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

Study acronym: DARANIVOVAX
StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Enrollment reduced: 54 → 19 participants Trial status changed: Recruiting → Active, Not Recruiting · Study sites: 2 to 1v7 Show 2 more changesShow less
    • Trial status changed: Recruiting → Active, Not Recruiting
    • Study sites: 2 to 1
  2. Primary completion date: Jan 2026 to Jun 2027 Completion date: Jan 2027 to Jun 2027 · Eligibility criteria expanded, about 20 wordsv6 Show 2 more changesShow less
    • Completion date: Jan 2027 to Jun 2027
    • Eligibility criteria expanded, about 20 words

    See this version in full on ClinicalTrials.gov ↗

  3. Primary completion date: Jan 2025 to Jan 2026 Study sites: 1 to 2 · Completion date: Jan 2026 to Jan 2027 · Eligibility criteria expanded, about 87 wordsv5 Show 3 more changesShow less
    • Study sites: 1 to 2
    • Completion date: Jan 2026 to Jan 2027
    • Eligibility criteria expanded, about 87 words

    See this version in full on ClinicalTrials.gov ↗

  4. Start date changed from estimate of Dec 2023 to Jan 31, 2024v4
  5. Trial status: Not Yet Recruiting to Recruiting Start date: Oct 2023 to Dec 2023 · Site details revisedv3 Show 2 more changesShow less
    • Start date: Oct 2023 to Dec 2023
    • Site details revised
  6. Secondary endpoints revised (5)v2 See this version in full on ClinicalTrials.gov ↗
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06015724
Lead Sponsor Georgetown University
Collaborators: Bristol-Myers Squibb, Janssen, LP, Targovax ASA
Conditions Pancreatic Ductal Adenocarcinoma, Refractory Non-Small Cell Lung Cancer
Enrollment 19 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov