Active not recruitingPHASE1INTERVENTIONAL

A Study to Test KISIMA-02 Vaccine-based Immunotherapy and Ezabenlimab in People With Pancreatic Cancer

This study is for adults with advanced pancreatic cancer. It's looking at a new treatment called immunotherapy, which helps your body's immune system fight cancer. This immunotherapy involves a protein given with a special virus that might kill cancer cells. It's also combined with a study medicine called ezabenlimab, an antibody designed to further boost your immune system against cancer. The main goals are to find the right and safest dose of this treatment, both on its own and with ezabenlimab. Researchers will also check if this combination can help people live longer compared to standard treatments. Two groups will be compared: one getting the new combination and one getting usual care. Participants will be closely monitored for up to a year.

At a glance

Status

Active not recruiting

Phase

PHASE1

Sponsor

Boehringer Ingelheim

Enrolment target

Start

11 May 2023

Estimated completion

08 Mar 2027

Pancreatic Ductal Adenocarcinoma

What is this study about?

This clinical study is designed for adults who have advanced pancreatic cancer. The researchers are looking at a new way to treat this cancer by using a special type of medicine called immunotherapy. Immunotherapy works by helping your own body's defence system, called the immune system, recognise and fight off cancer cells more effectively.

The treatment being tested is a combination of different components. Firstly, there's a protein treatment given together with a virus. This virus has been specially designed to hopefully target and destroy cancer cells, while also helping your immune system get stronger. Secondly, this immunotherapy is given along with another study medicine called ezabenlimab. Ezabenlimab is a particular type of antibody, which is a protein made by the immune system, and it's also designed to help your immune system fight the cancer.

The main aims of this study are to figure out the safest amount (dose) of this new immunotherapy treatment that people with pancreatic cancer can handle, both when used alone and when combined with ezabenlimab. They will carefully watch for any serious health problems to ensure the treatment is as safe as possible. Once safe doses are found, the study will compare this new combination treatment with standard care to see if it helps people live longer. This comparison is done by putting people into two groups randomly, so the results are fair.

Key takeaways

New study for adults with advanced pancreatic cancer.
Tests a combined immunotherapy treatment to boost your immune system.
Aims to find safe doses and see if it helps people live longer.
Involves regular check-ups and monitoring by a medical team.
You might receive the new treatment or standard care.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

This study is for adults diagnosed with pancreatic ductal adenocarcinoma, which is a specific type of pancreatic cancer. To be considered, your cancer should be advanced or have spread (metastatic). You would typically have already completed a period of standard chemotherapy or radiotherapy for at least 16 weeks and your cancer should not have worsened during that time, or you may have had surgery (R0 or R1 resection) and completed at least 3 months of combination chemotherapy after that, with no signs of the cancer coming back.

There are also some health requirements, such as being generally well enough to take part and not having other serious illnesses like certain autoimmune diseases or active infections. You also shouldn't have had certain other cancer treatments recently, like some types of chemotherapy, radiotherapy, or immunotherapies. Your doctor will carefully review your medical history to make sure this study is right for you and safe.

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 ductal adenocarcinoma?
Has your cancer advanced or spread, or have you had surgery and completed chemotherapy with no recurrence?
Are you generally well and able to carry out daily activities?
Have you discussed with your doctor if you've had specific treatments recently that might exclude you?
Do you have good overall health, without serious active infections or autoimmune diseases needing treatment?

Answer every question to see your result.

What does participation involve?

If you join this study, you could be in it for up to one year, or as long as the treatment is helping you and you are tolerating it well. You will have regular visits to the study site. During these visits, doctors and nurses will closely check your health, ask how you are feeling, and look for any changes or side effects. They will likely do blood tests, scans, and other examinations to monitor your cancer and your general well-being very carefully throughout the study.

Potential risks and benefits

Taking part in a clinical study means you might receive a new treatment that could potentially help you, but there's also a chance it might not be effective or could have side effects. Researchers will be carefully monitoring your health for any problems. You will be told about all known possible risks before you decide to join. Remember, taking part is completely your choice, and you can withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (20)

University of Southern California
Verified postcode
Los Angeles, United States
University of California Los Angeles
Verified postcode
Santa Monica, United States
University of Colorado Cancer Center
Verified postcode
Aurora, United States
University of Florida
Verified postcode
Gainesville, United States
Orlando Health Cancer Institute
Verified postcode
Orlando, United States
Karmanos Cancer Institute
Verified postcode
Detroit, United States
Perlmutter Cancer Center at NYU Langone Hospital - Long Island
Verified postcode
New York, United States
University Hospitals Cleveland Medical Center
Verified postcode
Cleveland, United States
The University of Texas MD Anderson Cancer Center
Verified postcode
Houston, United States
START South Texas Accelerated Research Therapeutics, LLC
Verified postcode
San Antonio, United States
Virginia Cancer Specialists, PC
Verified postcode
Fairfax, United States
Virginia Mason Medical Center
Verified postcode
Seattle, United States

Common questions

What is immunotherapy?

Immunotherapy is a type of cancer treatment that helps your body's own immune system fight the cancer more effectively.

What is ezabenlimab?

Ezabenlimab is a study medicine, a kind of antibody, that is designed to help your immune system identify and attack cancer cells.

Will I definitely get the new treatment?

Not necessarily. In part of the study, people are randomly put into groups. One group gets the new treatment, and the other gets standard treatment, so results can be compared fairly.

How long will I be in the study?

You could be in the study for up to one year, or as long as the treatment is working for you and you are feeling well enough to continue.

Can I leave the study if I change my mind?

Yes, you can choose to leave the study at any time, for any reason, and it won't affect your ongoing medical care.