Anti-CD38 + KRAS Vaccine + Anti-PD-1 for Pancreatic & Lung Cancer
(DARANIVOVAX Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
The goal of this clinical trial is to test the safety and tolerability of anti-CD38 monoclonal antibody (mAb), daratumumab, in combination with KRAS vaccine (Targovax TG-01/Stimulon QS-21) when given with anti-PD-1 (programmed cell death protein 1) mAb (nivolumab) in patients with advanced non-small cell lung cancer (NSCLC) or pancreatic ductal adenocarcinoma (PDAC). The main questions it aims to answer are:* How well does daratumumab and nivolumab, when given with a vaccine, control or stop these types of cancer?* How well does participants bodies handle these study drugs?* Does this combination of study drugs help participants live longer? Participants will receive daratumumab, nivolumab with KRAS vaccine and have regular tests and procedures to follow how the participants are doing on these study drugs.
Will I have to stop taking my current medications?
The trial protocol does not specify if you must stop taking your current medications. However, there are specific 'washout' periods (time without taking certain medications) for some treatments, such as a 1-week washout for certain targeted therapies and a 4-week washout for anti-PD-1/PD-L1 therapies. It's best to discuss your current medications with the trial team to understand any specific requirements.
What is known about the safety of nivolumab in cancer treatment?
Nivolumab, used in cancer treatment, can cause side effects like fatigue, rash, and nausea, with serious effects being less common. Some patients may experience severe reactions, such as akathisia (a movement disorder causing restlessness), and it's important to monitor for these during treatment.12345
How is the treatment with Daratumumab, KRAS vaccine, and Nivolumab unique for pancreatic and lung cancer?
This treatment is unique because it combines a KRAS vaccine, which targets a specific cancer mutation, with Daratumumab and Nivolumab, which are drugs that help the immune system attack cancer cells. This combination aims to enhance the body's immune response against cancer, offering a novel approach compared to traditional chemotherapy.678910
What data supports the effectiveness of the treatment Anti-CD38 + KRAS Vaccine + Anti-PD-1 for Pancreatic & Lung Cancer?
Research shows that combining a cancer vaccine with an anti-PD-1 drug like nivolumab can increase the number of immune cells attacking the tumor, which may improve survival in pancreatic cancer. This suggests that similar combinations, like the one in this trial, could potentially be effective.79101112
Who Is on the Research Team?
Samir Khleif, MD
Principal Investigator
Georgetown University
Are You a Good Fit for This Trial?
This trial is for adults over 18 with advanced non-small cell lung cancer or pancreatic ductal adenocarcinoma that's worsened despite treatment. Participants must have specific KRAS mutations, acceptable organ function, and no other recent cancers or severe illnesses. They can't be pregnant/nursing and must agree to use contraception.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive daratumumab, nivolumab with KRAS vaccine and have regular tests and procedures
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term Follow-up
Participants are monitored for overall survival and duration of response
What Are the Treatments Tested in This Trial?
Interventions
- Daratumumab
- KRAS vaccine
- Nivolumab
Daratumumab is already approved in European Union, United States for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Georgetown University
Lead Sponsor
Targovax ASA
Industry Sponsor
Bristol-Myers Squibb
Industry Sponsor
Christopher Boerner
Bristol-Myers Squibb
Chief Executive Officer since 2023
PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis
Deepak L. Bhatt
Bristol-Myers Squibb
Chief Medical Officer since 2024
MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania
Janssen, LP
Industry Sponsor
Joaquin Duato
Janssen, LP
Chief Executive Officer since 2022
MBA from ESADE, Master of International Management from Thunderbird School of Global Management
Dr. Jijo James, MD
Janssen, LP
Chief Medical Officer since 2014
MD from St. Johns Medical College, MPH from Columbia University