OncoMatch/Clinical Trials/NCT05482516
Evaluating Novel Therapies in ctDNA Positive GI Cancers
Is NCT05482516 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including Atezolizumab and Bevacizumab for colon adenocarcinoma.
Treatment: Atezolizumab · Bevacizumab — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Colorectal Cancer
Gastric Cancer
Pancreatic Cancer
Hepatocellular Carcinoma
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: curative-intent therapy (surgery and perioperative therapies as per tumor type and stage) — definitive
Must have completed all definitive SOC treatment with curative intent (neoadjuvant, surgery, radiation, and adjuvant treatments) for specific tumor-type and stage per investigator's/primary physician's or research team's judgment
Cannot have received: immune checkpoint blockade therapies (anti-CTLA-4, anti-PD-1, anti-PD-L1)
Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies
Lab requirements
Blood counts
ANC ≥1.5 x 10^9/L (1500/uL) without G-CSF support; lymphocyte count ≥ 0.5 x 10^9/L (500/uL); platelet count ≥ 75 x 10^9/L (75,000/uL) without transfusion; hemoglobin ≥ 90 g/L (9 g/dL), may be transfused; serum albumin ≥ 25 g/L (2.5 g/dL) (≥ 28 g/L for HCC)
Kidney function
Serum creatinine ≤ 1.5 x ULN or Creatinine clearance ≥ 50 mL/min; urine dipstick for proteinuria < 2+ (if ≥ 2+, must demonstrate < 1 g protein in 24 hours)
Liver function
AST, ALT, and ALP ≤ 3 x ULN (≤ 5 x ULN for HCC); serum bilirubin ≤ 1.5 x ULN (≤ 3 x ULN for Gilbert disease or HCC); INR or aPTT ≤ 1.5 x ULN (≤ 2 x ULN for HCC)
Adequate hematologic and end-organ function, defined by the following laboratory test results, obtained within 28 days prior to initiation of study treatment
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Georgetown Lombardi Comprehensive Cancer Center · Washington D.C., District of Columbia
- Medstar Washington Hospital Center · Washington D.C., District of Columbia
- John Theurer Cancer Center at Hackensack University Medical Center · Hackensack, New Jersey
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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