Testing a Combination of Immunotherapy and a Vaccine in People With Advanced Pancreatic or Lung Cancer

About the Study 

This study is testing a combination immunotherapy treatment in people whose cancers have not responded well to standard therapies. It combines three different approaches:

• An anti-CD38 antibody (daratumumab): a drug that may help the immune system target cancer cells by engaging immune pathways.

• A KRAS vaccine: an experimental vaccine designed to train the immune system to recognize specific changes in the KRAS gene that are common in several types of cancer.

• An anti-PD-1 antibody (nivolumab): a type of immunotherapy that helps the body’s immune system recognize and attack cancer cells.

The goal is to learn whether this combination can be given safely and whether it can help slow or control tumor growth in people with advanced pancreatic ductal adenocarcinoma (a type of pancreatic cancer) or non-small cell lung cancer (NSCLC) that continued to grow during or after treatment.

What the Study Involves

If a person joins this study, they will:

• Receive all three treatments (anti-CD38 antibody, KRAS vaccine, and anti-PD-1 antibody) on a regular schedule determined by the study team.

• Have regular clinic visits for infusions or doses of the study drugs.

• Have blood tests, scans, and other medical tests to check for side effects and see how the cancer responds.

• Be monitored closely by the medical team for safety and treatment effects throughout the study period.

Participants may continue on treatment as long as it is safe and shows benefit.

This study is open to:

Adults (age 18 and older) who have pancreatic cancer that has progressed after at least one prior treatment or non-small cell lung cancer (NSCLC) that has continued to grow despite prior standard immunotherapy, and:

• have tumors that imaging tests can measure.
• have a biomarker known as a KRAS mutation.
• must have adequate kidney, liver, and bone marrow function.

See full inclusion list here. 

People may not be able to participate if they:

• are younger than 18 years old.
• are currently receiving another investigational treatment for their cancer.
• have pancreatic cancer and previously received a type of immunotherapy known as an immune checkpoint inhibitor.
• have serious uncontrolled health conditions or infections that could interfere with treatment or safety.
• are pregnant, nursing, or unwilling to use birth control during the study.
• have certain other medical conditions (e.g., certain severe lung diseases, uncontrolled asthma, recent major surgeries, or certain bleeding disorders).
• have a history of severe allergic reactions to treatments similar to those used in this study.
• have been diagnosed with another cancer less than five years prior to enrolling (certain noninvasive and skin cancers are allowed). 

See full exclusion list here.