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A Study of Ponsegromab Combined with Chemotherapy for Adults with Pancreatic Cancer that has Spread and Caused Weight Loss

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study is looking at a condition called cancer cachexia in people who have metastatic pancreatic ductal adenocarcinoma, which is a type of cancer that starts in the pancreas and has spread to other parts of the body. Cancer cachexia means significant body weight loss, loss of muscle, and tiredness that can happen in people with cancer. The study will test a medicine called ponsegromab, which is also known by its code name PF-06946860. This medicine is a type of antibody that works against a protein in the body called GDF15. Some people in the study will receive ponsegromab while others will receive placebo, and all participants will also continue to receive their regular chemotherapy treatment with either nab-paclitaxel and gemcitabine or FOLFIRINOX.

The purpose of the study is to find out if ponsegromab can help people gain body weight, improve appetite-related symptoms, and see if it is safe to use. During the study, participants will receive either ponsegromab or placebo along with their regular chemotherapy treatment. The study will measure changes in body weight, appetite symptoms, physical activity levels, and body composition using CT scan or MRI imaging. The study will also look at how the cancer responds to treatment and track overall survival and quality of life measures. Participants will be monitored for side effects and any changes in their health throughout the study period.

The study will last for several years and includes regular visits where measurements will be taken at different time points, with an important assessment at week 12. The study also includes an open-label extension phase where participants may continue to receive ponsegromab. Throughout the study, doctors will check body weight, muscle mass, fat tissue, physical activity, fatigue levels, and overall well-being using questionnaires and physical measurements.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Starting treatment phase
The treatment phase begins after completing one cycle of first-line chemotherapy. If receiving nab-paclitaxel and gemcitabine, this means one 28-day cycle has been completed. If receiving FOLFIRINOX, this means two 14-day cycles have been completed.
The study treatment will be administered alongside the ongoing chemotherapy. The treatment received will be either ponsegromab or placebo, which will be given as an injection solution.
The assignment to receive either the active medicine or placebo is determined randomly, and neither the treating physician nor the participant will know which treatment is being administered.
Step 2
Week 12 assessments
At week 12, several measurements and assessments will be conducted to evaluate the treatment effects.
Body weight will be measured and compared to the weight recorded at the beginning of the study.
A CT scan (or MRI if allergic to CT contrast) will be performed to assess body composition, including measurements of muscle and fat tissue at specific locations in the abdomen.
Questionnaires will be completed to assess appetite-related symptoms, physical function, fatigue, and any side effects experienced.
Physical activity levels will be measured, including the time spent in non-sedentary activities.
The status of the cancer will be evaluated through imaging to determine if the tumors have changed in size.
Performance status will be assessed to evaluate the ability to perform daily activities.
Step 3
Ongoing treatment and monitoring
Throughout the study, regular monitoring will occur at scheduled visits.
Body weight will be measured at multiple time points to track changes over time.
Questionnaires about appetite, physical function, fatigue, and quality of life will be completed at various intervals.
Physical activity will continue to be monitored through measurements of activity levels.
Blood tests will be performed regularly to monitor safety and check for any abnormalities in laboratory values.
Vital signs such as blood pressure, heart rate, and temperature will be measured at each visit.
Electrocardiograms may be performed to monitor heart function.
Any adverse events or side effects will be recorded, including symptoms such as diarrhea, nausea, vomiting, decreased appetite, fatigue, and mouth sores.
CT scans (or MRI) will be repeated at scheduled intervals to continue monitoring the cancer and body composition.
Any changes to chemotherapy dosing, including dose reductions or interruptions, will be documented.
Step 4
Open-label extension phase
After completing the initial treatment phase, there may be an option to continue in an open-label extension phase.
In this phase, all participants will receive ponsegromab, and both the participant and the physician will know that the active medicine is being administered.
Body weight will continue to be measured and compared to the baseline measurements.
Safety monitoring will continue, including tracking of adverse events, serious adverse events, laboratory test abnormalities, and vital sign measurements.
The duration of participation in this extension phase will be determined by the study protocol and individual response to treatment.
Step 5
Long-term follow-up
Long-term outcomes will be monitored, including overall survival time from the start of the study.
The time until cancer progression will be assessed through regular imaging studies.
Information about the duration of any cancer response to treatment will be collected.
Follow-up may continue even after stopping the study treatment to gather information about long-term outcomes.

