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 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
2 other identifiers
interventional
982
12 countries
125
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Oct 2025
Typical duration for phase_2
125 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 7, 2025
CompletedFirst Posted
Study publicly available on registry
May 25, 2025
CompletedStudy Start
First participant enrolled
October 3, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 17, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 10, 2029
May 5, 2026
May 1, 2026
2.3 years
May 7, 2025
May 4, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Percent change from baseline in body weight for ponsegromab compared to placebo
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.
Baseline, Week 12
Secondary Outcomes (21)
Change from baseline in non-sedentary physical activity time
Baseline, Week 12
Overall survival
Randomization through completion of Phase 3 of the study, an average of 1 year
Change from baseline in body weight (kg)
Baseline, Week 12 and up to Week 52
Change from baseline at Week 12 in physical activity as measured by total vector magnitude
Baseline, Week 12
Effect on progression free survival
Randomization through completion of Phase 3 of the study, an average of 1 year
- +16 more secondary outcomes
Study Arms (3)
Double-Blind ponsegromab Treatment lower dose
EXPERIMENTALponsegromab 200 mg subcutaneous injection every 4 weeks
Double-Blind ponsegromab Treatment higher dose
EXPERIMENTALponsegromab 400 mg subcutaneous injection every 4 weeks
Double-Blind Placebo Treatment
PLACEBO COMPARATORMatch placebo subcutaneous injection every 4 weeks
Interventions
Double-Blind ponsegromab Treatment
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (125)
The Kirklin Clinic of UAB Hospital
Birmingham, Alabama, 35233, United States
The University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
Central Arkansas Radiation Therapy Institute, dba CARTI
Bryant, Arkansas, 72022, United States
Central Arkansas Radiation Therapy Institute, dba CARTI
Conway, Arkansas, 72034, United States
CARTI Cancer Center
Little Rock, Arkansas, 72205, United States
Central Arkansas Radiation Therapy Institute, dba CARTI
North Little Rock, Arkansas, 72117, United States
Central Arkansas Radiation Therapy Institute, dba CARTI
Pine Bluff, Arkansas, 71603, United States
Cedars-Sinai Cancer at Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
UCLA Department of Medicine - Hematology/Oncology
Los Angeles, California, 90095, United States
UCLA Hematology/Oncology - Santa Monica
Santa Monica, California, 90404, United States
Providence Medical Foundation
Santa Rosa, California, 95403, United States
Georgetown University Medical Center - Department of Pharmacy, Oncology Pharmacy
Washington D.C., District of Columbia, 20007, United States
Georgetown University Medical Center
Washington D.C., District of Columbia, 20007, United States
University Cancer & Blood Center, LLC
Athens, Georgia, 30607, United States
Invision, LLC
Honolulu, Hawaii, 96813, United States
University of Hawaii Cancer Center
Honolulu, Hawaii, 96813, United States
Cardiology Associates, Inc
‘Aiea, Hawaii, 96701, United States
Cancer Care Specialists of Illinois
Decatur, Illinois, 62526, United States
Decatur Memorial Hospital
Decatur, Illinois, 62526, United States
Hope and Healing Cancer Services
Hinsdale, Illinois, 60521, United States
Hope and Healing Cancer Services New Lenox
New Lenox, Illinois, 60451, United States
Cancer Care Specialists of Illinois - Cancer Care Center of O'Fallon
O'Fallon, Illinois, 62269, United States
University of Kentucky Research Foundation
Lexington, Kentucky, 40506, United States
University of Kentucky Healthcare - Markey Cancer Center
Lexington, Kentucky, 40536, United States
