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

What this study is about

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.

Who can join (things the study team will check)

✅ You may be able to join 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 be able to join 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

Where this trial is running

• The Kirklin Clinic of UAB Hospital, Birmingham, Alabama, United States
• The University of Alabama at Birmingham, Birmingham, Alabama, United States
• Mayo Clinic Hospital, Phoenix, Arizona, United States
• Central Arkansas Radiation Therapy Institute, dba CARTI, Bryant, Arkansas, United States
• Central Arkansas Radiation Therapy Institute, dba CARTI, Conway, Arkansas, United States
• CARTI Cancer Center, Little Rock, Arkansas, United States
• Central Arkansas Radiation Therapy Institute, dba CARTI, North Little Rock, Arkansas, United States
• Central Arkansas Radiation Therapy Institute, dba CARTI, Pine Bluff, Arkansas, United States
• UC San Diego Medical Center - Encinitas, Encinitas, California, United States
• Chao Family Comprehensive Cancer Center and Ambulatory Care, Irvine, California, United States
• UCI Health - Irvine, Irvine, California, United States
• UC San Diego Koman Family Outpatient Pavilion, La Jolla, California, United States

+ 202 more sites.

Who to contact

Pfizer CT.gov Call Center · 1-800-718-1021 · ClinicalTrials.gov_Inquiries@pfizer.com

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT06989437.