Pfizer is looking for adults living with cachexia (significant unintended weight loss) and metastatic pancreatic cancer (advanced cancer that has spread to other parts of the body) to take part in the RIVER Pancreatic clinical trial. 

We want to know if a targeted study medicine might improve cachexia, including the way people feel and function in their day-to-day lives, and how they tolerate cancer treatment.

Cachexia (kuh-KEK-see-uh) is more than just not feeling hungry. Scientists think that during the advanced stages of cancer, the body releases chemicals into the blood that cause inflammation and changes the way your body uses energy. 

People with cancer have more of a protein called growth differentiation factor (GDF-15) than normal. High amounts of GDF-15 change the way your body uses energy. In people with cancer cachexia, this can mean calories are burned faster, causing symptoms like extreme tiredness and unintended weight loss. The study medicine, called ponsegromab (pon-seg-roh-mab), is thought to work by blocking GDF-15 and reducing its effect.

Who may participate

 

To take part in the RIVER Pancreatic trial, you must:* 

• be over 18 years old 

• be diagnosed with pancreatic cancer that has spread to other areas of the body (metastatic cancer) 

• have lost weight without meaning to in the last 6 months 

*There will be other study requirements that the study team will discuss with you.

Condition

Cachexia and metastatic pancreatic cancer

Age

18+ years

Sex

Male or Female

Each clinical study has its own guidelines for who can participate, called eligibility criteria. However, only the research study staff can determine if you qualify to enroll in the study.

What to expect

Before joining 

• Receive all the study details and do tests to check this trial is right for you 

Taking the study medicine 

• You will be randomly assigned (like rolling dice) to receive either the study medicine (2 in 3 chance) or placebo (1 in 3 chance) 

• A placebo does not have any medicine in it but looks similar to the medicine being studied – it’s needed as there are no available medications for cancer cachexia to compare the study medicine to 

• All participants will receive chemotherapy, a treatment that kills or slows the growth of cancer cells 

Health monitoring 

• Your response to the study medicine will be recorded with regular exams, tests and questionnaires, including: 

             o Physical exam 

             o Walking test  

             o Scans to check the size and spread of the tumor(s) 

             o Blood and urine tests 

             o Questionnaires

Length of study treatment

Up to 48 weeks (may vary – see FAQs).

Number of study visits

Up to 14 treatment visits (may vary – see FAQs).

Long-term follow up

Continued checks of your health (may last several years).

About cachexia

Cachexia is a condition that can occur in people with advanced cancer. Cachexia is not a side effect of cancer treatment—it is its own, separate condition, causing severe unintended weight loss, muscle loss, poor appetite, anemia (low red blood cells) and extreme tiredness. 

Scientists think that during the advanced stages of cancer the body releases chemicals that cause inflammation and speed up calorie burning. This means that even if you can eat, the energy from food is being used up too quickly, causing significant muscle and fat loss. 

The symptoms of cachexia can be very distressing—you can look like you are wasting away and may feel extremely weak and less able to do your normal activities. Cachexia can also make it more difficult to tolerate or respond well to your cancer treatments.

About cachexia

Man holding grandchild in park – Pfizer Clinical Trials
Man holding grandchild in park – Pfizer Clinical Trials

About the study medicine

Woman pouring hot beverage for grandmother – Pfizer Clinical Trials
Woman pouring hot beverage for grandmother – Pfizer Clinical Trials

About the study medicine

People with cancer have more of a protein called growth differentiation factor (GDF-15) than normal. High amounts of GDF-15 change the way your body uses energy. In people with cancer cachexia, this can mean calories are burned faster, causing symptoms like extreme tiredness and unintended weight loss. 

The study medicine, ponsegromab, is a type of immune therapy that is thought to work by blocking GDF-15. By reducing the levels of GDF-15 in the body, ponsegromab may be able to control the symptoms of cachexia. The study medicine or placebo will be given as 2 injections under the skin of the stomach, legs or arms about every 4 weeks on the same day as cancer treatment.

Frequently asked questions

What is cachexia?

Cachexia is a condition that can affect people who have advanced cancer. Cachexia is not a side effect of cancer—it is its own, separate condition. It can make you feel extremely weak, less able to do your normal activities and more difficult to tolerate or respond well to cancer treatments. 

If you have cancer, you might also have cachexia if you are experiencing: 

• unintended weight loss 

• poor appetite 

• severe lack of energy

Is this helpful?
What current treatments are there for cachexia?

Only one country currently has a medication approved for the treatment of cancer cachexia. 

Your physician may make recommendations about nutrition and can sometimes prescribe medications to help ease the symptoms of cancer cachexia, like nausea and poor appetite. However, cancer cachexia can be difficult to treat, and existing appetite stimulants and supplements are not suitable for many patients.

Is this helpful?
Will I receive the study medicine?

All participants in the RIVER Pancreatic trial will be randomly assigned (like rolling dice) to receive either the study medicine or placebo. A placebo does not have any medicine in it but looks just like the medicine being studied. A placebo is a necessary part of this trial because there are no other options available for cancer cachexia to compare the study medicine to. 

If you participate in the trial, you will have a 2 in 3 chance of receiving the study medicine and a 1 in 3 chance of receiving the placebo.

Is this helpful?
Has the study medicine been studied before?

Yes, the study medicine has been studied in earlier clinical trials. To find out more, please ask a member of your medical team about the RIVER Pancreatic study.

Is this helpful?
How is the study medicine given?

The study medicine or placebo will be given as 2 injections under the skin of the stomach, legs or arms about every 4 weeks on the same day as cancer treatment.

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For how long will I receive the study medicine or placebo?

Participation will include visits about every 4 weeks from the first dose for the duration of the double-blind part of the trial. 

How long you stay in the clinical trial will depend on many factors such how you are feeling, tolerating the study medicine (or placebo), and your physician’s assessment. 

At the end of the initial study treatment period, you will be given the option of continuing to receive the study medicine. Your physician will discuss this fully with you beforehand.

It is important to remember that you can decide not to continue with the trial at any time and for any reason.

Is this helpful?
How will my health be monitored?

At the monthly study visits, the study staff will carry out regular exams, tests and questionnaires to monitor study participants’ health. People taking part in the trial will also be required to wear a wrist activity tracker (similar to a watch).

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Does taking part cost money?

Expenses related to this study may be covered for you and your caregiver. Please speak with a member of the study team to find out more.

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