Clinical Trial

Anti-CD38 Antibody With KRAS Vaccine and Anti-PD-1 Antibody in Subjects With Pancreatic Ductal Adenocarcinoma and Refractory Non-Small Cell Lung Cancer

Study acronym: DARANIVOVAX
Active, Not Recruiting Phase 2
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Summary
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.
Protocol Amendment History 2 changes
critical Trial status changed: Recruiting → Active, Not Recruiting 2026-07-01
notable Enrollment reduced: 54 -> 19 participants 2026-07-01
Trial Details
NCT Number NCT06015724
Lead Sponsor Georgetown University
Collaborators: Bristol-Myers Squibb, Janssen, LP, Targovax ASA
Conditions Pancreatic Ductal Adenocarcinoma, Refractory Non-Small Cell Lung Cancer
Enrollment 19 participants
Start Date 2024-01-31
Primary Completion 2027-06 (estimated)
Study Completion 2027-06 (estimated)
Updated on ClinicalTrials.gov 2026-06-30