Back to search results

Evaluating Atezolizumab and Bevacizumab for GI Cancers

This study is for people with certain gastrointestinal (GI) cancers, including colon, rectal, gastric, pancreatic, and liver cancer. You might be able to join if you've completed all standard treatments with curative intent, but a blood test (SignateraTM ctDNA) still shows signs of cancer, even if scans look clear. The study is testing two drugs: Atezolizumab, which helps your immune system fight cancer, and Bevacizumab, which works by blocking a protein that helps tumors grow. Researchers want to see how many patients with positive ctDNA can be identified, how many enroll, and if the ctDNA becomes undetectable after treatment. The study plans to enroll 20 participants, but its current status is unclear.

Study design
This is a pilot study, meaning it's an early look at the treatment. It's open-label, so you and your doctors will know which drugs you're receiving. It will involve 20 patients across multiple sites.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will measure how many patients are identified and enrolled over 12 months. It will also check for a complete response in ctDNA levels 12 weeks after starting treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05482516

Evaluating Novel Therapies in ctDNA Positive GI Cancers

Recruiting
PHASE3Ages 18+InterventionalTreatment
Georgetown University
~20 participants
Updated 2025-05-22 on ClinicalTrials.gov
What's tested:AtezolizumabBevacizumab

At a glance

Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Rates of SignateraTM ctDNA positive Patient identification
Measured over 12 months
+4 more outcomes measured

Conditions

Colon Adenocarcinoma
Rectal Adenocarcinoma
Gastric Adenocarcinoma
Pancreatic Adenocarcinoma
Hepatocellular Carcinoma
Adenocarcinoma of Biliary Tract
Gallbladder Adenocarcinoma

Explore related trials

Biliary Tract AdenocarcinomaColon AdenocarcinomaGallbladder AdenocarcinomaGastric AdenocarcinomaHepatocellular CarcinomaPancreatic AdenocarcinomaRectal AdenocarcinomaSolid NeoplasmCirculating Tumor-Derived DNA Negative

Where it's being run

3 sites across 2 states
District of Columbia2
New Jersey1

Study leadership

  • John L. Marshall, MD · PRINCIPAL_INVESTIGATOR · Georgetown University

Who to contact

Loyanna Hubbard
[email protected]
202-784-0038
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

ANC ≥1.5 x 109/L (1500/uL) without granulocyte colony-stimulating factor 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) Patients may be transfused to meet this criterion.
AST, ALT, and alkaline phosphatase (ALP) ≤ 3 x upper limit of normal (ULN)
Note: for HCC, AST, ALT, and alkaline phosphatase (ALP) ≤ 5 x upper limit of normal (ULN)
Serum bilirubin ≤ 1.5 x ULN with the following exception: Patients with known Gilbert disease or HCC: serum bilirubin ≤3 x ULN
Serum creatinine ≤ 1.5 x ULN or Creatinine clearance ≥ 50 mL/min (calculated using the Cockcroft-Gault formula)
Urine dipstick for proteinuria \< 2 + (if ≥ 2+ proteinuria on dipstick urinalysis, patient should undergo 24-hour urine collection and must demonstrate \< 1 g protein in 24 hours).
Serum albumin ≥ 25 g/L (2.5 g/dL). Cut-off of ≥ 28 g/L (2.8 g/dL) will be used for HCC patients.
For patients not receiving therapeutic anticoagulation: INR or aPTT ≤ 1.5 x ULN. Note: for HCC patients INR or aPTT should be ≤ 2 x ULN. 11. For patients receiving therapeutic anticoagulation: stable anticoagulant regimen 12. Negative HIV test at screening, with the following exception: patients with a positive HIV test at screening are eligible provided they are stable on anti-retroviral therapy, have a CD4 count ≥ 200µL, and have an undetectable viral load. 13. Select patients with well compensated, treated HBV infection and chronic HCV infection may be considered 14. Women of childbearing potential must have a negative serum test result within 28 days prior to initiation of study treatment. If a urine pregnancy test is positive, it must be confirmed by a serum pregnancy test. 15. Women must not be breastfeeding. 16. For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods, and agreement to refrain from donating eggs as defined below: o Women must remain abstinent or use contraceptive methods with a failure rate of \< 1% per year during the treatment period and for at least 5 months after the final dose of atezolizumab and for 6 months after the last dose of bevacizumab. o Women must refrain from donating eggs during this same period. o A woman is considered to be of childbearing potential if she is postmenarchal, has not reached a postmenopausal state (≥ 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and/or uterus). The definition of childbearing potential may be adapted for alignment with local guidelines or requirements. 17. For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm, as defined below: o With a female partner of childbearing potential who is not pregnant, men who are not surgically sterile must remain abstinent or use a condom plus an additional contraceptive method that together result in a failure rate of \< 1% per year during the treatment period and for 6 months after the final dose of bevacizumab. Men must refrain from donating sperm during this same period. o With a pregnant female partner, men must remain abstinent or use a condom during the treatment period and for 6 months after the final dose of bevacizumab to avoid exposing the embryo. o The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not adequate methods of contraception.

What this trial measures

  • Rates of SignateraTM ctDNA positive Patient identification12 months

    The number of local and regional SignateraTM ctDNA positive patients identified over 12 months in the setting of NED after all SOC definitive therapies (identified patients). This data will be obtained on a local and regional level through the SignateraTM company, Natera.

  • Rate of Enrollment12 months

    Percentage and absolute number of contacted patients who ultimately enrolled on trial (enrolled patients)

  • Rate of ctDNA Complete Response (CR)12 weeks from start of treatment

    Percentage of patients in each cohort (and collectively) who achieve ctDNA CR (defined as ctDNA clearance on two sequential tests compared to baseline ctDNA and ongoing NED clinically/radiographically) within 12 weeks ± 14 days of study therapy.

  • Rate of ctDNA Partial Response (PR)12 weeks from start of treatment

    Percentage of patients in each cohort (and collectively) who achieve ctDNA PR (ctDNA does not clear on two sequential tests, ctDNA does not double on each of two consecutive tests, does not increase on each of three consecutive tests, and ongoing NED clinically/radiographically) within 12 weeks ± 14 days of study therapy.

  • Rate of ctDNA Progression of Disease (POD) or Clinical/radiographic Relapse12 weeks from start of treatment

    Rate of ctDNA POD or clinical/radiographic relapse is defined as the percentage of patients in each cohort (and collectively) who experience ctDNA doubling (at least) on each of two consecutive, sequential tests using the prior ctDNA value as the reference point for doubling for each test, ctDNA rise on each of three consecutive ctDNA tests using the prior ctDNA value as the reference point for each test (ctDNA POD), or clinical/radiographic relapse within 12 weeks ± 14 days of study therapy.