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Chemo4METPANC Combination Chemokine Inhibitor, Immunotherapy, and Chemotherapy in Pancreatic Adenocarcinoma

StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Sponsor changed: Gulam Manji to Columbia University Enrollment increased: 10 → 118 participants · Enrollment closed, study ongoing · Study sites: 3 to 5 · 2 more Show 5 more changesShow less
    • Enrollment increased: 10 → 118 participants
    • Enrollment closed, study ongoing
    • Study sites: 3 to 5
    • Eligibility criteria expanded, about 65 words
    • Secondary endpoints: details revised at 1 of 5 entries
  2. Study sites: 2 to 3v9
  3. Primary completion date: Jul 2025 to Jun 2028 Completion date: Aug 2025 to Aug 2028 · Site contacts updated at 1 of 2 sitesv8 Show 2 more changesShow less
    • Completion date: Aug 2025 to Aug 2028
    • Site contacts updated at 1 of 2 sites
  4. Re-verified, no change to tracked fieldsv7
  5. Primary completion date: Jul 1, 2025 to Jul 2025 Completion date: Aug 1, 2025 to Aug 2025 · Start date changed from estimate of Dec 2021 to Nov 9, 2020v6 Show 2 more changesShow less
    • Completion date: Aug 1, 2025 to Aug 2025
    • Start date changed from estimate of Dec 2021 to Nov 9, 2020
Show 4 earlier versionsHide 4 earlier versions
  1. Study sites: 1 to 2 Start date: Nov 2021 to Dec 2021v5 Show 1 more changeShow less
    • Start date: Nov 2021 to Dec 2021
  2. Start date: Aug 30, 2021 to Nov 2021 Interventions: Cemiplimab (Drug), Gemcitabine (Drug), Motixafortide (BL-8040) (Drug), Nab paclitaxel (Drug) to Cemiplimab (Drug), Gemcitabine (Drug), Motixafortide (Drug), Nab paclitaxel (Drug) · Study title shortened, about 2 wordsv4 Show 2 more changesShow less
    • Interventions: Cemiplimab (Drug), Gemcitabine (Drug), Motixafortide (BL-8040) (Drug), Nab paclitaxel (Drug) to Cemiplimab (Drug), Gemcitabine (Drug), Motixafortide (Drug), Nab paclitaxel (Drug)
    • Study title shortened, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  3. Start date: Oct 30, 2020 to Aug 30, 2021v3
  4. Trial status: Not Yet Recruiting to Recruiting Site details revised · Study title expanded, about 4 wordsv2 Show 2 more changesShow less
    • Site details revised
    • Study title expanded, about 4 words

    See this version in full on ClinicalTrials.gov ↗

  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 purpose of this study is to determine if combination treatment with cemiplimab, motixafortide, gemcitabine, and nab-paclitaxel is effective in decreasing the size of the tumor(s), if it will prolong life in patients, and if it's safe. The treatment consists of standard chemotherapy (gemcitabine and nab-paclitaxel) which is FDA approved and is standard treatment for patients with pancreatic adenocarcinoma. Participants will receive immunotherapy (cemiplimab) which activates the body's immune system to attack cancer cells. Cemiplimab is FDA approved for treatment of skin cancer but not for pancreas cancer. Participants will also receive Motixafortide, a new medication which has shown in the laboratory to help immunotherapy work better. Motixafortide has been tested together with immunotherapy (Pembrolizumab), and chemotherapy (5-Fluorouracil and liposomal Irinotecan) and was deemed safe to test additional patients. Motixafortide has not been tested with the specific immunotherapy (Cemiplimab) and chemotherapy (gemcitabine and nab-paclitaxel) which participants will receive and is being tested in this clinical trial.
Trial Details
NCT Number NCT04543071
Lead Sponsor Columbia University
Collaborators: Regeneron Pharmaceuticals, BioLine Rx
Conditions Pancreatic Cancer, Adenocarcinoma of the Pancreas, Adenocarcinoma
Enrollment 118 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov