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

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 comb

Trial Details

NCT ID
NCT06015724
Phase
PHASE2
Sponsor
Georgetown University
Status
RECRUITING
Cancer Type
Adenocarcinoma Lung Cancer
Interventions
  • Daratumumab
  • KRAS vaccine
  • Nivolumab
Locations (sample)
  • Washington D.C., District of Columbia, United States|38.89511,-77.03637
  • Hackensack, New Jersey, United States|40.88593,-74.04347

Key Eligibility Criteria

  • Age ≥18 years
  • Patients with advanced NSCLC, progressing on frontline anti-PD-1/PD-L1 containing therapy (patient with rapid tumor progression will be excluded) a…
  • Measurable disease as defined by irRECIST criteria (See Section 7) NOTE: Tumor lesions in a previously irradiated area are not considered measurabl…
  • All patients with mutant KRAS status in either codon 12 (12A, C, D, R, S, V) or 13 (13D) will be included. The status of KRAS and LKB1 will be dete…

For full eligibility, visit ClinicalTrials.gov.

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