Testing a Combination of Immunotherapy and a Vaccine in People With Advanced Pancreatic or Lung Cancer
Treatment
Phase 2 treatment study for advanced pancreatic and lung cancer
Clinicaltrials.gov identifier:NCT06015724
Study Contact Information:
About the Study
This study is testing a combination treatment in people whose cancers have not responded well to standard therapies. It combines three different approaches:
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An anti-CD38 antibody (daratumumab): a drug that may help the immune system target cancer cells by engaging immune pathways.
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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.
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An anti-PD-1 antibody (nivolumab): a type of 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 (a type of pancreatic cancer) or non-small cell lung cancer (NSCLC) that continued to grow during or after treatment.
This Study is Open To:
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 , and:
- have tumors that imaging tests can measure.
- have a known as a KRAS mutation.
- must have adequate kidney, liver, and bone marrow function.
See full inclusion list here.
This Study is NOT Open To:
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 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.
What the Study Involves
If a person joins this study, they will:
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Receive all three treatments (anti-CD38 antibody, KRAS vaccine, and anti-PD-1 antibody) on a regular schedule determined by the study team.
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Have regular clinic visits for infusions or doses of the study drugs.
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Have blood tests, scans, and other medical tests to check for side effects and see how the cancer responds.
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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.
Study Contact Information:
Locations:
District of Columbia
City: Washington D.C. RECRUITING
Facility: Georgetown Lombardi Comprehensive Cancer Center
Contact Info:
[email protected]
202-784-5097
Benjamin Weinberg, MD
Joshua Reuss, MD
Samir N. Khleif, MD
New Jersey
City: Hackensack RECRUITING
Facility: John Theurer Cancer Center at Hackensack University Medical Center
Contact Info:
[email protected]
551-996-1777
Martin Gutierrez, MD
Treatment
Phase 2 treatment study for advanced pancreatic and lung cancer
Clinicaltrials.gov identifier:NCT06015724