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

June 9, 2026 updated by: Pfizer

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

982

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
    • New South Wales
      • Nowra, New South Wales, Australia, 2541
        • Recruiting
        • Shoalhaven District Memorial Hospital
      • Westmead, New South Wales, Australia, 2145
        • Recruiting
        • Westmead Hospital
    • South Australia
      • Kurralta Park, South Australia, Australia, 5037
        • Recruiting
        • ICON Cancer Centre - Kurralta Park
    • Tasmania
      • Hobart, Tasmania, Australia, 7000
        • Recruiting
        • Icon Cancer Centre Hobart
    • Victoria
      • St Albans, Victoria, Australia, 3021
        • Recruiting
        • Western Health-Sunshine & Footscray Hospitals
  • Belgium
      • Brussels, Belgium, 1000
        • Not yet recruiting
        • Institut Jules Bordet
    • Antwerpen
      • Turnhout, Antwerpen, Belgium, 2300
        • Recruiting
        • AZ Turnhout - Campus Sint-Elizabeth
    • Hainaut
      • Charleroi, Hainaut, Belgium, 6060
        • Not yet recruiting
        • Grand Hôpital de Charleroi
    • Vlaams-brabant
      • Leuven, Vlaams-brabant, Belgium, 3000
        • Not yet recruiting
        • UZ Leuven
  • Brazil
      • São Paulo, Brazil, 01246-000
        • Recruiting
        • Icesp - Instituto Do Câncer Do Estado de São Paulo
    • Espírito Santo
      • Vitória, Espírito Santo, Brazil, 29041-295
        • Recruiting
        • Hospital Santa Rita de Cassia
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brazil, 30.360-680
        • Recruiting
        • Oncocentro
    • Rio Grande do Norte
      • Natal, Rio Grande do Norte, Brazil, 59062-000
        • Recruiting
        • Liga Norte Riograndense contra o cancer
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil, 90560032
        • Recruiting
        • Hospital Moinhos de Vento
  • Bulgaria
      • Plovdiv, Bulgaria, 4002
        • Recruiting
        • Medical Center Futuremeds
      • Sofia, Bulgaria, 1330
        • Recruiting
        • MHAT for Women's Health Nadezhda
      • Sofia, Bulgaria, 1797
        • Not yet recruiting
        • University Multiprofile Hospital for Active Treatment Sofiamed
      • Sofia, Bulgaria, 1618
        • Not yet recruiting
        • MHAT - Sveta Sofia EOOD
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 5G2
        • Recruiting
        • Arthur J.E. Child Comprehensive Cancer Centre
    • Ontario
      • Ottawa, Ontario, Canada, K1H 8L6
        • Recruiting
        • The Ottawa Hospital - General Campus
      • Toronto, Ontario, Canada, M5B 1W8
        • Not yet recruiting
        • Unity Health Toronto, St. Michael's Hospital
      • Toronto, Ontario, Canada, M5G 2M9
        • Not yet recruiting
        • Princess Margaret Cancer Centre - University Health Network
    • Quebec
      • Chicoutimi, Quebec, Canada, G7H 5H6
        • Recruiting
        • CIUSSS- saguenay-Lac-Saint-Jean
      • Greenfield Park, Quebec, Canada, J4V 2H1
        • Recruiting
        • Centre Intégré de Santé et de Services Sociaux de la Montérégie-Centre
      • Montreal, Quebec, Canada, H3T 1E2
        • Recruiting
        • Jewish General Hospital
  • China
      • Beijing, China, 102218
        • Recruiting
        • Beijing Tsinghua Changgung Hospital
      • Shanghai, China, 200032
        • Not yet recruiting
        • Zhongshan Hospital Fudan University
      • Shanghai, China, 200080
        • Recruiting
        • Shanghai General Hospital
    • Anhui
      • Hefei, Anhui, China, 230071
        • Not yet recruiting
        • Anhui Provincial Hospital
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100730
        • Recruiting
        • Peking Union Medical College Hospital
      • Beijing, Beijing Municipality, China, 100021
        • Recruiting
        • Cancer Hospital Chinese Academy of Medical Science
    • Fujian
