Testing Ponsegromab With Chemotherapy in Pancreatic Cancer Patients With Weight Loss
Tests ponsegromab with chemotherapy in adults with spreading pancreatic cancer and weight loss.
Plain-language title generated from the registry record
Registry 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
Key facts
- Where
- Chiba, Chuo Ku, Fukuoka, Kashiwa, Kawasaki, Kita-gun, Koto-ku, Kyoto, Nagaizumi-chō, Nagoya, Suita, Ube, Wakayama, Wakayama-shi Kimiidera 870-2, and Yokohama, JapanSee the 16 sites
- Phase
- Phase 2/3
Where in Japan
- Chiba Cancer CenterChiba, JapanTaking people
- National Cancer Center HospitalChuo Ku, JapanTaking people
- Kyushu University HospitalFukuoka, JapanTaking people
- National Hospital Organization Kyushu Cancer CenterFukuoka, JapanTaking people
- National Cancer Center Hospital EastKashiwa, JapanTaking people
- St. Marianna University HospitalKawasaki, JapanTaking people
- Kagawa University HospitalKita-gun, JapanTaking people
- The Cancer Institute Hospital of JFCRKoto-ku, JapanTaking people
- University Hospital Kyoto Prefectural University of MedicineKyoto, JapanTaking people
- Shizuoka Cancer CenterNagaizumi-chō, JapanTaking people
- Aichi Cancer Center HospitalNagoya, JapanTaking people
- The University of Osaka HospitalSuita, JapanTaking people
- Yamaguchi University HospitalUbe, JapanTaking people
- Wakayama Medical University HospitalWakayama, JapanTaking people
- Wakayama Minami Radiology ClinicWakayama-shi Kimiidera 870-2, JapanTaking people
- Kanagawa Cancer CenterYokohama, JapanTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Pfizer
- Trial code
- NCT06989437EU 2025-522093-36-00
- Record updated
- 14 October 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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.
Exclusion: 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; 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%; Renal disease requiring dialysis or eGFR <30 mL/min/1.73m2; Current active reversible causes of decreased food intake; Cachexia caused by other reasons; Inadequate liver function.