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NCT06015724 · ClinicalTrials.gov registry record · Phase 2
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 of Pancreatic Ductal Adenocarcinoma and Refractory Non-Small Cell Lung Cancer, sponsored by Georgetown University.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 54
- Enrollment target
- 2
- Study locations
NCT06015724: Recruiting Phase 2 study of Pancreatic Ductal Adenocarcinoma and Refractory Non-Small Cell Lung Cancer, sponsored by Georgetown University.
NCT06015724 is a Phase 2 study of Pancreatic Ductal Adenocarcinoma and Refractory Non-Small Cell Lung Cancer that is actively recruiting participants, run by Georgetown University. The registered enrollment target is 54 participants, below the 600-participant average among 84 other Pancreatic Ductal Adenocarcinoma trials with a reported enrollment target (91% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06015724, a Phase 2 study of Pancreatic Ductal Adenocarcinoma and Refractory Non-Small Cell Lung Cancer, is actively recruiting participants, sponsored by Georgetown University.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 54 participants
- Enrollment target
- 2
- Study locations
Study 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.
Primary Outcome
Evaluation of response by ORR by irRECIST criteria. Response classification will follow the irRECIST criteria and will be defined as PR or CR. Patients who are lost to follow-up without a valid response assessment will be classified as NR (non-responder, progression). The ORR will be computed for all patients with at least one cycle of the study drug.
Conditions Studied
Interventions
- DRUG Nivolumab
- DRUG Daratumumab
- BIOLOGICAL KRAS vaccine
Study Locations (2)
District of Columbia
- Georgetown Lombardi Comprehensive Cancer Center - Washington D.C.
New Jersey
- John Theurer Cancer Center at Hackensack University Medical Center - Hackensack
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 54 participants |
| Start Date | 2024-01-31 |
| Est. Completion | 2027-01 |
| Phase | Phase 2 |
What NCT06015724 shows while recruiting
NCT06015724 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 54 participants, a relatively small participant target, below the 600-participant average among 84 other Pancreatic Ductal Adenocarcinoma trials with a reported enrollment target (91% lower).
The record links to 2 conditions, with Pancreatic Ductal Adenocarcinoma appearing as the primary indexed condition, and to 3 interventions - of which Nivolumab is the first listed.
NCT06015724 reports a single indexed study location in District of Columbia, New Jersey.
Frequently Asked Questions
What is clinical trial NCT06015724 about?
NCT06015724 is a clinical study titled "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...
What is the current status of trial NCT06015724?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 54 participants. The study started on 2024-01-31. Estimated completion is 2027-01.
What conditions does trial NCT06015724 study?
This clinical trial studies the following conditions: Pancreatic Ductal Adenocarcinoma, Refractory Non-Small Cell Lung Cancer.
What interventions are being tested in trial NCT06015724?
The interventions under investigation include: Nivolumab (DRUG), Daratumumab (DRUG), KRAS vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT06015724?
This trial is sponsored by Georgetown University, which has 227 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06015724 being conducted?
This trial has 2 study locations across District of Columbia, New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT06015724's enrollment target sits among peer trials
54 56th of 84 higher than 28 of 84 other Pancreatic Ductal Adenocarcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pancreatic Ductal Adenocarcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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