      • Fuzhou, Fujian, China, 350014
        • Recruiting
        • Fujian Cancer Hospital
    • Gansu
      • Lanzhou, Gansu, China, 730030
        • Recruiting
        • Second Hospital of Lanzhou University
    • Guangdong
      • Guangzhou, Guangdong, China, 510080
        • Recruiting
        • Guangdong General Hospital
      • Shenzhen, Guangdong, China, 518053
        • Recruiting
        • The University of Hong Kong-Shenzhen Hospital
    • Hebei
      • Baoding, Hebei, China, 071000
        • Recruiting
        • Affiliated Hospital of Hebei University
      • Langfang, Hebei, China, 065001
        • Recruiting
        • Cancer Hospital Chinese Academy of Medical Science
    • Henan
      • Zhengzhou, Henan, China, 450000
        • Recruiting
        • The First Affiliated Hospital of Zhengzhou University
    • Liaoning
      • Dalian, Liaoning, China, 116004
        • Recruiting
        • The Second Hospital of Dalian Medical University
    • Shaanxi
      • Xi'an, Shaanxi, China, 710061
        • Recruiting
        • The First Affiliated Hospital of Xi'an Jiaotong University
    • Shandong
      • Jinan, Shandong, China, 250012
        • Recruiting
        • Qilu Hospital of Shandong University
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200025
        • Recruiting
        • Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
    • Shanxi
      • Taiyuan, Shanxi, China, 030001
        • Recruiting
        • The First Hospital of Shanxi Medical University
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310015
        • Recruiting
        • Sir Run Run Shaw Hospital of Zhejiang University School of Medicine
      • Huzhou, Zhejiang, China, 313000
        • Recruiting
        • Huzhou Central Hospital
      • Wenzhou, Zhejiang, China, 325000
        • Recruiting
        • The First Affiliated Hospital of Wenzhou Medical University
  • France
      • Villejuif, France, 94800
        • Not yet recruiting
        • Hôpital Universitaire Paul Brousse
    • Val-de-marne
      • Créteil, Val-de-marne, France, 94010
        • Recruiting
        • Henri Mondor Hospital
  • Germany
      • Berlin, Germany, 10365
        • Not yet recruiting
        • Sana Klinikum Lichtenberg
    • North Rhine-Westphalia
      • Düsseldorf, North Rhine-Westphalia, Germany, 40225
        • Not yet recruiting
        • Universitaetsklinikum Duesseldorf
    • Saxony
      • Dresden, Saxony, Germany, 01307
        • Not yet recruiting
        • Universitaetsklinikum Carl Gustav Carus, Technischen Universitaet Dresden
      • Leipzig, Saxony, Germany, 04103
        • Not yet recruiting
        • Apotheke am Universitätsklinikum Leipzig
      • Leipzig, Saxony, Germany, 04103
        • Not yet recruiting
        • Klinik und Poliklinik für Diagnostische und Interventionelle Radiologie
      • Leipzig, Saxony, Germany, 04103
        • Not yet recruiting
        • Universität Leipzig - Med. Fakultät
  • India
    • Maharashtra
      • Mumbai, Maharashtra, India, 400012
        • Recruiting
        • Tata Memorial Hospital
    • National Capital Territory of Delhi
      • New Delhi, National Capital Territory of Delhi, India, 110085
        • Recruiting
        • Rajiv Gandhi Cancer Institute And Research Centre
      • New Delhi, National Capital Territory of Delhi, India, 110075
        • Recruiting
        • Venkateshwar Hospital
    • Rajasthan
      • Jaipur, Rajasthan, India, 302004
        • Recruiting
        • Sawai Man Singh Medical College Hospital (SMS Hospital)
    • West Bengal
      • Kolkata, West Bengal, India, 700160
        • Recruiting
        • Chittaranjan National Cancer Institute
  • Israel
    • Central District
      • Petah Tikva, Central District, Israel, 4941492
        • Recruiting
        • Rabin Medical Center
      • Ramat Gan, Central District, Israel, 5265601
        • Recruiting
        • Sheba Medical Center
    • Heifa
      • Haifa, Heifa, Israel, 3109601
        • Recruiting
