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RECRUITING
NCT06989437
PHASE2/PHASE3

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

Sponsor: Pfizer

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

982

Start Date

2025-10-03

Completion Date

2029-12-10

Last Updated

2026-04-08

Healthy Volunteers

No

Interventions

DRUG

ponsegromab

Double-Blind ponsegromab Treatment

DRUG

placebo

Double-Blind placebo Treatment

Locations (101)

The Kirklin Clinic of UAB Hospital

Birmingham, Alabama, United States

The University of Alabama at Birmingham

Birmingham, Alabama, United States

Central Arkansas Radiation Therapy Institute, dba CARTI

Bryant, Arkansas, United States

Central Arkansas Radiation Therapy Institute, dba CARTI

Conway, Arkansas, United States

CARTI Cancer Center

Little Rock, Arkansas, United States

Central Arkansas Radiation Therapy Institute, dba CARTI

North Little Rock, Arkansas, United States

Central Arkansas Radiation Therapy Institute, dba CARTI

Pine Bluff, Arkansas, United States

Cedars-Sinai Cancer at Cedars-Sinai Medical Center

Los Angeles, California, United States

UCLA Department of Medicine - Hematology/Oncology

Los Angeles, California, United States

UCLA Hematology/Oncology - Santa Monica

Santa Monica, California, United States

Providence Medical Foundation

Santa Rosa, California, United States

Georgetown University Medical Center - Department of Pharmacy, Oncology Pharmacy

Washington D.C., District of Columbia, United States

Georgetown University Medical Center

Washington D.C., District of Columbia, United States

Invision, LLC

Honolulu, Hawaii, United States

University of Hawaii Cancer Center

Honolulu, Hawaii, United States

Cardiology Associates, Inc

‘Aiea, Hawaii, United States

Hope and Healing Cancer Services

Hinsdale, Illinois, United States

Hope and Healing Cancer Services New Lenox

New Lenox, Illinois, United States

University of Kentucky Research Foundation

Lexington, Kentucky, United States

University of Kentucky Healthcare - Markey Cancer Center

Lexington, Kentucky, United States

University of Kentucky Medical Center

Lexington, Kentucky, United States

University of Kentucky, Markey Cancer Center Clinical Research Office (UK MCC CRO)

Lexington, Kentucky, United States

JHU Oncology Central Kit Services

Baltimore, Maryland, United States

Johns Hopkins Hospital

Baltimore, Maryland, United States

Oncology Investigational Drug Service (IDS)

Baltimore, Maryland, United States

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 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

OHSU Center for Health & Healing 1

Portland, Oregon, United States

Oregon Health and Science University

Portland, Oregon, United States

OSHU Center for Health and Healing 2

Portland, Oregon, United States

Houston Methodist Hospital

Houston, Texas, United States

Virginia Mason Medical Center

Seattle, Washington, United States

Shoalhaven District Memorial Hospital

Nowra, New South Wales, Australia

Westmead Hospital

Westmead, New South Wales, Australia

ICON Cancer Centre - Kurralta Park

Kurralta Park, South Australia, Australia

Icon Cancer Centre Hobart

Hobart, Tasmania, Australia

Western Health-Sunshine & Footscray Hospitals

St Albans, Victoria, Australia

Hospital Santa Rita de Cassia

Vitória, Espírito Santo, Brazil

Oncocentro

Belo Horizonte, Minas Gerais, Brazil

Liga Norte Riograndense Contra o Câncer

Natal, Rio Grande do Norte, Brazil

Hospital Moinhos de Vento

Porto Alegre, Rio Grande do Sul, Brazil

Icesp - Instituto Do Câncer Do Estado de São Paulo

São Paulo, Brazil

CIUSSS- saguenay-Lac-Saint-Jean

Chicoutimi, Quebec, Canada

Centre Intégré de Santé et de Services Sociaux de la Montérégie-Centre

Greenfield Park, Quebec, Canada

Jewish General Hospital

Montreal, Quebec, Canada

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

The University of Hong Kong-Shenzhen Hospital

Shenzhen, Guangdong, China

The Second Hospital of Dalian Medical University

Dalian, Liaoning, China

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, China

Qilu Hospital of Shandong University

Jinan, Shandong, China

Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

The First Hospital of Shanxi Medical University

Taiyuan, Shanxi, China

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

Shanghai General Hospital

Shanghai, China

Tata Memorial Hospital

Mumbai, Maharashtra, India

Venkateshwar Hospital

New Delhi, National Capital Territory of Delhi, India

Rajiv Gandhi Cancer Institute And Research Centre

New Delhi, National Capital Territory of Delhi, India

Chittaranjan National Cancer Institute

Kolkata, West Bengal, India

Rabin Medical Center

Petah Tikva, Central District, Israel

Sheba Medical Center

Ramat Gan, Central District, Israel

Rambam Health Care Campus

Haifa, Heifa, Israel

Shaare Zedek Medical Center

Jerusalem, Jerusalem, Israel

Hadassah Medical Center

Jerusalem, Jerusalem, Israel

Sourasky Medical Center

Tel Aviv, TELL ABĪB, Israel

Aichi Cancer Center Hospital

Nagoya, Aichi-ken, Japan

Chiba cancer center

Chiba, Chiba, Japan

National Cancer Center Hospital East

Kashiwa, Chiba, Japan

Kagawa University Hospital

Kita-gun, Kagawa-ken, Japan

St. Marianna University Hospital

Kawasaki, Kanagawa, Japan

Kanagawa cancer center

Yokohama, Kanagawa, Japan

The University of Osaka Hospital

Suita, Osaka, Japan

Shizuoka Cancer Center

Nagaizumi-cho, Shizuoka, 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 - Dorado Office

Dorado, Puerto Rico

Pan American Center for Oncology Trials, LLC - Mayaguez Office

Mayagüez, Puerto Rico

Pan American Center for Oncology Trials, LLC

Rio Piedras, Puerto Rico

Pan American Center for Oncology Trials, LLC

San Juan, Puerto Rico

Inha University Hospital

Incheon, Incheon-gwangyeoksi [incheon], South Korea

Seoul National University Bundang Hospital

Seongnam, Kyǒnggi-do, South Korea

CHA Bundang Medical Center, CHA University

Seongnam-si, Kyǒnggi-do, South Korea

Asan Medical Center

Seoul, Seoul Teukbyeolsi, South Korea

Seoul National University Hospital

Seoul, Seoul-teukbyeolsi [seoul], South Korea

Severance Hospital, Yonsei University Health System

Seoul, Seoul-teukbyeolsi [seoul], South Korea

Samsung Medical Center

Seoul, Seoul-teukbyeolsi [seoul], South Korea

The Catholic Univ. of Korea Seoul St. Mary's Hospital

Seoul, Seoul-teukbyeolsi [seoul], South Korea

Keimyung University Dongsan Hospital

Daegu, Taegu-kwangyǒkshi, South Korea

Inje University Haeundae Paik Hospital

Busan, South Korea

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Taiwan

China Medical University Hospital

Taichung, Taiwan

National Cheng Kung University Hospital

Tainan, Taiwan

National Taiwan University Hospital

Taipei, Taiwan

Taipei Veterans General Hospital

Taipei, Taiwan