Evaluating Novel Therapies and ctDNA as a Marker in Curatively-Treated Gastrointestinal Cancers With Microscopic Residual Disease
Georgetown University
Summary
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Signed Informed Consent Form 2. Age \>= 18 years at time of signing Informed Consent Form 3. Ability to comply with the study protocol, in the investigator's judgment 4. Histologically or cytologically confirmed colorectal adenocarcinoma, gastric adenocarcinoma, pancreatic adenocarcinoma, hepatocellular carcinoma, or extra-hepatic/intra-hepatic/gallbladder adenocarcinoma. Patients may be enrolled irrespective of any mutational analyses. 5. Must have been diagnosed with any stage disease (including localized and metastatic disease) that was felt to have already been trea…
Interventions
- DrugAtezolizumab
Atezolizumab is a monoclonal antibody that belongs to a class of drugs that bind to either the programmed death-receptor 1 (PD-1) or the PD-ligand 1 (PD-L1), blocking the PD-1/PD-L1 pathway,
- DrugBevacizumab
Bevacizumab is a tumor-starving (anti-angiogenic) therapy. Avastin is designed to block a protein called vascular endothelial growth factor, or VEGF.
Locations (3)
- Georgetown Lombardi Comprehensive Cancer CenterWashington D.C., District of Columbia
- Medstar Washington Hospital CenterWashington D.C., District of Columbia
- John Theurer Cancer Center at Hackensack University Medical CenterHackensack, New Jersey