        • Rambam Health Care Campus
    • Jerusalem
      • Jerusalem, Jerusalem, Israel, 9112001
        • Recruiting
        • Hadassah Medical Center
      • Jerusalem, Jerusalem, Israel, 9103102
        • Recruiting
        • Shaare Zedek Medical Center
    • TELL ABĪB
      • Tel Aviv, TELL ABĪB, Israel, 6423906
        • Recruiting
        • Sourasky Medical Center
  • Italy
      • Ancona, Italy, 60126
        • Recruiting
        • Azienda Ospedaliero Universitaria delle Marche
  • Japan
      • Fukuoka, Japan, 812-8582
        • Recruiting
        • Kyushu University Hospital
      • Fukuoka, Japan, 811-1395
        • Recruiting
        • National Hospital Organization Kyushu Cancer Center
      • Kyoto, Japan, 602-8566
        • Recruiting
        • University Hospital,Kyoto Prefectural University of Medicine
      • Wakayama, Japan, 641-8510
        • Recruiting
        • Wakayama Medical University Hospital
    • Aichi-ken
      • Nagoya, Aichi-ken, Japan, 464-8681
        • Recruiting
        • Aichi Cancer Center Hospital
    • Chiba
      • Chiba, Chiba, Japan, 260-8717
        • Recruiting
        • Chiba cancer center
      • Kashiwa, Chiba, Japan, 277-8577
        • Recruiting
        • National Cancer Center Hospital East
    • Kagawa-ken
      • Kita-gun, Kagawa-ken, Japan, 761-0793
        • Recruiting
        • Kagawa University Hospital
    • Kanagawa
      • Kawasaki, Kanagawa, Japan, 216-8511
        • Recruiting
        • St. Marianna University Hospital
      • Yokohama, Kanagawa, Japan, 2418515
        • Recruiting
        • Kanagawa Cancer Center
    • Osaka
      • Suita, Osaka, Japan, 565-0871
        • Recruiting
        • The University of Osaka Hospital
    • Shizuoka
      • Nagaizumi-cho, Shizuoka, Japan, 411-8777
        • Recruiting
        • Shizuoka Cancer Center
    • Tokyo
      • Chuo-ku, Tokyo, Japan, 104-0045
        • Recruiting
        • National Cancer Center Hospital
      • Koto-ku, Tokyo, Japan, 135-8550
        • Recruiting
        • The Cancer Institute Hospital of JFCR
    • Wakayama
      • Wakayama-shi Kimiidera 870-2, Wakayama, Japan, 641-0012
        • Recruiting
        • Wakayama Minami Radiology Clinic
    • Yamaguchi
      • Ube, Yamaguchi, Japan, 755-8505
        • Recruiting
        • Yamaguchi University Hospital
  • Mexico
      • San Luis Potosí City, Mexico, 78200
        • Recruiting
        • Centro de Atención e Investigación Cardiovascular del Potosí S.C.
    • Oaxaca
      • Oaxaca City, Oaxaca, Mexico, 68020
        • Recruiting
        • Centro de Investigacion Clinica de Oaxaca
  • Poland
      • Koszalin, Poland, 75-581
        • Not yet recruiting
        • Szpital Wojewódzki im. Mikołaja Kopernika w Koszalinie
      • Poznan, Poland, 60-569
        • Not yet recruiting
        • Uniwersytecki Szpital Kliniczny W Poznaniu
      • Tomaszów Mazowiecki, Poland, 97-200
        • Not yet recruiting
        • Specjalistyczny Szpital Onkologiczny NU-MED Sp. z o.o.
    • Masovian Voivodeship
      • Warsaw, Masovian Voivodeship, Poland, 02-034
        • Not yet recruiting
        • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie
    • Warmian-Masurian Voivodeship
      • Olsztyn, Warmian-Masurian Voivodeship, Poland, 10-228
        • Recruiting
        • Szpital Kliniczny Ministerstwa Spraw Wewnętrznych i Administracji z Warmińsko - Mazurskim Centrum Onkologii w Olsztynie
  • Puerto Rico
      • Dorado, Puerto Rico, 00646
        • Recruiting
        • Pan American Center for Oncology Trials, LLC - Dorado Office
      • Mayagüez, Puerto Rico, 00680
        • Recruiting
        • Pan American Center for Oncology Trials, LLC - Mayaguez Office
      • Rio Piedras, Puerto Rico, 00935
        • Recruiting
        • Pan American Center for Oncology Trials, LLC
      • San Juan, Puerto Rico, 00909
        • Recruiting
        • Pan American Center for Oncology Trials, LLC
  • Slovakia
      • Bratislava, Slovakia, 833 10
        • Recruiting
        • Narodny Onkologicky Ustav
      • Michalovce, Slovakia, 07101
        • Recruiting
        • Nemocnica s poliklinikou Stefana Kukuru Michalovce, a.s.
      • Nové Zámky, Slovakia, 940 34
        • Recruiting
        • Fakultna nemocnica s poliklinikou Nove Zamky
      • Trnava, Slovakia, 917 75
        • Recruiting
        • Fakultna nemocnica Trnava
  • South Korea
      • Busan, South Korea, 48108
        • Recruiting
        • Inje University Haeundae Paik Hospital
    • Incheon-gwangyeoksi [incheon]
      • Incheon, Incheon-gwangyeoksi [incheon], South Korea, 22332
        • Recruiting
        • Inha University Hospital
    • Kyǒnggi-do
      • Seongnam, Kyǒnggi-do, South Korea, 13620
        • Recruiting
        • Seoul National University Bundang Hospital
      • Seongnam-si, Kyǒnggi-do, South Korea, 13496
        • Recruiting
        • CHA Bundang Medical Center, CHA University
    • Seoul Teukbyeolsi
      • Seoul, Seoul Teukbyeolsi, South Korea, 05505
        • Recruiting
        • Asan Medical Center
    • Seoul-teukbyeolsi [seoul]
      • Seoul, Seoul-teukbyeolsi [seoul], South Korea, 03080
        • Recruiting
        • Seoul National University Hospital
      • Seoul, Seoul-teukbyeolsi [seoul], South Korea, 06351
        • Recruiting
        • Samsung Medical Center
      • Seoul, Seoul-teukbyeolsi [seoul], South Korea, 03722
        • Recruiting
        • Severance Hospital, Yonsei University Health System
      • Seoul, Seoul-teukbyeolsi [seoul], South Korea, 06591
        • Recruiting
        • The Catholic Univ. of Korea Seoul St. Mary's Hospital
    • Taegu-kwangyǒkshi
      • Daegu, Taegu-kwangyǒkshi, South Korea, 42601
        • Recruiting
        • Keimyung University Dongsan Hospital
  • Spain
      • Málaga, Spain, 29011
        • Recruiting
        • H.R.U Málaga - Hospital General
    • Barcelona [barcelona]
      • Barcelona, Barcelona [barcelona], Spain, 08035
        • Not yet recruiting
        • Hospital Universitari Vall d'Hebron
    • Catalunya [cataluña]
      • Barcelona, Catalunya [cataluña], Spain, 08036
        • Recruiting
        • Hospital Clinic de Barcelona
    • Madrid, Comunidad de
      • Madrid, Madrid, Comunidad de, Spain, 28034
        • Not yet recruiting
        • Hospital Universitario Ramón y Cajal
  • Taiwan
      • Kaohsiung City, Taiwan, 807
        • Recruiting
        • Kaohsiung Medical University Chung-Ho Memorial Hospital
      • Taichung, Taiwan, 404332
        • Recruiting
        • China Medical University Hospital
      • Tainan, Taiwan, 704
        • Recruiting
        • National Cheng Kung University Hospital
      • Taipei, Taiwan, 10002
        • Recruiting
        • National Taiwan University Hospital
      • Taipei, Taiwan, 11217
        • Recruiting
        • Taipei Veterans General Hospital
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Recruiting
        • The University of Alabama at Birmingham
      • Birmingham, Alabama, United States, 35233
        • Recruiting
        • The Kirklin Clinic of UAB Hospital
    • Arkansas
      • Bryant, Arkansas, United States, 72022
        • Recruiting
        • Central Arkansas Radiation Therapy Institute, dba CARTI
      • Conway, Arkansas, United States, 72034
        • Recruiting
        • Central Arkansas Radiation Therapy Institute, dba CARTI
      • Little Rock, Arkansas, United States, 72205
        • Recruiting
        • CARTI Cancer Center
      • North Little Rock, Arkansas, United States, 72117
        • Recruiting
        • Central Arkansas Radiation Therapy Institute, dba CARTI
      • Pine Bluff, Arkansas, United States, 71603
        • Recruiting
        • Central Arkansas Radiation Therapy Institute, dba CARTI
    • California
      • Encinitas, California, United States, 92024
        • Recruiting
        • UC San Diego Medical Center - Encinitas
      • Irvine, California, United States, 92612
        • Recruiting
        • Chao Family Comprehensive Cancer Center and Ambulatory Care
      • Irvine, California, United States, 92612
        • Recruiting
        • UCI Health - Irvine
      • La Jolla, California, United States, 92037
        • Recruiting
        • UC San Diego Medical Center - La Jolla (Jacobs Medical Center / Thornton Pavilion)
      • La Jolla, California, United States, 92037
        • Recruiting
        • UC San Diego Sulpizio Cardiovascular Center
      • La Jolla, California, United States, 92037
        • Recruiting
        • UC San Diego Moores Cancer Center
      • La Jolla, California, United States, 92037
        • Recruiting
        • UC San Diego Koman Family Outpatient Pavilion
      • Los Angeles, California, United States, 90095
        • Recruiting
        • UCLA Department of Medicine - Hematology/Oncology
      • Los Angeles, California, United States, 90048
        • Recruiting
        • Cedars-Sinai Cancer at Cedars-Sinai Medical Center
      • Orange, California, United States, 92868
        • Recruiting
        • UC Irvine Health
      • San Diego, California, United States, 92103
        • Recruiting
        • UC San Diego Medical Center - Hillcrest
      • San Diego, California, United States, 92101
        • Recruiting
        • UC San Diego Medical Center - Bankers Hill
      • San Diego, California, United States, 92103
        • Recruiting
        • UC San Diego McGrath Outpatient Pavilion - Hillcrest
      • San Diego, California, United States, 92127
        • Recruiting
        • UC San Diego Medical Center - Rancho Bernardo
      • Santa Monica, California, United States, 90404
        • Recruiting
        • UCLA Hematology/Oncology - Santa Monica
      • Santa Rosa, California, United States, 95403
        • Recruiting
        • Providence Medical Foundation
      • Vista, California, United States, 92081
        • Recruiting
        • UC San Diego Medical Center - Vista
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20007
        • Recruiting
        • Georgetown University Medical Center
      • Washington D.C., District of Columbia, United States, 20007
        • Recruiting
        • Georgetown University Medical Center - Department of Pharmacy, Oncology Pharmacy
    • Georgia
      • Athens, Georgia, United States, 30607
        • Recruiting
        • University Cancer & Blood Center, LLC
    • Hawaii
      • Honolulu, Hawaii, United States, 96813
        • Recruiting
        • University of Hawaii Cancer Center
      • Honolulu, Hawaii, United States, 96813
        • Recruiting
        • Invision, LLC
      • ‘Aiea, Hawaii, United States, 96701
        • Recruiting
        • Cardiology Associates, Inc
    • Illinois
      • Decatur, Illinois, United States, 62526
        • Recruiting
        • Decatur Memorial Hospital
      • Decatur, Illinois, United States, 62526
        • Recruiting
        • Cancer Care Specialists of Illinois
      • Hinsdale, Illinois, United States, 60521
        • Recruiting
        • Hope and Healing Clinical Research LLC
      • New Lenox, Illinois, United States, 60451
        • Recruiting
        • Hope and Healing Clinical Research LLC New Lenox- Research Department
      • O'Fallon, Illinois, United States, 62269
        • Recruiting
        • Cancer Care Specialists of Illinois - Cancer Care Center of O'Fallon
    • Kansas
      • Lenexa, Kansas, United States, 66215
        • Recruiting
        • United Imaging Consultants
      • Merriam, Kansas, United States, 66204
        • Recruiting
        • MidAmerica Cancer Care- American Oncology Partners
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • Recruiting
        • University of Kentucky Medical Center
      • Lexington, Kentucky, United States, 40506
        • Recruiting
        • University of Kentucky Research Foundation
      • Lexington, Kentucky, United States, 40536
        • Recruiting
        • University of Kentucky Healthcare - Markey Cancer Center
      • Lexington, Kentucky, United States, 40536
