A Phase 2b/3, Randomized, Double-Blind Study to Investigate the Efficacy, Safety, and Tolerability of Ponsegromab (PF-06946860) Compared With Placebo Both With Background First-Line Chemotherapy in Adult Participants With Cachexia and Metastatic Pancreatic Ductal Adenocarcinoma
Status: Recruiting
Location: See all (188) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
SUMMARY
Study to investigate the efficacy, safety and tolerability of systemic chemotherapy plus ponsegromab versus systemic chemotherapy plus placebo for the first-line treatment in adult participants with cachexia and metastatic pancreatic ductal adenocardinoma.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Signed Informed Consent Document
• Documented active diagnosis of metastatic pancreatic ductal adenocarcinoma
• Cachexia defined by Fearon criteria of weight loss
• Completed 1 x 28-day cycle of first-line systemic nab-paclitaxel and gemcitabine chemotherapy or 2 x 14-day cycles of FOLFIRINOX chemotherapy and prior to receiving Cycle 2 chemotherapy
• ECOG PS ≤1 with life expectancy of at least 4 months
Locations
United States
Alabama
The Kirklin Clinic of UAB Hospital
RECRUITING
Birmingham
The University of Alabama at Birmingham
RECRUITING
Birmingham
Arkansas
Central Arkansas Radiation Therapy Institute, dba CARTI
RECRUITING
Bryant
Central Arkansas Radiation Therapy Institute, dba CARTI
RECRUITING
Conway
CARTI Cancer Center
RECRUITING
Little Rock
Central Arkansas Radiation Therapy Institute, dba CARTI
RECRUITING
North Little Rock
Central Arkansas Radiation Therapy Institute, dba CARTI
RECRUITING
Pine Bluff
California
UC San Diego Medical Center - Encinitas
RECRUITING
Encinitas
Chao Family Comprehensive Cancer Center and Ambulatory Care
RECRUITING
Irvine
UCI Health - Irvine
RECRUITING
Irvine
UC San Diego Koman Family Outpatient Pavilion
RECRUITING
La Jolla
UC San Diego Medical Center - La Jolla (Jacobs Medical Center / Thornton Pavilion)
RECRUITING
La Jolla
UC San Diego Moores Cancer Center
RECRUITING
La Jolla
UC San Diego Sulpizio Cardiovascular Center
RECRUITING
La Jolla
Cedars-Sinai Cancer at Cedars-Sinai Medical Center
RECRUITING
Los Angeles
UCLA Department of Medicine - Hematology/Oncology
RECRUITING
Los Angeles
UC Irvine Health
RECRUITING
Orange
UC San Diego McGrath Outpatient Pavilion - Hillcrest
RECRUITING
San Diego
UC San Diego Medical Center - Bankers Hill
RECRUITING
San Diego
UC San Diego Medical Center - Hillcrest
RECRUITING
San Diego
UC San Diego Medical Center - Rancho Bernardo
RECRUITING
San Diego
UCLA Hematology/Oncology - Santa Monica
RECRUITING
Santa Monica
Providence Medical Foundation
RECRUITING
Santa Rosa
UC San Diego Medical Center - Vista
RECRUITING
Vista
Washington, D.c.
Georgetown University Medical Center
RECRUITING
Washington D.c.
Georgetown University Medical Center - Department of Pharmacy, Oncology Pharmacy
RECRUITING
Washington D.c.
