Ponsegromab plus chemotherapy for adults with metastatic pancreatic cancer and cachexia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 2b/3, randomized, double-blind, multicenter study comparing two doses of ponsegromab plus standard first-line chemotherapy versus placebo plus chemotherapy in adults with metastatic pancreatic ductal adenocarcinoma and cachexia. Eligible participants must complete an initial cycle of nab-paclitaxel/gemcitabine or two cycles of FOLFIRINOX before randomization and are assigned 1:1:1 to one of the two ponsegromab doses or placebo. Ponsegromab or placebo is given subcutaneously every four weeks alongside the participant's planned chemotherapy, with a double-blind period followed by an optional open-label extension. The trial measures safety, tolerability, and clinical efficacy outcomes related to cancer and cachexia.

Why it matters

Who can join: the full rules

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

Where it's running

• The Kirklin Clinic of UAB Hospital
  Birmingham, Alabama, United States Recruiting
• The University of Alabama at Birmingham
  Birmingham, Alabama, United States Recruiting
• Mayo Clinic Hospital
  Phoenix, Arizona, United States Recruiting
• Central Arkansas Radiation Therapy Institute, dba CARTI
  Bryant, Arkansas, United States Recruiting
• Central Arkansas Radiation Therapy Institute, dba CARTI
  Conway, Arkansas, United States Recruiting
• CARTI Cancer Center
  Little Rock, Arkansas, United States Recruiting

+180 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Pfizer CT.gov Call Center
• Email: ClinicalTrials.gov_Inquiries@pfizer.com
• Phone: 1-800-718-1021

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.