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Evaluating Novel Therapies in ctDNA Positive GI Cancers

Study acronym: MRD-GI
StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary endpoints: details revised at 1 of 5 entries Enrollment closed, study ongoing · Final enrollment: 11 participants (planned 20) · Primary completion date changed from estimate of Dec 2026 to Aug 20, 2026 · 4 more Show 7 more changesShow less
    • Enrollment closed, study ongoing
    • Final enrollment: 11 participants (planned 20)
    • Primary completion date changed from estimate of Dec 2026 to Aug 20, 2026
    • Completion moved earlier from Dec 2028 to Dec 2027
    • Study sites: 3 to 1
    • Eligibility criteria expanded, about 59 words
    • Secondary endpoints: details revised at 1 of 2 entries
  2. Site contacts updated at 1 of 3 sitesv9
  3. Site details revised at 1 of 3 sitesv8
  4. Study sites: 2 to 3v7
  5. Study sites: 1 to 2v6
Show 4 earlier versionsHide 4 earlier versions
  1. Site contact updatedv5
  2. Start date changed from estimate of Mar 2023 to Mar 29, 2023 Site contact updatedv4 Show 1 more changeShow less
    • Site contact updated
  3. Trial status: Not Yet Recruiting to Recruiting Start date: Feb 2023 to Mar 2023 · Site details revisedv3 Show 2 more changesShow less
    • Start date: Feb 2023 to Mar 2023
    • Site details revised
  4. Start date: Dec 2022 to Feb 2023 Site contact updatedv2 Show 1 more changeShow less
    • Site contact updated
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Georgetown University
65 trials monitored
See 7 trials at risk
Pancreatic Cancer
1,639 trials monitored
See 91 trials at risk
Liver Cancer
1,512 trials monitored
See 63 trials at risk
Gastric Cancer
1,201 trials monitored
See 59 trials at risk
and 1 more disease
This study is a non-randomized, open-label, multi-cohort, multi-site, pilot feasibility therapeutic trial. The study will enroll 20 patients across 4 cohorts (CRC, gastric, PDAC, and HCC/intra-hepatic-/extra-hepatic-, gall bladder adenocarcinomas) diagnosed with histologically confirmed GI cancers. These patients will have already completed all Standard of Care (SOC) treatments (including neoadjuvant, surgery, local therapies, and/or adjuvant therapy as applicable), as defined by the treating primary physician or research team, with curative intent but have a positive SignateraTM tumor-informed ctDNA test and NED radiographically by standard imaging within 28 days prior to enrollment and within 1 year of completing all curative-intent therapy. All patients will be treated with intravenous (IV) atezolizumab 1200 mg IV and bevacizumab 15 mg/kg on Day 1 of 21-day cycles until disease recurrence, ctDNA POD, unacceptable toxicity, or subject withdrawal of consent with a maximum 12 month total duration of study therapy. Atezolizumab and bevacizumab drug will be provided.
Trial Details
NCT Number NCT05482516
Lead Sponsor Georgetown University
Collaborators: Genentech, Inc., Natera, Inc.
Conditions Colon Adenocarcinoma, Rectal Adenocarcinoma, Gastric Adenocarcinoma, Pancreatic Adenocarcinoma, Hepatocellular Carcinoma, Adenocarcinoma of Biliary Tract, Gallbladder Adenocarcinoma
Enrollment 11 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov