OncoMatch/Clinical Trials/NCT05482516
Evaluating Novel Therapies in ctDNA Positive GI Cancers
Is NCT05482516 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Immunotherapy
Targeted therapy
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 →Frequently asked questions
Is NCT05482516 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior immune checkpoint blockade therapies disqualifies patients from enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages