CachexiaPhase 2/3NCT06989437
A Study to Learn About the Medicine Ponsegromab in Adults With Cancer of the Pancreas Which Has Spread and Caused Significant Body Weight Loss and Fatigue
A Phase 2/3 study testing ponsegromab in people with Cachexia and Metastatic Pancreatic Ductal Adenocarcinoma, run by Pfizer at 230 sites in 21 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cachexia, Metastatic Pancreatic Ductal Adenocarcinoma
- What is being tested?
- ponsegromab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 982 participants
- Where
- 230 sitesin 21 countries
- Study dates
- 3 Oct 2025to 24 Dec 2029
- Phase
- Phase 2/3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Current active reversible causes of decreased food intake
- Cachexia caused by other reasons
- Any prior or current clinical diagnosis of heart failure, irrespective of left ventricular ejection fraction or New York Heart Association classification
- Left ventricular ejection fraction <50%
- Receiving tube feedings or parenteral nutrition at the time of Screening or Randomization
- History of allergic or anaphylactic reaction to any therapeutic or diagnostic monoclonal antibody
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- History of allergy or hypersensitivity to any of the chemotherapeutics or any of their excipients
- Neuroendocrine (carcinoid, islet cell) or acinar pancreatic carcinoma, symptomatic brain metastasis, leptomeningeal disease or other active CNS metastases
- Inadequate liver function
- Renal disease requiring dialysis or eGFR <30 mL/min/1.73m2
Trial locations and contacts
230 sites in 21 countries. Contact the study team or a site near you to ask about taking part.
230 sites in 21 countries
United States91 sites, 91 recruiting
- Recruiting
Cardiology Associates, Inc
‘Aiea, Hawaii, 96701
- Recruiting
University Cancer & Blood Center, LLC
Athens, Georgia, 30607
- Recruiting
JHU Oncology Central Kit Services
Baltimore, Maryland, 21205
- Recruiting
Johns Hopkins Hospital
Baltimore, Maryland, 21287
- Recruiting
Oncology Investigational Drug Service (IDS)
Baltimore, Maryland, 21287
- Recruiting
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21287
- Recruiting
The Kirklin Clinic of UAB Hospital
Birmingham, Alabama, 35233
- Recruiting
The University of Alabama at Birmingham
Birmingham, Alabama, 35294
- Recruiting
Central Arkansas Radiation Therapy Institute, dba CARTI
Bryant, Arkansas, 72022
- Recruiting
UNC Hospitals, The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27514
- Recruiting
Levine Cancer Institute
Charlotte, North Carolina, 28204
- Recruiting
Central Arkansas Radiation Therapy Institute, dba CARTI
Conway, Arkansas, 72034
- Recruiting
University of Texas Southwestern Medical Center - Simmons Cancer Center
Dallas, Texas, 75235
- Recruiting
University of Texas Southwestern Medical Center-William P. Clements Jr. University Hospital
Dallas, Texas, 75235
- Recruiting
University of Texas Southwestern Medical Center-Zale Lipshy University Hospital
Dallas, Texas, 75390
- Recruiting
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
- Recruiting
Cancer Care Specialists of Illinois
Decatur, Illinois, 62526
- Recruiting
Decatur Memorial Hospital
Decatur, Illinois, 62526
- Recruiting
UC San Diego Medical Center - Encinitas
Encinitas, California, 92024
- Recruiting
University of North Carolina Hospitals at Hillsborough
Hillsborough, North Carolina, 27278
- Recruiting
Hope and Healing Clinical Research LLC
Hinsdale, Illinois, 60521
- Recruiting
Invision, LLC
Honolulu, Hawaii, 96813
- Recruiting
University of Hawaii Cancer Center
Honolulu, Hawaii, 96813
- Recruiting
Houston Methodist Hospital
Houston, Texas, 77030
- Recruiting
Chao Family Comprehensive Cancer Center and Ambulatory Care
Irvine, California, 92612
- Recruiting
UCI Health - Irvine
Irvine, California, 92612
- Recruiting
Mayo Clinic Pharmacy
Jacksonville, Florida, 32224
- Recruiting
Mayo Clinic
Jacksonville, Florida, 32224
- Recruiting
Premier Imaging
Kansas City, Missouri, 64114
- Recruiting
St. Joseph Medical Center
Kansas City, Missouri, 64114
- Recruiting
MidAmerica Cancer Care - American Oncology Partners
Kansas City, Missouri, 64132
- Recruiting
UC San Diego Koman Family Outpatient Pavilion
La Jolla, California, 92037
- Recruiting
UC San Diego Medical Center - La Jolla (Jacobs Medical Center / Thornton Pavilion)
La Jolla, California, 92037
- Recruiting
UC San Diego Moores Cancer Center
La Jolla, California, 92037
- Recruiting
UC San Diego Sulpizio Cardiovascular Center
La Jolla, California, 92037
- Recruiting
United Imaging Consultants
Lenexa, Kansas, 66215
- Recruiting
University of Kentucky Research Foundation
Lexington, Kentucky, 40506
- Recruiting
University of Kentucky Healthcare - Markey Cancer Center
Lexington, Kentucky, 40536
- Recruiting
University of Kentucky Medical Center
Lexington, Kentucky, 40536
- Recruiting
University of Kentucky, Markey Cancer Center Clinical Research Office (UK MCC CRO)
Lexington, Kentucky, 40536
- Recruiting
CARTI Cancer Center
Little Rock, Arkansas, 72205
- Recruiting
Cedars-Sinai Cancer at Cedars-Sinai Medical Center
Los Angeles, California, 90048
- Recruiting
UCLA Department of Medicine - Hematology/Oncology
Los Angeles, California, 90095
- Recruiting
MidAmerica Cancer Care- American Oncology Partners
Merriam, Kansas, 66204
- Recruiting
Froedtert Hospital and the Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
- Recruiting
Atlantic Health System / Morristown Medical Center
Morristown, New Jersey, 07960
- Recruiting
Henry-Joyce Cancer Clinic
Nashville, Tennessee, 37232
- Recruiting
Jack & Sheryl Morris Cancer Center
New Brunswick, New Jersey, 08901
- Recruiting
Rutgers Cancer Institute
New Brunswick, New Jersey, 08901
- Recruiting
Hope and Healing Clinical Research LLC New Lenox- Research Department
New Lenox, Illinois, 60451
- Recruiting
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
- Recruiting
Central Arkansas Radiation Therapy Institute, dba CARTI
North Little Rock, Arkansas, 72117
- Recruiting
Cancer Care Specialists of Illinois - Cancer Care Center of O'Fallon
O'Fallon, Illinois, 62269
- Recruiting
Nebraska Medicine
Omaha, Nebraska, 68105
- Recruiting
Nebraska Medicine - Village Pointe
Omaha, Nebraska, 68118
- Recruiting
University of Nebraska Medical Center
Omaha, Nebraska, 68198
- Recruiting
UC Irvine Health
Orange, California, 92868
- Recruiting
Mayo Clinic Hospital
Phoenix, Arizona, 85054
- Recruiting
Central Arkansas Radiation Therapy Institute, dba CARTI
Pine Bluff, Arkansas, 71603
- Recruiting
OHSU Center for Health & Healing 1
Portland, Oregon, 97239
- Recruiting
Oregon Health and Science University
Portland, Oregon, 97239
- Recruiting
OSHU Center for Health and Healing 2
Portland, Oregon, 97239
- Recruiting
Renown Health Medical Oncology
Reno, Nevada, 89502
- Recruiting
Renown Office of Clinical Research
Reno, Nevada, 89502
- Recruiting
Renown Regional Medical Center
Reno, Nevada, 89502
- Not yet recruiting
VCU Medical Center Gateway Building
Richmond, Virginia, 23219
- Not yet recruiting
Virginia Commonwealth University
Richmond, Virginia, 23219
- Not yet recruiting
VCU Health Short Pump Pavilion
Richmond, Virginia, 23233
- Not yet recruiting
VCU Health Stony Point
Richmond, Virginia, 23235
- Not yet recruiting
Massey Cancer Center Clinical & Translational Research Lab
Richmond, Virginia, 23298
- Not yet recruiting
Virginia Commonwealth University
Richmond, Virginia, 23298
- Recruiting
Mayo Clinic Cancer Center Outpatient Pharmacy
Rochester, Minnesota, 55905
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55905
- Recruiting
University of Rochester Medical Center
Rochester, New York, 14642
- Recruiting
UC San Diego Medical Center - Bankers Hill
San Diego, California, 92101
- Recruiting
UC San Diego McGrath Outpatient Pavilion - Hillcrest
San Diego, California, 92103
- Recruiting
UC San Diego Medical Center - Hillcrest
San Diego, California, 92103
- Recruiting
UC San Diego Medical Center - Rancho Bernardo
San Diego, California, 92127
- Recruiting
UCLA Hematology/Oncology - Santa Monica
Santa Monica, California, 90404
- Recruiting
Providence Medical Foundation
Santa Rosa, California, 95403
- Recruiting
Virginia Mason Medical Center
Seattle, Washington, 98101
- Recruiting
Fred Hutchinson Cancer Center
Seattle, Washington, 98109
- Recruiting
University of Washington Medical Center
Seattle, Washington, 98195
- Recruiting
RWJ University Hospital Somerset, Steeplechase Cancer Center
Somerville, New Jersey, 08876
- Recruiting
Rwj University Hospital Somerset
Somerville, New Jersey, 08876
- Recruiting
Atlantic Health System / Overlook Medical Center
Summit, New Jersey, 07901
- Not yet recruiting
VCU Health Tappahannock Hospital
Tappahannock, Virginia, 22560
- Recruiting
Baylor Scott & White Vasicek Cancer Treatment Center
Temple, Texas, 76508
- Recruiting
UC San Diego Medical Center - Vista
Vista, California, 92081
- Recruiting
Georgetown University Medical Center - Department of Pharmacy, Oncology Pharmacy
Washington D.C., District of Columbia, 20007
- Recruiting
Georgetown University Medical Center
Washington D.C., District of Columbia, 20007
China21 sites, 21 recruiting
- Recruiting
Affiliated Hospital of Hebei University
Baoding, Hebei, 071000
- Recruiting
Cancer Hospital Chinese Academy of Medical Science
Beijing, Beijing Municipality, 100021
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
- Recruiting
Beijing Tsinghua Changgung Hospital
Beijing, 102218
- Recruiting
The Second Hospital of Dalian Medical University
Dalian, Liaoning, 116004
- Recruiting
Fujian Cancer Hospital
Fuzhou, Fujian, 350014
- Recruiting
Guangdong General Hospital
Guangzhou, Guangdong, 510080
- Recruiting
Sir Run Run Shaw Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310015
- Recruiting
Anhui Provincial Hospital
Hefei, Anhui, 230071
- Recruiting
Huzhou Central Hospital
Huzhou, Zhejiang, 313000
- Recruiting
Qilu Hospital of Shandong University
Jinan, Shandong, 250012
- Recruiting
Cancer Hospital Chinese Academy of Medical Science
Langfang, Hebei, 065001
- Recruiting
Second Hospital of Lanzhou University
Lanzhou, Gansu, 730030
- Recruiting
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200025
- Recruiting
Zhongshan Hospital Fudan University
Shanghai, 200032
- Recruiting
Shanghai General Hospital
Shanghai, 200080
- Recruiting
The University of Hong Kong-Shenzhen Hospital
Shenzhen, Guangdong, 518053
- Recruiting
The First Hospital of Shanxi Medical University
Taiyuan, Shanxi, 030001
- Recruiting
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000
- Recruiting
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710061
- Recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450000
Japan16 sites, 16 recruiting
- Recruiting
Chiba cancer center
Chiba, Chiba, 260-8717
- Recruiting
National Cancer Center Hospital
Chuo-ku, Tokyo, 104-0045
- Recruiting
National Hospital Organization Kyushu Cancer Center
Fukuoka, 811-1395
- Recruiting
Kyushu University Hospital
Fukuoka, 812-8582
- Recruiting
National Cancer Center Hospital East
Kashiwa, Chiba, 277-8577
- Recruiting
St. Marianna University Hospital
Kawasaki, Kanagawa, 216-8511
- Recruiting
Kagawa University Hospital
Kita-gun, Kagawa-ken, 761-0793
- Recruiting
The Cancer Institute Hospital of JFCR
Koto-ku, Tokyo, 135-8550
- Recruiting
University Hospital,Kyoto Prefectural University of Medicine
Kyoto, 602-8566
- Recruiting
Shizuoka Cancer Center
Nagaizumi-cho, Shizuoka, 411-8777
- Recruiting
Aichi Cancer Center Hospital
Nagoya, Aichi-ken, 464-8681
- Recruiting
The University of Osaka Hospital
Suita, Osaka, 565-0871
- Recruiting
Yamaguchi University Hospital
Ube, Yamaguchi, 755-8505
- Recruiting
Wakayama Medical University Hospital
Wakayama, 641-8510
- Recruiting
Wakayama Minami Radiology Clinic
Wakayama-shi Kimiidera 870-2, Wakayama, 641-0012
- Recruiting
Kanagawa cancer center
Yokohama, Kanagawa, 2418515
South Korea10 sites, 10 recruiting
- Recruiting
Inje University Haeundae Paik Hospital
Busan, 48108
- Recruiting
Keimyung University Dongsan Hospital
Daegu, Taegu-kwangyǒkshi, 42601
- Recruiting
Inha University Hospital
Incheon, Incheon-gwangyeoksi [incheon], 22332
- Recruiting
Seoul National University Bundang Hospital
Seongnam, Kyǒnggi-do, 13620
- Recruiting
CHA Bundang Medical Center, CHA University
Seongnam-si, Kyǒnggi-do, 13496
- Recruiting
Asan Medical Center
Seoul, Seoul Teukbyeolsi, 05505
- Recruiting
Seoul National University Hospital
Seoul, Seoul-teukbyeolsi [seoul], 03080
- Recruiting
Severance Hospital, Yonsei University Health System
Seoul, Seoul-teukbyeolsi [seoul], 03722
- Recruiting
Samsung Medical Center
Seoul, Seoul-teukbyeolsi [seoul], 06351
- Recruiting
The Catholic Univ. of Korea Seoul St. Mary's Hospital
Seoul, Seoul-teukbyeolsi [seoul], 06591
Canada8 sites, 8 recruiting
- Recruiting
Arthur J.E. Child Comprehensive Cancer Centre
Calgary, Alberta, T2N 5G2
- Recruiting
CIUSSS- saguenay-Lac-Saint-Jean
Chicoutimi, Quebec, G7H 5H6
- Recruiting
Centre Intégré de Santé et de Services Sociaux de la Montérégie-Centre
Greenfield Park, Quebec, J4V 2H1
- Recruiting
Jewish General Hospital
Montreal, Quebec, H3T 1E2
- Recruiting
The Ottawa Hospital - General Campus
Ottawa, Ontario, K1H 8L6
- Recruiting
Sunnybrook Research Institute
Toronto, Ontario, M4N 3M5
- Recruiting
Unity Health Toronto, St. Michael's Hospital
Toronto, Ontario, M5B 1W8
- Recruiting
Princess Margaret Cancer Centre - University Health Network
Toronto, Ontario, M5G 2M9
Germany8 sites, 8 recruiting
- Not yet recruiting
Sana Klinikum Lichtenberg
Berlin, 10365
- Recruiting
Universitaetsklinikum Carl Gustav Carus, Technischen Universitaet Dresden
Dresden, Saxony, 01307
- Recruiting
Universitaetsklinikum Duesseldorf
Düsseldorf, North Rhine-Westphalia, 40225
- Not yet recruiting
Apotheke am Universitätsklinikum Leipzig
Leipzig, Saxony, 04103
- Not yet recruiting
Klinik und Poliklinik für Diagnostische und Interventionelle Radiologie
Leipzig, Saxony, 04103
- Not yet recruiting
Universität Leipzig - Med. Fakultät
Leipzig, Saxony, 04103
- Recruiting
Muenchen Klinik Neuperlach, Klinik fuer Haematologie und Onkologie
München, Bavaria, 81737
- Not yet recruiting
Klinikum rechts der Isar der Technischen Universität München
München, 81675
United Kingdom7 sites, 7 recruiting
- Recruiting
Addenbrooke's Hospital
Cambridge, Cambridgeshire, CB2 2QQ
- Recruiting
Western General Hospital
Edinburgh, Midlothian, EH4 2XU
- Recruiting
The Clatterbridge Cancer Centre
Liverpool, L7 8YA
- Recruiting
Royal Free Hospital
London, England, NW32QG
- Recruiting
Guy's & St Thomas' NHS Foundation Trust
London, SE1 9RT
- Recruiting
Royal Marsden Hospital (Chelsea)
London, SW3 6JJ
- Recruiting
Hammersmith Hospital
London, W12 0HS
India6 sites, 6 recruiting
- Recruiting
Sawai Man Singh Medical College Hospital (SMS Hospital)
Jaipur, Rajasthan, 302004
- Recruiting
Chittaranjan National Cancer Institute
Kolkata, West Bengal, 700160
- Recruiting
Tata Memorial Hospital
Mumbai, Maharashtra, 400012
- Not yet recruiting
Vardhman Mahavir Medical College and Safdarjung Hospital
New Delhi, National Capital Territory of Delhi, 110029
- Recruiting
Venkateshwar Hospital
New Delhi, National Capital Territory of Delhi, 110075
- Recruiting
Rajiv Gandhi Cancer Institute And Research Centre
New Delhi, National Capital Territory of Delhi, 110085
Israel6 sites, 6 recruiting
- Recruiting
Rambam Health Care Campus
Haifa, Heifa, 3109601
- Recruiting
Shaare Zedek Medical Center
Jerusalem, Jerusalem, 9103102
- Recruiting
Hadassah Medical Center
Jerusalem, Jerusalem, 9112001
- Recruiting
Rabin Medical Center
Petah Tikva, Central District, 4941492
- Recruiting
Sheba Medical Center
Ramat Gan, Central District, 5265601
- Recruiting
Sourasky Medical Center
Tel Aviv, TELL ABĪB, 6423906
Slovakia6 sites, 6 recruiting
- Recruiting
Narodny onkologicky ustav
Bratislava, 833 10
- Recruiting
Vychodoslovensky Onkologicky Ustav a.s.
Košice, 040 01
- Recruiting
Nemocnica s poliklinikou Stefana Kukuru Michalovce, a.s.
Michalovce, 07101
- Recruiting
Fakultna nemocnica s poliklinikou Nove Zamky
Nové Zámky, 940 34
- Recruiting
Fakultna nemocnica Trencin
Trenčín, Trenčín Region, 911 01
- Recruiting
Fakultna nemocnica Trnava
Trnava, 917 75
Spain6 sites, 6 recruiting
- Recruiting
Hospital Universitari Vall d'Hebron
Barcelona, Barcelona [barcelona], 08035
- Recruiting
Hospital Clínic de Barcelona
Barcelona, Catalunya [cataluña], 08036
- Recruiting
Hospital Universitario Ramón y Cajal
Madrid, Madrid, Comunidad de, 28034
- Recruiting
Hospital General Universitario Gregorio Marañon
Madrid, 28007
- Recruiting
H.R.U Málaga - Hospital General
Málaga, 29011
- Not yet recruiting
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, 33011
Australia5 sites, 5 recruiting
- Recruiting
Icon Cancer Centre Hobart
Hobart, Tasmania, 7000
- Recruiting
ICON Cancer Centre - Kurralta Park
Kurralta Park, South Australia, 5037
- Recruiting
Shoalhaven District Memorial Hospital
Nowra, New South Wales, 2541
- Recruiting
Western Health-Sunshine & Footscray Hospitals
St Albans, Victoria, 3021
- Recruiting
Westmead Hospital
Westmead, New South Wales, 2145
Belgium5 sites, 5 recruiting
- Recruiting
Cliniques universitaires Saint-Luc
Brussels, Bruxelles-capitale, Région de, 1200
- Not yet recruiting
Institut Jules Bordet
Brussels, 1000
- Recruiting
Grand Hôpital de Charleroi
Charleroi, Hainaut, 6060
- Recruiting
UZ Leuven
Leuven, Vlaams-brabant, 3000
- Recruiting
AZ Turnhout - Campus Sint-Elizabeth
Turnhout, Antwerpen, 2300
Brazil5 sites, 5 recruiting
- Recruiting
Oncocentro
