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RECRUITING 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

NCT06015724 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 54 participants
Start Date 2024-01-31
Est. Completion 2027-01
Phase Phase 2

Sponsor

Georgetown University

109 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06015724

The ClinicalTrials.gov registry entry for NCT06015724 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 54 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Georgetown University, which has 109 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06015724 reports 2 study locations spanning 2 distinct geographic areas — top geographies include District of Columbia, New Jersey. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06015724?

The interventions under investigation include: Nivolumab (DRUG), Daratumumab (DRUG), KRAS vaccine (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06015724?

This trial is sponsored by Georgetown University, which has 109 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial