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

NCT06989437
clinicaltrials.gov
Phase
Phase 2/Phase 3
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Recruitment status
Recruiting
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Participants
982
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Lead sponsor
Pfizer
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Start date
2025-10-03
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Number of sites
220
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Summary
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.
clinicaltrials.gov
Short 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
clinicaltrials.gov
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
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Control arm
Placebo
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 2/Phase 3
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Study type
Interventional
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Completion date
2029-12-10
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First posted
2025-05-25
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Registry last updated
2026-08-24
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Primary completion date
2028-01-17
clinicaltrials.gov
Start date
2025-10-03
clinicaltrials.gov

Participants
982
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Participant count basis
Estimated
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Planned participants
982
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Protocol amendments
3
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Randomisation ratio
1:1:1
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Number of sites
220
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
Pfizer
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Source registry
ClinicalTrials.gov
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Registry ID
NCT06989437
clinicaltrials.gov
ClinicalTrials.gov ID
NCT06989437
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Quadruple masking
Masked roles
Participants, Care providers, Investigators, Outcome assessors
Sources for study design
clinicaltrials.gov

  1. Percent change from baseline in body weight for ponsegromab compared to placebo

    Timeframe: Baseline, Week 12

  2. Change from baseline in Functional Assessment of Anorexia/Cachexia Therapy 5-item Anorexia Symptom Scale scores

    Timeframe: Baseline, Week 12

    Scale consists of five items, each rated 0-4. Total score ranges from 0 (minimum) to 20 (maximum). Higher scores are associated with a better outcome.

  1. Change from baseline in non-sedentary physical activity time

    Timeframe: Baseline, Week 12

    measured by wearable Digital Health Technology watch

  2. Overall survival

    Timeframe: Randomization through completion of Phase 3 of the study, an average of 1 year

    Outcome defined as the time from randomization to occurrence of all-cause death

  3. Change from baseline in body weight (kg)

    Timeframe: Baseline, Week 12 and up to Week 52

  4. Change from baseline at Week 12 in physical activity as measured by total vector magnitude

    Timeframe: Baseline, Week 12

    measured by wearable Digital Health Technology watch

  5. Effect on progression free survival

    Timeframe: Randomization through completion of Phase 3 of the study, an average of 1 year

    determined by Blinded Independent Central Review

  6. Effect on objective response rate

    Timeframe: Baseline, Week 52

    determined by Blinded Independent Central Review

  7. Effect on disease control rate

    Timeframe: Baseline, Week 52

    determined by Blinded Independent Central Review

  8. Effect on duration of response

    Timeframe: Baseline, Week 52

    determined by Blinded Independent Central Review

  9. Change from baseline in skeletal muscle area and radiodensity at third lumbar vertebra (L3)

    Timeframe: Baseline, Week 12

    measured by CT (or MRI) scan

  10. Change from baseline in intermuscular adipose area and radiodensity at L3

    Timeframe: Baseline, Week 12

    measured by CT (or MRI) scan

  11. Change from baseline in subcutaneous adipose area and radiodensity at L3

    Timeframe: Baseline, Week 12

    measured by CT (or MRI) scan

  12. Change from baseline in visceral adipose area and radiodensity at L3

    Timeframe: Baseline, Week 12

    measured by CT (or MRI) scan

  13. Number of participants with incidence of Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Adverse Events (AEs) leading to permanent discontinuation from study intervention or from study.

    Timeframe: Baseline, Week 12 and up to Week 52

  14. Number of participants with laboratory test abnormalities.

    Timeframe: Baseline, Week 12 and up to Week 52

  15. Number of participants with vital signs abnormalities.

    Timeframe: Baseline, Week 12 and up to Week 52

  16. Change in physical function, assessed on participant completed Patient-Reported Outcomes Measurement Information System Physical Function (version 8c) questionnaire.

    Timeframe: Baseline, Week 12 and up to Week 52

    The overall score range for the T-score is 0-100. Higher scores indicate better outcome.

  17. Change in fatigue, as assessed on participant completed Patient-Reported Outcomes Measurement Information System - Fatigue (version 7a) questionnaire.

    Timeframe: Baseline, Week 12 and up to Week 52

    The overall score range for the T-score is 29.4-83.2. Lower scores indicate better outcome.

  18. Occurrence and severity of symptomatic AEs including diarrhea, nausea, vomiting, decreased appetite, fatigue and mouth sores by maximum grade as assessed by the NCI PRO CTCAE.

    Timeframe: Baseline, Week 52

  19. Change from baseline on ECOG PS

    Timeframe: Baseline, Week 12 and up to Week 52

  20. Occurrence of chemotherapy dosing changes (including dosing reductions, dosing interruptions, and dosing discontinuations) due to occurrence of the TEAEs of nausea, vomiting, diarrhea, loss of appetite, or fatigue

    Timeframe: Baseline, up to Week 52

  21. Tumor status

    Timeframe: Baseline, Week 12 and up to Week 52

    Assessment of tumor response to treatment as determined by Blinded Independent Central Review assessment per RECIST 1.1 using CT scan (or MRI)

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

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
Sources for eligibility
clinicaltrials.gov

  • The Kirklin Clinic of UAB HospitalBirmingham, United StatesRecruiting
  • The University of Alabama at BirminghamBirmingham, United StatesRecruiting
  • Mayo Clinic HospitalPhoenix, United StatesRecruiting
  • Central Arkansas Radiation Therapy Institute, dba CARTIBryant, United StatesRecruiting
  • Central Arkansas Radiation Therapy Institute, dba CARTIConway, United StatesRecruiting
  • CARTI Cancer CenterLittle Rock, United StatesRecruiting
  • Central Arkansas Radiation Therapy Institute, dba CARTINorth Little Rock, United StatesRecruiting
  • Central Arkansas Radiation Therapy Institute, dba CARTIPine Bluff, United StatesRecruiting
  • UC San Diego Medical Center - EncinitasEncinitas, United StatesRecruiting
  • Chao Family Comprehensive Cancer Center and Ambulatory CareIrvine, United StatesRecruiting
  • UCI Health - IrvineIrvine, United StatesRecruiting
  • UC San Diego Koman Family Outpatient PavilionLa Jolla, United StatesRecruiting
  • UC San Diego Medical Center - La Jolla (Jacobs Medical Center / Thornton Pavilion)La Jolla, United StatesRecruiting
  • UC San Diego Moores Cancer CenterLa Jolla, United StatesRecruiting
  • UC San Diego Sulpizio Cardiovascular CenterLa Jolla, United StatesRecruiting
  • Cedars-Sinai Cancer at Cedars-Sinai Medical CenterLos Angeles, United StatesRecruiting
  • UCLA Department of Medicine - Hematology/OncologyLos Angeles, United StatesRecruiting
  • UC Irvine HealthOrange, United StatesRecruiting
  • UC San Diego Medical Center - Bankers HillSan Diego, United StatesRecruiting
  • UC San Diego McGrath Outpatient Pavilion - HillcrestSan Diego, United StatesRecruiting
  • UC San Diego Medical Center - HillcrestSan Diego, United StatesRecruiting
  • UC San Diego Medical Center - Rancho BernardoSan Diego, United StatesRecruiting
  • UCLA Hematology/Oncology - Santa MonicaSanta Monica, United StatesRecruiting
  • Providence Medical FoundationSanta Rosa, United StatesRecruiting
  • UC San Diego Medical Center - VistaVista, United StatesRecruiting

And 195 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

  • 2025
  • 2025-522093-36-00
Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (2)