University of Kentucky Medical Center
Lexington, Kentucky, 40536, United States
University of Kentucky, Markey Cancer Center Clinical Research Office (UK MCC CRO)
Lexington, Kentucky, 40536, United States
JHU Oncology Central Kit Services
Baltimore, Maryland, 21205, United States
Johns Hopkins Hospital
Baltimore, Maryland, 21287, United States
Oncology Investigational Drug Service (IDS)
Baltimore, Maryland, 21287, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21287, United States
Nebraska Medicine
Omaha, Nebraska, 68105, United States
Nebraska Medicine - Village Pointe
Omaha, Nebraska, 68118, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198, United States
Renown Health Medical Oncology
Reno, Nevada, 89502, United States
Renown Office of Clinical Research
Reno, Nevada, 89502, United States
Renown Regional Medical Center
Reno, Nevada, 89502, United States
University of Rochester Medical Center
Rochester, New York, 14642, United States
UNC Hospitals, The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27514, United States
University of North Carolina Hospitals at Hillsborough
Hillsborough, North Carolina, 27278, United States
OHSU Center for Health & Healing 1
Portland, Oregon, 97239, United States
Oregon Health and Science University
Portland, Oregon, 97239, United States
OSHU Center for Health and Healing 2
Portland, Oregon, 97239, United States
Houston Methodist Hospital
Houston, Texas, 77030, United States
Baylor Scott & White Vasicek Cancer Treatment Center
Temple, Texas, 76508, United States
Virginia Mason Medical Center
Seattle, Washington, 98101, United States
Shoalhaven District Memorial Hospital
Nowra, New South Wales, 2541, Australia
Westmead Hospital
Westmead, New South Wales, 2145, Australia
ICON Cancer Centre - Kurralta Park
Kurralta Park, South Australia, 5037, Australia
Icon Cancer Centre Hobart
Hobart, Tasmania, 7000, Australia
Western Health-Sunshine & Footscray Hospitals
St Albans, Victoria, 3021, Australia
Hospital Santa Rita de Cassia
Vitória, Espírito Santo, 29041-295, Brazil
Oncocentro
Belo Horizonte, Minas Gerais, 30.360-680, Brazil
Liga Norte Riograndense Contra o Câncer
Natal, Rio Grande do Norte, 59062-000, Brazil
Hospital Moinhos de Vento
Porto Alegre, Rio Grande do Sul, 90560032, Brazil
Icesp - Instituto Do Câncer Do Estado de São Paulo
São Paulo, 01246-000, Brazil
The Ottawa Hospital - General Campus
Ottawa, Ontario, K1H 8L6, Canada
CIUSSS- saguenay-Lac-Saint-Jean
Chicoutimi, Quebec, G7H 5H6, Canada
Centre Intégré de Santé et de Services Sociaux de la Montérégie-Centre
Greenfield Park, Quebec, J4V 2H1, Canada
Jewish General Hospital
Montreal, Quebec, H3T 1E2, Canada
Cancer Hospital Chinese Academy of Medical Science
Beijing, Beijing Municipality, 100021, China
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730, China
Fujian Cancer Hospital
Fuzhou, Fujian, 350014, China
Second Hospital of Lanzhou University
Lanzhou, Gansu, 730030, China
Guangdong General Hospital
Guangzhou, Guangdong, 510080, China
The University of Hong Kong-Shenzhen Hospital
Shenzhen, Guangdong, 518053, China
Affiliated Hospital of Hebei University
Baoding, Hebei, 071000, China
Cancer Hospital Chinese Academy of Medical Science
Langfang, Hebei, 065001, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450000, China
The Second Hospital of Dalian Medical University
Dalian, Liaoning, 116004, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710061, China
Qilu Hospital of Shandong University
Jinan, Shandong, 250012, China
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200025, China
The First Hospital of Shanxi Medical University
Taiyuan, Shanxi, 030001, China
Sir Run Run Shaw Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310015, China
Huzhou Central Hospital
Huzhou, Zhejiang, 313000, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000, China
Beijing Tsinghua Changgung Hospital
