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New treatment option for Colon Adenocarcinoma
Official title Evaluating Novel Therapies in ctDNA Positive GI Cancers
ClinicalTrials.gov ID: NCT05482516
What this study is testing
What is Atezolizumab?
Atezolizumab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for colon adenocarcinoma.
Also referred to as TECENTRIQ.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Signed Informed Consent Form
- Age \>= 18 years at time of signing Informed Consent Form
- Ability to comply with the study protocol, in the investigator's judgment
- Histologically or cytologically confirmed colorectal adenocarcinoma, gastric adenocarcinoma, pancreatic adenocarcinoma, hepatocellular carcinoma, or...
- Must have been diagnosed with any stage disease (including localized and metastatic disease) that was felt to have already been treated completely...
You likely can't join if
- There is suspicion or evidence of gross residual, recurrent, or metastatic disease present on physical exam, imaging, or by biopsy within 28 days of...
- Patients who were/are eligible for but have not received all guideline-recommended standard of care therapy within the recommended time-frame for...
- Active or history of autoimmune disease or immune deficiency, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis...
- History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis...
- Active tuberculosis
- Clinically significant cardiovascular disease, such as cerebrovascular accidents within 12 months prior to randomization, myocardial infarction...
See the full eligibility criteria
Who can join
- Signed Informed Consent Form
- Age \>= 18 years at time of signing Informed Consent Form
- Ability to comply with the study protocol, in the investigator's judgment
- Histologically or cytologically confirmed colorectal adenocarcinoma, gastric adenocarcinoma, pancreatic adenocarcinoma, hepatocellular carcinoma, or extra-hepatic/intra-hepatic/gallbladder adenocarcinoma. Patients may...
- Must have been diagnosed with any stage disease (including localized and metastatic disease) that was felt to have already been treated completely with curative-intent per investigator's, primary physician's, or...
- Patients who have undergone definitive, curative-intent treatment of oligometastatic (synchronous or metachronous) disease with NED per investigator judgement are acceptable for enrollment.
- Must have disease-free status documented by complete physical examination and imaging studies with no evidence of recurrent, residual, or metastatic disease on standard imaging (chest, abdomen, and pelvis captured by CT...
- Must have a tumor-specific ctDNA SignateraTM test with a positive result (any mean tumor molecule/mL) drawn within 1 year of completing all curative-intent treatment and within 28 days prior to enrollment. In the...
- ECOG Performance Status of 0-2
- Adequate hematologic and end-organ function, defined by the following laboratory test results, obtained within 28 days prior to initiation of study treatment:
- 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.
- For patients receiving therapeutic anticoagulation: stable anticoagulant regimen
- 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...
- Select patients with well compensated, treated HBV infection and chronic HCV infection may be considered
- 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.
- Women must not be breastfeeding.
- 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...
- 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...
What rules you out
- There is suspicion or evidence of gross residual, recurrent, or metastatic disease present on physical exam, imaging, or by biopsy within 28 days of starting study treatment.
- Patients who were/are eligible for but have not received all guideline-recommended standard of care therapy within the recommended time-frame for definitive treatment. The exception (permitting inclusion) would be if...
- Active or history of autoimmune disease or immune deficiency, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel...
- History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed...
- Active tuberculosis
- Clinically significant cardiovascular disease, such as cerebrovascular accidents within 12 months prior to randomization, myocardial infarction within 12 months prior to study treatment, unstable angina, New York Heart...
- Significant vascular disease (e.g., aortic aneurysm requiring surgical repair or recent arterial thrombosis) within 6 months prior to randomization.
- Inadequately controlled hypertension (defined as systolic blood pressure \>150mmHg and/or diastolic blood pressure \>100 mmHg), based on an average of ≥ 3 BP blood pressure readings on ≥ 2 sessions. Anti-hypertensive...
- History of hypertensive crisis or hypertensive encephalopathy
- History of Grade ≥ 4 venous thromboembolism
- History or evidence upon physical or neurological examination of central nervous system bleed
- History of Grade ≥ 2 hemoptysis (defined as ≥ 2.5 mL of bright red blood per episode) within 1 month prior to screening.
- History or evidence of inherited bleeding diathesis or significant coagulopathy at risk of bleeding (i.e., in the absence of therapeutic anticoagulation).
- Current or recent (\ 325 mg/day), or clopidogrel (\>75 mg/day) Note: The use of full-dose oral or parenteral anticoagulants for therapeutic purpose is permitted as long as the INR and/or aPTT is within therapeutic...
- Chronic daily treatment with a non-steroidal anti-inflammatory drug (NSAID); o Occasional use of NSAIDs for the symptomatic relief of medical conditions such as headache or joint pain is allowed.
- Surgical procedure (including open biopsy, surgical resection, wound revision, or any other major surgery involving entry into a body cavity) or significant traumatic injury within 28 days prior to initiation of study...
- Local therapy to liver or other organ (e.g. radiofrequency ablation, percutaneous ethanol or acetic acid injection, cryoablation, high-intensity focused ultrasound, transarterial chemoembolization, transarterial...
- Untreated or incompletely treated esophageal and/or gastric varices with bleeding or high risk for bleeding in high-risk patients (patients with HCC, cirrhosis, or other conditions predisposing patients to high-risks of...
- High risk patients must undergo an esophagogastroduodenoscopy (EGD) and all size of varices (small to large) must be assessed and treated per local standard of care prior to enrollment. Patients who have undergone an...
- A prior bleeding event due to esophageal and/or gastric varices within 6 months prior to initiation of study treatment
- Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to initiation of study treatment.
- Placement of a vascular access device should be at least 2 days prior to initiation of study treatment.
- Active infection requiring IV antibiotics at the time of initiation of study treatment.
- Severe infection within 4 weeks prior to initiation of study treatment, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia, or any active infection that could...
- History of abdominal fistula, GI perforation, intra-abdominal abscess, or active GI bleeding within 6 months prior to study treatment. o If GI bleeding was from a lesion or a condition that was appropriately treated and...
- Serious, non-healing wound, active ulcer, or untreated bone fracture
- people with previous malignancies (separate from the malignancy for which patient is being enrolled) are excluded. Exceptions include another malignancy for which a complete remission was achieved at least 5 years prior...
- Prior allogeneic stem cell or solid organ transplantation
- Any other disease, active infection, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug, may affect the interpretation of the...
- Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study treatment, or anticipation of need for such a vaccine during atezolizumab treatment or within 5 months after the final dose of...
- Treatment with investigational therapy within 28 days prior to initiation of study treatment
- Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies
- Treatment with systemic immunostimulatory agents (including, but not limited to, interferon and interleukin 2 [IL-2]) within 4 weeks or 5 half-lives of the drug (whichever is longer) prior to initiation of study...
- Treatment with systemic immunosuppressive medication (including, but not limited to, corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-TNF-alpha agents) within 2 weeks prior to...
- History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins
- Known hypersensitivity to Chinese hamster ovary cell products or to any component of the atezolizumab or bevacizumab formulation
- Pregnancy or breastfeeding, or intention of becoming pregnant during study treatment or within 5 months after the final dose of atezolizumab or 6 months after the final dose of bevacizumab. Women of childbearing...
- Uncontrolled or symptomatic hypercalcemia (ionized calcium \> 1.5 mmol/L, calcium \> 12 mg/dL or corrected serum calcium \> ULN)
- History of leptomeningeal disease
- Uncontrolled tumor-related pain
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently); Patients with indwelling catheters (e.g., PleurX) are allowed.
- Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases. Brain scans are not required to be performed at screening but can be done at the clinician's or investigator's discretion...
The study team makes the final eligibility decision.
Where it's taking place
- Washington D.C., District of Columbia, United States
- Hackensack, New Jersey, United States
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Washington D.C., District of Columbia, United States; Hackensack, New Jersey, United States. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.