Belo Horizonte, Minas Gerais, 30.360-680
- Recruiting
Liga Norte Riograndense Contra o Câncer
Natal, Rio Grande do Norte, 59062-000
- Recruiting
Hospital Moinhos de Vento
Porto Alegre, Rio Grande do Sul, 90560032
- Recruiting
Icesp - Instituto Do Câncer Do Estado de São Paulo
São Paulo, 01246-000
- Recruiting
Hospital Santa Rita de Cassia
Vitória, Espírito Santo, 29041-295
France5 sites, 5 recruiting
- Recruiting
Henri Mondor Hospital
Créteil, Val-de-marne, 94010
- Recruiting
Institut Paoli-Calmettes
Marseille, Provence-Alpes-Côte d'Azur Region, 13273
- Recruiting
Centre Hospitalier Universitaire de Poitiers
Poitiers, Vienne, 86 000
- Not yet recruiting
Gustave Roussy
Villejuif, Val-de-marne, 94800
- Recruiting
Hôpital Universitaire Paul Brousse
Villejuif, 94800
Poland5 sites, 5 recruiting
- Recruiting
Szpital Wojewódzki im. Mikołaja Kopernika w Koszalinie
Koszalin, 75-581
- Recruiting
Szpital Kliniczny Ministerstwa Spraw Wewnętrznych i Administracji z Warmińsko - Mazurskim Centrum Onkologii w Olsztynie
Olsztyn, Warmian-Masurian Voivodeship, 10-228
- Recruiting
Uniwersytecki Szpital Kliniczny w Poznaniu
Poznan, 60-569
- Recruiting
Specjalistyczny Szpital Onkologiczny NU-MED Sp. z o.o.
Tomaszów Mazowiecki, 97-200
- Recruiting
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie
Warsaw, Masovian Voivodeship, 02-034
Taiwan5 sites, 5 recruiting
- Recruiting
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, 807
- Recruiting
China Medical University Hospital
Taichung, 404332
- Recruiting
National Cheng Kung University Hospital
Tainan, 704
- Recruiting
National Taiwan University Hospital
Taipei, 10002
- Recruiting
Taipei Veterans General Hospital
Taipei, 11217
Bulgaria4 sites, 4 recruiting
- Recruiting
Medical Center Futuremeds
Plovdiv, 4002
- Recruiting
MHAT for Women's Health Nadezhda
Sofia, 1330
- Recruiting
MHAT - Sveta Sofia EOOD
Sofia, 1618
- Recruiting
University Multiprofile Hospital for Active Treatment Sofiamed
Sofia, 1797
Italy4 sites, 4 recruiting
- Recruiting
Azienda Ospedaliero Universitaria delle Marche
Ancona, 60126
- Recruiting
Azienda Ospedaliera Universitaria Careggi
Florence, Tuscany, 50134
- Recruiting
Azienda Ospedaliera Universitaria Ospedali Riuniti - Foggia
Foggia, 71122
- Recruiting
Niguarda Cancer Center, ASST Grande Ospedale Metropolitano Niguarda
Milan, Milan, 20162
Puerto Rico4 sites, 4 recruiting
- Recruiting
Pan American Center for Oncology Trials, LLC - Dorado Office
Dorado, 00646
- Recruiting
Pan American Center for Oncology Trials, LLC - Mayaguez Office
Mayagüez, 00680
- Recruiting
Pan American Center for Oncology Trials, LLC
Rio Piedras, 00935
- Recruiting
Pan American Center for Oncology Trials, LLC
San Juan, 00909
Mexico3 sites, 3 recruiting
- Recruiting
Antiguo Hospital Civil de Guadalajara "Fray Antonio Alcalde"
Guadalajara, Jalisco, 44280
- Recruiting
Centro de Investigacion Clinica de Oaxaca
Oaxaca City, Oaxaca, 68020
- Recruiting
Centro de Atención e Investigación Cardiovascular del Potosí S.C.
San Luis Potosí City, 78200
About this study
Official title: 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
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.
Read the detailed description
A Phase 2b/3, randomized, double-blind, multicenter, multinational 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 mPDAC. The first-line chemotherapies will either be nab-paclitaxel plus gemcitabine or FOLFIRINOX (or mFOLFIRINOX). The double-blind period is followed by an optional open-label extension period.