Georgia
University Cancer & Blood Center, LLC
RECRUITING
Athens
Hawaii
Cardiology Associates, Inc
RECRUITING
‘aiea
Invision, LLC
RECRUITING
Honolulu
University of Hawaii Cancer Center
RECRUITING
Honolulu
Illinois
Cancer Care Specialists of Illinois
RECRUITING
Decatur
Decatur Memorial Hospital
RECRUITING
Decatur
Hope and Healing Clinical Research LLC
RECRUITING
Hinsdale
Hope and Healing Clinical Research LLC New Lenox- Research Department
RECRUITING
New Lenox
Cancer Care Specialists of Illinois - Cancer Care Center of O'Fallon
RECRUITING
O'fallon
Kansas
United Imaging Consultants
RECRUITING
Lenexa
MidAmerica Cancer Care- American Oncology Partners
RECRUITING
Merriam
Kentucky
University of Kentucky Healthcare - Markey Cancer Center
RECRUITING
Lexington
University of Kentucky Medical Center
RECRUITING
Lexington
University of Kentucky Research Foundation
RECRUITING
Lexington
University of Kentucky, Markey Cancer Center Clinical Research Office (UK MCC CRO)
RECRUITING
Lexington
Maryland
JHU Oncology Central Kit Services
RECRUITING
Baltimore
Johns Hopkins Hospital
RECRUITING
Baltimore
Oncology Investigational Drug Service (IDS)
RECRUITING
Baltimore
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
RECRUITING
Baltimore
Missouri
MidAmerica Cancer Care - American Oncology Partners
RECRUITING
Kansas City
Premier Imaging
RECRUITING
Kansas City
St. Joseph Medical Center
RECRUITING
Kansas City
North Carolina
UNC Hospitals, The University of North Carolina at Chapel Hill
RECRUITING
Chapel Hill
University of North Carolina Hospitals at Hillsborough
RECRUITING
Hillsborough
Nebraska
Nebraska Medicine
RECRUITING
Omaha
Nebraska Medicine - Village Pointe
RECRUITING
Omaha
University of Nebraska Medical Center
RECRUITING
Omaha
New Jersey
Atlantic Health System / Morristown Medical Center
NOT_YET_RECRUITING
Morristown
Jack & Sheryl Morris Cancer Center
RECRUITING
New Brunswick
Rutgers Cancer Institute
RECRUITING
New Brunswick
Rwj University Hospital Somerset
RECRUITING
Somerville
RWJ University Hospital Somerset, Steeplechase Cancer Center
RECRUITING
Somerville
Atlantic Health System / Overlook Medical Center
NOT_YET_RECRUITING
Summit
Nevada
Renown Health Medical Oncology
RECRUITING
Reno
Renown Office of Clinical Research
RECRUITING
Reno
Renown Regional Medical Center
RECRUITING
Reno
New York
Icahn School of Medicine at Mount Sinai
NOT_YET_RECRUITING
New York
University of Rochester Medical Center
RECRUITING
Rochester
Oregon
OHSU Center for Health & Healing 1
RECRUITING
Portland
Oregon Health and Science University
RECRUITING
Portland
OSHU Center for Health and Healing 2
RECRUITING
Portland
Texas
Houston Methodist Hospital
RECRUITING
Houston
Baylor Scott & White Vasicek Cancer Treatment Center
RECRUITING
Temple
Washington
Fred Hutchinson Cancer Center
NOT_YET_RECRUITING
Seattle
University of Washington Medical Center
NOT_YET_RECRUITING
Seattle
Virginia Mason Medical Center
RECRUITING
Seattle
Other Locations
Australia
Icon Cancer Centre Hobart
RECRUITING
Hobart
ICON Cancer Centre - Kurralta Park
RECRUITING
Kurralta Park
Shoalhaven District Memorial Hospital
RECRUITING
Nowra
Western Health-Sunshine & Footscray Hospitals
RECRUITING
St Albans
Westmead Hospital
RECRUITING
Westmead
Belgium
Institut Jules Bordet
NOT_YET_RECRUITING
Brussels
Grand Hôpital de Charleroi
NOT_YET_RECRUITING
Charleroi
UZ Leuven
NOT_YET_RECRUITING
Leuven
AZ Turnhout - Campus Sint-Elizabeth
RECRUITING
Turnhout
Brazil
Oncocentro
RECRUITING
Belo Horizonte
Liga Norte Riograndense Contra o Câncer
RECRUITING
Natal
Hospital Moinhos de Vento
RECRUITING
Porto Alegre
Icesp - Instituto Do Câncer Do Estado de São Paulo
RECRUITING
São Paulo
Hospital Santa Rita de Cassia
RECRUITING
Vitória
Bulgaria
Medical Center Futuremeds
RECRUITING
Plovdiv
MHAT - Sveta Sofia EOOD
NOT_YET_RECRUITING
Sofia
MHAT for Women's Health Nadezhda
RECRUITING
Sofia
University Multiprofile Hospital for Active Treatment Sofiamed
NOT_YET_RECRUITING
Sofia
Canada
Arthur J.E. Child Comprehensive Cancer Centre
