RecruitingPHASE2, PHASE3INTERVENTIONAL

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

This research study is for adults with pancreatic cancer that has spread to other parts of the body, particularly those who are experiencing significant weight loss and tiredness, a condition known as cachexia. Researchers are investigating a new medicine called ponsegromab. This medicine is given alongside the usual chemotherapy treatments. The study aims to find out if ponsegromab is safe, if it helps patients feel better, and if it improves how well chemotherapy works compared to just receiving chemotherapy with a dummy medicine (placebo). It's a two-stage study (Phase 2 and Phase 3) that compares different doses of ponsegromab and includes a follow-up period.

At a glance

Status

Recruiting

Phase

PHASE2, PHASE3

Sponsor

Pfizer

Enrolment target

982

Start

03 Oct 2025

Estimated completion

10 Dec 2029

Cachexia Metastatic Pancreatic Ductal Adenocarcinoma

What is this study about?

This study is about a type of cancer that starts in the pancreas and has spread to other parts of the body. When cancer spreads, it's called 'metastatic.' Many people with this type of cancer also experience a lot of weight loss and tiredness, even if they're eating. Doctors call this condition 'cachexia.' It can make people feel very weak and can be hard to manage. This study is testing a new medicine, called ponsegromab, to see if it can help people with these specific problems.

The main goal is to find out if adding ponsegromab to the usual chemotherapy treatments works better than just chemotherapy alone. The study wants to see if the new medicine is safe for people to take and if it can improve their health. This research is important because it could lead to new ways to help people with advanced pancreatic cancer manage their weight loss and fatigue, potentially improving their quality of life.

Participants in the study will receive standard chemotherapy, either 'nab-paclitaxel plus gemcitabine' or 'FOLFIRINOX,' which are common treatments for this type of cancer. Some participants will also receive ponsegromab, while others will receive a 'placebo' – a dummy medicine that looks like ponsegromab but has no active ingredients. This helps researchers fairly compare the effects of the new medicine.

Key takeaways

This study is for adults with advanced pancreatic cancer and significant weight loss/fatigue.
It tests a new medicine, ponsegromab, alongside standard chemotherapy.
The study compares ponsegromab to a dummy medicine (placebo).
Study medicine is given as an injection under the skin every four weeks.
Your normal chemotherapy will continue as advised by your doctor.
You can withdraw from the study at any time.

Who may be eligible?

To join this study, you must be an adult with pancreatic cancer that has spread to other parts of your body. You also need to be experiencing cachexia, which means you've lost a significant amount of weight. You will have already started one cycle of a specific type of chemotherapy (either nab-paclitaxel and gemcitabine or FOLFIRINOX) and be ready to begin your next cycle.

There are also some things that would mean you can't take part. For instance, if your weight loss is due to other easily fixable reasons, or if you have certain heart or kidney problems. You also can't have a history of severe allergic reactions to similar medicines or to the chemotherapy drugs used in the study. If you have cancer that has spread to your brain causing symptoms, or certain other types of pancreatic cancer, you also wouldn't be able to join. Your doctor will carefully check all these points to see if the study is right for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you an adult with pancreatic cancer that has spread?
Have you experienced significant weight loss and tiredness (cachexia)?
Have you already completed one cycle of your prescribed chemotherapy and are due for your next?
Do you have any severe heart or kidney conditions, or a history of serious allergic reactions to similar medicines?
Are you able to attend regular clinic visits and follow study instructions?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll first need to complete an initial chemotherapy cycle for your pancreatic cancer. Then, you'll be randomly assigned to one of three groups: two groups will receive different doses of the new medicine (ponsegromab) along with your standard chemotherapy, and one group will receive a dummy medicine (placebo) with your chemotherapy. Neither you nor your study doctor will know which group you are in during the main part of the study.

The study medicine (ponsegromab or placebo) will be given as an injection under the skin once every four weeks. You'll take this medicine on the same day you start your next chemotherapy cycle, and before you receive your chemotherapy dose. Your regular doctors will decide the exact timing and dose of your chemotherapy based on their usual guidelines. You'll have regular visits to the clinic for medical checks, blood tests, and to make sure the treatment is safe and working well. After the main part of the study, there might be an option to continue receiving the active medicine if it's proving helpful. The full duration of your participation, including follow-up, will be explained by the study team.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. You might benefit from the new medicine, ponsegromab, which could help manage your weight loss and fatigue and potentially improve how your chemotherapy works. However, there's no guarantee it will work for you, and like all medicines, ponsegromab could have side effects. These will be fully explained by the study team. You'll be closely monitored for any reactions or side effects throughout the study. It's very important to remember that joining this study is completely your choice, and you can withdraw at any time, for any reason, without it affecting your usual medical care.

Locations (211)

The Kirklin Clinic of UAB Hospital
Verified postcode
Birmingham, United States· Recruiting
The University of Alabama at Birmingham
Verified postcode
Birmingham, United States· Recruiting
Mayo Clinic Hospital
Verified postcode
Phoenix, United States· Not yet recruiting
Central Arkansas Radiation Therapy Institute, dba CARTI
Verified postcode
Bryant, United States· Recruiting
Central Arkansas Radiation Therapy Institute, dba CARTI
Verified postcode
Conway, United States· Recruiting
CARTI Cancer Center
Verified postcode
Little Rock, United States· Recruiting
Central Arkansas Radiation Therapy Institute, dba CARTI
Verified postcode
North Little Rock, United States· Recruiting
Central Arkansas Radiation Therapy Institute, dba CARTI
Verified postcode
Pine Bluff, United States· Recruiting
UC San Diego Medical Center - Encinitas
Verified postcode
Encinitas, United States· Recruiting
Chao Family Comprehensive Cancer Center and Ambulatory Care
Verified postcode
Irvine, United States· Recruiting
UCI Health - Irvine
Verified postcode
Irvine, United States· Recruiting
UC San Diego Koman Family Outpatient Pavilion
Verified postcode
La Jolla, United States· Recruiting

Common questions

What is 'cachexia'?

Cachexia is severe weight loss and weakness that can happen with serious illnesses like cancer, even if you are eating normally.

What is a 'placebo'?

A placebo is a dummy medicine that looks like the real treatment but doesn't contain any active ingredients. It helps researchers compare the new medicine fairly.

Will I know if I'm getting the new medicine or the placebo?

During the main part of the study, neither you nor your doctors will know if you're getting ponsegromab or the placebo. This is to ensure the results are fair.

How is the study medicine given?

The study medicine (ponsegromab or placebo) is given as an injection under the skin once every four weeks.

Can I leave the study at any time?

Yes, you can choose to leave the study at any point, for any reason, and it will not affect your ongoing medical care.

How to find out more

Pfizer CT.gov Call Center

clinicaltrials.gov_inquiries@pfizer.com 1-800-718-1021 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.