Home › Cachexia › NCT06989437
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
- ponsegromab (drug)
- placebo (drug)
Sponsor: Pfizer · Participants: 982 · Started: Oct 3, 2025
Contact the study team
Official record on ClinicalTrials.gov — NCT06989437
Locations in the U.S.
| Alabama | The Kirklin Clinic of UAB Hospital, Birmingham The University of Alabama at Birmingham, Birmingham |
| Arizona | Mayo Clinic Hospital, Phoenix |
| Arkansas | Central 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 |
| California | UC 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 Columbia | Georgetown University Medical Center, Washington D.C. Georgetown University Medical Center - Department of Pharmacy, Oncology Pharmacy, Washington D.C. |
| Florida | Mayo Clinic, Jacksonville Mayo Clinic Pharmacy, Jacksonville |
| Georgia | University Cancer & Blood Center, LLC, Athens |
| Hawaii | Invision, LLC, Honolulu University of Hawaii Cancer Center, Honolulu Cardiology Associates, Inc, ‘Aiea |
| Illinois | Cancer 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 |
| Kansas | United Imaging Consultants, Lenexa MidAmerica Cancer Care- American Oncology Partners, Merriam |
| Kentucky | University 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 |
| Maryland | JHU Oncology Central Kit Services, Baltimore Johns Hopkins Hospital, Baltimore Oncology Investigational Drug Service (IDS), Baltimore Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore |
| Minnesota | Mayo Clinic, Rochester Mayo Clinic Cancer Center Outpatient Pharmacy, Rochester |
| Missouri | MidAmerica Cancer Care - American Oncology Partners, Kansas City Premier Imaging, Kansas City St. Joseph Medical Center, Kansas City |
| Nebraska | Nebraska Medicine, Omaha Nebraska Medicine - Village Pointe, Omaha University of Nebraska Medical Center, Omaha |
| Nevada | Renown Health Medical Oncology, Reno Renown Office of Clinical Research, Reno Renown Regional Medical Center, Reno |
| New Jersey | Atlantic 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 York | Icahn School of Medicine at Mount Sinai, New York University of Rochester Medical Center, Rochester |
| North Carolina | UNC Hospitals, The University of North Carolina at Chapel Hill, Chapel Hill Levine Cancer Institute, Charlotte University of North Carolina Hospitals at Hillsborough, Hillsborough |
| Oregon | OHSU Center for Health & Healing 1, Portland OSHU Center for Health and Healing 2, Portland Oregon Health and Science University, Portland |
| Tennessee | Henry-Joyce Cancer Clinic, Nashville (Not yet recruiting) |
| Texas | University 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 |
| Washington | Fred Hutchinson Cancer Center, Seattle University of Washington Medical Center, Seattle Virginia Mason Medical Center, Seattle |
| Wisconsin | Froedtert 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.