Initial enrollment will be in Phase 2b. If all eligibility criteria are met, participants will be randomized in a 1:1:1 allocation to study intervention (one of the two doses of ponsegromab, or placebo) plus first-line systemic chemotherapy. Participants must have completed their first-line pre-randomization systemic chemotherapy (1 x 28-day cycle of nab-paclitaxel and gemcitabine or 2 x 14-days cycles of FOLFIRINOX) prior to the start of receiving their first dose (Day 1) of study intervention (ponsegromab or placebo). Day 1 study intervention must be taken on the same day participants start their next cycle of nab-paclitaxel and gemcitabine chemotherapy or FOLFIRINOX chemotherapy and prior to receiving chemotherapy. All chemotherapy dosing is to be determined by the participant's health care provider in accordance with local guidelines. Study intervention will be administered Q4W SC.
Following enrollment completion of Phase 2b, Phase 3 enrollment will begin, and eligible participants will be randomized in a 1:1:1 allocation to study intervention (one of the two doses of ponsegromab, or placebo). Participants must have completed their first-line pre-randomization systemic chemotherapy (1 x 28-day cycle of nab-paclitaxel and gemcitabine or 2 x 14-day cycles of FOLFIRINOX) prior to the start of receiving their first dose (Day 1) of study intervention (ponsegromab or placebo). Day 1 study intervention must be taken on the same day participants start their next cycle of nab-paclitaxel and gemcitabine chemotherapy or FOLFIRINOX chemotherapy and prior to receiving chemotherapy. All chemotherapy dosing is to be determined by the participant's health care provider in accordance with local guidelines. Study intervention will be administered Q4W SC.
Once all Phase 2b participants have completed Week 12 procedures, an analysis of Phase 2b will be performed, from which one of the 2 ponsegromab doses will be selected. After the Phase 3 ponsegromab dose has been selected, continuing Phase 2b participants will:
- Continue the ponsegromab dose selected for Phase 3 if already randomized to that dose, OR
- Be switched to the ponsegromab dose selected for Phase 3 if randomized to the non-selected ponsegromab dose, OR
- Continue receiving placebo if randomized to placebo
- Remain blinded to study treatment
After the ponsegromab dose has been selected, continuing Phase 3 participants will:
- Continue the ponsegromab dose selected for Phase 3 if already randomized to that dose, OR
- Be switched to the ponsegromab dose selected for Phase 3 if randomized to the non-selected ponsegromab dose, OR
- Continue receiving placebo if randomized to placebo
- Remain blinded to study treatment Phase 3 participants enrolled after dose selection will be randomized 1:1 (ponsegromab selected dose: placebo). Participants must have completed their first-line pre-randomization systemic chemotherapy (1 x 28-day cycle of nab-paclitaxel and gemcitabine or 2 x 14-days cycles of FOLFIRINOX) prior to the start of receiving their first dose (Day 1) of study intervention (selected Phase 3 ponsegromab dose or placebo). Day 1 study intervention must be taken on the same day participants start their next cycle of nab-paclitaxel and gemcitabine chemotherapy or FOLFIRINOX chemotherapy and prior to receiving chemotherapy.
During the Phase 3 portion of the study, there will be an optional sub-study for primary caregivers of participants with cachexia and mPDAC to evaluate the effectiveness of ponsegromab in improving the quality of life and well-being of the primary caregivers.
Study intervention (ponsegromab selected dose or placebo) will continue regardless of chemotherapy treatment until permanent discontinuation of study intervention, withdrawal of consent, death, or the end of the Phase 3 double-blind portion of the study has been reached when the approximate number of overall survival events have been accrued for the Phase 3 analysis of overall survival.
Participants will have tumor assessments performed approximately every 6 to 8 weeks during the double-blind period by blinded, independent, central reader radiologists.
When the number of overall survival events has been accrued to terminate the Phase 3 double-blind portion of the study, active participants can continue in the optional open-label extension where they will receive ponsegromab for up to 12 months.
