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Taking people in SpainPhase 2/3

Testing Ponsegromab With Chemotherapy in Pancreatic Cancer Patients With Weight Loss

Tests ponsegromab with chemotherapy in adults with spreading pancreatic cancer and weight loss.

Key facts

Who runs it
Pfizer
Where
Barcelona, Madrid, Málaga, and Oviedo, SpainSee the 6 sitesAlso in 20 other countries, 223 sites
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
Status
Recruiting
Phase
Phase 2/3
People taking part
982 people, planned
Started
3 Oct 2025
Expected to end
24 Dec 2029
Type of study
Interventional, 3 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • ponsegromab
  • placebo
Record updated
14 October 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with pancreatic cancer that has spread, who have lost body weight (cachexia) and are starting first-line chemotherapy.

Age
18 years or older
Sex
All sexes can join
Disease stage
Pancreatic ductal adenocarcinoma that has spread (metastatic), with cachexia (weight loss) as defined by the Fearon criteria. ECOG PS ≤1 and life expectancy of at least 4 months.
Earlier treatment
Must have finished 1 x 28-day cycle of nab-paclitaxel and gemcitabine, or 2 x 14-day cycles of FOLFIRINOX, and not yet started Cycle 2 chemotherapy.

Main reasons for not taking part

  • Any past or current heart failure, or left ventricular ejection fraction below 50%
  • Tube feeding or parenteral nutrition at screening or randomization
  • Past allergic reaction to a monoclonal antibody or to the chemotherapy drugs
  • Neuroendocrine or acinar pancreatic cancer, or active brain or other central nervous system spread
  • Kidney disease needing dialysis or eGFR <30 mL/min/1.73m2

The registry criteria, word for word

Show all 15 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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

Where in Spain

Also in 20 other countries, 223 sites

  • Hospital Clinic de BarcelonaBarcelona, SpainTaking people
  • Hospital Universitari Vall d'HebronBarcelona, SpainTaking people
  • Hospital General Universitario Gregorio MarañónMadrid, SpainTaking people
  • Hospital Universitario Ramón y CajalMadrid, SpainTaking people
  • H.R.U Málaga - Hospital GeneralMálaga, SpainTaking people
  • Hospital Universitario Central De AsturiasOviedo, SpainNot yet recruiting

About the trial

What the trial wants to find out

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.

The 3 groups in the trial

  • Double-Blind ponsegromab Treatment lower doseTreatment being tested

    ponsegromab 200 mg subcutaneous injection every 4 weeks

    Treatment: ponsegromab

  • Double-Blind ponsegromab Treatment higher doseTreatment being tested

    ponsegromab 400 mg subcutaneous injection every 4 weeks

    Treatment: ponsegromab

  • Double-Blind Placebo TreatmentPlacebo, for comparison

    Match placebo subcutaneous injection every 4 weeks

    Treatment: placebo

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
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
Plain-language title
Testing Ponsegromab With Chemotherapy in Pancreatic Cancer Patients With Weight LossGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
14 October 2026