda, Oncologia Medica Falck | Milano | |
Italy | IRCCS Ospedale San Raffaele | Milano | |
Italy | Istituto Europeo di Oncologia | Milano | |
Italy | AOU Federico II | Napoli | |
Italy | Istituto Clinico Humanitas | Rozzano | |
Italy | CRC di Verona | Verona | |
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 Budang Hospital | Seongnam-si | Geyonggi-do |
Korea, Republic of | Samsung Medical Center | Seoul | |
Korea, Republic of | Seoul National University Hospital | Seoul | |
Korea, Republic of | Severance Hospital, Yonsei University Health System | Seoul | |
Korea, Republic of | The Catholic University of Korea, Seoul St. Mary's Hospital | Seoul | |
Spain | Hospital de la Santa Creu i Sant Pau | Barcelona | |
Spain | Hospital Universitaro Vall D'Hebron | Barcelona | |
Spain | Institut Catalá d'Oncologia (ICO Girona). Hospital Dr. Josep Trueta | Girona | |
Spain | Hospital Clinico San Carlos | Madrid | |
Spain | Hospital General Universitario Gregorio Marañon | Madrid | |
Spain | MD Anderson Cancer Center | Madrid | |
Spain | Hospital Clinico Universitario de Valencia | Valencia | |
Spain | Alvaro Cunqueiro Hospital | Vigo | Pontevedra |
Spain | Hospital Universitario Miguel Servet | Zaragoza | |
United Kingdom | Imperial College Healthcare NHS Trust | London | |
United Kingdom | University College London Hospitals NHS Foundation Trust | London | |
United States | New Mexico Cancer Care Alliance | Albuquerque | New Mexico |
United States | University of Michigan | Ann Arbor | Michigan |
United States | University of Cincinnati Medical Center | Cincinnati | Ohio |
United States | Ohio State University | Columbus | Ohio |
United States | Karmanos Cancer Institute | Detroit | Michigan |
United States | Elmhurst Memorial Hospital - Nancy W. Knowles Cancer Center | Elmhurst | Illinois |
United States | Inova Schar Cancer Institute | Fairfax | Virginia |
United States | Baylor College of Medicine | Houston | Texas |
United States | Indiana University Melvin and Bren Simon Comprehensive Cancer Center | Indianapolis | Indiana |
United States | Saint Luke's Hospital | Kansas City | Missouri |
United States | UC San Diego Moores Cancer Center | La Jolla | California |
United States | UCLA | Los Angeles | California |
United States | Norton Cancer Institute, Audubon Hospital Campus | Louisville | Kentucky |
United States | West Virginia University | Morgantown | West Virginia |
United States | Edward Cancer Center | Naperville | Illinois |
United States | Yale New Haven Hospital | New Haven | Connecticut |
United States | NYU Langone Health | New York | New York |
United States | University of Nebraska Medical Center | Omaha | Nebraska |
United States | Thomas Jefferson University | Philadelphia | Pennsylvania |
United States | St. Joseph's Hospital and Medical Cancer Center | Phoenix | Arizona |
United States | Allegheny General Hospital | Pittsburgh | Pennsylvania |
United States | UC Davis Comprehensive Cancer Center | Sacramento | California |
United States | University of Washington Medical Center | Seattle | Washington |
United States | Virginia Mason Medical Center | Seattle | Washington |
United States | Maine Health Cancer Care | South Portland | Maine |
United States | Stony Brook University | Stony Brook | New York |
United States | SUNY Upstate Medical University | Syracuse | New York |
United States | Baylor Scott & White Medical Center | Temple | Texas |
United States | Renovatio Clinic | The Woodlands | Texas |
United States | Reading Hospital McGlinn Cancer Institute | West Reading | Pennsylvania |
United States | University of Kansas Hospital | Westwood | Kansas |
United States | University of Massachusetts | Worcester | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
FibroGen |
United States, Austria, Belgium, Canada, China, France, Germany, Israel, Italy, Korea, Republic of, Spain, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Overall Survival (OS) | Randomization to death due to any cause or until the last participant to complete treatment reaches 18 months post-treatment | ||
Secondary | Event-free survival (EFS) | Randomization until one of the following events, whichever occurs first: resection failure or progression that precludes surgery, local or distant recurrence, death (assessed up to 6 years) | ||
Secondary | Progression-free survival (PFS) | Randomization until disease progression or death, whichever occurs first (assessed up to 6 years) | ||
Secondary | Best Overall Objective Response Rate (ORR), as Assessed Per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 | Best ORR is defined as the percentage of participants who achieve complete response (CR) or partial response (PR) during treatment period. | Randomization until centrally-assessed progressive disease (PD), death, or first administration of anti-tumor treatment (other than study medication), whichever occurs first (assessed up to 6 years) |
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