- Being tested
- ponsegromab, placebo
- Keywords
- pancreatic cancer, metastatic cancer, cancer, anorexia, cachexia, weight loss, loss of appetite, fatigue
- Medical subject headings
- Cachexia, Pancreatic Neoplasms, Neoplasm Metastasis, Neoplasms, Anorexia, Weight Loss, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ponsegromabDrug
Double-Blind ponsegromab Treatment
placeboDrug
Double-Blind placebo Treatment
| Study group | Role | What they receive |
|---|---|---|
| Double-Blind ponsegromab Treatment lower dose | Experimental | ponsegromab 200 mg subcutaneous injection every 4 weeks Receives: Drug: ponsegromab |
| Double-Blind ponsegromab Treatment higher dose | Experimental | ponsegromab 400 mg subcutaneous injection every 4 weeks Receives: Drug: ponsegromab |
| Double-Blind Placebo Treatment | Placebo comparator | Match placebo subcutaneous injection every 4 weeks Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change from baseline in body weight for ponsegromab compared to placebo
Measured: Baseline, Week 12
Change from baseline in Functional Assessment of Anorexia/Cachexia Therapy 5-item Anorexia Symptom Scale scores
Scale consists of five items, each rated 0-4. Total score ranges from 0 (minimum) to 20 (maximum). Higher scores are associated with a better outcome.
Measured: Baseline, Week 12
Secondary outcomes (21)
Change from baseline in non-sedentary physical activity time
measured by wearable Digital Health Technology watch
Measured: Baseline, Week 12
Overall survival
Outcome defined as the time from randomization to occurrence of all-cause death
Measured: Randomization through completion of Phase 3 of the study, an average of 1 year
Change from baseline in body weight (kg)
Measured: Baseline, Week 12 and up to Week 52
Change from baseline at Week 12 in physical activity as measured by total vector magnitude
measured by wearable Digital Health Technology watch
Measured: Baseline, Week 12
Effect on progression free survival
determined by Blinded Independent Central Review
Measured: Randomization through completion of Phase 3 of the study, an average of 1 year
Effect on objective response rate
determined by Blinded Independent Central Review
Measured: Baseline, Week 52
Effect on disease control rate
determined by Blinded Independent Central Review
Measured: Baseline, Week 52
Effect on duration of response
determined by Blinded Independent Central Review
Measured: Baseline, Week 52
Change from baseline in skeletal muscle area and radiodensity at third lumbar vertebra (L3)
measured by CT (or MRI) scan
Measured: Baseline, Week 12
Change from baseline in intermuscular adipose area and radiodensity at L3
measured by CT (or MRI) scan
Measured: Baseline, Week 12
Change from baseline in subcutaneous adipose area and radiodensity at L3
measured by CT (or MRI) scan
Measured: Baseline, Week 12
Change from baseline in visceral adipose area and radiodensity at L3
measured by CT (or MRI) scan
Measured: Baseline, Week 12
Number of participants with incidence of Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Adverse Events (AEs) leading to permanent discontinuation from study intervention or from study.
Measured: Baseline, Week 12 and up to Week 52
Number of participants with laboratory test abnormalities.
Measured: Baseline, Week 12 and up to Week 52
Number of participants with vital signs abnormalities.
Measured: Baseline, Week 12 and up to Week 52
Change in physical function, assessed on participant completed Patient-Reported Outcomes Measurement Information System Physical Function (version 8c) questionnaire.
The overall score range for the T-score is 0-100. Higher scores indicate better outcome.
Measured: Baseline, Week 12 and up to Week 52
Change in fatigue, as assessed on participant completed Patient-Reported Outcomes Measurement Information System - Fatigue (version 7a) questionnaire.
The overall score range for the T-score is 29.4-83.2. Lower scores indicate better outcome.
Measured: Baseline, Week 12 and up to Week 52
Occurrence and severity of symptomatic AEs including diarrhea, nausea, vomiting, decreased appetite, fatigue and mouth sores by maximum grade as assessed by the NCI PRO CTCAE.
Measured: Baseline, Week 52
Change from baseline on ECOG PS
Measured: Baseline, Week 12 and up to Week 52
Occurrence of chemotherapy dosing changes (including dosing reductions, dosing interruptions, and dosing discontinuations) due to occurrence of the TEAEs of nausea, vomiting, diarrhea, loss of appetite, or fatigue
Measured: Baseline, up to Week 52
Tumor status
Assessment of tumor response to treatment as determined by Blinded Independent Central Review assessment per RECIST 1.1 using CT scan (or MRI)
Measured: Baseline, Week 12 and up to Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2025
- Study start3 Oct 2025
- Primary completion23 Jan 2028 (estimated)
- Study completion24 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CachexiaStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 982 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06989437
- Sponsor's protocol ID
- C3651021
- Other IDs
- 2025-522093-36-00, 2025
- Status last verified
- Oct 2026
- First submitted
- 7 May 2025
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.