Dendritic Cell Vaccine + Pembrolizumab for Lung Cancer
Trial Summary
What is the purpose of this trial?
This trial tests a special vaccine made from the patient's own cells and a virus, combined with a drug that boosts the immune system, in patients with advanced lung cancer who have already tried other treatments. The vaccine helps the immune system recognize cancer, and the drug helps the immune system attack it.
Do I have to stop taking my current medications for the trial?
The trial does not specify if you need to stop taking your current medications, but you cannot use systemic corticosteroids within 10 days of starting the treatment. It's best to discuss your specific medications with the trial team.
What data supports the effectiveness of the drug pembrolizumab for lung cancer?
Is the combination of Dendritic Cell Vaccine and Pembrolizumab safe for humans?
Pembrolizumab (also known as Keytruda or MK-3475) has been studied in various cancers and is generally considered safe, but it can cause side effects like fatigue, cough, nausea, and immune-related issues such as inflammation of the lungs, liver, or thyroid. In nonhuman primate studies, pembrolizumab showed no significant toxic effects, supporting its safety profile in humans.12678
What makes the dendritic cell vaccine and pembrolizumab treatment unique for lung cancer?
This treatment combines a dendritic cell vaccine, which helps the immune system recognize and attack cancer cells, with pembrolizumab, a drug that blocks a protein called PD-1 to boost the immune response against cancer. This combination aims to enhance the body's ability to fight lung cancer more effectively than using pembrolizumab alone.12356
Research Team
Edward B. Garon
Principal Investigator
UCLA / Jonsson Comprehensive Cancer Center
Eligibility Criteria
This trial is for adults with stage IV non-small cell lung cancer (NSCLC) who have already tried systemic anti-cancer therapy. They must be physically able to perform daily activities (ECOG status 0 or 1), have proper kidney, liver, and blood function, and not be pregnant or breastfeeding. Participants need measurable disease by RECIST v1.1 standards and agree to use contraception.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Dose Escalation
Patients receive pembrolizumab intravenously followed by intratumoral injection of Ad-CCL21-DC to determine the safety and maximum tolerated dose
Dose Expansion
Evaluate the objective response rate with the established dose of Ad-CCL21-DC and pembrolizumab
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Autologous Dendritic Cell-Adenovirus CCL21 Vaccine
- Pembrolizumab
Find a Clinic Near You
Who Is Running the Clinical Trial?
Jonsson Comprehensive Cancer Center
Lead Sponsor
California Institute for Regenerative Medicine (CIRM)
Collaborator
Merck Sharp & Dohme LLC
Industry Sponsor
Chirfi Guindo
Merck Sharp & Dohme LLC
Chief Marketing Officer since 2022
Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business
Robert M. Davis
Merck Sharp & Dohme LLC
Chief Executive Officer since 2021
JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University
LUNGevity Foundation
Collaborator
National Cancer Institute (NCI)
Collaborator
Lungevity Foundation
Collaborator