Actively Recruiting
A Phase 2b3 Randomized, Double-Blind Study Evaluating Ponsegromab With First-Line Chemotherapy in Adults With Cachexia and Metastatic Pancreatic Ductal Adenocarcinoma
Led by Pfizer · Updated on 2026-06-05
982
Participants Needed
180
Research Sites
99 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness, safety, and tolerability of adding ponsegromab to systemic chemotherapy for adults with metastatic pancreatic ductal adenocarcinoma mPDAC who also have cachexia, a condition marked by significant weight loss and fatigue. This Phase 2b3 randomized, double-blind study compares ponsegromab plus chemotherapy to chemotherapy plus placebo as first-line treatment. The study explores two doses of ponsegromab alongside common chemotherapy regimens nab-paclitaxel plus gemcitabine or FOLFIRINOX. Participants will be randomly assigned to receive one of two ponsegromab doses or placebo, each combined with their chemotherapy. The study intervention is administered subcutaneously every four weeks, starting on the same day as the chemotherapy cycle. After an initial Phase 2b period, researchers will select one ponsegromab dose for continued evaluation in Phase 3, where participants may continue or switch doses while remaining blinded. An optional open-label extension allows continued ponsegromab treatment for up to 12 months after the double-blind phase ends. There is also a sub-study to assess the impact of ponsegromab on the quality of life of caregivers. Participants will undergo tumor assessments every 6 to 8 weeks during the double-blind phase, with various evaluations measuring body weight changes, anorexia symptoms, physical activity, survival, muscle and fat composition, and side effects. Safety monitoring includes tracking adverse events, laboratory tests, and vital signs through Week 52. The study aims to gather data on the overall survival and physical function of participants, with involvement lasting until permanent discontinuation, withdrawal, death, or study completion.
CONDITIONS
Brief Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent document
- Documented active diagnosis of metastatic pancreatic ductal adenocarcinoma
- Cachexia defined by Fearon criteria of weight loss
- Completed 1 cycle of 28-day nab-paclitaxel and gemcitabine chemotherapy or 2 cycles of 14-day FOLFIRINOX chemotherapy prior to next chemotherapy
- ECOG performance status of 0 or 1 with life expectancy of at least 4 months
You will not qualify if you...
- Current active reversible causes of decreased food intake
- Cachexia caused by reasons other than metastatic pancreatic ductal adenocarcinoma
- Any prior or current diagnosis of heart failure regardless of severity
- Left ventricular ejection fraction less than 50%
- Receiving tube feeding or parenteral nutrition at screening or randomization
- History of allergic or anaphylactic reaction to monoclonal antibodies
- History of allergy or hypersensitivity to chemotherapeutic agents or their ingredients
- Neuroendocrine or acinar pancreatic cancers, symptomatic brain metastases, leptomeningeal disease, or other active central nervous system metastases
- Inadequate liver function
- Renal disease requiring dialysis or estimated glomerular filtration rate below 30 mL/min/1.73m2
Research Team
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Pfizer CT.gov Call Center
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