RECRUITING
Calgary
CIUSSS- saguenay-Lac-Saint-Jean
RECRUITING
Chicoutimi
Centre Intégré de Santé et de Services Sociaux de la Montérégie-Centre
RECRUITING
Greenfield Park
Jewish General Hospital
RECRUITING
Montreal
The Ottawa Hospital - General Campus
RECRUITING
Ottawa
Princess Margaret Cancer Centre - University Health Network
NOT_YET_RECRUITING
Toronto
Unity Health Toronto, St. Michael's Hospital
NOT_YET_RECRUITING
Toronto
China
Affiliated Hospital of Hebei University
RECRUITING
Baoding
Beijing Tsinghua Changgung Hospital
RECRUITING
Beijing
Cancer Hospital Chinese Academy of Medical Science
RECRUITING
Beijing
Peking Union Medical College Hospital
RECRUITING
Beijing
The Second Hospital of Dalian Medical University
RECRUITING
Dalian
Fujian Cancer Hospital
RECRUITING
Fuzhou
Guangdong General Hospital
RECRUITING
Guangzhou
Sir Run Run Shaw Hospital of Zhejiang University School of Medicine
RECRUITING
Hangzhou
Anhui Provincial Hospital
NOT_YET_RECRUITING
Hefei
Huzhou Central Hospital
RECRUITING
Huzhou
Qilu Hospital of Shandong University
RECRUITING
Jinan
Cancer Hospital Chinese Academy of Medical Science
RECRUITING
Langfang
Second Hospital of Lanzhou University
RECRUITING
Lanzhou
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
RECRUITING
Shanghai
Shanghai General Hospital
RECRUITING
Shanghai
Zhongshan Hospital Fudan University
NOT_YET_RECRUITING
Shanghai
The University of Hong Kong-Shenzhen Hospital
RECRUITING
Shenzhen
The First Hospital of Shanxi Medical University
RECRUITING
Taiyuan
The First Affiliated Hospital of Wenzhou Medical University
RECRUITING
Wenzhou
The First Affiliated Hospital of Xi'an Jiaotong University
RECRUITING
Xi'an
The First Affiliated Hospital of Zhengzhou University
RECRUITING
Zhengzhou
France
Henri Mondor Hospital
RECRUITING
Créteil
Hôpital Universitaire Paul Brousse
NOT_YET_RECRUITING
Villejuif
Germany
Sana Klinikum Lichtenberg
NOT_YET_RECRUITING
Berlin
Universitaetsklinikum Carl Gustav Carus, Technischen Universitaet Dresden
NOT_YET_RECRUITING
Dresden
Universitaetsklinikum Duesseldorf
NOT_YET_RECRUITING
Düsseldorf
Apotheke am Universitätsklinikum Leipzig
NOT_YET_RECRUITING
Leipzig
Klinik und Poliklinik für Diagnostische und Interventionelle Radiologie
NOT_YET_RECRUITING
Leipzig
Universität Leipzig - Med. Fakultät
NOT_YET_RECRUITING
Leipzig
India
Sawai Man Singh Medical College Hospital (SMS Hospital)
RECRUITING
Jaipur
Chittaranjan National Cancer Institute
RECRUITING
Kolkata
Tata Memorial Hospital
RECRUITING
Mumbai
Rajiv Gandhi Cancer Institute And Research Centre
RECRUITING
New Delhi
Venkateshwar Hospital
RECRUITING
New Delhi
Israel
Rambam Health Care Campus
RECRUITING
Haifa
Hadassah Medical Center
RECRUITING
Jerusalem
Shaare Zedek Medical Center
RECRUITING
Jerusalem
Rabin Medical Center
RECRUITING
Petah Tikva
Sheba Medical Center
RECRUITING
Ramat Gan
Sourasky Medical Center
RECRUITING
Tel Aviv
Italy
Azienda Ospedaliero Universitaria delle Marche
RECRUITING
Ancona
Japan
Chiba cancer center
RECRUITING
Chiba
National Cancer Center Hospital
RECRUITING
Chuo-ku
Kyushu University Hospital
RECRUITING
Fukuoka
National Hospital Organization Kyushu Cancer Center
RECRUITING
Fukuoka
National Cancer Center Hospital East
RECRUITING
Kashiwa
St. Marianna University Hospital
RECRUITING
Kawasaki
Kagawa University Hospital
RECRUITING
Kita-gun
The Cancer Institute Hospital of JFCR
RECRUITING
Koto-ku
University Hospital,Kyoto Prefectural University of Medicine
RECRUITING
Kyoto
Shizuoka Cancer Center
RECRUITING
Nagaizumi-cho
Aichi Cancer Center Hospital
RECRUITING
Nagoya
The University of Osaka Hospital
RECRUITING
Suita
Yamaguchi University Hospital
RECRUITING
Ube
Wakayama Medical University Hospital
RECRUITING
Wakayama
Wakayama Minami Radiology Clinic
RECRUITING
Wakayama-shi Kimiidera 870-2
Kanagawa cancer center
RECRUITING
Yokohama
Mexico
Centro de Investigacion Clinica de Oaxaca
RECRUITING
Oaxaca City
Centro de Atención e Investigación Cardiovascular del Potosí S.C.
