NCT06015724

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

A Phase 2 Study Evaluating the Efficacy of Anti-CD38 Antibody in Combination With KRAS Vaccine and Anti-PD-1 Antibody in Subjects With Pancreatic Ductal Adenocarcinoma and Refractory Non-Small Cell Lung Cancer

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 54 (estimated)
• Sponsor: Georgetown University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pancreatic Ductal Adenocarcinoma
• Refractory Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Daratumumab	anti-CD38 monoclonal antibody (mAb)
BIOLOGICAL	KRAS vaccine	Stimulon QS-21 and Targovax TG01
DRUG	Nivolumab	anti-PD-1 (programmed cell death protein 1) monoclonal antibody (mAb)

Timeline

• Start date: 2024-01-31
• Primary completion: 2026-01-01
• Completion: 2027-01-01
• First posted: 2023-08-29
• Last updated: 2025-07-28

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study