Beijing, 102218, China
Shanghai General Hospital
Shanghai, 200080, China
Tata Memorial Hospital
Mumbai, Maharashtra, 400012, India
Venkateshwar Hospital
New Delhi, National Capital Territory of Delhi, 110075, India
Rajiv Gandhi Cancer Institute And Research Centre
New Delhi, National Capital Territory of Delhi, 110085, India
Sawai Man Singh Medical College Hospital (SMS Hospital)
Jaipur, Rajasthan, 302004, India
Chittaranjan National Cancer Institute
Kolkata, West Bengal, 700160, India
Rabin Medical Center
Petah Tikva, Central District, 4941492, Israel
Sheba Medical Center
Ramat Gan, Central District, 5265601, Israel
Rambam Health Care Campus
Haifa, Heifa, 3109601, Israel
Shaare Zedek Medical Center
Jerusalem, Jerusalem, 9103102, Israel
Hadassah Medical Center
Jerusalem, Jerusalem, 9112001, Israel
Sourasky Medical Center
Tel Aviv, TELL ABĪB, 6423906, Israel
Aichi Cancer Center Hospital
Nagoya, Aichi-ken, 464-8681, Japan
Chiba cancer center
Chiba, Chiba, 260-8717, Japan
National Cancer Center Hospital East
Kashiwa, Chiba, 277-8577, Japan
Kagawa University Hospital
Kita-gun, Kagawa-ken, 761-0793, Japan
St. Marianna University Hospital
Kawasaki, Kanagawa, 216-8511, Japan
Kanagawa cancer center
Yokohama, Kanagawa, 2418515, Japan
The University of Osaka Hospital
Suita, Osaka, 565-0871, Japan
Shizuoka Cancer Center
Nagaizumi-cho, Shizuoka, 411-8777, Japan
National Cancer Center Hospital
Chuo-ku, Tokyo, 104-0045, Japan
The Cancer Institute Hospital of JFCR
Koto-ku, Tokyo, 135-8550, Japan
Wakayama Minami Radiology Clinic
Wakayama-shi Kimiidera 870-2, Wakayama, 641-0012, Japan
Yamaguchi University Hospital
Ube, Yamaguchi, 755-8505, Japan
National Hospital Organization Kyushu Cancer Center
Fukuoka, 811-1395, Japan
Kyushu University Hospital
Fukuoka, 812-8582, Japan
University Hospital,Kyoto Prefectural University of Medicine
Kyoto, 602-8566, Japan
Wakayama Medical University Hospital
Wakayama, 641-8510, Japan
Centro de Atención e Investigación Cardiovascular del Potosí S.C.
San Luis Potosí City, 78200, Mexico
Pan American Center for Oncology Trials, LLC - Dorado Office
Dorado, 00646, Puerto Rico
Pan American Center for Oncology Trials, LLC - Mayaguez Office
Mayagüez, 00680, Puerto Rico
Pan American Center for Oncology Trials, LLC
Rio Piedras, 00935, Puerto Rico
Pan American Center for Oncology Trials, LLC
San Juan, 00909, Puerto Rico
Inha University Hospital
Incheon, Incheon-gwangyeoksi [incheon], 22332, South Korea
Seoul National University Bundang Hospital
Seongnam, Kyǒnggi-do, 13620, South Korea
CHA Bundang Medical Center, CHA University
Seongnam-si, Kyǒnggi-do, 13496, South Korea
Asan Medical Center
Seoul, Seoul Teukbyeolsi, 05505, South Korea
Seoul National University Hospital
Seoul, Seoul-teukbyeolsi [seoul], 03080, South Korea
Severance Hospital, Yonsei University Health System
Seoul, Seoul-teukbyeolsi [seoul], 03722, South Korea
Samsung Medical Center
Seoul, Seoul-teukbyeolsi [seoul], 06351, South Korea
The Catholic Univ. of Korea Seoul St. Mary's Hospital
Seoul, Seoul-teukbyeolsi [seoul], 06591, South Korea
Keimyung University Dongsan Hospital
Daegu, Taegu-kwangyǒkshi, 42601, South Korea
Inje University Haeundae Paik Hospital
Busan, 48108, South Korea
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, 807, Taiwan
China Medical University Hospital
Taichung, 404332, Taiwan
National Cheng Kung University Hospital
Tainan, 704, Taiwan
National Taiwan University Hospital
Taipei, 10002, Taiwan
Taipei Veterans General Hospital
Taipei, 11217, Taiwan
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 7, 2025
First Posted
May 25, 2025
Study Start
October 3, 2025
Primary Completion (Estimated)
January 17, 2028
Study Completion (Estimated)
December 10, 2029
Last Updated
May 5, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will share
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.