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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

RecruitingPhase 2/3

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

Who can join

Ages 18 and older · All sexes

Full eligibility criteria
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

About the study

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.

What is being tested

Sponsor: Pfizer · Participants: 982 · Started: Oct 3, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT06989437

Locations in the U.S.

AlabamaThe Kirklin Clinic of UAB Hospital, Birmingham
The University of Alabama at Birmingham, Birmingham
ArizonaMayo Clinic Hospital, Phoenix
ArkansasCentral Arkansas Radiation Therapy Institute, dba CARTI, Bryant
Central Arkansas Radiation Therapy Institute, dba CARTI, Conway
CARTI Cancer Center, Little Rock
Central Arkansas Radiation Therapy Institute, dba CARTI, North Little Rock
Central Arkansas Radiation Therapy Institute, dba CARTI, Pine Bluff
CaliforniaUC San Diego Medical Center - Encinitas, Encinitas
Chao Family Comprehensive Cancer Center and Ambulatory Care, Irvine
UCI Health - Irvine, Irvine
UC San Diego Koman Family Outpatient Pavilion, La Jolla
UC San Diego Medical Center - La Jolla (Jacobs Medical Center / Thornton Pavilion), La Jolla
UC San Diego Moores Cancer Center, La Jolla
UC San Diego Sulpizio Cardiovascular Center, La Jolla
Cedars-Sinai Cancer at Cedars-Sinai Medical Center, Los Angeles
UCLA Department of Medicine - Hematology/Oncology, Los Angeles
UC Irvine Health, Orange
UC San Diego McGrath Outpatient Pavilion - Hillcrest, San Diego
UC San Diego Medical Center - Bankers Hill, San Diego
UC San Diego Medical Center - Hillcrest, San Diego
UC San Diego Medical Center - Rancho Bernardo, San Diego
UCLA Hematology/Oncology - Santa Monica, Santa Monica
Providence Medical Foundation, Santa Rosa
UC San Diego Medical Center - Vista, Vista
District of ColumbiaGeorgetown University Medical Center, Washington D.C.
Georgetown University Medical Center - Department of Pharmacy, Oncology Pharmacy, Washington D.C.
FloridaMayo Clinic, Jacksonville
Mayo Clinic Pharmacy, Jacksonville
GeorgiaUniversity Cancer & Blood Center, LLC, Athens
HawaiiInvision, LLC, Honolulu
University of Hawaii Cancer Center, Honolulu
Cardiology Associates, Inc, ‘Aiea
IllinoisCancer Care Specialists of Illinois, Decatur
Decatur Memorial Hospital, Decatur
Hope and Healing Clinical Research LLC, Hinsdale
Hope and Healing Clinical Research LLC New Lenox- Research Department, New Lenox
Cancer Care Specialists of Illinois - Cancer Care Center of O'Fallon, O'Fallon
KansasUnited Imaging Consultants, Lenexa
MidAmerica Cancer Care- American Oncology Partners, Merriam
KentuckyUniversity of Kentucky Healthcare - Markey Cancer Center, Lexington
University of Kentucky Medical Center, Lexington
University of Kentucky Research Foundation, Lexington
University of Kentucky, Markey Cancer Center Clinical Research Office (UK MCC CRO), Lexington
MarylandJHU Oncology Central Kit Services, Baltimore
Johns Hopkins Hospital, Baltimore
Oncology Investigational Drug Service (IDS), Baltimore
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore
MinnesotaMayo Clinic, Rochester
Mayo Clinic Cancer Center Outpatient Pharmacy, Rochester
MissouriMidAmerica Cancer Care - American Oncology Partners, Kansas City
Premier Imaging, Kansas City
St. Joseph Medical Center, Kansas City
NebraskaNebraska Medicine, Omaha
Nebraska Medicine - Village Pointe, Omaha
University of Nebraska Medical Center, Omaha
NevadaRenown Health Medical Oncology, Reno
Renown Office of Clinical Research, Reno
Renown Regional Medical Center, Reno
New JerseyAtlantic Health System / Morristown Medical Center, Morristown
Jack & Sheryl Morris Cancer Center, New Brunswick
Rutgers Cancer Institute, New Brunswick
RWJ University Hospital Somerset, Steeplechase Cancer Center, Somerville
Rwj University Hospital Somerset, Somerville
Atlantic Health System / Overlook Medical Center, Summit
New YorkIcahn School of Medicine at Mount Sinai, New York
University of Rochester Medical Center, Rochester
North CarolinaUNC Hospitals, The University of North Carolina at Chapel Hill, Chapel Hill
Levine Cancer Institute, Charlotte
University of North Carolina Hospitals at Hillsborough, Hillsborough
OregonOHSU Center for Health & Healing 1, Portland
OSHU Center for Health and Healing 2, Portland
Oregon Health and Science University, Portland
TennesseeHenry-Joyce Cancer Clinic, Nashville (Not yet recruiting)
TexasUniversity of Texas Southwestern Medical Center, Dallas
University of Texas Southwestern Medical Center - Simmons Cancer Center, Dallas
University of Texas Southwestern Medical Center-William P. Clements Jr. University Hospital, Dallas
University of Texas Southwestern Medical Center-Zale Lipshy University Hospital, Dallas
Houston Methodist Hospital, Houston
Baylor Scott & White Vasicek Cancer Treatment Center, Temple
WashingtonFred Hutchinson Cancer Center, Seattle
University of Washington Medical Center, Seattle
Virginia Mason Medical Center, Seattle
WisconsinFroedtert Hospital and the Medical College of Wisconsin, Milwaukee

Conditions

From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.