Anti-CD38 Antibody With KRAS Vaccine and Anti-PD-1 Antibody in Subjects With Pancreatic Ductal Adenocarcinoma and Refractory Non-Small Cell Lung Cancer
Part of paid clinical trials in Washington D.C., District of Columbia.
- Sponsor
- Georgetown University
- Study ID
- NCT06015724
- Phase
- PHASE2
- Status
- Active Not Recruiting
Conditions
- Pancreatic Ductal Adenocarcinoma
- Refractory Non-Small Cell Lung Cancer
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Daratumumab — DRUGanti-CD38 monoclonal antibody (mAb)
- KRAS vaccine — BIOLOGICALStimulon QS-21 and Targovax TG01
- Nivolumab — DRUGanti-PD-1 (programmed cell death protein 1) monoclonal antibody (mAb)
Study Details
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.
Key Dates
- First listed
- Aug 29, 2023
- Start date
- Jan 31, 2024
- Status verified
- Jun 2026
- Primary completion
- Jun 30, 2027
- Completion
- Jun 30, 2027
Study Design
- Enrollment
- 19 participants (actual)
- Allocation
- NON_RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Pancreatic Ductal Adenocarcinoma
- Experimental: Refractory Non-Small Cell Lung Cancer
Primary Outcome Measure
Objective Response Rate (ORR) (Efficacy) [ Time Frame: every 8 weeks, approximately 2 years ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Georgetown Lombardi Comprehensive Cancer Center | Washington D.C. | District of Columbia | 20007 | - |
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