Who can join the trial?

8 criteria

You must be at least 18 years old or older at the time of the screening visit
You must have a confirmed diagnosis of metastatic pancreatic ductal adenocarcinoma, which means cancer that started in the pancreas and has spread to other parts of the body. This diagnosis must be confirmed by examining tissue or cells under a microscope. Locally advanced disease, which means cancer that has not spread far from the pancreas, does not qualify
You must have measurable disease, which means at least one tumor that can be seen and measured on a CT scan (a special type of X-ray that creates detailed pictures of the inside of your body) or MRI (a scan that uses magnets and radio waves to create pictures) if you are allergic to CT contrast dye
You must have completed one full cycle of first-line chemotherapy treatment. This means either one 28-day cycle of nab-paclitaxel and gemcitabine, or two 14-day cycles of FOLFIRINOX chemotherapy. You must be ready to start your next cycle of chemotherapy
You must have cachexia, which is unintentional weight loss and muscle wasting. You meet this requirement if you have a BMI (body mass index, which is a measurement comparing your weight to your height) less than 20 and have lost more than 2% of your body weight without trying over the past 6 months
You also meet the cachexia requirement if you have lost more than 5% of your body weight without trying over the past 6 months, regardless of your BMI
Your doctor must determine that you have an ECOG performance status of 1 or less. This is a scale that measures how well you can perform daily activities, where 0 means you are fully active and 1 means you have some restrictions but can still do light work
Your doctor must estimate that your life expectancy, which is how long you are expected to live, is at least 4 months or longer

Who cannot join the trial?

3 criteria

The source document does not provide specific exclusion criteria for this clinical trial
Exclusion criteria are conditions or factors that would prevent someone from joining a study
For detailed information about who cannot participate in this trial, the complete study documentation would need to be reviewed

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Azienda Ospedaliero Universitaria Careggi
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Florence, Italy
Cliniques Universitaires Saint-Luc
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Woluwe-Saint-Lambert, Belgium
Grand Hopital De Charleroi
Responsive
Charleroi, Belgium

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Investigated drugs

Ponsegromab
is an investigational medication being studied for the treatment of cachexia in patients with metastatic pancreatic cancer. Cachexia is a condition that causes severe weight loss and muscle wasting. This medication is designed to help patients maintain or gain body weight and improve their appetite. It is given alongside standard chemotherapy treatment for pancreatic cancer.
First-line chemotherapy
refers to the standard cancer treatment medications that are typically used when someone is first diagnosed with metastatic pancreatic cancer. These are drugs that work to kill or slow the growth of cancer cells. In this study, all participants will receive this standard chemotherapy treatment as their background therapy.

Ponsegromab

What is already known about the treatment

Ponsegromab – Ponsegromab is an investigational medication currently being studied in clinical trials for the treatment of cancer cachexia, a condition where cancer patients experience severe weight loss and muscle wasting. This drug is administered to patients with metastatic pancreatic cancer who are also receiving chemotherapy, and it works by blocking specific molecules in the body that contribute to the loss of appetite and muscle breakdown. The main goal of using ponsegromab is to help patients maintain or gain body weight and improve their appetite-related symptoms, which can significantly affect their quality of life during cancer treatment.

Investigated diseases

Cancer Cachexia – Cancer cachexia is a complex condition that occurs in people with cancer, characterized by progressive and involuntary weight loss. The condition involves the loss of both muscle mass and fat tissue, which cannot be fully reversed by increasing food intake alone. People with cancer cachexia often experience a significant decrease in appetite and reduced food consumption. The condition also leads to decreased physical function and increased fatigue, affecting daily activities. Cancer cachexia involves metabolic changes in the body that cause the breakdown of muscle and fat tissue. This condition progresses alongside the underlying cancer and can affect body composition and overall physical strength.