        • Recruiting
        • University of Kentucky, Markey Cancer Center Clinical Research Office (UK MCC CRO)
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Recruiting
        • Johns Hopkins Hospital
      • Baltimore, Maryland, United States, 21287
        • Recruiting
        • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
      • Baltimore, Maryland, United States, 21205
        • Recruiting
        • JHU Oncology Central Kit Services
      • Baltimore, Maryland, United States, 21287
        • Recruiting
        • Oncology Investigational Drug Service (IDS)
    • Missouri
      • Kansas City, Missouri, United States, 64114
        • Recruiting
        • Premier Imaging
      • Kansas City, Missouri, United States, 64114
        • Recruiting
        • St. Joseph Medical Center
      • Kansas City, Missouri, United States, 64132
        • Recruiting
        • MidAmerica Cancer Care - American Oncology Partners
    • Nebraska
      • Omaha, Nebraska, United States, 68198
        • Recruiting
        • University of Nebraska Medical Center
      • Omaha, Nebraska, United States, 68105
        • Recruiting
        • Nebraska Medicine
      • Omaha, Nebraska, United States, 68118
        • Recruiting
        • Nebraska Medicine - Village Pointe
    • Nevada
      • Reno, Nevada, United States, 89502
        • Recruiting
        • Renown Regional Medical Center
      • Reno, Nevada, United States, 89502
        • Recruiting
        • Renown Health Medical Oncology
      • Reno, Nevada, United States, 89502
        • Recruiting
        • Renown Office of Clinical Research
    • New Jersey
      • Morristown, New Jersey, United States, 07960
        • Not yet recruiting
        • Atlantic Health System / Morristown Medical Center
      • New Brunswick, New Jersey, United States, 08901
        • Recruiting
        • Rutgers Cancer Institute
      • New Brunswick, New Jersey, United States, 08901
        • Recruiting
        • Jack & Sheryl Morris Cancer Center
      • Somerville, New Jersey, United States, 08876
        • Recruiting
        • RWJ University Hospital Somerset, Steeplechase Cancer Center
      • Somerville, New Jersey, United States, 08876
        • Recruiting
        • Rwj University Hospital Somerset
      • Summit, New Jersey, United States, 07901
        • Not yet recruiting
        • Atlantic Health System / Overlook Medical Center
    • New York
      • New York, New York, United States, 10029
        • Not yet recruiting
        • Icahn School of Medicine at Mount Sinai
      • Rochester, New York, United States, 14642
        • Recruiting
        • University of Rochester Medical Center
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
        • Recruiting
        • UNC Hospitals, The University of North Carolina at Chapel Hill
      • Hillsborough, North Carolina, United States, 27278
        • Recruiting
        • University of North Carolina Hospitals at Hillsborough
    • Oregon
      • Portland, Oregon, United States, 97239
        • Recruiting
        • Oregon Health and Science University
      • Portland, Oregon, United States, 97239
        • Recruiting
        • OHSU Center for Health & Healing 1
      • Portland, Oregon, United States, 97239
        • Recruiting
        • OSHU Center for Health and Healing 2
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • Houston Methodist Hospital
      • Temple, Texas, United States, 76508
        • Recruiting
        • Baylor Scott & White Vasicek Cancer Treatment Center
    • Washington
      • Seattle, Washington, United States, 98101
        • Recruiting
        • Virginia Mason Medical Center
      • Seattle, Washington, United States, 98195
        • Not yet recruiting
        • University of Washington Medical Center
      • Seattle, Washington, United States, 98109
        • Not yet recruiting
        • Fred Hutchinson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Key inclusion Criteria:

  • 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

Key Exclusion Criteria:

  • 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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Double-Blind ponsegromab Treatment lower dose
ponsegromab 200 mg subcutaneous injection every 4 weeks
Drug: ponsegromab
Double-Blind ponsegromab Treatment
Experimental: Double-Blind ponsegromab Treatment higher dose
ponsegromab 400 mg subcutaneous injection every 4 weeks
Drug: ponsegromab
Double-Blind ponsegromab Treatment
Placebo Comparator: Double-Blind Placebo Treatment
Match placebo subcutaneous injection every 4 weeks
Drug: placebo
Double-Blind placebo Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent change from baseline in body weight for ponsegromab compared to placebo
Time Frame: Baseline, Week 12
Baseline, Week 12
Change from baseline in Functional Assessment of Anorexia/Cachexia Therapy 5-item Anorexia Symptom Scale scores
Time Frame: Baseline, Week 12
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.
Baseline, Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in non-sedentary physical activity time
Time Frame: Baseline, Week 12
measured by wearable Digital Health Technology watch
Baseline, Week 12
Overall survival
Time Frame: Randomization through completion of Phase 3 of the study, an average of 1 year
Outcome defined as the time from randomization to occurrence of all-cause death
Randomization through completion of Phase 3 of the study, an average of 1 year
Change from baseline in body weight (kg)
Time Frame: Baseline, Week 12 and up to Week 52
Baseline, Week 12 and up to Week 52
Change from baseline at Week 12 in physical activity as measured by total vector magnitude
Time Frame: Baseline, Week 12
measured by wearable Digital Health Technology watch
Baseline, Week 12
Effect on progression free survival
Time Frame: Randomization through completion of Phase 3 of the study, an average of 1 year
determined by Blinded Independent Central Review
Randomization through completion of Phase 3 of the study, an average of 1 year
Effect on objective response rate
Time Frame: Baseline, Week 52
determined by Blinded Independent Central Review
Baseline, Week 52
Effect on disease control rate
Time Frame: Baseline, Week 52
determined by Blinded Independent Central Review
Baseline, Week 52
Effect on duration of response
Time Frame: Baseline, Week 52
determined by Blinded Independent Central Review
Baseline, Week 52
Change from baseline in skeletal muscle area and radiodensity at third lumbar vertebra (L3)
Time Frame: Baseline, Week 12
measured by CT (or MRI) scan
Baseline, Week 12
Change from baseline in intermuscular adipose area and radiodensity at L3
Time Frame: Baseline, Week 12
measured by CT (or MRI) scan
Baseline, Week 12
Change from baseline in subcutaneous adipose area and radiodensity at L3
Time Frame: Baseline, Week 12
measured by CT (or MRI) scan
Baseline, Week 12
Change from baseline in visceral adipose area and radiodensity at L3
Time Frame: Baseline, Week 12
measured by CT (or MRI) scan
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.
Time Frame: Baseline, Week 12 and up to Week 52
Baseline, Week 12 and up to Week 52
Number of participants with laboratory test abnormalities.
Time Frame: Baseline, Week 12 and up to Week 52
Baseline, Week 12 and up to Week 52
Number of participants with vital signs abnormalities.
Time Frame: Baseline, Week 12 and up to Week 52
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.
Time Frame: Baseline, Week 12 and up to Week 52
The overall score range for the T-score is 0-100. Higher scores indicate better outcome.
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.
Time Frame: Baseline, Week 12 and up to Week 52
The overall score range for the T-score is 29.4-83.2. Lower scores indicate better outcome.
Baseline, Week 12 and up to Week 52
Tumor status
Time Frame: Baseline, Week 12 and up to Week 52
Assessment of tumor response to treatment as determined by Blinded Independent Central Review assessment per RECIST 1.1 using CT scan (or MRI)
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.
Time Frame: Baseline, Week 52
Baseline, Week 52
Change from baseline on ECOG PS
Time Frame: Baseline, Week 12 and up to Week 52
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
Time Frame: Baseline, up to Week 52
Baseline, up to Week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Investigators

  • Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 3, 2025

Primary Completion (Estimated)

January 17, 2028

Study Completion (Estimated)

December 10, 2029

Study Registration Dates

First Submitted

May 7, 2025

First Submitted That Met QC Criteria

May 16, 2025

First Posted (Actual)

May 25, 2025

Study Record Updates

Last Update Posted (Actual)

June 10, 2026

Last Update Submitted That Met QC Criteria

June 9, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C3651021
  • 2025-522093-36-00 (Registry Identifier: CTIS (EU))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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