Testing a KRAS Vaccine With Immunotherapy for Advanced Pancreatic and Colorectal Cancer

https://www.facingourrisk.org/research-clinical-trials/study/384 /testing-a-kras-vaccine-with-immunotherapy-for-advanced-pancreatic-and-colorectal-cancer

Clinicaltrials.gov identifier:
NCT06411691 (https://clinicaltrials.gov/show/NCT06411691)

Treatment
Phase 1b treatment study enrolling adults with advanced pancreatic or colorectal cancer that has a KRAS mutation and has been previously treated with chemotherapy

Study Contact Information:

For additional information, please contact:

Name: Colleen Apostol, RN

Phone Number: 410-614-3644

Email: GIClinicalTrials@jhmi.edu

About the Study

This study is testing a new treatment that combines a KRAS-targeted cancer vaccine (ELI-002) with two immunotherapy drugs (balstilimab and botensilimab) in people with advanced colorectal or pancreatic cancers.

This vaccine is designed to help the immune system recognize changes in a protein called KRAS, which is commonly involved in these cancers. The immunotherapy drugs are used to help the immune system better find and attack cancer cells.

Participants must have previously received chemotherapy for their cancer. The study is designed to determine how well this combination treatment works after initial therapy and whether it is safe and may slow or control cancer growth.

What the Study Involves

All participants will receive the study treatment.

Participants will receive a KRAS-targeted vaccine (ELI-002) given as an injection to help stimulate the immune system to recognize cancer cells
Participants will also receive immunotherapy drugs (balstilimab and botensilimab) given through an IV
Treatment is given in cycles, with regular clinic visits for monitoring

Participants in the study will:

Attend regular clinic visits for treatment and monitoring
Undergo imaging scans (such as CT or MRI) to evaluate tumor response
Have blood tests to monitor safety and immune response
Provide tumor samples (biopsies) when possible

Treatment will continue as long as it is helping and side effects are manageable.

This Study is Open To:

This study is open to people who are 18 years old and older and meet the following criteria:

Have pancreatic cancer or colorectal cancer that has spread and cannot be removed with surgery
Have a tumor with a KRAS mutation that matches the study vaccine
Have already received prior chemotherapy for their cancer
Are healthy enough to participate based on lab tests and overall condition
Are willing to attend study visits and undergo required testing
For women, be non-pregnant and use contraceptives while in the study
For men, use contraceptives while in the study

This Study is Not Open To:

This study is not open to people who:

Can have their cancer removed with surgery
Have cancer that has spread to the brain or spinal fluid
Have previously received certain immunotherapy treatment
Have an active autoimmune condition or require medications that weaken the immune system
Have certain serious or uncontrolled medical conditions
Have active infections such as HIV, hepatitis B, or hepatitis C
Have had major surgery or a live vaccine within 28 days of study treatment
Are pregnant or breastfeeding
Have certain complications such as fluid buildup (ascites/pleural effusion) or bowel obstruction
Have a known allergy to the study drug (Hiltonol)

About FORCE

FORCE is a national nonprofit organization, established in 1999. Our mission is to improve the lives of individuals and families affected by adult hereditary cancers.