RECRUITING
San Luis Potosí City
Poland
Szpital Wojewódzki im. Mikołaja Kopernika w Koszalinie
NOT_YET_RECRUITING
Koszalin
Szpital Kliniczny Ministerstwa Spraw Wewnętrznych i Administracji z Warmińsko - Mazurskim Centrum Onkologii w Olsztynie
RECRUITING
Olsztyn
Uniwersytecki Szpital Kliniczny w Poznaniu
NOT_YET_RECRUITING
Poznan
Specjalistyczny Szpital Onkologiczny NU-MED Sp. z o.o.
NOT_YET_RECRUITING
Tomaszów Mazowiecki
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie
NOT_YET_RECRUITING
Warsaw
Puerto Rico
Pan American Center for Oncology Trials, LLC - Dorado Office
RECRUITING
Dorado
Pan American Center for Oncology Trials, LLC - Mayaguez Office
RECRUITING
Mayagüez
Pan American Center for Oncology Trials, LLC
RECRUITING
Rio Piedras
Pan American Center for Oncology Trials, LLC
RECRUITING
San Juan
Republic of Korea
Inje University Haeundae Paik Hospital
RECRUITING
Busan
Keimyung University Dongsan Hospital
RECRUITING
Daegu
Inha University Hospital
RECRUITING
Incheon
Seoul National University Bundang Hospital
RECRUITING
Seongnam
CHA Bundang Medical Center, CHA University
RECRUITING
Seongnam-si
Asan Medical Center
RECRUITING
Seoul
Samsung Medical Center
RECRUITING
Seoul
Seoul National University Hospital
RECRUITING
Seoul
Severance Hospital, Yonsei University Health System
RECRUITING
Seoul
The Catholic Univ. of Korea Seoul St. Mary's Hospital
RECRUITING
Seoul
Slovakia
Narodny onkologicky ustav
RECRUITING
Bratislava
Nemocnica s poliklinikou Stefana Kukuru Michalovce, a.s.
RECRUITING
Michalovce
Fakultna nemocnica s poliklinikou Nove Zamky
RECRUITING
Nové Zámky
Fakultna nemocnica Trnava
RECRUITING
Trnava
Spain
Hospital Clínic de Barcelona
RECRUITING
Barcelona
Hospital Universitari Vall d'Hebron
NOT_YET_RECRUITING
Barcelona
Hospital Universitario Ramón y Cajal
NOT_YET_RECRUITING
Madrid
H.R.U Málaga - Hospital General
RECRUITING
Málaga
Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
RECRUITING
Kaohsiung City
China Medical University Hospital
RECRUITING
Taichung
National Cheng Kung University Hospital
RECRUITING
Tainan
National Taiwan University Hospital
RECRUITING
Taipei
Taipei Veterans General Hospital
RECRUITING
Taipei
Contact Information
Primary
Pfizer CT.gov Call Center
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021
Time Frame
Start Date: 2025-10-03
Estimated Completion Date: 2029-12-10
Participants
Target number of participants: 982
Treatments
Experimental: Double-Blind ponsegromab Treatment lower dose
ponsegromab 200 mg subcutaneous injection every 4 weeks
Experimental: Double-Blind ponsegromab Treatment higher dose
ponsegromab 400 mg subcutaneous injection every 4 weeks
Placebo_comparator: Double-Blind Placebo Treatment
Match placebo subcutaneous injection every 4 weeks
Related Therapeutic Areas
Sponsors
Leads: Pfizer