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
NCT ID: NCT06989437
Last Updated: 2025-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2/PHASE3
982 participants
INTERVENTIONAL
2025-10-03
2029-12-23
Brief Summary
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Detailed Description
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Initial enrollment will be in Phase 2b. If all eligibility criteria are met, participants will be randomized in a 1:1:1 allocation to study intervention (one of the two doses of ponsegromab, or placebo) plus first-line systemic chemotherapy. Participants must have completed their first-line pre-randomization systemic chemotherapy (1 x 28-day cycle of nab-paclitaxel and gemcitabine or 2 x 14-days cycles of FOLFIRINOX) prior to the start of receiving their first dose (Day 1) of study intervention (ponsegromab or placebo). Day 1 study intervention must be taken on the same day participants start their next cycle of nab-paclitaxel and gemcitabine chemotherapy or FOLFIRINOX chemotherapy and prior to receiving chemotherapy. All chemotherapy dosing is to be determined by the participant's health care provider in accordance with local guidelines. Study intervention will be administered Q4W SC.
Following enrollment completion of Phase 2b, Phase 3 enrollment will begin, and eligible participants will be randomized in a 1:1:1 allocation to study intervention (one of the two doses of ponsegromab, or placebo). Participants must have completed their first-line pre-randomization systemic chemotherapy (1 x 28-day cycle of nab-paclitaxel and gemcitabine or 2 x 14-day cycles of FOLFIRINOX) prior to the start of receiving their first dose (Day 1) of study intervention (ponsegromab or placebo). Day 1 study intervention must be taken on the same day participants start their next cycle of nab-paclitaxel and gemcitabine chemotherapy or FOLFIRINOX chemotherapy and prior to receiving chemotherapy. All chemotherapy dosing is to be determined by the participant's health care provider in accordance with local guidelines. Study intervention will be administered Q4W SC.
Once all Phase 2b participants have completed Week 12 procedures, an analysis of Phase 2b will be performed, from which one of the 2 ponsegromab doses will be selected. After the Phase 3 ponsegromab dose has been selected, continuing Phase 2b participants will:
* Continue the ponsegromab dose selected for Phase 3 if already randomized to that dose, OR
* Be switched to the ponsegromab dose selected for Phase 3 if randomized to the non-selected ponsegromab dose, OR
* Continue receiving placebo if randomized to placebo
* Remain blinded to study treatment
After the ponsegromab dose has been selected, continuing Phase 3 participants will:
* Continue the ponsegromab dose selected for Phase 3 if already randomized to that dose, OR
* Be switched to the ponsegromab dose selected for Phase 3 if randomized to the non-selected ponsegromab dose, OR
* Continue receiving placebo if randomized to placebo
* Remain blinded to study treatment Phase 3 participants enrolled after dose selection will be randomized 1:1 (ponsegromab selected dose: placebo). Participants must have completed their first-line pre-randomization systemic chemotherapy (1 x 28-day cycle of nab-paclitaxel and gemcitabine or 2 x 14-days cycles of FOLFIRINOX) prior to the start of receiving their first dose (Day 1) of study intervention (selected Phase 3 ponsegromab dose or placebo). Day 1 study intervention must be taken on the same day participants start their next cycle of nab-paclitaxel and gemcitabine chemotherapy or FOLFIRINOX chemotherapy and prior to receiving chemotherapy.
During the Phase 3 portion of the study, there will be an optional sub-study for primary caregivers of participants with cachexia and mPDAC to evaluate the effectiveness of ponsegromab in improving the quality of life and well-being of the primary caregivers.
Study intervention (ponsegromab selected dose or placebo) will continue regardless of chemotherapy treatment until permanent discontinuation of study intervention, withdrawal of consent, death, or the end of the Phase 3 double-blind portion of the study has been reached when the approximate number of overall survival events have been accrued for the Phase 3 analysis of overall survival.
Participants will have tumor assessments performed approximately every 6 to 8 weeks during the double-blind period by blinded, independent, central reader radiologists.
When the number of overall survival events has been accrued to terminate the Phase 3 double-blind portion of the study, active participants can continue in the optional open-label extension where they will receive ponsegromab for up to 12 months.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Double-Blind ponsegromab Treatment lower dose
ponsegromab 200 mg subcutaneous injection every 4 weeks
ponsegromab
Double-Blind ponsegromab Treatment
Double-Blind ponsegromab Treatment higher dose
ponsegromab 400 mg subcutaneous injection every 4 weeks
ponsegromab
Double-Blind ponsegromab Treatment
Double-Blind Placebo Treatment
Match placebo subcutaneous injection every 4 weeks
placebo
Double-Blind placebo Treatment
Interventions
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ponsegromab
Double-Blind ponsegromab Treatment
placebo
Double-Blind placebo Treatment
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* Cachexia caused by other reasons
* History of heart failure
* 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
18 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Hope and Healing Cancer Services
Hinsdale, Illinois, United States
Hope and Healing Cancer Services New Lenox
New Lenox, Illinois, United States
Renown Health Medical Oncology
Reno, Nevada, United States
Renown Office of Clinical Research
Reno, Nevada, United States
Renown Regional Medical Center
Reno, Nevada, United States
Virginia Mason Medical Center
Seattle, Washington, United States
ICON Cancer Centre - Kurralta Park
Kurralta Park, South Australia, Australia
Icon Cancer Centre Hobart
Hobart, Tasmania, Australia
Rabin Medical Center
Petah Tikva, Central District, Israel
Hadassah Medical Center
Jerusalem, Jerusalem, Israel
Kagawa University Hospital
Kita-gun, Kagawa-ken, Japan
St. Marianna University Hospital
Kawasaki, Kanagawa, Japan
The University of Osaka Hospital
Suita, Osaka, Japan
National Cancer Center Hospital
Chuo-ku, Tokyo, Japan
The Cancer Institute Hospital of JFCR
Koto-ku, Tokyo, Japan
Wakayama Minami Radiology Clinic
Wakayama-shi Kimiidera 870-2, Wakayama, Japan
Yamaguchi University Hospital
Ube, Yamaguchi, Japan
National Hospital Organization Kyushu Cancer Center
Fukuoka, , Japan
Kyushu University Hospital
Fukuoka, , Japan
University Hospital,Kyoto Prefectural University of Medicine
Kyoto, , Japan
Wakayama Medical University Hospital
Wakayama, , Japan
Pan American Center for Oncology Trials, LLC
Rio Piedras, , Puerto Rico
Countries
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Central Contacts
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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C3651021
Identifier Type: -
Identifier Source: org_study_id